#why do the monoclonal antibodies ACT like that

[vizthedatum]

I don’t know why you did it (I read articles and books… I talk to my friends… I cry and try to process with my psychiatrist, therapist, nurses, and other doctors):

Why did you ruthlessly control my life? Keep me trapped? Berate me for being disabled? Refuse to get help for our VERY SERIOUS rodent infestation? Not get your fucking covid booster when I asked you to? Tell me I was going to die and you were going to be permanently disabled because I went to an apartment-warming party full of immunocompromised people who I hadn’t seen in years?

Why did you not fight with me on our wedding day when you fought me on all the others?

Why can’t I remember so many days in 2020?

Why do I remember you ignoring me, giving me the silent treatment, while you talked with a stranger online about… absolutely nothing? I begged for your attention.

I think you’re the one that gave us covid… I keep thinking over and over about it. Because… I wanted to isolate after coming back from the wedding, and you told me you were suicidal about me isolating… so I didn’t isolate. And then we got covid. I don’t even know if you actually had it tbh - YOU NEVER TOOK A TEST. I took a test. Both of our symptoms were so mild. Were you faking yours? I even got monoclonal antibodies (which you refused to get despite your stupid fears of being permanently disabled (like wtf, everyone is or will be disabled in this life) (also I AM FUCKING PERMANENTLY DISABLED, YOU DUMB FUCK)) because you had me so scared I was going to die despite me knowing that my conditions might get worse with long covid but that I would be okay because of the vaccines and access to healthcare. I kept telling you that it would be ok - I’m a fucking epidemiologist, and you have no healthcare know-how. I tried to tell you about the statistics - you didn’t care. Covid was the most convenient thing for you to use as control.

You devalued me - and I let you. I truly believed I wasn’t worth anything I wanted. You kept me full of air by telling me I was smart and pretty - but it was all just a lie because you questioned all of my decisions to the point of gaslighting. You gaslit me so hard that it was criminal. You gave up even faking an interest in my gender presentation, my beauty, my aesthetics, my art - you lost affection for me - you slut shamed me, you fucking ableist prick. You, a person who’s been poly and sexually active since high school, slut shamed your fucking spouse and best friend who kept you as their number one priority until the day they left you.

You gave me a sham wedding. No ring. I wish we could have invited our friends digitally. You broke all your vows. Fake promises. Love bombing and breadcrumbing. You only touched me because it benefited you. You pretended everything was fine when we were around other people. You hated how I made friends. You resented going to the doctor’s office with me.

I think you started resenting me when I needed help with laundry back when we started dating.

Or maybe it was after my endo surgery?

Or maybe it was when you told me you felt betrayed when I was furiously packing before our friends gave us a ride to that one gaming con?

Or maybe it’s because I couldn’t play the games you wanted to play.

Maybe it’s because I wasn’t the puppet you wanted - the puppet you wanted to control, learn only the things you wanted to learn, listen to you rant for hours, fuck in only the ways you wanted without any regard for what would really make me feel good (I fucking adored you and would always try to make you feel good - and you didn’t care).

I fawned and people-pleased so much - just to keep the peace. I was throwing my life away so you could have yours.

That’s it, right? You’re not the only ex who just kept me around because I could do some things that they took advantage of, was nice enough (unless ofc I “acted up” (they all got scared when I was just myself)), and had a warm body to have sex with.

I hate you.

I hate you.

And now, you’re going around telling people that I abused you, that I’m ruining your life, etc.

You’re probably citing my recent relationships and my legal actions against you as signs of how unhinged I am, right? Maybe you think that because I’m openly talking about the abuse, then that’s a sign that I’m crazy and making things up?

I am healing now because I’m not tethered to you.

I fucking dare you to speak your truth. I WANT YOU TO TELL PEOPLE WHAT HAPPENED. You think I’m abusing you? Call me fucking out then.

You are so fucking abusive and delusional. You ruined my life. You have no right to judge me after I broke my body and soul to fucking serve you. You were the one who betrayed me at every turn.

You have no idea how lucky you are that I didn’t and haven’t pressed criminal charges. I hate the justice system more than you do (and you will never know why because you lack the necessary self-awareness and neural pathways to actually empathize with people, which is why you’ll keep abusing your partners, have shallow friendships, and wallow in your fucking useless controlling paranoia) - and Angela Davis? She would totally do what I did.

I hope you stay stoned and dissociated, pretending to be a “kind person” and just isolate yourself indefinitely like you wanted - because then maybe you won’t be such a danger to others.

I hate you.

[st-musings]

From breakthrough to blockbuster, the business of biotechnology Donald Drakeman

============================

Recombinant DNA, monoclonal antibody twin foundations of modern biotechnology

Antisense technology, gene therapy, tumour vaccines, stem cell therapy, combinatorial chemistry, high throughput screening, gene chips, tissue engineering, bioinformatics,proteomics, rational drug design, novel delivery technologies

Tufts study

Estimated cost of drug development at $2.56 billion

After all these opportunity costs are factored in the actual money spent in the drug development process is estimated at $1.4 billion

Only a tiny number of the largest biotech companies have integrated R&D organizations capable of discovering new product candidates and then developing them all the way to the commercial market.

Contract research organizations enabled "virtual" biotech companies. The expertise of CROs spans the entire spectrum of the drug development process, from creating initial compounds to performing in vitro, in vivo and human clinical testing to manufacturing the necessary quantities of the product to applying for FDA approval and even providing contracted sales and marketing services.

The drug development process

Academic research - many thousands of ideas

Early research and preclinical - invitro invivo testing

IND submission (Investigative new drug)

Clinical trials - phase I safety, phase 2 safety and efficacy, phase 3 safety and efficacy at large scale

NDA/ BLA submission

FDA approval

In looking at drugs entering clinical development 11.83% of the product candidates had reached FDA approval

Bayh-Dole Act university patent technology licensing bolstered economy by$1.3 trillion. Life sciences accounted for 70% of licenses and 93% of gross technology transfer revenues.

Few cases where venture capitalists wait to successfully develop a new drug. They are focused on having the biotech company

achieve whatever technical and corporate milestones will create opportunities for a successful exit

Since there are dramatic ebbs and flows in the overall availability of investment capital for biotech companies, there can be a boom-or-burst feeling in the early stage biotech arena, irrespective of the rate at which exciting new technologies and products emerge from research universities and other medical centers.

Qualities for biotech entrepreneurship.

Do you always think there is a better way to do things?

Are you willing to take on just about anything, even if you don't know much about it?

Are you comfortable taking risks?

Do you like to do new things, or do you prefer routine?

Can you accept rejection and failure?

Why Biotech companies are more innovative than pharmaceutical companies

In contrast to a large centralized environment that can be prone to limiting the overall number of projects and then be slow to stop the unsuccessful one,a decentralized environment of multiple external investors maximizes the potential for following the two critical principles of (1) initiating many diverse projects and (2) stopping the ones that are not working out. Having many different decision makers who are responsible for allocating funding creates a favorable environment for trying many different things. It also minimizes the effects of the sunk cost fallacy and the intra-organizational perspectives that make it difficult for large, cemtralized structures to make responsive termination decisions.

In fields outside the life sciences, technological advances often lead of ways to do things faster, better amd cheaper.

The crucial financial point is that biotech's breakthroughs may be lifesaving but rarely been cost saving

Scientists and physicians can figure out if a new drug actually extends lives, and mathematicians can calculate the costs; but none of those analyses lead directly to a considered judgment about who should have those benefits and at what price.

National Institute of health social value judgments 4 principles

respect for autonomy

non-maleficence

beneficence

distributive justice

Eg monoclonal antibody technology was discoved in England but is so expensive that the NHS refused to pay for them. It will be cold comfort to know that the UK economy was stimulated by research funding that contributed to the development of a new drug if that stimulus was not financially potent enough to allow the nation to be able to afford to pay for the drug itself

[helvaticacare]

ANTIBODY THERAPIES FOR VIRAL INFECTION PREVENTION AND TREATMENT

The recent and still ongoing pandemic of Covid-19 shook the world in ways unimaginable. Labs worldwide were urged to find therapies to prevent and treat this deadly viral infection. Today one often hears the word ‘antibodies’ mentioned during this disease’s treatment and recovery phase.

But,

What are antibodies?

What are the antibody therapies?

What purpose do they serve in preventing, treating, and curing viral diseases?

In this article, HHC summarises all you need to know about antibodies by answering these vital questions and highlighting their importance in preventing and treating viral infections.

WHAT ARE ANTIBODIES?

In simple terms, antibodies comprise host proteins in serum that work as the first immune response to infections or viral pathogens. These proteins, produced by the immune system, fortify the human body’s defence mechanism, and combat bacterial, viral diseases, or antigens (originating from within the body or foreign, whether they be carbohydrates, proteins, nucleic acids, or lipids) and obstruct them from affecting human cells.

When encountered with a viral or bacterial infection, the immune system produces antibodies to fight the infection. For certain diseases, such as SARS-CoV-2 or Covid-19, vaccinations enable the immune system to imbibe the creation of antibodies. Antibodies provide a certain amount of protection from a disease once the host produces them.

In case of repeated or eventual infection, host antibodies can prevent serious illness as the host immune system now knows how to combat the disease. That said, it is difficult to state the duration and the extent to which antibodies can protect against the disease without considering the host profile, the condition, and other factors.

WHAT ARE ANTIBODY THERAPIES?

Because antibodies can bind an antigen with great affinity and accuracy, they are used in many scientific and medical fields. They are ubiquitously used in therapy as research and diagnostic reagents and have proved crucial, over decades, in the identification and detection of target proteins in several clinical functions. In addition to mediating or controlling physiological responses, they are utilised for analysis, purification, and enrichment in the treatment of diseases and health improvement.

Given their positive impact on the next-gen therapeutic applications, today, antibodies can be developed by scientists artificially in labs which are called ‘antibody therapies’. These synthetic proteins act like natural antibodies, replicating and improving the human body’s innate immune response.

THE ANATOMY OF ANTIBODIES

Antibodies constitute Y-shaped immunoglobulin molecules (Ig), produced by B lymphocytes or plasma cells that activate the primary response of the adaptive immune system when a foreign molecule is detected. The Y-shaped structure constitutes two identical heavy and light chains which contain multiple constant (C) and one variable (V) regions connected by disulphide bonds. In the structure of the Y-shaped immunoglobulin molecules, the antigen-binding domains are at the tip of the two arms (Fab), while the effector domains are situated in the tail (Fc).

