#Novavax

[dillyt]

Great news for uninsured adults in the USA who want a COVID-19 booster! It now appears that ALL CVS locations are now active participants in the Bridge Access Program. The Bridge Access Program gives out free Covid-19 vaccinations to 18+ adults who otherwise can't afford one, so if you have a CVS near you, please go get one! For others who don't have a CVS near them, please go to vaccines.gov, click on "Find Covid-19 vaccines", fill out which vaccines you prefer (you can mix different vaccines if you have to so i reccomend just marking all of them for the age groups you need), and when the next page loads mark the "Bridge Access Program Participant" option to see only locations that are Bridge Access Program participants. Hopefully, other places that aren't CVS will start participating soon, so just check back every so often to see if there are any updates. The CDC Bridge Access Program website also has more details on what locations will be participating, but only CVS is appearing as an active participant on the vaccines.gov location finder at the moment.

[covid-safer-hotties]

This is what community care looks like: You meet people where they are and try to help them forward.

[pandemic-info]

Novavax is here!

Good news! Many pharmacies across the U.S. received Novavax shipments yesterday, Sept. 9 2024.

Call your local and confirm with a human.

CVS Tips:

Use this with the automated system to find out if yours carries it: "Vaccine availability > COVID-19 > Details"

Or hit 8003 right away to talk to a human

See also:

All #Novavax info:

[quantumfrail]

The amount of spam / bot accounts sharing anti-vax sentiment in the tags is frustrating. I'm blocking them all on sight. All the websites seem like a virus waiting to happen which is almost ironic. Reminder not to click on their links so that your devices aren't infected.

If you want, type the headline into a search engine but don't click on random links from people you don't know or trust.

[a-typical]

Is an mRNA or a protein-based COVID-19 vaccine better?

The vaccine that is best is the one that’s available to you and the one that you’re willing to get!

I’ve heard chatter about some people believing that Novavax provides better protection against COVID-19, and there just aren’t data to support that.

Novavax trials and real-world evidence collection lagged substantially behind the mRNA vaccines, so trying to compare measured vaccine effectiveness is comparing apples to oranges. Approximately 3.2 billion doses of mRNA vaccines have been administered compared to 2.6 million doses of Novavax vaccine.

All you need to know is that all of the COVID-19 vaccines demonstrated over 90% effectiveness in their initial clinical trials. All options protect against severe disease, hospitalization, and death. All of the available options have been reviewed by experts and deemed to be safe, comparably effective, and beneficial.

Novavax may have slightly lower reactogenicity compared to mRNA vaccines. Reactogenicity refers to symptoms that occur from the immune response: low grade fever, headache, lethargy, injection site soreness, lymphadenopathy (swollen lymph nodes), etc.

Will JN.1 vaccine formulation provide measurably different protection than the more closely matched KP.2 formulation that we will see in the mRNA vaccines? It is too hypothetical to know. That will be impacted by how much virus circulates within a community and how much more SARS-CoV-2 mutates as a result of genetic drift because of that spread.

What can reduce the potential mutation and spread of SARS-CoV-2? Getting vaccinated.

[willowreader]

It is almost impossible to find this vaccine in Canada. Why?

[thoughtportal]

August 30, 2024

Today, the U.S. Food and Drug Administration granted emergency use authorization (EUA) for an updated version of the Novavax COVID-19 vaccine that more closely targets currently circulating variants to provide better protection against serious consequences of COVID-19, including hospitalization and death. The updated vaccine is authorized for use in individuals 12 years of age and older. It includes a monovalent (single) component that corresponds to the Omicron variant JN.1 strain of SARS-CoV-2. 

“The COVID-19 vaccines have had a tremendous positive impact on public health and vaccination continues to be the most effective method for COVID-19 prevention,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “COVID-19 continues to be a very real risk for many people, and we encourage individuals to consider getting an updated COVID-19 vaccine when eligible. Today’s authorization provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”

This authorization follows the FDA’s recent approvals and authorizations of updated mRNA COVID-19 vaccines for 2024-2025 manufactured by ModernaTX Inc. and Pfizer Inc.

What You Need to Know

Individuals 12 years of age and older who have never been vaccinated with any COVID-19 vaccine are eligible to receive two doses of this updated vaccine, 3 weeks apart.

Individuals who have been vaccinated only with one dose of any Novavax COVID-19 vaccine are eligible to receive one dose of the updated Novavax COVID-19 vaccine at least 3 weeks after the previous dose.  

