FDA Grants EUA for Novavax’s COVID Vaccine

FDA Grants EUA for Novavax’s COVID Vaccine

Opinion | On July 13, 2022, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to Novavax to distribute its experimental two-dose NVX-CoV2373 (also known as “Nuvaxovid” and “Covovax”) COVID-19 vaccine for use by adults. The decision was expected, given the favorable recommendation by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on June 6.1 2 3

In fact, so anticipated was the EUA approval that two days prior to the FDA decision, on July 11, the Biden administration announced its intention to procure 3.2 million doses of Nuvaxovid. In a July 11 press release, the U.S Department of Health and Human Services (HHS) stated it had “secured 3.2 million doses of Novavax’s COVID-19 vaccine.”4 5 6 HHS added:

The protein-based, adjuvanted vaccine will be made available for free to states, jurisdictions, federal pharmacy partners, and federally qualified health centers if it receives U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA), and recommendation from the Centers for Disease Control and Prevention (CDC). The company is expected to complete all necessary quality testing in the next few weeks, which would support final release of the product.5

Securing these vaccines leverages preexisting U.S. Government agreements with Novavax, including a July 2020 agreement for the development and demonstration of large-scale manufacturing of a SARS-CoV2 vaccine. The government will be taking delivery of COVID-19 vaccine doses manufactured using funds remaining on the existing agreement, pending completion of all quality testing.5

Nuvaxovid is a Protein-Based COVID Vaccine

While three COVID biologics have already been approved for use in the United States by the FDA, Nuvaxovid is a more conventional protein-based vaccine than the messenger RNA (mRNA) biologics (BNT162b2 and mRNA-1273) developed by Pfizer/BioNTech and Moderna/NIAID, which use never-before-licensed genetic engineering technology. The Pfizer and Moderna COVID vaccines have been associated with more than one million adverse event reports to the federal Vaccine Adverse Event Reporting System (VAERS).7

Novavax and public health officials have expressed hopes that Novaxovid will be an acceptable COVID vaccine option for people who do not feel comfortable with the new mRNA technology.

“Novavax COVID-19 Vaccine offers an option to individuals who may have an allergic reaction to mRNA vaccines or who have a personal preference for receiving a vaccine other than a mRNA-based vaccine,” notes HHS.5

According to an article in The Vaccine Reaction last month:

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.8

Blood Clot Risk with J&J’s Adenovirus-Based DNA COVID Vaccine

The third COVID biologic that was approved by the FDA prior to the Novavax COVID vaccine is one produced by Johnson & Johnson/Janssen. It is different from both the Pfizer/BioNTech and Moderna/NIAID biologics, as well as the Novavax vaccine. The adenovirus-based J&J biologic is known as Ad26.COV2.S and it works by delivering a piece of the genetic material (DNA) of the SARS-CoV-2 virus to cells, which then  produce the spike protein. The immune system then responds by creating antibodies.9

“Once the adenovirus gets inside your cell, the spike protein gets manufactured by your own cellular mechanisms,” James Lawler, MD, MPH said.9

The one-dose Ad26.COV2.S, however, has had safety problems and has not been as widely distributed to the U.S. population compared to Pfizer’s BNT162b2 (also known as “Comirnaty”) and Moderna’s mRNA-1273 (or “Spikevax”) biologics. On May 6, 2022, the FDA limited the use of Ad26.COV2.S to individuals 18 years old over for whom “other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive the Janssen COVID-19 vaccine because they would otherwise not get a COVID-19 vaccine.”10

In a press release, the FDA said:

After conducting an updated analysis, evaluation and investigation of reported cases, the FDA has determined that the risk of thrombosis with thrombocytopenia syndrome (TTS), a syndrome of rare and potentially life-threatening blood clots in combination with low levels of blood platelets with onset of symptoms approximately one to two weeks following administration of the Janssen COVID-19 Vaccine, warrants limiting the authorized use of the vaccine.10