According to the Ig class, a given antibody may consist of up to five structural molecules. The Ig class determines the type and the timing of the immune response. There are three classes of Ig in avians (IgY, IgM, and IgA) and five classes of Ig in mammals (IgG, IgM, IgA, IgD, and IgE). In some mammals, due to variations in the conserved areas of the heavy chain, IgG and IgA are further divided into subclasses, also called isotypes. IgG or gamma globulins is the most common isotope of antibodies used in research.

Based on the expected research outcomes, scientists can develop two antibody therapies: Polyclonal antibodies (PAbs) and Monoclonal antibodies (MAbs).

Let’s understand what these two therapies consist of and why they are essential in studying and preventing viral pathogens.

WHAT ARE MONOCLONAL ANTIBODIES (MABS)?

Once an antibody is developed to detect and target specific pathogens, scientists can replicate or clone the antibody in a lab. Antibodies thus created are called monoclonal antibodies. Monoclonal antibodies (MAbs) are produced by cloning a single B lymphocyte and comprise a single IgG that binds to one epitope (the region of an antigen where an antibody binds). Monospecific antibodies are obtained from identical immune cells and clone a single parent cell.

WHAT ARE POLYCLONAL ANTIBODIES (PABS)?

Polyclonal antibodies result from a combination of different antibodies produced by various B lymphocyte lineages. PAbs are a collection of IgG molecules that bind to different epitopes on a target antigen. A polyclonal antibody response is effective given the complexity of antigens with multiple epitopes identified by many lymphocytes. The process entails the activation of each lymphocyte, leading to their proliferation and differentiation into plasma cells.

POLYCLONAL ANTIBODIES VS MONOCLONAL ANTIBODIES

Whether to utilise a PAb or MAb depends on several variables, the most crucial of which are the antibody’s intended purpose and whether it is easily accessible from researchers or commercial providers.

Below we understand the advantages and disadvantages of each of the antibody preparations.

Principally, when compared with MAbs, PAbs can be produced

relatively faster,

at lower costs

with less technical expertise than is necessary to create MAbs and

with higher binding affinity against antigens as they detect several epitopes on the target antigen molecule.

While the production of MAbs often takes a year and sometimes even longer, PAbs can be generated several months after commencing vaccination. MAbs require, therefore, more time and expense for their production. PAbs, on the other hand, become easier to procure off-the-shelf therapeutic reagents.

In reactivity, polyclonal antibodies are more sensitive and can identify low-quantity proteins. They have a high potential in capturing target protein in immunoassays such as sandwich ELISA and have high-affinity outcomes due to rapid binding to target antigens in assays like IP or ChIP. 

PAbs are easy to combine with antibody labels, do not impact binding efficiency, and are more likely to identify a native protein. In terms of specificity, PAbs are better than MAbs as they are secreted by many B lymphocyte clones, each generating antibodies to a particular epitope. A collection of antibodies with distinct specificities makes up polyclonal sera. However, MAbs are monospecific antibodies and show greater levels of purity and strength.

Despite the advantages, PAbs are not as viable commercially for the following reasons.

PAbs are produced at different times in different animals, and so each batch may vary from the other.

A polyclonal antibody response may lead to cross-reactivity as multiple epitopes are identified.

One of the most important advantages of MAbs is that they are

consistent,

homogenous, and

instrumental in analysing the modifications in protein-protein interactions, phosphorylation states, and molecular shape, as well as for recognising members of a particular protein family.

Because they are monospecific, monobodies also enable the possibility of investigating the molecular structure of the antibody. In contrast to PAbs, MAbs are easier to obtain consistently once the required hybridoma has been generated. Their homogenous nature and binding specificity provide for detecting a specific epitope, reducing the likelihood of a cross-reaction with proteins other than the targeted one.

It is worth noting that despite being superior to PAbs in many ways, the utility of MAbs is limited due to their monospecificity. While monobodies can be affected significantly by minor changes in an epitope’s structure, polyclonal antibodies, being heterogeneous and able to target a host of epitopes, are unlikely to be impacted by such modifications.

RECOMBINANT MONOCLONAL ANTIBODIES

Recombinant antibodies are the latest technology in the production of monoclonal antibody therapies. They are the future monoclonal antibody therapies obtained by in vitro cloning of heavy and light chain DNA sequences of the antibody from the immunised B plasma cells of animals. This antibody manufacturing process entails the generation of MAbs by introducing the recombinant vectors into expression hosts such as E. coli and not from hybridomas, as done in the classic technique.

Over the last two decades, the production of recombinant monoclonal antibodies for therapeutic applications has grown exponentially. Scientists have developed numerous recombinant monoclonal antibodies to target and fight against infectious diseases and human viral proteins such as Ebola and Covid-19 that represent increased potential health risks.

MAb therapies have proved significant in the treatment and prevention of a growing number of diseases, such as:

autoimmune diseases (Crohn’s disease)

metabolic diseases (asthma and rheumatoid arthritis),

cancers (bladder cancer)

respiratory syncytial virus

Clostridioides difficile and

Anthrax

In recent years, many monoclonal antibodies have been investigated in clinical trials or under regulatory assessment to determine whether they have the potential to prevent or treat a variety of illnesses and viral infections such as Covid-19. People with specific ailments, such as malignancies and autoimmune diseases, may be more susceptible to infectious diseases because of these underlying illnesses, immune-suppressing drugs, or age.

In this situation, monoclonal antibody therapies may be used to treat patients with an underlying condition and lower their risk of developing a serious illness requiring hospitalisation or death. They may also be used to treat patients who are at risk of infection or more likely to develop a disease.

To further and fortify the constant human endeavour against infectious human pathogens and viruses, Helvetica Health Care (HHC) offers a comprehensive range of monoclonal and polyclonal antibodies. These antibodies, created with the help of the latest manufacturing techniques and expertise, are directed against particular human viral proteins and are highly specific in immunoassays. Our range of MONOBODIES™ can be used in different applications, including ELISA, immunoblotting and immunochemistry.

Our motto is to positively impact and improve life and health by supplying our partners with innovative science products and technologies of the highest quality. We are available to answer your queries and would like to hear from you soon. Contact us today to know more about our products and services!

Originally posted on Helvetica Healthcare

[longlava]

Blue waffle disease webmd

The study showed that evolocumab lowered LDL to the target level in 96% of patients when it was added to statin medications. A study called FOURIER showed that evolocumab decreased the risk of heart failure death, heart attack, stroke, and hospitalization for chest pain.Īnother study looked at the effect of Repatha and statin treatment for patients who need to decrease their LDL levels in the hospital. Repatha® (evolocumab) is administered every two weeks (140 mg) or once a month (420 mg). Therefore, by blocking PCSK9, there are more receptors available on the surface of the liver to reduce the amount of LDL cholesterol in the bloodstream. These drugs block an enzyme in the liver (proprotein convertase subtilisin kexin 9) that inactivates receptors on the liver responsible for breaking down LDL cholesterol. PCSK9 inhibitors are a type of biologic drug called monoclonal antibodies that specifically target LDL (lousy) cholesterol. “ L” for Lousy LDL – is known as lousy/bad cholesterol because too much of it will harden the arteries and lead to decreased oxygen-rich blood and increase the risk of blood clots.“ H” for Healthy HDL – is known as healthy/good cholesterol because it acts like a vacuum sucking up cholesterol that can build up on the sides of your arteries.They are commonly referred to as “bad” cholesterol and “good” cholesterol, respectively.īut how do you remember which type of cholesterol is which? The two most common lipoproteins are low-density lipoproteins (LDL) and high-density lipoproteins (HDL). When cholesterol is present in the blood, it clumps together and forms lipoproteins. These agents lower cholesterol so well (up to 60% in some cases) that they are being touted as game-changing agents for the management of high cholesterol. In 2015, a new class of medication called PCSK9 inhibitors became available in the U.S. There are various reasons this may occur, such as unable to tolerate statins due to side effects or the drug treatment just isn’t enough to control their cholesterol. Unfortunately, for some individuals, these interventions aren’t enough, and their cholesterol levels remain too high. So, if you are one of these Americans, then your primary care provider has probably recommended lifestyle changes (i.e., diet and exercise), and, if warranted, a statin drug may have been prescribed. Scroll through to find our best baked chicken wing recipes of all time, including baked Buffalo wings, baked teriyaki wings, baked BBQ wings, baked lemon pepper wings, and more.Nearly one-third of Americans have high cholesterol putting them at risk for heart disease and stroke (two leading causes of death within the United States). And you don't even need any fancy appliances to cook them because all these recipes are made in the oven for extra crispy wings that are packed with finger-licking-good flavor. Plus, how many foods come with their own convenient built-in handle? When it comes to flavors, the mighty chicken wing has something for everyone, so whether you like them spicy, cheesy, or a little bit sweet, you'll find a recipe that's just right for you on Allrecipes. Whether you're serving them as a snack at a party, an appetizer before dinner, or dinner itself, no one is able to resist this delectable finger food. Our 15 Best Baked Chicken Wing Recipes of All Time Are Why Napkins Were Invented Chicken wings are a real crowd-pleaser.

[nyxi-pixie]

me anytime ppl post milkvan takes in the tag

[thatheathen]

Hey @spotify drop @joeroganexperience | @joerogan He’s responsible for covid misinformation resulting in sickness and deaths. Joe Rogan hates actual facts and covid data that goes against his pathetic narrative pandering to his antivaxxer audience to appear anti-government when it’s all a LARP and sheer ignorance.

It doesn’t matter if you’re “too young for a vaccine”, you can still carry viruses and spread it to people who can easily be hospitalized and/or die from them especially covid.

Conservatives want it both ways; blame Biden for covid deaths, but at the same time mitigating the pandemic.

Conservatives wants everyone to believe covid is just the flu (it’s not) ignoring the pandemic, thus getting millions hospitalized overwhelming nurses and be given monoclonal antibodies and medical debt. How are conservatives gonna pay for all this? Why do the rightwing and libertarians think hospitals are a limitless institution and resources are infinite and free? It’s almost like there should be Medicare for all huh?

Fuck these people, they don’t care. None of these wealthy clowns care, it’s all about keeping businesses open and profits flowing. Peak late stage capitalism.

Rogan is a piece of shit closet conservative and I’m sick of people acting like he can’t be criticized for his horseshit misinformation peddling. Fuck you Rogan.

