The FDA, between now and May 8, is accepting public comments for their upcoming vaccine committee meeting. Let them know that all of us need access to COVID vaccines at least twice a year.
Make your voice heard and ask the FDA Vaccines and Related Biological Products Advisory Committee Meeting to:
Ensure vaccine manufacturers anticipate the upcoming dominant strain of SARS-CoV-2.
Recommend updated COVID vaccines for all ages AND
Strengthen our vaccine drive by recommending more frequent boosting (at least every six months) and more frequent updates to the vaccines, adjusted for the latest variants.
Submit a public comment. Feel free to use our sample language below.
You can also register to give Oral Public Comment at the upcoming May 16 online FDA Vaccines and Related Biological Products Advisory Committee Meeting at:
[email protected] on May 1, 2024. THAT’S TONIGHT!
Submitted written comments for the meeting must be received by the FDA via the Federal Register no later than May 8, 2024 at 11:59 Eastern Daylight Time.
It’s important to submit a personalized comment, which could include the importance of anticipating the next dominant viral strain, the lack of vaccine access that has impacted or would impact you, or how out-of-pocket costs are a barrier in your family or community. Feel free to take inspiration from or borrow the language in our sample public comment below.
Docket No. FDA–2024–N–0970
Scientific evidence indicates updated vaccines are needed to address the ongoing changes in COVID variants, and they should ideally be allowed, available, and fully covered by public funds and/or insurance, for people of all ages at least every six months.
The vaccine schedule should address waning efficacy in the months following vaccination [1-3] as well as emergence of new SARS-CoV-2 strains. The FDA’s decision will affect the current and future vaccine approach including what healthcare providers recommend, what health insurance covers, and level of public engagement.
It is of utmost importance that the FDA anticipates the newest viral variants and provides recommendations that anticipates the next dominant strain in the next six months. This requires that the FDA ensure that manufacturers anticipate the newest variants.
Restricting vaccinations to only annual updates misses an opportunity, given that there is the potential to update the vaccines to better match perpetually emerging variants. Updates to all vaccine types are needed, and mRNA vaccines are particularly suited to frequent updates.
The recommendation for only annual vaccination also creates barriers for vulnerable people and discourages high risk people from getting needed vaccine boosters.
The FDA must ensure support equitable and affordable access to updated vaccines and prevent limited access because of financial constraints or demographics by advocating for programs such as the CDC’s bridge program that ensures no cost access. [4]
References:
Link-Gelles R. COVID-19 vaccine effectiveness updates. Presented at: FDA VRBPAC Meeting; June 15, 2023. Accessed February 9, 2024. https://www.fda.gov/media/169536/download
Wu N, Joyal-Desmarais K, Vieira AM, et al. COVID-19 boosters versus primary series: update to a living review. The Lancet Respiratory Medicine. 2023;11(10):e87-e88. doi:10.1016/S2213-2600(23)00265-5
Menegale F, Manica M, Zardini A, et al. Evaluation of Waning of SARS-CoV-2 Vaccine–Induced Immunity: A Systematic Review and Meta-analysis. JAMA Netw Open. 2023;6(5):e2310650. doi:10.1001/jamanetworkopen.2023.10650
https://www.cdc.gov/vaccines/programs/bridge/index.html
Full instructions for written and oral comment and meeting information can be found at: https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-may-16-2024-meeting-announcement
FDA Vaccines and Related Biological Products Advisory Committee Meeting on the Federal Register: https://www.federalregister.gov/documents/2024/03/04/2024-04523/vaccines-and-related-biological-products-advisory-committee-notice-of-meeting-establishment-of-a
13 notes
·
View notes
Opinion Here’s how to get free Paxlovid as many times as you need it
When the public health emergency around covid-19 ended, vaccines and treatments became commercial products, meaning companies could charge for them as they do other pharmaceuticals. Paxlovid, the highly effective antiviral pill that can prevent covid from becoming severe, now has a list price of nearly $1,400 for a five-day treatment course.
