FDA Panel Recommends EUA for Novavax COVID-19 Vaccine

FDA Panel Recommends EUA for Novavax COVID-19 Vaccine

Despite concerns about the risk of developing myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining of the heart) following vaccination with Novavax’s experimental NVX-CoV2373 (also known as “Nuvaxovid” and “Covovax”) COVID-19 vaccine, the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted on June 6, 2022 to recommend Emergency Use Authorization (EUA) for the vaccine for adults.1 2 3 4

The advisory panel voted 21-0, with one abstention, opening the way for EUA approval for NVX-CoV2373 by the FDA, which would make NVX-CoV2373 the fourth COVID biologic approved for use in the United States after Pfizer/BioNTech’s BNT162b2 (“Comirnaty”), Moderna/NIAID’s mRNA-1273 (“Spikevax”) and Johnson & Johnson/Janssen’s  Ad26.COV2.S.1 2 3 4 5

The lone abstention was from Bruce Gellin, MD, MPH of the Rockefeller Foundation. Dr. Gellin was not satisfied with the fact that Novavax had not provided VRBPAC with data on how NVX-CoV2373 performs against the Omicron variants that are currently circulating. Novavax also did not provide data on how long NVX-CoV2373 is effective in preventing severe COVID disease.3

Unlike the BNT162b2 and mRNA-1273 messenger RNA (mRNA) products, Novavax’s COVID vaccine does not induce human cells to produce the SARS-CoV-2 spike protein. Nuvaxovid takes a key protein from the SARS-CoV-2 virus and produces it in insect cells, which are then mixed with the Matrix-M adjuvant (from saponin compounds in the bark of the Soapbark tree) that stimulates a strong inflammatory response and the production of antibodies.6 7

FDA Should Include Warning About Heart Risks of NVX-CoV2373

VRBPAC member Michael Nelson, MD of the University of Virginia School of Medicine said that while he believes the benefits of NVX-CoV2373 “outweigh the risks,” he thinks the FDA should include a warning about the heart inflammation risks in the vaccine’s package insert.3 Dr. Nelson said:

It would be a travesty if we didn’t mention this in the documentation for the public to show the concern that we have.3

In an 80-page briefing document released on June 3 by the FDA, scientists at the agency expressed concerns about cases of myocarditis and pericarditis associated with NVX-CoV2373 (particularly in young males and within seven days after the second shot), similar to those that have been reported following receipt of the novel mRNA BNT162b2 and mRNA-1273 biologics.6 8 9

FDA scientists said that the identification of several vaccine-associated heart inflammation cases in the safety database with Novavax’s COVID vaccine “raises concern that if causally associated, the risk of myocarditis following NVX-CoV2373 could be higher than reported during post-authorization use of mRNA COVID-19 vaccines.” They also noted that the heart issues, which have been linked to the mRNA shots after Pfizer and Moderna were awarded an EUA to distribute their mRNA COVID vaccines in December 2020, had not been identified before the FDA granted the two companies permission to distribute their vaccines.6

FDA Reviewing Change in Novavax’s Manufacturing Process for NVX-CoV2373

The FDA stated that the granting of an EUA for NVX-CoV2373 would depend on evaluation Novavax’s manufacturing process for the product. Novavax informed the agency on June 3 that it had made changes to its manufacturing process for NVX-CoV2373. According to FDA scientists, “Testing and submission of manufacturing and product information for the NVX-CoV2373 product intended for use under EUA were still in process at the time of this review.”6 10

NVX-CoV2373 is designed to be given in two doses 21 days apart. It has reportedly been approved for distribution in about 40 countries.11


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9 Responses to "FDA Panel Recommends EUA for Novavax COVID-19 Vaccine"

  1. Tom   June 14, 2022 at 3:12 pm

    I’d trust the NY mafia before the FDA.

    Reply
  2. Jello   June 14, 2022 at 3:39 pm

    FDA is a revolving door for pHARMa employees.
    Regulatory capture.
    The fox is guarding the hen house.
    Defund & disband the FDA.

    Reply
  3. Greg Hill   June 14, 2022 at 3:48 pm

    “The FDA stated that the granting of an EUA for NVX-CoV2373 would depend on evaluation [of] Novavax’s manufacturing process for the product.” Since this authorization would not be legal if there were not an actual “emergency,” of course there will be no evaluation of whether or not there really is an emergency. Everyone with two neurons to rub together knows full well that there is no real emergency today. Everyone with three neurons to rub together knows that there never was a real emergency since day one of this “pandemic.” The proper place for anyone who is in any way responsible for providing Emergency Use Authorization for any “pandemic” related product of any kind today, be it a “vaccine” or a “medication,” is in prison, after having been tried and convicted for knowingly committing egregious fraud.

    Reply
  4. Ely   June 14, 2022 at 3:50 pm

    You’re still getting the spike protein which is toxic.

    Reply
  5. Gertrude   June 14, 2022 at 4:31 pm

    Why haven’t they labeled the mRNA vaccines with warnings about myocarditis and pericarditis? There have been lots of documented cases of those events (as well as other harmful events) in patients who have received them. The FDA has been putting off EUA for Novavax for a year or more. They are just pushing the mRNA vaccines. That is bothersome.

    Reply
  6. Data Detective   June 15, 2022 at 4:47 am

    How can the benefits out weigh the risks if it doesn’t work on omicron or the next strain?
    For what population is the benefits supposed outweigh the risks. Definitely not all.
    FDA has lost all creditability.
    At first people were lineing up to get a appointment for a vaccine.
    Now they won’t get a vaccine to save their job.
    Everybody knows the covid vaccine don’t work.
    Many know covid vaccine are dangerous.

    It is time to rid our government of all officials that supports vaccine mandate.
    VOTE

    Reply
  7. Jason   June 16, 2022 at 10:13 pm

    Those legislators who demanded forced vacations to the public and children should be treated weekly with the vaccination. All of congress as well.

    Reply
    • Kimberly   June 20, 2022 at 4:58 pm

      Great idea, however can we trust them to use an actual vaccine or just saline? If we could be certain it is what they want in all of us for some insane reason…Fauci needs to get jabbed weekly on television.

      Reply
  8. Register Voter   July 3, 2022 at 2:06 pm

    Not all of congress support vaccine mandate.!
    The US Senate voted 2X to remove vaccine mandate.

    In December 2021 US Senate voted to remove the OSHA vaccine mandatory.
    All Republican senators and 2 Democratic senators vote to remove vaccine mandate. 48 of 50 Democratic senator vote to keep OSHA vaccine mandatory.

    In 2022 US Senate vote to remove Medical vaccine mandatory.
    49 Republican senator vote to remove vaccine mandate. 42 Democratic senator vote to keep vaccine mandate.
    When all senators knew covid vaccine was not working and dangerous.
    The other 7 senators didn’t show.

    All Democratic senator vote to keep at least 1 mandate. While all Republican senators vote to remove vaccine mandatory.

    VOTE 🚫💉

    Reply

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