[deargodsno]

Delta is more dangerous in many ways. It has an incubation period of four days, rather than six, making people contagious sooner. When the pandemic began, people spread the original coronavirus to an average of two or three people. Today, people infected with delta infect six people, on average.

As of this week, the delta variant had caused at least 92% of the new infections in the United States, according to covariants.org, a research firm in Bern, Switzerland.

Although delta isn’t necessarily any more lethal than other variants, it can kill huge numbers of people simply because it infects so many more, said Dr. Eric Topol, founder and director of the Scripps Research Translational Institute.

Scientists have sequenced delta’s mutations but are still trying to understand their significance, said Angela Rasmussen, a virologist at the University of Saskatchewan’s Vaccine and Infectious Disease Organization. “When we see the same mutations appearing repeatedly and independently, that suggests they’re important,” Rasmussen said.

Scientists have the best understanding of mutations on the so-called spike protein — which sticks out from the surface of the virus like a club — and which have been studied the most intensely because of its serious ramifications, Rasmussen said. The coronavirus uses the spike protein to enter human cells, and changes in the spike can help the virus evade antibodies.

Scientists believe one of the most important areas of the spike is the receptor-binding domain, the specific part of the protein that allows the virus to latch onto a receptor on the surface of our cells, said Vaughn Cooper, a professor of microbiology and molecular genetics at the University of Pittsburgh. Receptors are like sockets or docking stations that allow proteins to interact with the cell. Once the virus gains entry to the cell, it can cause havoc, hijacking the cell’s genetic machinery and turning it into a virus-making factory.

Delta’s Worrisome Mix

Delta’s rapid spread is particularly surprising given it lacks two mutations that made earlier variants so scary.

Delta doesn’t have the N501Y spike mutation found in the alpha, beta and gamma variants, which enabled them to invade cells more successfully than the original virus. That mutation changed one amino acid — a building block of proteins — in the receptor-binding domain.

Delta also lacks the E484K mutation, which has made the gamma variant so worrisome. This genetic change, sometimes called “Eek,” allows the virus to spread even among vaccinated people.

(Scientists use the Greek alphabet to name variants of concern.)

“The ‘D’ in delta stands for ‘different’ and a ‘detour’ to a different genomic mutation path,” Topol said. “But it doesn’t mean ‘doom,’” he said, noting that existing covid vaccines remain mostly effective against the delta variant.

Vaccines protect people from covid by providing them with antibodies that attach themselves to the spike protein, preventing the virus from entering cells. By dramatically reducing the number of viruses that enter cells, vaccines can prevent people from developing severe disease and make them less infectious to others.

Delta does share mutations with other successful variants. Like all the identified variants in circulation, delta contains a spike mutation called D614G, sometimes known as “Doug,” which became ubiquitous last year.

Scientists think Doug increases the density of spike protein on the surface of viral particles and makes it easier for the virus to enter cells.

Delta also has a spike mutation called P681R, which closely resembles a mutation in the alpha variant that appears to produce higher viral loads in patients, Cooper said. People infected with delta have 1,000 times more virus in their respiratory tract, making them more likely to spread the virus when they sneeze, cough or talk.

The P681R mutation, also found in the kappa variant, is located at the beginning of a part of the genome called the furin cleavage site, Cooper said.

Furin is a naturally occurring human enzyme that gets hijacked by the coronavirus, which uses it to slice the spike protein into the optimal shape for entering the cell, Rasmussen said. The new mutation makes that sculpting more efficient, Rasmussen said.

Another delta mutation — also found in kappa and epsilon — is called L452R. Experiments suggest this mutation, which also affects the receptor-binding domain, acts to prevent antibodies from neutralizing the virus, Cooper said.

These mutations appear to be more formidable as a team than alone.

The genetic changes “are certainly doing something, but why that combination makes the delta variant more fit is not entirely obvious,” Bedford said. “Putting them together seems to matter.”

Delta also has developed genetic changes not seen in other variants.

One such spike mutation is called D950N. “This might be unique,” Cooper said. “We don’t see that anywhere else.”

The D950N mutation is different than other mutations because it’s located outside the receptor-binding domain in an area of the coronavirus genome that helps the virus fuse with human cells, Cooper said. Fusing with human cells allows the coronavirus to dump its genetic material into those cells.

This mutation could affect which types of cells the virus infects, potentially allowing it to harm different organs and tissues. Mutations in this region are also associated with higher viral loads, Cooper said.

Delta also contains mutations in a part of the spike protein called the N-terminal domain, which provides a “supersite” for antibodies to latch onto the virus and prevent it from entering cells, said Dr. Hana Akselrod, an infectious diseases specialist at the George Washington University School of Medicine & Health Sciences.

Mutations in this region make monoclonal antibodies less effective in treating covid and increases the delta variant’s ability to escape vaccine-generated antibodies, Akselrod said. That may explain why vaccinated people are slightly more likely to become infected with delta, causing mostly mild illness but allowing them to transmit the virus.

[parenthood7]

Explained: As you take the Covid-19 vaccine, some do’s and don’ts

Covid-19 vaccine: Here are some of the things you need to know, and some precautions that you should take before getting vaccinated.

More than 1.63 crore people have received a coronavirus vaccine in India so far. While there has been no case of any adverse effect on anyone, some recipients have reported some side-effects or mild illness.

Related Article:

How effective are the two COVID-19 vaccines rolled out in India, and are there concerns about safety?

A large number of experts have underlined that these are expected in a small number of cases — and that these ought not to dissuade people from taking the shot.

Dr Shashank Joshi, member of Maharashtra’s Covid-19 task force, said both the vaccines being used in India, Bharat Biotech’s Covaxin and Serum Institute of India’s Covishield, a version of the Oxford-AstraZeneca vaccine, are absolutely safe — and minor side-effects are expected in some cases, not just for these particular vaccines, but any other vaccine as well.

Here are some of the things you need to know, and some precautions that you should take before getting vaccinated.

Before vaccination

In case a person has allergies to medication or drugs, it is important to get an all-clear from a medical practitioner. A complete blood count (CBC), C-reactive protein (CRP), or Immunoglobulin-E (IgE) levels can be checked under medical advice.

One should eat well and take medicines, if prescribed, ahead of vaccination. One should try to be as relaxed as possible; counseling can help people who are feeling anxious.

People with diabetes or blood pressure need to keep these in check. Cancer patients, especially those on chemotherapy, must act on medical advice.

People who have received blood plasma or monoclonal antibodies as part of Covid-19 treatment or those who have been infected in the last one and a half months are advised to not take the vaccine right now.

After vaccination

A recipient of the vaccine is monitored at the vaccine centre itself to guard against any immediate severe allergic reaction. People are allowed to leave only after it has been ascertained that this is not the case.

Also Read:

Why are coronavirus cases falling in India

Side effects like pain at the injection site and fever are common. This is no reason to panic. Some other side effects like chills and fatigue might also be expected, but these go away in a few days.

Important to note

Vaccines teach our immune system how to recognize and fight an external threat — in this case, the virus that causes Covid-19. It typically takes a few weeks after vaccination for the body to build protection (immunity) against the virus.

Suggested Article:

Children & teens can get COVID-19.

This means that a person could still get infected by Covid-19 in the few days immediately following the vaccination because the person would not have had enough time to develop immunity.

Therefore, basic precautionary measures must be followed even after vaccination. Face masks, hand hygiene, and physical distancing in public places must not be abandoned just because a vaccine has been taken. Cough/sneeze etiquette also needs to be followed.

Source: The Indianexpress

[scenes-in-between]

En Ami

CGB

Months of planning. Layers upon layers of subterfuge. Dominoes meticulously arrayed, men placed just so on a chessboard, whatever metaphor you please. A different story for each participant, painstakingly crafted to ensure his or her cooperation. After all, without all of the players working in concert, the whole thing unravels.

How unexpected, then, when I learn of Scully’s visit to Doctor Parenti. Of her unwitting inclusion in a program under my direct purview. So she wants a child, does she?

“Of course none of the samples she brought in are viable, but it’s no matter. We can proceed with something from the next test batch. I’m sure we are getting closer.”

The program is on its last legs, and Parenti knows it. A less experienced man might be fooled, but I am no stranger to sycophants; these are merely the words of a man desperate not to lose his funding. Another failure, and it will surely be another failure, wouldn’t matter in the case of some random test subject, but a failure with Scully? She will not be deceived so easily, and after she exposes every last person involved, Mulder will come riding in on his steed of self-righteousness and burn the place to the ground.

Could we recover from it? Of course. But it’s an expense and a complication I don’t need. I already have enough knives in the air.

“No, use what she gave you. Let it fail, and let her go. I have another use for her, later.”

What I don’t tell him is that her failed conception will serve my purposes quite nicely. An unplanned gift of leverage.

And, ultimately, a means by which I can not only repay her for her cooperation in the larger plan, but potentially drive Parenti’s program into obsolescence.

***

Mulder

“I don’t understand. You said I was getting better.”

“I said the medication seemed to be helping slow the progression, as we’d hoped it would. Unfortunately, it hasn’t stopped the progression entirely, and the differences I’m seeing between your scan from two months ago and the one from today are significant.”

“But how is that possible? I feel fine! I’ve had no symptoms, no headaches, nothing. How can there be something progressively rotting my brain without there being any outward sign?”

“I confess it is puzzling. Given the areas of encroachment, I would expect you to be having all manner of difficulty with your auditory processing. It is possible, I suppose, that you have been experiencing low-level auditory hallucinations and simply haven’t recognized them as such.”

The walk-ins. Samantha, Amber Lynn, the boy who led me to Samantha’s diary… Scully didn’t see them. What if…? But no, he said auditory, not visual. No, they were real, I’m sure of it.

“So what do we do next? Where do we go from here?”

“I’m, uh… I’m afraid, Mr. Mulder, that I am at a loss. I’ve conferred with several colleagues about your case, and none of us has ever encountered a pathology quite like this before. We’ve exhausted all of the conventional avenues of treatment.”

“Okay, well what about the unconventional ones?”

“There are a handful of experimental therapies being explored, primarily overseas. Monoclonal antibody therapy, various stem cell treatments. But they’re all unproven, still very early in development. You would also have to be selected for the clinical trials, of course, and I’m afraid there’s no guarantee you’ll meet the criteria.”

“So… so, what, I’m just supposed to do nothing and wait around for this to kill me? I refuse to accept that. There has to be something else to try.”