Thanks to an innovative agreement between the Biden administration and the drug’s manufacturer, Pfizer, Americans can still access the medication free or at very low cost through a program called Paxcess. The problem is that too few people — including pharmacists — are aware of it.
I learned of Paxcess only after readers wrote that pharmacies were charging them hundreds of dollars — or even the full list price — to fill their Paxlovid prescription. This shouldn’t be happening. A representative from Pfizer, which runs the program, explained to me that patients on Medicare and Medicaid or who are uninsured should get free Paxlovid. They need to sign up by going to paxlovid.iassist.com or by calling 877-219-7225. “We wanted to make enrollment as easy and as quick as possible,” the representative said.
Indeed, the process is straightforward. I clicked through the web form myself, and there are only three sets of information required. Patients first enter their name, date of birth and address. They then input their prescriber’s name and address and select their insurance type.
All this should take less than five minutes and can be done at home or at the pharmacy. A physician or pharmacist can fill it out on behalf of the patient, too. Importantly, this form does not ask for medical history, proof of a positive coronavirus test, income verification, citizenship status or other potentially sensitive and time-consuming information.
But there is one key requirement people need to be aware of: Patients must have a prescription for Paxlovid to start the enrollment process. It is not possible to pre-enroll. (Though, in a sense, people on Medicare or Medicaid are already pre-enrolled.)
Once the questionnaire is complete, the website generates a voucher within seconds. People can print it or email it themselves, and then they can exchange it for a free course of Paxlovid at most pharmacies.
Pfizer’s representative tells me that more than 57,000 pharmacies are contracted to participate in this program, including major chain drugstores such as CVS and Walgreens and large retail chains such as Walmart, Kroger and Costco. For those unable to go in person, a mail-order option is available, too.
The program works a little differently for patients with commercial insurance. Some insurance plans already cover Paxlovid without a co-pay. Anyone who is told there will be a charge should sign up for Paxcess, which would further bring down their co-pay and might even cover the entire cost.
Several readers have attested that Paxcess’s process was fast and seamless. I was also glad to learn that there is basically no limit to the number of times someone could use it. A person who contracts the coronavirus three times in a year could access Paxlovid free or at low cost each time.
Unfortunately, readers informed me of one major glitch: Though the Paxcess voucher is honored when presented, some pharmacies are not offering the program proactively. As a result, many patients are still being charged high co-pays even if they could have gotten the medication at no cost.
This is incredibly frustrating. However, after interviewing multiple people involved in the process, including representatives of major pharmacy chains and Biden administration officials, I believe everyone is sincere in trying to make things right. As we saw in the early days of the coronavirus vaccine rollout, it’s hard to get a new program off the ground. Policies that look good on paper run into multiple barriers during implementation.
Those involved are actively identifying and addressing these problems. For instance, a Walgreens representative explained to me that in addition to educating pharmacists and pharmacy techs about the program, the company learned it also had to make system changes to account for a different workflow. Normally, when pharmacists process a prescription, they inform patients of the co-pay and dispense the medication. But with Paxlovid, the system needs to stop them if there is a co-pay, so they can prompt patients to sign up for Paxcess.
Here is where patients and consumers must take a proactive role. That might not feel fair; after all, if someone is ill, people expect that the system will work to help them. But that’s not our reality. While pharmacies work to fix their system glitches, patients need to be their own best advocates. That means signing up for Paxcess as soon as they receive a Paxlovid prescription and helping spread the word so that others can get the antiviral at little or no cost, too.
{source}
24K notes
·
View notes
Noubar Afeyan PhD ’87 gives new MIT graduates a special assignment
New Post has been published on https://thedigitalinsider.com/noubar-afeyan-phd-87-gives-new-mit-graduates-a-special-assignment/
Noubar Afeyan PhD ’87 gives new MIT graduates a special assignment
Biotechnology leader Noubar Afeyan PhD ’87 urged the MIT Class of 2024 to “accept impossible missions” for the betterment of the world, in a rousing keynote speech at the OneMIT Commencement ceremony this afternoon.