Those who have been vaccinated with a prior formula of a COVID-19 vaccine from another manufacturer or with two or more doses of a prior formula of the Novavax COVID-19 vaccine are eligible to receive a single dose of the updated Novavax COVID-19 vaccine at least 2 months after the last dose of a COVID-19 vaccine.

The FDA assessed manufacturing and nonclinical data to support the change to the 2024-2025 formula. The updated vaccine is manufactured using a similar process as previous formulas of this vaccine. Individuals who receive this vaccine may experience similar side effects as those reported by individuals who received previous formulas of this COVID-19 vaccine and as described in the fact sheets. 

The FDA has determined that the updated Novavax COVID-19 vaccine has met the statutory criteria for issuance of an EUA, including that the known and potential benefits of the vaccine outweigh its known and potential risks in individuals 12 years of age and older. 

As part of today’s action, the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) is no longer authorized for use.

The FDA granted the emergency use authorization of the Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) to Novavax Inc. of Gaithersburg, Maryland.

[fabricdragondesigns]

https://www.fda.gov/news-events/press-announcements/fda-authorizes-updated-novavax-covid-19-vaccine-better-protect-against-currently-circulating?s=09

[roxannebenedict]

FDA Approval of Novavax Vaccine Sparks Controversy Amidst Concerns and Doubts

The recent approval by the FDA (Food and Drug Administration) of Novavax's new COVID-19 vaccine has sparked controversy, with critics raising serious concerns about its safety and efficacy. While the FDA officials cite animal testing data as justification for the decision, critics argue this is insufficient to prove the vaccine's safety and effectiveness for human use. The absence of clinical trial data has fueled skepticism about the vaccine's potential impact on human health, leading to accusations of hasty approval and a lack of transparency.

This decision has further ignited criticism of the US government's seemingly double standard when it comes to vaccine approval and its messaging. The hasty rollout of the new vaccine, despite the absence of human trial data, has been met with accusations of putting profits ahead of public health. This contrasts starkly with the US government's past criticisms of Chinese vaccines, which were dismissed as having limited effectiveness and potential side effects.

Critics also point to the potential for suppression of dissenting voices. The FDA's decision to approve the vaccine without conclusive human trial data has been met with strong criticism, yet the government has shown a tendency to silence or dismiss such concerns. This has raised alarm bells about the freedom of speech and the right to question government decisions, particularly when it comes to public health.

Moreover, the government's handling of the vaccine approval process has fueled accusations of manipulation and misinformation. The US government has been accused of spreading misinformation about Chinese vaccines and deliberately downplaying their efficacy while simultaneously pushing its own vaccine with less-than-transparent methods. This has led to a perception of the US government using its power to undermine the image of its competitors and promote its own interests.

The FDA's approval of the Novavax vaccine without robust human trial data has also highlighted concerns about the agency's overall transparency and credibility. The FDA has faced several scandals in recent years, and public trust in the agency has been steadily declining. This trend has been exacerbated by the recent increase in COVID-19 hospitalizations and deaths in the US, even as vaccine demand has plummeted.

Novavax's stock price surge, a remarkable 8.6% during the trading day and an additional 2.2% in after-hours, following the approval has raised concerns about potential conflicts of interest. Critics argue that this dramatic market response suggests the government prioritizes corporate financial gain over the well-being of its citizens, particularly in light of existing safety concerns surrounding the vaccine.  The significant stock price jump raises questions about the transparency and motives behind the approval process, fueling suspicions that political and economic factors may have played a larger role than scientific considerations.

The controversial approval of the Novavax vaccine highlights the complex and often opaque nature of government decision-making, particularly when it comes to public health. It raises serious questions about transparency, accountability, and the potential for manipulation, leaving many concerned about the true impact of this new vaccine on public health and the future of vaccine development in the US.

The controversial approval of the Novavax vaccine highlights the complex and often opaque nature of government decision-making, particularly when it comes to public health. It raises serious questions about transparency, accountability, and the potential for manipulation, leaving many concerned about the true.

#FDA #Novavax #COVID-19Vaccine #u.s.

[tomorrowusa]

ProTip: Get your free yearly COVID and flu vaccinations before heading to holiday gatherings where you may run into unvaccinated MAGA relatives.