There has to be. Damn it, I was getting better! I can’t leave her alone, not like this. And how in the hell can I tell her now, when she’s still so sad about the IVF? Oh my god, the IVF. I only agreed to it because I thought I was getting better…  

“I wish I had something more to offer at this point. I’m sorry, I truly am. It’s worth bearing in mind that we don’t know the timeline on this. It’s… unlikely, but not impossible, that you could carry on as you have been for quite some time before you become drastically symptomatic. I know it’s hard to think about things like putting your affairs in order, and while I want to stress that it’s a good idea for you to start considering that, I’m also not suggesting that you give up hope altogether.”

“Oh, believe me, I’m not. You may not be able to help me, but that doesn’t mean there isn’t someone who can.”

***

Scully

“Shit. Shit, shit, shit…”

*sound of fabric scraping across the microphone*

“Mulder, I don’t know how this happened. I don’t know where I am, but I think he’s found me out. He has to have found… He changed my damned clothes. He drugged me and moved me from the car, and I’m in a room in… I don’t know, a house or a hotel or something. My, uh… my bag is here. My things are all here.”

*more rustling*

“But he put me in pajamas, which means he has to have seen the wire. I don’t know why he didn’t take it. I don’t know if he’s even still here. Maybe he saw the wire and decided the deal’s off. I’m so angry, I’m so… I’m furious with myself for letting my guard down.”

*unintelligible*

“--orry this turned out to be nothing but a waste of time. I thought… I really thought I could get this cure, could give other cancer patients the same chance I got. The same chance Jason McPeck got. But I’m done making deals with CGB Spender. Once I figure out where in the hell I am, I’m coming home.”

***

CGB

Of course I drugged her.

Oh, she fell asleep on her own, that much was true. But even as tired as she was, she never would have slept through being carried to the house.  Couldn’t have her waking up before I had a chance to give her my gift, could I?

It's miraculous technology, the chip in her neck. And it's not even the latest model. Of course, that's of little matter in light of advancements such as software patches and wireless data transfer. The human body is a complex machine, but once you hold the key to reprogram it at will, well… anything is possible.

Once-depleted ovaries, for example, could easily be stimulated to produce anew.

And given her previous exposure to both the alien virus and vaccine, given Mulder's exposure to the same, if the two of them were to conceive a child naturally, they just might be able to accomplish that which we’ve spent decades trying and failing to do artificially.

My lies to her in the car were by design, of course. I know full well the degree to which the two of them have become entangled. But a claim to believe otherwise was carefully calculated to let her believe she still had secrets. To let her believe, in a sense, that she had the upper hand, just as I let her believe, for a time, that I didn't know about the wire.

It’s admirable, if unfortunate, that she is capable of such deceit. Having her complete trust would make things easier, but I suppose I have more respect for her, knowing she is smart enough to protect herself, to not stroll willingly into danger without taking precautionary measures.

Still, it was time to let her know she’s not fooled me. I could have put her into bed fully clothed, preserved the illusion of ignorance. Instead, I chose to send a message: I know what she’s up to, and I’m not threatened by it in the least.

Well, that and I truly did want her to be comfortable. Not every word out of my mouth is a lie.

It was a calculated risk -- she nearly decided to walk away this morning -- but I gambled on her fundamentally altruistic nature. For the moment, at least, it remains a bet of the safest sort.

***

Mulder

“It’s not her.”

“Mulder--”

“I’m telling you, it’s not her! It’s impossible. Look at the date and time stamp on this. There’s no way she could have sent this email because we were in California then, and she didn’t even have her laptop on that trip.”

“Are you sure?”

“Damn it, Frohike, of course I’m sure! And this one. This is from a week ago. At 11:35pm, we were sitting together at her kitchen table. She never even left the room. It’s. Not. Her.”

“Okay, well if you’re a hundred percent certain she didn’t write these, then who did?”

“You guys tell me. I thought you were the hacking experts. Can you figure out who gained access to her account?”

“Depends on how much they covered their tracks. This could take some time.”

“She may not have much time. Someone has gone to a hell of a lot of trouble to set her up, and if it’s the son of a bitch she’s with right now, he won’t think twice about using her as bait. We’ve got to figure out if this is related to wherever she’s gone or if it’s a whole separate operation.”

“Look, man, you know I’m the last guy on Earth who wants to see her get hurt. I promise you, we’ll try to get some answers for you as soon as we can.”

“I guess we’re having a slumber party at my place, then. You want me to put coffee on?”

***

Scully

“Mulder, it’s me.”

“Scully! Where are you, are you okay?”

“I’m okay. I’m southbound on Highway 209, on my way home. I should be there in about four and a half hours.”

“What the hell were you thinking?”

“Excuse me?”

“Do you have any idea how much danger you were in?”

More than you even know. “Look, I took the necessary precautions. I’m unharmed, and once I get back, I will be happy to walk you through exactly why I did what I did. But I don’t think it’s a good idea to discuss it any further over the phone.”

“Call me every hour. If I don’t hear from you, I’m sending out the highway patrol.”

“Mulder--”

“He could have had you killed!”

“But he didn’t! So you can stop acting like you’ve never put yourself in danger for the greater good.”

“...”

“I’ll call you in an hour.” *click*

***

CGB

It might seem like a long way to go, just to kill a man. On the face of it, certainly, there could have been simpler methods. But they would have been messier, and far less comprehensive.

It wasn’t just the killing of the man, after all. It wasn’t even that we needed the research. Everything on that disc he handed Scully, I already have.

I am not actually dying. That was another necessary lie.

Cobra worked for the project, once. He was one of the brighter ones, making connections others couldn’t, spinning gold from the virtual straw we gave him. Bits of translated hieroglyphs from the Ivory Coast craft. Biological and genetic data from an exterminated EBE. Nanoprocessor technology from another recovered ship. The advancements he made in a few short years were astounding.

Unfortunately, his genius ultimately became a liability. He developed a conscience, which is, shall we say, problematic in this line of work. We could tell he was getting ready to bolt, that he’d already smuggled data out of the office, data we absolutely couldn’t risk falling into the wrong hands. In the end, it was merely a matter of making sure he bolted in the right direction.

Enter Dana Scully.

Even the most brilliant of men can be led around by the nose by a smart and beautiful woman. Impersonating her via email was child’s play, and though it may have taken months of careful grooming, “Scully” eventually convinced Cobra to destroy all but one copy of the research with which he’d absconded, to turn that final copy over to “her” for safekeeping. Luring him out into the open took some skill, I’m not afraid to boast, but it would require Scully’s actual physical presence in the end. And there were those who wanted to see her eliminated as well, once she had completed what we needed of her.

Perhaps I am growing soft and sentimental in my old age. Or perhaps I am just as susceptible to her charms as Cobra was. I can couch my decision to countermand her kill order in any number of justifications, all of them valid, but it remains possible that I am simply losing my stomach for it.

Why, then, didn’t I let her keep the data? I confess I was tempted. If there were ever a person to trust with it, someone who would truly only use it with the best of intentions, it would be her. But maybe that’s sentimental of me as well. The sad truth is that the world itself cannot support the possibility of so many cured. Six billion people on this Earth, and how many suffer already from starvation? How many overcrowded, over-polluted cities could handle a population that never got sick and died?

This is why there have to be men like me, men holding all the cards, who make the difficult decisions for the greater good. It is a lonely existence; if I had my life to do over again, I… well, I don’t know if all this power truly is worth the sacrifice. Some days I really don’t know.

***

Mulder

I had hoped to never have to write in this journal again, Dana. I foolishly believed I had won, or dodged a bullet at least. I guess I only heard what I wanted to hear.

Turns out that “not worse” is not the same thing as “better.”

I know I made a lot of promises. I hope one day you will understand why I’m continuing to break them now.

If I had never told you about the ova I kept, if you had simply carried on exploring other options, you would have been spared all that needless heartache. You might have conceived on the first try with a donor egg and the sperm of a man not slowly dying of some unprecedented brain disease. Now I fear you might be unwilling to try again, after how badly this went.

The doctors say they can’t help me. I’ve got a whole drawer of cases that say doctors aren’t the only option. Once I have exhausted those avenues too, or once the progression of my condition is such that I can no longer hide it from you, that is when I will tell you.

I know that you already feel bad about the empty disc, about being promised this miracle cure only to have it yanked away like the football in a Peanuts comic strip. I remember what it was like, finding the chip that cured your cancer. I remember what it felt like when I thought I’d been deceived too, finding a vial filled with water instead of some miracle elixir I thought I was after. To tell you now that you maybe could have had something that would cure me… I won’t compound your frustration and guilt. I won’t do it.

I was angry when you went off alone with him, but if I'm honest, I was really just afraid. Afraid you wouldn't see him for the snake he is, afraid he would dangle promises in front of you all while leading you to slaughter like a sacrificial lamb.

I should have given you more credit. I'm sorry I let my fear turn me into an asshole.

I’m embarking out on my own now for the same reasons you did these past few days. I want to try to fix this without you getting hurt. I don’t know if I will succeed, but I have to try.

***

Scully

Initially, I thought the worst part of this whole thing was seeing the disappointment and anger on Mulder’s face. At first I felt indignant (Who was he to talk, given the number of times he’s run off on his own?), but after the blank disc and the empty office, I started thinking maybe he was right to be disappointed in me.

And then it seemed the worst part was having been so thoroughly played for a fool. I thought I was so clever. I thought I could play him, that I could pretend to go along with his demands but still maintain the upper hand in the end. How incredibly naive. There wasn’t a moment after we left my apartment that I was in control.

Finding out I had been used so comprehensively threw me for a loop. Mulder and the Gunmen explained how my email had been hacked and cloned, showed me the messages that had been sent in my name. Well, the Gunmen did most of the explaining. Mulder mostly glowered. Seeing it there on the screen, evidence of months of correspondence between Cobra and someone pretending to be me, made me sick to my stomach. That this could have all been going on, for as long as it did, while I was none the wiser, is nearly impossible to believe.

It is only now, days later, that I finally realize even this wasn’t the worst part.

Because I can’t seem to stop thinking about those last few moments before Cobra’s death. Because I have woken up in a cold sweat four times in the past three nights, haunted by the look on his face when he realized he’d been set up. When he thought I’d set him up. Because my stomach still turns at the memory of watching the bullet hit him, watching him fall over the side of his boat, struggling and failing to grab hold of him as shots were fired at me, too.

Because I know, now, that if I had just walked away after I woke up in the lake house, he might still be alive. If I’d failed to turn up at our rendezvous, he probably never would have come out of hiding. And all his work, all that science, never would have fallen into the hands of that double-crossing, cigarette-smoking son of a bitch.