Afeyan is chair and co-founder of the biotechnology firm Moderna, whose groundbreaking Covid-19 vaccine has been distributed to billions of people in over 70 countries. In his remarks, Afeyan briefly discussed Moderna’s rapid development of the vaccine but focused the majority of his thoughts on this year’s graduating class — while using the “Mission: Impossible” television show and movies, a childhood favorite of his, as a motif.
“What I do want to talk about is what it takes to accept your own impossible missions and why you, as graduates of MIT, are uniquely prepared to do so,” Afeyan said. “Uniquely prepared — and also obligated. At a time when the world is beset by crises, your mission is nothing less than to salvage what seems lost, reverse what seems inevitable, and save the planet. And just like the agents in the movies, you need to accept the mission — even if it seems impossible.”
Afeyan spoke before an audience of thousands on MIT’s Killian Court, where graduates gathered in attendance along with family, friends, and MIT community members, during an afternoon of brightening weather that followed morning rain.
Play video
“Welcome long odds,” Afeyan told the graduates. “Embrace uncertainty, and lead with imagination.”
Afeyan’s speech was followed by an address from MIT President Sally Kornbluth, who described the Institute’s graduating class as a “natural wonder,” in a portion of her remarks directed to family and friends.
“You know how delightful and inspiring and thoughtful they are,” Kornbluth said of this year’s graduates. “It has been our privilege to teach them, and to learn together with them. And we share with you the highest hopes for what they will do next.”
The OneMIT Commencement ceremony is an Institute-wide event serving as a focal point for three days of graduation activities, from May 29 through May 31.
MIT’s Class of 2024 comprises 3,666 students, earning a total of 1,386 undergraduate and 2,715 graduate degrees.
Photo: Gretchen Ertl
The OneMIT Commencement ceremony is an Institute-wide event serving as a focal point for three days of graduation activities.
Photo: Gretchen Ertl
Sally Kornbluth, Noubar Afeyan, Cynthia Barnhart, and other MIT community members led the procession of faculty and administration onto Killian Court. R. Robert Wickham ’93, SM ’95, president of the MIT Alumni Association and chief marshal of the Commencement ceremony, carried the ceremonial golden mace.
Photo: Jake Belcher
“You already have a head start, quite a significant one,” Afeyan told MIT’s graduates. “You graduate today from MIT, and that says volumes about your knowledge, talent, vision, passion, and perseverance — all essential attributes of the elite 21st-century agent.” He then drew laughs by quipping, “Oh, and I forgot to mention our relaxed, uncompetitive nature, outstanding social skills, and the overall coolness that characterizes us MIT grads.”
Photo: Gretchen Ertl
The Chorallaries sang the national anthem, as well as the school song, “In praise of MIT,” and another Institute anthem, “Take Me Back to Tech.”
Photo: Gretchen Ertl
“Let us step forward from today with a commitment not only to further our own goals, but also to use our skills and knowledge to contribute positively to our communities and the world,” said Lieutenant Mikala Nicole Molina, president of the Graduate Student Council.
Photo: Gretchen Ertl
Penny Brant, president of the undergraduate Class of 2024, offered a salute to her classmates: “I know I would not be graduating here today if not for all of you who have helped me along the way. You all have had such a profound and positive impact on me, our community, and the world.”
Photo: MIT News
President Sally Kornbluth, issuing the president’s traditional “charge to the graduates,” lauded the Class of 2024 for being “a community that runs on an irrepressible combination of curiosity and creativity and drive. A community in which everyone you meet has something important to teach you. A community in which people expect excellence of themselves — and take great care of one another.”Sally Kornbluth, wearing gray and red academic regalia, speaks at a podium with the MIT seal on the front.
Photo: Gretchen Ertl
Previous item
Next item
MIT’s Class of 2024 encompasses 3,666 students, earning a total of 1,386 undergraduate and 2,715 graduate degrees. (Some students are receiving more than one degree at a time.) Undergraduate and graduate students also have separate ceremonies, organized by academic units, in which their names are read as they walk across a stage.
