FDA approves Novavax COVID-19 shot but with unusual restrictions

[BumRushDaShow]

Source: AP

Updated 10:21 PM EDT, May 17, 2025


WASHINGTON (AP) — The Food and Drug Administration has issued a long-awaited approval of Novavax’s COVID-19 vaccine but with unusual restrictions. Novavax makes the nation’s only traditional protein-based coronavirus vaccine – and until now it had emergency authorization from FDA for use in anyone 12 and older.

But late Friday, the FDA granted the company full approval for its vaccine for use only in adults 65 and older – or those 12 to 64 who have at least one health problem that puts them at increased risk from COVID-19. Vaccines made by Novavax’s competitors Pfizer and Moderna already are fully licensed for use in anyone 12 and older, and also are authorized for use in children as young as 6 months.

Next month, influential advisers to the Centers for Disease Control and Prevention were set to debate if yearly COVID vaccines still should be recommended for everyone or only certain people at higher risk. The Novavax decision suggests the Trump administration may already have decided how to proceed in advance of that meeting.

Novavax chief executive John C. Jacobs welcomed the licensure. “Market research and U.S. CDC statistics indicate that older individuals and those with underlying conditions are the populations most likely to seek out COVID-19 vaccination seasonally. This significant milestone demonstrates our commitment to these populations and is a significant step towards availability of our protein-based vaccine option,” he said.

Read more: https://apnews.com/article/novavax-covid19-vaccine-fda-a477c1aa612ceb293e70d904b46611b0

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Link to FDA page on this - NUVAXOVID

Link to approval LETTER (PDF) - https://www.fda.gov/media/186545/download?attachment

This means it is no longer considered under an "Emergency Use Authorization" but is now fully licensed (and would use a "brand name" which is now "Nuvaxoivid" ).

[Bernardo de La Paz]

1. Bizarre. It's the Pfizer & Moderna vaccines maga hates because they are MRNA

maga thinks MRNA is all about reprogramming people to become sheeple -- so says the herd of the brain dead that form the cult content that they have been "red-pilled" and are smart enough to avoid vaccines.

[doc03]

2. I am hesitant to take any vaccine today with RFK Jr. running things. nt

[hlthe2b]

3. Good heavens. He isn't involved in producing the vaccines, but rather the companies' retain control

He can only try to assert his ignorance to stall approvals of the new vaccines, such that we will have deaths and hospitalizations from COVID-19 and influenza as a result. Your suggestion it is the vaccine manufacturers who are the problem-- is to accept his idiocy. He has no clue and thinks that a simple update of the fully evaluated methodology used to create all the COVID-19 and Influenza vaccines thus far, including a newly emergent COVID-19 variant or known influenza strain, requires going back to a two-year or more placebo control study. Those who know better and have been involved in this work know that these require a comparison trial to show efficacy against the prior vaccines, but not a repeat of placebo as the comparison group. Using a placebo with active virus circulating puts those individuals at well-established risk and is thus unethical at that point-- not to mention all the rest of the population put at risk, given the long delays this would mean for getting the updated vaccines out there.

No.. Right now, those who know better will have maximal skepticism toward RFK Jr.'s stance on the vaccine, and if confidence is to be put anywhere, it is going to be with the virologists/vaccinologists outside of government who have independently evaluated what the vaccine producers are doing. And in this case, there will undoubtedly be more faith in the latter--the companies-- than the former. To put your trust in RFK Jr. over the vaccine companies right now is to buy into his decades of idiocy--that very warped and limited understanding of immunology, virology, bacteriology, vaccinology, epidemiology, public health, and medicine that has made him the current most dangerous anti-vaccine spewer out there.

Please rethink for your own well-being and that of those you care about.

[doc03]

5. The FDA issued approval, with RFK Jr can we trust the FDA. I don't know if we can

trust anything coming out of this administration. Can we trust the economic statistics we get from the
government now? Can we trust the DOJ, FDA, FAA, OSHA or anything else coming out of the government
today.

[hlthe2b]

6. doc03, NOWHERE did I say we should trust RFK Jr. You have totally misunderstood my post..

Please don't do this. Your reaction is the opposite of not taking advice from RFK JR. You are seemingly buying into his anti-vax stances that he will use to influence CDC, FDA, NIH, NIOSH, etc. But those within--their responses will be to go silent while they attempt to do damage control from within. There ARE OUTSIDE virology experts like, Dr. Peter Hotez who frequently provide commentary or make appearances on CNN and MSNBC and elsewhere. He, along with Dr. Maria Elena Bottazzi are noted virologists at the Texas Children's Center for Vaccine Development, part of Baylor College of Medicine in Houston, and created a traditional method (less expensive) COVID-19 vaccine that they kept patent-free for low-cost distribution in developing countries with the goal of enabling equitable access globally. Dr. Hotez, by the way received a NOBEL Prize for that patent-free vaccine development and his "global vaccine diplomacy." He and others WILL speak out in valid ways to counter any lack of information or misinformation emanating from RFK Jr.-controlled agencies.

Other nongovernmental experts that you can follow include former CDC directors and epidemiologists, former NIH staff, and former FDA directors/staff. They are out there and will speak out. Those within and still employed cannot. They are gagged, but that does not mean they are not doing all possible from within to "do the right things regardless." But listen to those clear experts who once worked at these agencies and are now in academia or other outlets that allow them to freely talk. DO NOT assume that anyone who has previously worked in public health at these agencies are "selling" you the RFK Jr. line.