In trying to do the “right” thing, I only messed everything up. An innocent and arguably brilliant man is dead, and life-saving, world-changing information has been stolen by someone who will only use it for personal gain.

My instincts in this case were so utterly, disastrously wrong, and because of that, I became an instrument of the very group of men responsible for some of the greatest evil I have ever encountered. That is the thing I am not likely to get over for a very long time.

[jobsearchtips02]

Costs Gates: 3 life-saving coronavirus treatments might be all set soon

Antibodies for the coronavirus in some cases appear in the blood of people who have actually had COVID-19, but it’s possible they could also be offered to patients therapeutically to assist combat the infection.

Mike Cohen/Getty Images for The New York City Times; Samantha Lee/Business Expert; Robyn Beck/AFP by means of Getty Images.

Expense Gates is confident that eventually there will be an effective coronavirus vaccine.

Go to Service Expert’s homepage for more stories

” The really first vaccine will not be like a lot of vaccines, where it’s a 100%transmission-blocking and 100%avoids the person who gets the vaccine getting ill,” the billionaire philanthropist told Insider

Vaccine trials take months, they do not have to produce completely effective shots, and they won’t help protect people who are currently sick.

” It’s a lot easier to test a healing than it is a vaccine,” he said during a wide-ranging chat previously today.

His best guess is that there are 3 kinds of healing treatments that might be offered for coronavirus patients in just a “couple of months.”

It’s not rather a factor to declare the end of the pandemic, but it’s a start.

” It doesn’t let you go to sporting occasions or hang out at the bars,” he stated. “You got ta get herd resistance [through vaccination] prior to you truly do that.”

However these treatments, if revealed efficient at assisting people recover faster and much better from the infection, might be a game changer for the mounting coronavirus death toll. Currently, more than 150,000 people are dead from the coronavirus in the US. Numerous quotes suggest about 40% of those deaths are linked to nursing homes

” These things where nursing homes get infected, and extremely high death rates, the therapeutics will make a huge distinction there,” he said.

Here’s a breakdown of the three kinds of treatments Gates is most thrilled about.

Antiviral drugs

Vials of Remdesivir.

Ulrich Perrey/Pool/AFP/ Getty Images.

Antivirals (as the name suggests) goal to act versus an infection. They do this by preventing the virus from multiplying and recreating. (The antiviral Tamiflu, for example, can assist make flu infections much shorter and less extreme, if taken early on.)

One antiviral drug being used right now to deal with the coronavirus is Remdesivir, a broad-spectrum antiviral and when stopped working Ebola treatment Research Studies suggest it helps shorten coronavirus recovery time in patients who are very ill. In the United States, Remdesivir is recommended only for emergency situation usage in healthcare facilities (it’s approved in Japan). It is delivered intravenously.

Remdesivir maker Gilead announced on July 10 that its early trial outcomes recommend the drug may cut hospitalized patients’ danger of death by 62%, when compared with the requirement of care, calling it “a crucial finding that requires verification.”

More research study on the drug is being carried out on thousands more hospitalized coronavirus clients, with results anticipated “in the coming months,” the business stated in a release

Gates stated he pictured “reformulating Remdesivir to be much easier to provide,” as well as getting other antiviral drugs tested for the coronavirus.

Corticosteroids

Dexamethasone.

Associated Press.

Corticosteroids are drugs that are comparable to our natural human hormonal agent cortisol.

One steroid Gates is thrilled about for dealing with the coronavirus is dexamethasone, which some early studies suggest may minimize the threat of death in badly ill coronavirus patients

” Our foundation funded the UK trial that found dexamethasone,” Gates stated.

” Provided the general public health importance of these outcomes, we are now working to release the complete information as soon as possible,” they stated in a press release

Monoclonal antibodies

A coronavirus-antibody quick serological test.

Robyn Beck/ AFP via Getty Images.

Monoclonal antibodies are a produced kind of protection cloned from the most powerful natural protective antibodies that people who have had the infection have actually developed.

The truth that these 3 kinds of coronavirus treatment trials might yield outcomes “within a few months” is why Gates stated the field of rehabs was “getting less attention than perhaps it deserves,” as opposed to vaccines.

” At least a few of those are likely to work before the end of the year,” he said. “We’re trying to ensure that the ease of giving them, and the expense, and the accessibility, looks after the entire world.”

Learn More:

Costs Gates: We will have a coronavirus vaccine, but the illness will keep coming back if there’s a United States ‘management vacuum’

The pandemic routine of Costs Gates: distanced tennis, masked walks, and ‘one haircut’

This color-coded chart will assist you choose when to leave your home during the pandemic

Anti-maskers are the new anti-vaxxers

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Coronavirus: Scientists around the world are working on different vaccines for COVID-19

New Post has been published on https://apzweb.com/coronavirus-scientists-around-the-world-are-working-on-different-vaccines-for-covid-19/

Coronavirus: Scientists around the world are working on different vaccines for COVID-19

A team of scientists jostled for a view of the lab dish, staring impatiently for the first clue that an experimental vaccine against the new coronavirus just might work.

After weeks of round-the-clock research at the U.S. National Institutes of Health, it was time for a key test. If the vaccine revs up the immune system, the samples in that dish — blood drawn from immunized mice — would change colour.

Minutes ticked by, and finally they started glowing blue.

READ MORE: Coronavirus: China sees lowest number of cases within single day since count began

“Especially at moments like this, everyone crowds around,” said Kizzmekia Corbett, an NIH research fellow leading the vaccine development. When her team sent word of the positive results, “it was absolutely amazing.”

Dozens of research groups around the world are racing to create a vaccine as COVID-19 cases continue to grow. Importantly, they’re pursuing different types of vaccines — shots developed from new technologies that not only are faster to make than traditional inoculations but might prove more potent.

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Some researchers even aim for temporary vaccines, such as shots that might guard people’s health a month or two at a time while longer-lasting protection is developed.

4:14 COVID-19: World Health Organization advises 10 basic ways people can protect themselves and others

COVID-19: World Health Organization advises 10 basic ways people can protect themselves and others

“Until we test them in humans we have absolutely no idea what the immune response will be,” cautioned vaccine expert Dr. Judith O’Donnell, infectious disease chief at Penn Presbyterian Medical Center.

“Having a lot of different vaccines — with a lot of different theories behind the science of generating immunity — all on a parallel track really ultimately gives us the best chance of getting something successful.”

First-step testing in small numbers of young, healthy volunteers is set to start soon. There’s no chance participants could get infected from the shots, because they don’t contain the virus itself. The goal is purely to check that the vaccines show no worrisome side effects, setting the stage for larger tests of whether they protect.

READ MORE: Here’s why frequent handwashing is recommended in preventing spread of COVID-19

First in line is the Kaiser Permanente Washington Health Research Institute in Seattle. It is preparing to test 45 volunteers with different doses of shots co-developed by NIH and Moderna Inc.

Next, Inovio Pharmaceuticals aims to begin safety tests of its vaccine candidate next month in a few dozen volunteers at the University of Pennsylvania and a testing center in Kansas City, Missouri, followed by a similar study in China and South Korea.

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Even if initial safety tests go well, “you’re talking about a year to a year and a half” before any vaccine could be ready for widespread use, stressed Dr. Anthony Fauci, director of NIH’s National Institute of Allergy and Infectious Diseases.

1:28 Health Canada: the do’s and don’ts of stockpiling

Health Canada: the do’s and don’ts of stockpiling

That still would be a record-setting pace. But manufacturers know the wait — required because it takes additional studies of thousands of people to tell if a vaccine truly protects and does no harm — is hard for a frightened public.

“I can really genuinely understand everybody’s frustration and maybe even confusion,” said Kate Broderick, Inovio’s research and development chief. “You can do everything as fast as possible, but you can’t circumvent some of these vital processes.”

BEHIND-THE-SCENES IN NIH’S LAB

The new coronavirus is studded with a protein aptly named “spike” that lets the virus burrow into human cells. Block that protein, and people won’t get infected. That makes “spike” the target of most vaccine research.

Not so long ago, scientists would have had to grow the virus itself to create a vaccine. The NIH is using a new method that skips that step. Researchers instead copy the section of the virus’ genetic code that contains the instructions for cells to create the spike protein, and let the body become a mini-factory.

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READ MORE: Why coffee shops are banning reusable cups amid coronavirus concerns

Inject a vaccine containing that code, called messenger RNA or mRNA, and people’s cells produce some harmless spike protein. Their immune system spots the foreign protein and makes antibodies to attack it. The body would then be primed to react quickly if the real virus ever comes along.

Corbett’s team had a head start. Because they’d spent years trying to develop a vaccine against MERS, a cousin of the new virus, they knew how to make spike proteins stable enough for immunization, and sent that key ingredient to Moderna to brew up doses.

How to tell it’s a good candidate to test in people?

1:42 Ferrets, a Saskatoon lab and the leading edge of the race for a Coronavirus vaccine

Ferrets, a Saskatoon lab and the leading edge of the race for a Coronavirus vaccine

Corbett’s team grew spike protein in the lab — lots of it — and stored it frozen in vials. Then with the first research doses of vaccine Moderna dubbed “mRNA-1273,” the NIH researchers immunized dozens of mice.

Days later, they started collecting blood samples to check if the mice were producing antibodies against that all-important spike protein. One early test: Mix the mouse samples with thawed spike protein and various color-eliciting trackers, and if antibodies are present, they bind to the protein and glow.

Corbett says the work couldn’t have moved so quickly had it not been for years of behind-the-scenes lab testing of a possible MERS vaccine that works the same way.

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“I think about it a lot, how many of the little experimental questions we did not have to belabor” this time around, she said. When she saw the first promising mouse tests, “I felt like there was a beginning of all of this coming full circle.”

READ MORE: Coronavirus: Do Canadians really need to stockpile household items?

INOVIO’S APPROACH

Inovio’s approach is similar — again using genetic code, in this case packaged inside a piece of synthetic DNA that acts as the vaccine. One advantage Broderick cites for a DNA approach is that unlike many types of vaccines, it may not need refrigeration.

A MERS vaccine that Inovio designed the same way passed initial safety studies in people, paving the way for testing the new COVID-19 vaccine candidate. Inovio is doing similar animal testing to look for presumably protective antibodies.

While it gets ready for human safety tests, Inovio also is prepping for another piece of evidence — what’s called a challenge study. Vaccinated animals will be put in a special high-containment lab and exposed to the new coronavirus to see if they get infected or not.