Afeyan is a founder and the CEO of Flagship Pioneering, a venture firm started in 2000 that has developed more than 100 companies in the biotechnology industry, which combined have more than 60 drugs in clinical development.
A member of the MIT Corporation who earned his PhD from the Institute in biochemical engineering, Afeyan also served as a senior lecturer at the MIT Sloan School of Management for 16 years. He is currently on the advisory board of the MIT Abdul Latif Jameel Clinic for Machine Learning and has been a featured speaker at events such as MIT Solve. Afeyan is the co-founder of the Aurora Prize for Awakening Humanity, among other philanthropic efforts.
“You already have a head start, quite a significant one,” Afeyan told MIT’s graduates. “You graduate today from MIT, and that says volumes about your knowledge, talent, vision, passion, and perseverance — all essential attributes of the elite 21st-century agent.” He then drew laughs by quipping, “Oh, and I forgot to mention our relaxed, uncompetitive nature, outstanding social skills, and the overall coolness that characterizes us MIT grads.”
Afeyan also heralded the Institute itself, citing it as a place crucial to the development of the “telephone, digital circuits, radar, email, internet, the Human Genome Project, controlled drug delivery, magnetic confinement fusion energy, artificial intelligence and all it is enabling — these and many more breakthroughs emerged from the work of extraordinary change agents tied to MIT.”
Long before Afeyan himself came to MIT, he grew up in an immigrant Armenian family in Beirut. After civil war came to Lebanon in 1975, he spent long hours in the family apartment watching “Mission: Impossible” re-runs on television.
As Afeyan noted, the special agents in the show always received a message beginning, “Your mission, should you choose to accept it … ” He added: “No matter how long the odds, or how great the risk, the agents always took the assignment. In the 50 years since, I have been consistently drawn to impossible missions, and today I hope to convince each and every one of you that you should be too.”
To accomplish difficult tasks, Afeyan said, people often do three things: imagine, innovate, and immigrate, with the latter defined broadly, not just as a physical relocation but an intellectual exploration.
“Imagination, to my mind, is the foundational building block of breakthrough science,” Afeyan said. “At its best, scientific research is a profoundly creative endeavor.”
Breakthroughs also deploy innovation, which Afeyan defined as “imagination in action.” To make innovative leaps, he added, requires a kind of “paranoid optimism. This means toggling back and forth between extreme optimism and deep-seated doubt,” in a way that “often starts with an act of faith.”
Beyond that, Afeyan said, “you will also need the courage of your convictions. Make no mistake, you leave MIT as special agents in demand. As you consider your many options, I urge you to think hard about what legacy you want to leave, and to do this periodically throughout your life. … You are far more than a technologist. You are a moral actor. The choice to maximize solely for profits and power will in the end leave you hollow. To forget this is to fail the world — and ultimately to fail yourself.”
Finally, Afeyan noted, to make great innovative leaps, it is often necessary to “immigrate,” something that can take many forms. Afeyan himself, as an Armenian from Lebanon who came to the U.S., has experienced it as geographic and social relocation, and also as the act of changing things while remaining in place.
“Here’s the really interesting thing I’ve learned over the years,” Afeyan said. “You don’t need to be from elsewhere to immigrate. If the immigrant experience can be described as leaving familiar circumstances and being dropped into unknown territory, I would argue that every one of you also arrived at MIT as an immigrant, no matter where you grew up. And as MIT immigrants, you are all at an advantage when it comes to impossible missions. You’ve left your comfort zone, you’ve entered unchartered territory, you’ve foregone the safety of the familiar.”
Synthesizing these points, Afeyan suggested, “If you imagine, innovate, and immigrate, you are destined to a life of uncertainty. Being surrounded by uncertainty can be unnerving, but it’s where you need to be. This is where the treasure lies. It’s ground zero for breakthroughs. Don’t conflate uncertainty and risk — or think of it as extreme risk. Uncertainty isn’t high risk; it’s unknown risk. It is, in essence, opportunity.”