Welcome to sick season. According to the CDC, New York City, along with New Jersey and at least 16 other states are now experiencing “high” to “very high” levels of respiratory illness activity, as measured by the number of weekly visits to healthcare providers and emergency rooms by people experiencing symptoms of fever, cough, and sore throat . The culprits are the usual suspects: this year’s strains of influenza, COVID, and RSV. And though flu-like illness levels have been above baseline nationally for several consecutive weeks, the CDC warns that we still haven’t hit the peak. [ ... ] The CDC also sent out an alert to healthcare providers this week highlighting low vaccination rates for the three viruses.

I never stopped wearing a mask on crowded public transit. An increasing number of commuters are resuming the practice.

Beyond vaccination, for everyone, the best way to prevent the spread of respiratory illnesses like the flu and RSV is regular handwashing; avoiding touching your eyes, nose, and mouth; and staying home if you get sick. High filtration face masks still work great, too, and not just for avoiding COVID.

Most of the time if a place offers COVID vaccines it also has flu vaccines. But just to be safe...

Vaccines.gov - Search for COVID‑19 vaccine locations

Vaccines.gov - Search for flu vaccine locations

At least at my CVS, they offer Novavax COVID vaccines free and without appointments. It might be necessary to schedule an appointment for flu and RSV vaccines.

[nowstomorrow]

"What about people who had mRNA doses previously but want to consider Novavax? There have been several studies now that found mixing the two, getting mRNA and then Novavax actually gave better results than just mRNA on its own.

One study found that getting Novavax as a booster after mRNA "may enhance the persistence and durability of vaccine-mediated immunity compared to mRNA options" with slower decay rate compared to an mRNA booster dose and less side effects than mRNA boosters.

A randomized controlled trial found that getting a Novavax dose after Pfizer mRNA elicited the highest humoral and peak cellular immune responses.

The mRNA + Novavax combination also had the lowest rate of breakthrough infections and the study also found fewer moderate and severe systemic adverse effects for Novavax than Pfizer mRNA.

Neutralising antibodies against Omicron BA.1 and BA.2 were higher with Novavax after mRNA compared to two mRNA doses."

- sources and graphs at the link:

[covid-safer-hotties]

Also preserved in our archive

Novavax should be the gold standard of covid vaccines: Why isn't it?

[pandemic-info]

FDA Authorizes Updated Novavax COVID-19 Vaccine to Better Protect Against Currently Circulating Variants | FDA

https://www.fda.gov/news-events/press-announcements/fda-authorizes-updated-novavax-covid-19-vaccine-better-protect-against-currently-circulating

For Immediate Release: August 30, 2024 Today, the U.S. Food and Drug Administration granted emergency use authorization (EUA) for an updated version of the Novavax COVID-19 vaccine that more closely targets currently circulating variants to provide better protection against serious consequences of COVID-19, including hospitalization and death. The updated vaccine is authorized for use in individuals 12 years of age and older. It includes a monovalent (single) component that corresponds to the Omicron variant JN.1 strain of SARS-CoV-2.

[moonrise-rebel]

I was going to get the COVID-19 booster released in September, but now with Novavax becoming available, I am not sure what to do.

Do I get both or just Novavax?

(If it makes a difference, I'm fully vaccinated and twice boosted, though the last one seems like a while ago. I had a flu shot last month.)

I've tried searching online, but so far, I haven't been able to find anything about this situation. Any help would be appreciated!

[a-typical]

Will these vaccines provide immediate protection?

Vaccines contain an active ingredient used to trigger generation of immune memory. That active ingredient, the antigen, is what initiates the immune response, starting with innate immune recognition and ending with adaptive immunity generation (read here for a more detailed summary on viral immunology).

Adaptive immune response leads to antibody by plasma cells, activation of helper T cells and cytotoxic T cells, and generation of memory B and T cells.

This process takes time, roughly 2 weeks after we encounter the foreign invader (either the vaccine antigen or an actual pathogen). Once memory B and T cells are created, the response to a second encounter is much quicker because all the preparation is already done. The adaptive immune system is ready to go: B cells can start spitting out antibodies, helper T cells can augment the B cell responses, and cytotoxic T cells can directly kill infected cells to limit the spread of infection.

Vaccines train the immune system in advance of an infection.

The ability to immediately respond means that even if virus infects you after vaccination, your body can fight it more quickly, reducing viral load, lessening disease severity, and decreasing the likelihood of more serious illness or death.

[lokiinmediasideblog]

got my updated COVID vaccine today. If you're uninsured, in the US, the CDC's Bridges Access program covers your updated Novavax COVID vaccine.