7:27 Political Panel – How is government handling the COVID-19 outbreak?

Political Panel – How is government handling the COVID-19 outbreak?

PLACEHOLDER VACCINES?

Regeneron Pharmaceuticals is exploring a different approach: simply injecting people with coronavirus-fighting antibodies instead of teaching the body to make its own. This method could provide temporary protection against infection or work as a treatment for someone already infected.

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Regeneron vaccinated mice genetically engineered to make human antibodies. From small blood samples, researchers culled hundreds of different antibodies, and now they’re teasing out which seem most potent against that notorious spike protein, said Christos Kyratsous, Regeneron’s chief of infectious disease research.

Regeneron developed this “monoclonal antibody” approach as a life-saving treatment for Ebola. Last year, it performed a successful safety test of experimental antibodies designed to fight MERS.

READ MORE: Coronavirus: Booked a cruise and want to cancel? Here’s what you need to know

The difference between using antibodies as a treatment or a vaccine? Low-dose shots in the arm every few months might give enough antibodies to temporarily ward off infection, while treatment likely would require far higher doses delivered intravenously, Kyratsous said. Regeneron is pursuing both, and hopes to begin first-step safety testing in early summer.

“The antibodies are the same,” he said. “We would like to have an antibody that is as flexible in administration as possible.”

Whichever of these approaches, or others in the pipeline, pan out, NIH’s Corbett said scientists one day hope to have vaccines on the shelf that could be used against entire families of viruses. One frustration when scientists have to start from scratch is that outbreaks too often are waning by the time vaccine candidates are ready for widespread testing.

6:57 Local filmmaker tackles xenophobia in a new film about COVID-19

Local filmmaker tackles xenophobia in a new film about COVID-19

“This is the fastest we have gone,” Fauci said of the NIH’s vaccine candidate, although he warned it might not be fast enough.

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Still, he called it “quite conceivable” that COVID-19 “will go beyond just a season, and come back and recycle next year. In that case, we hope to have a vaccine.”

© 2020 The Canadian Press

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University Of Cambridge And Animal Testing

Animal research plays an essential role in our understanding of health and disease and in the development of modern medicines and surgical techniques. Without the use of animals, we would not have many of the modern medicines, antibiotics, vaccines and surgical techniques that we take for granted in both human and veterinary medicine. Some of the important and pioneering work for which Cambridge is best known and which has led to major improvements in people’s lives was only possible using animals, from the development of IVF techniques through to human monoclonal antibodies. They say that they place good welfare at the centre of all our animal research and aim to meet the highest standards: good animal welfare and good science go hand-in-hand. Their research is scrutinised by the Animal Welfare and Ethical Review Body, who strive to reduce the number of animals used. Although animals will play a role in biomedical research for the foreseeable future, we strive to use the minimum number possible. Our researchers are actively looking at techniques to refine their experiments and help us reduce – and ultimately replace – their use. 

What types of animal are used at Cambridge?

The majority of the animals they use are mice and zebrafish – they make up 97% of all procedures at Cambridge. Where these species are not suitable, they use a small number of other animals, such as xenopus frogs, rats and sheep, as well as non-human primates, namely marmosets and macaques. 

What types of animal research do they carry out?

Some of the work carried out is fundamental research, aimed at understanding how humans and animals develop and how our immune systems and brains work, for example. This knowledge is essential for underpinning our understanding of health and disease for both medical and veterinary purposes. 

Other work is aimed at tackling specific diseases, for example in helping us understand how Parkinson’s disease affects the brain and motor system and how it might be tackled, or in developing new treatments for autoimmune diseases such as type 1 diabetes and multiple sclerosis.

Why has the number of procedures in the UK increased year upon year?

Whilst every attempt is made to minimise the number of procedures undertaken in research, there has been an overall increase over the last decade due to the use of genetically-modified (GM) mice. If these breeding figures were to be excluded, the total number of procedures carried out year upon year would decrease slightly.

How severe were these procedures? When applying to use animals for research purposes, researchers must assign a severity classification to the procedures they plan to undertake before authority to do the work is authorised by the Home Office.  Once their licence has been granted they must also record the actual level of suffering, i.e. severity experienced by each animal during the course of a procedure.

The prospective severity classification of a procedure is determined by the degree of pain, suffering, distress or lasting harm expected to be experienced by an individual animal during the course of the procedure.  After an experiment has been completed the researcher must record the actual level of suffering experienced by each animal.  The prospective severity classifications are defined by the EU Directive as Non-recovery, Mild, Moderate and Severe, examples of which are provided below.

Non-recovery Procedures, which are performed entirely under general anaesthesia from which the animal shall not recover consciousness.

Mild Procedures on animals as a result of which the animals are likely to experience short term mild pain, suffering or distress, as well as procedures with no significant impairment of the wellbeing or general condition of the animals.

Mild procedures include:

anaesthesia

non-invasive imaging, like and MRI scan

short-term social isolation

taking a blood sample

superficial non-surgical procedures e.g. ear biopsies in mice and non-surgical implantation of recording devices and minipumps

Moderate Procedures on animals as a result of which the animals are likely to experience short term moderate pain, suffering or distress, or long-lasting mild pain, suffering or distress as well as procedures that are likely to cause moderate impairment of the wellbeing or general condition of the animals.

Moderate procedures include:

invasive surgery under general anaesthetic e.g. surgical implantation of a catheter into a blood vessel for long term drug delivery

causing cancer in an animal where the tumour growth impairs normal behaviour

feeding a modified diet which is deficient in an essential nutrient such that it affects the health of the animal

exposing the animal to something that they would normally run away from, without enabling them to run away

the breeding of genetically altered animals where the animals health is affected, e.g. genetic models of diabetes.

Severe Procedures on animals as a result of which the animals are likely to experience severe pain, suffering or distress, or long-lasting moderate pain, suffering or distress as well as procedures, that are likely to cause severe impairment of the wellbeing or general condition of the animals.

any test where death is the end-point or where deaths are expected and it is not easy to determine when an animal is likely to die, e.g. models of aortic aneurysm

testing a device that could cause pain/death if it were to fail, e.g. testing devices designed to support patients at risk of heart disease

inescapable electric shock treatments, e.g. to induce a model of learned helplessness

breeding animals with genetic disorders that are expected to experience severe and persistent impairment of general condition, for example Huntington’s disease, and muscular dystrophy

Actual severity: The above definitions and examples also provide a good insight into what animals could have experienced when undergoing procedures and so reflect how actual severity is determined.  The only difference is that in the UK the Home Office introduced a further actual severity classification known as sub-threshold.  This classification therefore appears when UK annual returns of procedures are published.

Sub-threshold This is for procedures which were originally assigned an above-threshold pain or suffering classification, but when the work was undertaken the actual level of suffering was below that which would exceed the threshold at which procedures are licenced under the Act.

Sub-threshold procedures include:

breeding of genetically altered animals under project licence authority but without a harmful phenotype

dosing with a compound in feed where the animals ate normally and suffered no consequences of being dosed

Finally, any animals that are undergoing experimental procedures that are found dead and death could have been procedure related will be automatically classified as Severe unless the researcher can proved that the death was not procedure related.

How do they ensure high standards of animal welfare? They believe that good science and good animal welfare go hand in hand. The UK has the most rigorous animal welfare regulations in the world, and they consider adherence to these regulations as a minimum and will continue to aim for the highest possible standards of animal care.

They strongly agree with, and rigidly follow, the guiding principles emphasised by the Home Office on the need to refine protocols, keep the numbers of animals used to a minimum and replace the use of animals with other methods where possible. To this end, they encourage all staff involved in animal research and husbandry to continuously develop and improve on existing welfare standards, offering incentives to those that contribute, and rewarding those that are recognised by the laboratory animal welfare organisations.

Are they looking for alternatives to animal use? They are committed to refining, reducing and replacing the use of animals in research - known as the 3Rs. Animals are only used where no alternatives are viable. Cambridge scientists are also leading research looking at finding viable alternatives. For example, in 2014, Dr Meritxell Huch from the Gurdon Institute won the UK’s international prize for the scientific and technological advance with the most potential to achieve the 3Rs for work to grow “mini-livers” from adult mouse stem cells.

Do they test cosmetics and household products on animals? No. It is not permitted anywhere within the UK or the European Union to test cosmetics or household products on animals.

[kathleenseiber]

‘Ice cream’ method could create lifetime flu vaccine

A new approach could shake up the annual flu vaccination ritual and protect people against pandemic flu like the one that killed 40 to 50 million people in 1918, say researchers.

If the virus that causes flu were an ice cream cone, then the yearly vaccine teaches the immune system to recognize just the scoop—chocolate one year, strawberry the next. As the virus changes each year, the vaccine needs to change, too.

The new method teaches the body to recognize the “cone” portion of the virus—the part that stays the same year-to-year. Researchers working on the technique say it works in lab animals, but warn they still need to make the vaccine more specific and show it works in much larger studies before testing it in people.

“We think it could be very generalizable,” says Peter Kim, professor of biochemistry at Stanford University and the lead investigator of the infectious disease initiative at the Chan Zuckerberg Biohub. “It could be important for coming up with a universal flu vaccine that would protect against pandemic flu, as well as for HIV.”

Flu vaccine primer

The idea behind a vaccine is to inject a person with either a killed virus or just a single protein normally found on the virus surface. The immune system learns to recognize bits of that artificial invader, and mounts a defense that it can activate months or even years later if it sees that protein again.

The challenge is that some portions of a protein are, for whatever reason, a lot easier for the immune system to detect. In the case of flu, that easily detected portion is the ice cream end—the annual vaccine against the flavor of the year. Try though they might, scientists haven’t been able to effectively direct the immune system’s attention to the cone.

The idea for the new approach came about when chemistry graduate student Payton Weidenbacher heard a talk about a protein that can bind very specifically to exactly the spot on the flu virus protein they want the immune system to recognize. Scientists call the protein, a monoclonal antibody—“mono” because it binds to just one spot and “clonal” because they can make a lot of identical copies of it.

“You should be able to do this on anything—that’s the dream.”

During the talk, scientists wondered if they could use the monoclonal antibody as a guide and create a way for the immune system to bind to the same spot.

Listening in, Weidenbacher remembered a chemical trick that he thought might offer a different approach. Instead of just learning from the monoclonal antibody, why not make use of it? His idea was to latch this highly specific monoclonal antibody onto the flu virus protein in the lab and use it as a stencil.