Afeyan also noted that many people are “deeply troubled by the conflicts and tragedies we are witnessing” in the world today.
“I wish I had answers for all of us, but of course, I don’t,” Afeyan said. “But I do know this: Having conviction should not be confused with having all the answers. Over my many years engaged in entrepreneurship and humanitarian philanthropy, I have learned that there is enormous benefit in questioning what you think you know, listening to people who think differently, and seeking common ground,” a remark that drew an ovation from the audience.
In conclusion, Afeyan urged the Class of 2024 to face up to the world’s many challenges while getting used to a life defined by tackling tough tasks.
“Graduates, set forth on your impossible missions,” Afeyan said. “Accept them. Embrace them. The world needs you, and it’s your turn to star in the action-adventure called your life.”
Next, Kornbluth, issuing the president’s traditional “charge to the graduates,” lauded the Class of 2024 for being “a community that runs on an irrepressible combination of curiosity and creativity and drive. A community in which everyone you meet has something important to teach you. A community in which people expect excellence of themselves — and take great care of one another.”
As Kornbluth noted, most of the seniors in the undergraduate Class of 2024 had to study through, and work around, the Covid-19 pandemic. MIT, Kornbluth said, is a place where people “fought the virus with the tools of measurement and questioning and analysis and self-discipline — and was therefore able to pursue its mission almost undeterred.”
The campus community, she added, “understands, in a deep way, that the vaccines were not some ‘overnight miracle’ — but rather the final flowering of decades of work by thousands of people, pushing the boundaries of fundamental science.”
And while the Class of 2024 has acquired a great deal of knowledge in the classroom and lab, Kornbluth thanked its members for what they have given to MIT, as well.
“The Institute you are graduating from is — thanks in part to you — always reflecting and always changing,” Kornbluth said. “And I take that as your charge to us.”
The OneMIT Commencement event started with a parade for alumni from the class of 1974, back on campus for their 50th anniversary reunion. The MIT Police Honor Guard entered next as part of the ceremonial procession, followed by administration and faculty. The MIT Wind Ensemble, conducted by Fred Harris, Jr., provided the accompanying music.
Mark Gorenberg ’76, chair of the MIT Corporation, formally opened the ceremony, and Thea Keith-Lucas, chaplain to the Institute, gave an invocation. The Chorallaries of MIT sang the national anthem.
Afeyan’s remarks followed, but were delayed for several minutes by protesters holding signs. After his speech, Lieutenant Mikala Nicole Molina, president of the Graduate Student Council, delivered remarks as well.
“Let us step forward from today with a commitment not only to further our own goals, but also to use our skills and knowledge to contribute positively to our communities and the world,” Molina said. “Our actions reflect the excellence and integrity that MIT has instilled in us.”
Penny Brant, president of the undergraduate Class of 2024, then offered a salute to her classmates, saying “I know I would not be graduating here today if not for all of you who have helped me along the way. You all have had such a profound and positive impact on me, our community, and the world.”
Kornbluth’s speech, which followed, was momentarily interrupted by shouting from an audience member, before students and other audience members gave Kornbluth a sustained ovation and ceremonies resumed as planned.
R. Robert Wickham ’93, SM ’95, president of the MIT Alumni Association and chief marshal of the Commencement ceremony, also offered a traditional greeting for graduates saying he was “welcoming you into our alumni family, your infinite connection to MIT.” There are now almost 147,000 MIT alumni worldwide.
The Chorallaries sang the school song, “In praise of MIT,” as well as another Institute anthem, “Take Me Back to Tech,” moments after Gorenburg formally closed the ceremony.
Preceding Afeyan, recent MIT Commencement speakers have been engineer and YouTuber Mark Rober, in 2023; Director-General of the World Trade Organization Ngozi Okonjo-Iweala, in 2022; lawyer and activist Bryan Stevenson, in 2021; and retired U.S. Navy four-star admiral William McRaven, in 2020.
0 notes