There will be push-back from experts like these to support the appropriate processes for FDA to review and approve these vaccines and drugs. RFK's role that you should scrutinize would be in misinformation, lack of public support, inappropriate interference in CDC's ability to make wide recommendations, and delays in approvals with FDA. Those delays are damaging, no doubt because those vaccines need to get out there. But if you think he is somehow going to be able to interfere with vaccine or drug development so as to make unsafe products be more rapidly and inappropriately licensed, that is beyond his ability, control, and yes, motivation (no matter how much disdain I have for him).

[BumRushDaShow]

8. Remember that this vaccine was being developed starting WAY back during the beginning of the pandemic

(during the first term) as one of the "Operation Warp Speed" recipients -

U.S. Will Pay $1.6 Billion to Novavax for Coronavirus Vaccine


By Katie Thomas
Published July 7, 2020 Updated Jan. 28, 2021


The federal government will pay the vaccine maker Novavax $1.6 billion to expedite the development of a coronavirus vaccine. It’s the largest deal to date from Operation Warp Speed, the sprawling federal effort to make coronavirus vaccines and treatments available to the American public as quickly as possible.

The deal would pay for Novavax to produce 100 million doses of its new vaccine by the beginning of next year — if the vaccine is shown to be effective in clinical trials. That’s a significant bet on Novavax, a Maryland company that has never brought a product to market. With this deal, the federal government has now invested nearly $4 billion in companies pursuing vaccines, but has provided little information about how Operation Warp Speed is spending money, which agencies the funding is coming from or how decisions are being made.

That money has gone to six companies with varying track records and, in many cases, promising but untested technologies. British drugmaker AstraZeneca has received $1.2 billion in federal assistance for its vaccine, which uses a harmless virus to provoke an immune response. Moderna Therapeutics, which has received more than $500 million, also has never brought a product to market and is using a genetic technology that is valued for its speed but has never led to a successful human vaccine.

Some say the administration’s strategy — backing a variety of approaches, including some that are cutting-edge but may not work — is the best way to move quickly in the middle of a deadly pandemic. But critics say the public deserves to know more about how taxpayer money is being spent at this critical moment.

(snip)

This was back when Fauci was still there. They were pretty much the "last ones" still running and finally crossed the finish line - several years late. The only others still alive are Pfizer (not part of Operation Warp Speed) & Moderna. J&J's (Janssen) & Astrazeneca's (both using similar platforms) were pulled due to the adverse reactions, and Merck & Sanofi/GSK's attempts were delayed, and then dropped.

This new one is the only "non-mRNA" type of COVID vaccine (to date) approved in the U.S.

[live love laugh]

9. Why's it taken so long? There must be a reason. The delay make me skeptical.

[BumRushDaShow]

10. Well look what happened with J&J and Astrazeneca!

Both were non-mRNA platformed vaccines and both produced unexpected results when rushed to market. This is mainly because the "traditional" methods for vaccine development typically take many YEARS - not a year or two.

The mRNA vaccines had been toyed around with, back almost 20 years prior during the earlier SARS-CoV-1 outbreak (2003) - https://web.archive.org/web/20040812124322/http://www.who.int/mediacentre/releases/2003/pr31/en/ (Way Back Machine archived link)

So they had sort of a "head start".

[hlthe2b]

12. Yes... Posters should remember there was ALREADY a mRNA vaccine produced in response to SARS....

SARS-COV-1, Severe Acute Respiratory Syndrome--likewise a coronavirus that circulated after its introduction in 2002 across the globe before being contained with well-established public health measures before it could fully "take hold." Thus, that vaccine was never required, although it left the platform for rapid COVID-19 vaccine development decades later.

Routine ("traditional" ) methods of vaccine development DO take years. While I don't expect the lay public to understand or know this, that RFK Jr and those he has hired are either that ignorant, ill-informed or afraid to counter the bullshit opinions now "en vogue" is putting us all at risk.

[BumRushDaShow]

13. Brainworm host has zero idea of what REALLY goes on with the vaccine processs

other than reading some research papers and perhaps being aware of the "public comments" portions of both the CDC ACIP & FDA VRBPAC meetings and those in the public who might register a protest to the product during those scheduled sessions.

I know that during the peak of the pandemic, I literally watched the streams of almost ALL of both CDC's & FDA's sessions (if I was home) - most that went on for many hours, and posted LBN OPs of the results (with screenshots of some of the slides in the slide decks shown and of the vote results).

[cadoman]

15. it may be unethical, but given the abundant # of people not taking the shot a placebo is hardly impractical

I sometimes wish they'd add some level of placebo control just to remove the talking point.

But I understand there is a cost involved to doing so, and generally the population that participates in the study understands the benefits of vaccines and wants some vaccination--even if it's not the one that emerges as the best.

[mopinko]

4. iow

novavax hasnt kissed the ring.

[BumRushDaShow]

11. Well the ring hadn't been fitted yet

They got money from 45's "Operation Warp Speed" back in 2020 and were the last ones in of the original approved group.

[mopinko]

14. will they ever learn?

it’s not enough just to kiss the ring. u have to line the pocket, too.

[IbogaProject]

7. I am happy with Novavax

But at least one of our members had a strong reaction to it. I feel it is good to have competing technologies since mRNA is still a new tech. I will be forever pissed at Moderna bribing U Pitt Medical Center to suppress their vaccine patch in the spring of 2020. It was made of super sharp sugar spikes coated in protein to generate immune reaction in the capillaries.