He could paint the rest of the protein with molecules that act as a chemical cloak, rendering it invisible to the immune system. Removing the stencil would leave only a tiny portion of the protein visible for the immune system to learn to recognize and eventually attack.

Using that mostly cloaked protein as a vaccine may push the immune system to mount an attack against the cone—the portion of the virus shared across flu strains, including pandemic flu.

Simple idea, difficult process

Weidenbacher mentioned his idea to Kim after the talk, but both assumed someone else would have thought of such a simple idea. Then, Weidenbacher got a late-night email from Kim. “Peter was like, ‘nobody’s done it, start now,'” says Weidenbacher.

“Payton is a chemist,” Kim says. “What he did is come up with a way of using the monoclonal antibody not as something you look at but as a reagent.”

Although the idea was simple, carrying it out was not. Weidenbacher encountered some hurdles getting the system to work, but the team’s early tests, which appear in the Proceedings of the National Academy of Sciences, look promising.

Lab animals that receive this cleverly cloaked flu protein also show an immune response to other strains of the flu—something that would only happen if they’d learned to recognize the consistent bits in the cone. Animals that received a normal vaccine didn’t respond well to other flu strains.

The researchers “skewed” the immune response, but they have work to do to get it to be more specific. If they succeed, they say it could become an approach that works for many different infectious agents.

“You should be able to do this on anything—that’s the dream,” Weidenbacher says. “With the right chemistry, you could take any monoclonal antibody off the shelf and do this.”

The Virginia and D. K. Ludwig Fund for Cancer Research and the Chan Zuckerberg Biohub funded the work.

Source: Stanford University

The post ‘Ice cream’ method could create lifetime flu vaccine appeared first on Futurity.

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[stephenmccull]

Rural Hospital Remains Entrenched in Covid ‘War’ Even Amid Vaccine Rollout

Editor’s note: KHN wrote about St. James Parish Hospital in April, when it was experiencing its first surge of covid-19 patients. Ten months later, we checked in to see how the hospital and its staff were faring.

This story also ran on The Guardian. It can be republished for free.

The “heroes work here” sign in front of St. James Parish Hospital has been long gone, along with open intensive care unit beds in the state of Louisiana.

Staffers at the rural hospital spent hours each day in January calling larger hospitals in search of the elusive beds for covid-19 patients. They leveraged personal connections and begged nurses elsewhere to take patients they know are beyond their hospital’s care level.

But as patients have waited to be transferred out of the hospital, which is about 45 minutes outside New Orleans, doctors such as Landon Roussel are forced to make unthinkable choices. As recently as Jan. 29, he had to decide between two patients: Which one should get the sole available BiPAP machine to push oxygen into their lungs?

That’s like a “war situation, which is not a situation that I want to be in — in the United States,” he said.

As the nation’s attention shifts to the vaccine rollout, rural hospitals such as St. James Parish Hospital have struggled to handle their communities’ sick following the holiday surge of covid patients.

“We knew it was coming. We saw it coming,” Mary Ellen Pratt, St. James Parish Hospital’s CEO, said by phone. “It really has to happen to their family for them to really go, ‘OK, wow.’”

And even though the vaccines have arrived and caseloads continue to improve after the holiday surge, only about 30% of staffers have opted to get their shots. Disparities in the broader community persist: In the initial rollout, only 9% of those vaccinated were Black in a parish — the Louisiana equivalent of a county — that is nearly 49% Black.

Staff members are burned out from months of handling never-ending covid crises.

“They had been giving 150%, and they’re just getting really tired,” Pratt said. “It’s just exhausting.”

‘Sometimes, Your Best Isn’t Enough’

In mid-January, the closest intensive care bed the staff could find was some 600 miles away in Brownsville, Texas — so far that a plane would have been necessary to transport a patient. After three days, a closer bed was found at a Veterans Affairs hospital about 45 miles away.

Staffers have tried Mississippi and Alabama with mixed luck. One patient they tried to transfer four hours away couldn’t go because the ambulance didn’t have enough oxygen to make it that far. A hospital in Florida even called them looking for ICU beds at St. James Parish Hospital, which has never had any.

More than half of U.S. counties are like St. James Parish and have no intensive care beds, full or empty. Rural hospitals in those communities are designed for step-down care: They often serve as a stopping point to stabilize people before they can be sent to larger hospitals with more specialized staff and equipment.

Across the country, rural residents’ mortality rate from covid has been consistently higher than that of urban residents since August, according to the Rural Policy Research Institute Center for Rural Health Policy Analysis. That has occurred even though covid incidence has been lower among rural populations than urban ones since the middle of December, said Fred Ullrich, who runs the health policy department at the University of Iowa’s College of Public Health and co-authored the study.

But, he said, rural populations are typically older, sicker and poorer than urban populations. And the nation has lost at least 179 rural hospitals over the past 17 years.

“This crisis is just magnifying existing access issues in a rural context,” said Alan Morgan, the head of the National Rural Health Association. “If you don’t have a local hospital, that impacts the diagnosis, the initial treatment, the complex treatment. It has multiple impacts, all leading to what we’re seeing: higher mortality.”

And at the hospitals that remain, such as St. James Parish Hospital, the stress level is palpable, because the level of care needed for such sick patients is higher than what staffers normally handle, said Karley Babin, the hospital’s acute nurse manager.

“It’s just an uncomfortable spot,” she said. “You know you’re doing everything you can and that patient just needs more.”

That’s led to many sleepless nights for Pratt.

“Sometimes your best isn’t enough if you don’t have the right resources,” she said.

‘We Know All These People’

Radiology technologist Brooke Michel lives seven minutes from the hospital, where she works with her husband and five other relatives. Her grandfather, grandmother and aunt were hospitalized there in December with covid.

Her family brought folding chairs to sit outside her 83-year-old grandfather’s hospital window each day, keeping vigil through the glass on Christmas Eve. He died Jan. 3 while family members stood outside, taking turns looking in and praying.

“It gave us a sense of closure,” Michel said. “We were all together. We were with him. We would never have gotten that at a bigger hospital.”

Seeing multiple family members hospitalized at the same time is tough on the staff, said Scott Dantonio, the hospital’s pharmacy director. “We know all these people,” he said.

Dozens of hospital staffers also have battled covid, and three have been hospitalized. A nurse’s aide died last summer after contracting it. One staffer, who was particularly close to that aide, now has a hard time treating covid patients, said Rhonda Zeringue, chief nursing officer.

“It’s a reminder: ‘You took my person,’” she said.

‘It’s Just Exhausting’

St. James Parish Hospital has been running short-staffed, because they haven’t been able to hire more nurses or pay traveling nurses — they’re just too expensive. Amid the pandemic, traveling nurses can command more than double what the staff nurses make.

So Babin’s kids ask often why she works all the time.

Community praise has died down, she said. People aren’t thanking them in grocery stores anymore. One upside? Pratt is happy to have finally lost the “covid 19” — the weight she put on from the community bringing food to the hospital back in the spring.

Pratt and Zeringue have offered staff members counseling, massage sessions, coffee and doughnuts. But it’s not enough.

Zeringue said the stress has gone through the staff in waves: First they were scared to death of being the front line in the spring. Now she sees burnout and sheer exhaustion.

The vaccines were supposed to offer hope. But when Pratt heard they would be distributed through CVS and Walgreens, she knew immediately the logistics of getting the ultra-cold Pfizer vaccine from its cooler into residents’ arms would fall to them. She said the community has no chain pharmacies nearby and the local health department is overloaded.

“We get an email at, like, 4:30 on Friday which says, ‘We’re going to send you another 350 vaccines on Wednesday and you have to respond in the next 10 minutes,’” Pratt said. “There’s not enough planning or time to do it.”

Staff members, who are juggling monoclonal antibody infusions and elective surgeries to deal with the backlog from the spring on top of the surge, must also call members of the community to let them know they have the vaccine available. And then the problems begin.

“People don’t answer the phone or they’re not available,” Dantonio said. “Or they can’t come at that time or they scheduled somewhere else.”

Most of the people coming in following the hospital’s advertising online and on Facebook have been white. So Pratt called on the people she had relied on during the rollout of the Affordable Care Act: Black preachers and well-respected Black local leaders such as Democratic state Rep. Kendricks Brass. After word from the pulpit spread and Brass’ team staffed a phone line, the vaccine distribution the next week jumped to 30% Black residents from the prior week’s 9%.

Even some among the St. James Parish Hospital staff have been reluctant. Many have told Zeringue they’re worried about their fertility. Others just don’t want to be first. So the hospital’s line of defense has many holes.

And the covid patients keep coming.

“This is a nightmare,” said Kassie Roussel, the hospital’s marketing director. “It’s crazy because it’s at the same time we marketed the beginning of the end.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

USE OUR CONTENT

This story can be republished for free (details).

Rural Hospital Remains Entrenched in Covid ‘War’ Even Amid Vaccine Rollout published first on https://smartdrinkingweb.weebly.com/

[gordonwilliamsweb]

Rural Hospital Remains Entrenched in Covid ‘War’ Even Amid Vaccine Rollout

Editor’s note: KHN wrote about St. James Parish Hospital in April, when it was experiencing its first surge of covid-19 patients. Ten months later, we checked in to see how the hospital and its staff were faring.

This story also ran on The Guardian. It can be republished for free.

The “heroes work here” sign in front of St. James Parish Hospital has been long gone, along with open intensive care unit beds in the state of Louisiana.

Staffers at the rural hospital spent hours each day in January calling larger hospitals in search of the elusive beds for covid-19 patients. They leveraged personal connections and begged nurses elsewhere to take patients they know are beyond their hospital’s care level.

But as patients have waited to be transferred out of the hospital, which is about 45 minutes outside New Orleans, doctors such as Landon Roussel are forced to make unthinkable choices. As recently as Jan. 29, he had to decide between two patients: Which one should get the sole available BiPAP machine to push oxygen into their lungs?

That’s like a “war situation, which is not a situation that I want to be in — in the United States,” he said.

As the nation’s attention shifts to the vaccine rollout, rural hospitals such as St. James Parish Hospital have struggled to handle their communities’ sick following the holiday surge of covid patients.

“We knew it was coming. We saw it coming,” Mary Ellen Pratt, St. James Parish Hospital’s CEO, said by phone. “It really has to happen to their family for them to really go, ‘OK, wow.’”

And even though the vaccines have arrived and caseloads continue to improve after the holiday surge, only about 30% of staffers have opted to get their shots. Disparities in the broader community persist: In the initial rollout, only 9% of those vaccinated were Black in a parish — the Louisiana equivalent of a county — that is nearly 49% Black.

Staff members are burned out from months of handling never-ending covid crises.

“They had been giving 150%, and they’re just getting really tired,” Pratt said. “It’s just exhausting.”

‘Sometimes, Your Best Isn’t Enough’

In mid-January, the closest intensive care bed the staff could find was some 600 miles away in Brownsville, Texas — so far that a plane would have been necessary to transport a patient. After three days, a closer bed was found at a Veterans Affairs hospital about 45 miles away.

Staffers have tried Mississippi and Alabama with mixed luck. One patient they tried to transfer four hours away couldn’t go because the ambulance didn’t have enough oxygen to make it that far. A hospital in Florida even called them looking for ICU beds at St. James Parish Hospital, which has never had any.

More than half of U.S. counties are like St. James Parish and have no intensive care beds, full or empty. Rural hospitals in those communities are designed for step-down care: They often serve as a stopping point to stabilize people before they can be sent to larger hospitals with more specialized staff and equipment.

Across the country, rural residents’ mortality rate from covid has been consistently higher than that of urban residents since August, according to the Rural Policy Research Institute Center for Rural Health Policy Analysis. That has occurred even though covid incidence has been lower among rural populations than urban ones since the middle of December, said Fred Ullrich, who runs the health policy department at the University of Iowa’s College of Public Health and co-authored the study.

But, he said, rural populations are typically older, sicker and poorer than urban populations. And the nation has lost at least 179 rural hospitals over the past 17 years.

“This crisis is just magnifying existing access issues in a rural context,” said Alan Morgan, the head of the National Rural Health Association. “If you don’t have a local hospital, that impacts the diagnosis, the initial treatment, the complex treatment. It has multiple impacts, all leading to what we’re seeing: higher mortality.”

And at the hospitals that remain, such as St. James Parish Hospital, the stress level is palpable, because the level of care needed for such sick patients is higher than what staffers normally handle, said Karley Babin, the hospital’s acute nurse manager.

“It’s just an uncomfortable spot,” she said. “You know you’re doing everything you can and that patient just needs more.”

That’s led to many sleepless nights for Pratt.

“Sometimes your best isn’t enough if you don’t have the right resources,” she said.

‘We Know All These People’

Radiology technologist Brooke Michel lives seven minutes from the hospital, where she works with her husband and five other relatives. Her grandfather, grandmother and aunt were hospitalized there in December with covid.

Her family brought folding chairs to sit outside her 83-year-old grandfather’s hospital window each day, keeping vigil through the glass on Christmas Eve. He died Jan. 3 while family members stood outside, taking turns looking in and praying.

“It gave us a sense of closure,” Michel said. “We were all together. We were with him. We would never have gotten that at a bigger hospital.”

Seeing multiple family members hospitalized at the same time is tough on the staff, said Scott Dantonio, the hospital’s pharmacy director. “We know all these people,” he said.

Dozens of hospital staffers also have battled covid, and three have been hospitalized. A nurse’s aide died last summer after contracting it. One staffer, who was particularly close to that aide, now has a hard time treating covid patients, said Rhonda Zeringue, chief nursing officer.

“It’s a reminder: ‘You took my person,’” she said.

‘It’s Just Exhausting’

St. James Parish Hospital has been running short-staffed, because they haven’t been able to hire more nurses or pay traveling nurses — they’re just too expensive. Amid the pandemic, traveling nurses can command more than double what the staff nurses make.

So Babin’s kids ask often why she works all the time.

Community praise has died down, she said. People aren’t thanking them in grocery stores anymore. One upside? Pratt is happy to have finally lost the “covid 19” — the weight she put on from the community bringing food to the hospital back in the spring.

Pratt and Zeringue have offered staff members counseling, massage sessions, coffee and doughnuts. But it’s not enough.

Zeringue said the stress has gone through the staff in waves: First they were scared to death of being the front line in the spring. Now she sees burnout and sheer exhaustion.

The vaccines were supposed to offer hope. But when Pratt heard they would be distributed through CVS and Walgreens, she knew immediately the logistics of getting the ultra-cold Pfizer vaccine from its cooler into residents’ arms would fall to them. She said the community has no chain pharmacies nearby and the local health department is overloaded.

“We get an email at, like, 4:30 on Friday which says, ‘We’re going to send you another 350 vaccines on Wednesday and you have to respond in the next 10 minutes,’” Pratt said. “There’s not enough planning or time to do it.”

Staff members, who are juggling monoclonal antibody infusions and elective surgeries to deal with the backlog from the spring on top of the surge, must also call members of the community to let them know they have the vaccine available. And then the problems begin.

“People don’t answer the phone or they’re not available,” Dantonio said. “Or they can’t come at that time or they scheduled somewhere else.”

Most of the people coming in following the hospital’s advertising online and on Facebook have been white. So Pratt called on the people she had relied on during the rollout of the Affordable Care Act: Black preachers and well-respected Black local leaders such as Democratic state Rep. Kendricks Brass. After word from the pulpit spread and Brass’ team staffed a phone line, the vaccine distribution the next week jumped to 30% Black residents from the prior week’s 9%.

Even some among the St. James Parish Hospital staff have been reluctant. Many have told Zeringue they’re worried about their fertility. Others just don’t want to be first. So the hospital’s line of defense has many holes.

And the covid patients keep coming.

“This is a nightmare,” said Kassie Roussel, the hospital’s marketing director. “It’s crazy because it’s at the same time we marketed the beginning of the end.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

USE OUR CONTENT

This story can be republished for free (details).

Rural Hospital Remains Entrenched in Covid ‘War’ Even Amid Vaccine Rollout published first on https://nootropicspowdersupplier.tumblr.com/

[kristinsimmons]

Will Cancer Drugs Ever Be As Affordable As Retrovirals in Developing Countries?

By ASHLEY ANDREOU

In 2014, the majority of international health aid was dedicated to HIV. So, one might reasonably assume that this is the largest health problem facing the world. Yet, HIV only constitutes 4% of the global burden of disease. In 2014, noncommunicable diseases (NCDs) made up 50% of the entire disease burden, but only received 2% of all global health funds.

The disease burden of NCDs is fast outpacing that of infectious diseases. Despite this, the proportion of global health financing dedicated to combatting NCDs has remained constant over the past 15 years at 1 to 2%.

Currently, 32.6 million individuals are living with cancer (diagnosed in the last five years). In 1970, 15% of new cases were in low- and middle-income countries. In 2008, 56% were in low- and middle-income countries. By 2030, this proportion is expected to be 70%. So, not only is the burden of NCDs rising globally, but it is also beginning to disproportionately affect countries with the least resources to deal with them.

But, if NCDs have been steadily increasing in low- and middle-income countries, why has global action not followed suit? The HIV epidemic reversed the reduction of infectious disease deaths in children and young adults and, as a result, stunted the epidemiological and demographic transition, particularly in sub-Saharan Africa. Consequently, preventing HIV and other major infectious diseases became the focus of the Millennium Development Goals (MDGs) set in 2000. Likewise, in 2001, the United Nations General Assembly committed all governments to prioritizing the HIV epidemic, shelving the issue of NCDs for the next decade. Accordingly, the World Health Organization (WHO) and UNAIDS updated their “Strategies for the Prevention and Control of Diseases” to reflect this HIV and infectious-disease focused agenda; within this document, NCDs were not mentioned.

This concerted advocacy and mobilization around HIV/ AIDS gave way to an international surge of funding that gave millions of people in low-resource settings access to antiretroviral therapy (ART). Although this global movement to fight AIDS came too late for many, today HIV/AIDS is largely seen as a manageable condition rather than a death sentence.

Analyzing how HIV was internationally addressed offers important lessons on the barriers, and potential points of intervention, for NCD treatment, such as cancer.  Although a similar end point needs to be reached in the fight for cancer care—high quality, affordable, accessible, sustainable treatment—there are different pharmaceutical barriers to addressing cancer in low- and middle-resource settings.

Once adequate health systems are in place, medicine is indispensable for treating and managing NCDs. However, the pricing, development, and administration for cancer drugs are markedly different than that of HIV. An important point of divergence between HIV treatment and cancer treatment is the level of generic competition: generics were integral in making ART internationally affordable.

Many cancer treatments are biologics (i.e. a virus, therapeutic serum, toxin, antitoxin, hormone or protein, including monoclonal antibodies or similar products used to diagnose, prevent, treat or cure a disease) rather than small molecules (i.e. small, chemically manufactured active-substance molecules). In contrast, the class of drugs used to treat HIV/AIDS, antiretroviral therapy (ART), is a small molecule. This means that the research and development (R&D) process as well as regulatory landscape is different. New cancer medications are increasingly biotechnology products, meaning they are produced using living systems such as plant or animal cells, bacteria, viruses, and yeast. This has a significant impact on how generic versions are made and regulated.

The generic market played a crucial role in making ART internationally affordable. For a manufacturer to obtain marketing authorization and WHO prequalification of generic versions of a drug, they must simply demonstrate interchangeability. For small-molecule products, relatively simple bioequivalence studies establish interchangeability, such as testing a compound’s melting point. Approving generics does not require fully repeat efficacy and safety clinical trials. However, the regulatory requirements for biologics are different. Due to the biological nature, biosimilars are never the exact same molecule. As a result, the repeat tests to demonstrate interchangeability with the originator are much more extensive. For FDA approval, biosimilar companies must repeat clinical trials that may have taken the originator company upwards of five years and hundreds of millions in investment to complete. As a result, biosimilars cost much more to produce than traditional small-molecule generics and require significant investment by the generic producer. The immense cost for biosimilar R&D is a large part of why there is a lack of generic competition and, thus, the high, monopolized prices of cancer therapy.

Reduction of cancer mortality will be suboptimal without treatment. Like HIV drugs, cancer treatment must be affordable and reliable. However, given the biologic nature of many cutting-edge cancer therapies, the current approval process for generic cancer drugs is inadequate. As such, regulatory agencies need to acknowledge that the current approval process is effectively acting as a barrier for generic competition in the cancer drug market. If we envision a future where cancer treatment is as widely accessible as ART, health organizations need to start prioritizing NCDs as much as they do infectious ones—streamlining the biosimilar drug approval is a necessary first step.

Ashley Andreou is graduate student in the MPH program at Yale University

Will Cancer Drugs Ever Be As Affordable As Retrovirals in Developing Countries? published first on https://wittooth.tumblr.com/