The blood clotting problem has persistently plagued J&J’s Ad26.COV2.S vaccine. Last year, the FDA ordered a 10-day pause on its distribution. FDA warnings of heart and neurological issues, including a possible link to Guillain-Barré syndrome (GBS), have had the effect of lowering public confidence in the product.8 11 12 13

The reported safety issues with the Pfizer and Moderna mRNA COVID vaccines, as well as with J&J’s adenovirus vectored DNA vaccine, may have helped open the way for Nuvaxovid as an alternative, despite reported risks of developing myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining of the heart) following vaccination with the Novavax product

EMA Warns of Severe Adverse Reactions to Novavax COVID Vaccine

The day after the FDA approved Nuvaxovid, the European Medicines Agency (EMA) issued a warning of severe allergic reactions as a rare adverse reaction to that vaccine. Within the European Union (E.U.), approximately 250,000 doses of Nuvaxovid have been administered, and there have been a few cases of anaphylaxis reported shortly after vaccination. “Because anaphylaxis can occur with all vaccines and based on these cases, Novavax and the EMA agreed to update the [vaccine’s product] label accordingly,” Novavax  said in a public statement.14

The EMA plans to place a warning label on the Nuvaxovid vaccine for the risk of anaphylaxis, paraesthesia (tingling, pricking, chilling, burning or numbness of the skin) and hypoaesthesia (decreased feeling or sensitivity in a part of the body, but especially the skin).15


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Note: This commentary provides referenced information and perspective on a topic related to vaccine science, policy, law or ethics being discussed in public forums and by U.S. lawmakers.  The websites of the U.S. Department of Health and Human Services (DHHS) provide information and perspective of federal agencies responsible for vaccine research, development, regulation and policymaking.

Click here to view References:

1 Constantino AK. Novavax’s new Covid vaccine is perfect for people scared of mRNA tech—but it won’t win over the unvaccinated. CNBC July 15, 2022.
2 Johnson CY. FDA authorizes Novavax coronavirus vaccine, adding to pandemic arsenal. The Washington Post July 13, 2022.
3 Reuters. U.S. FDA authorizes Novavax COVID vaccine for adults. July 14, 2022.
4 Howell T. Biden team secures 3.2M doses of Novavax COVID-19 vaccine ahead of FDA action. The Washington Times July 11, 2022.
5 Press Release. Biden-Harris Administration secures 3.2 million doses of Novavax COVID-19 Vaccine. U.S. Department of Health and Human Services July 11, 2022.
6 Scripps National. Biden administration orders millions of Novavax COVID-19 vaccine doses. ABC7 Denver July 11, 2022.
7 National Vaccine Information Center. MedAlerts.org.
8 TVR Staff. FDA Panel Recommends EUA for Novavax COVID-19 Vaccine. The Vaccine Reaction June 13, 2022.
9 Nebraska Medicine. How the Johnson & Johnson COVID-19 vaccine works. Apr. 12, 2021.
10 Press Release. Coronavirus (COVID-19) Update: FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals. FDA May 5, 2022.
11 Bugos C. Johnson & Johnson Vaccine to Include Warning About Guillain-Barré Syndrome. Verywell Health July 22, 2021.
12 Hobley N. Worry About Johnson & Johnson COVID Vaccine Safety Persists. The Vaccine Reaction Aug. 2, 2022.
13 Parpia R. Johnson & Johnson’s COVID-19 Vaccine Suspended After Blood Disorder Reports. The Vaccine Reaction Apr. 19, 2021.
14 Newman C. EMA adds allergic reaction warning to Novavax’s COVID-19 vaccine. Biopharma Dive July 15, 2022.
15 Parkinson J. EMA Plans Anaphylaxis Label on Novavax COVID-19 Vaccine. Contagion Live July 15, 2022.

3 Responses to "FDA Grants EUA for Novavax’s COVID Vaccine"

  1. Fowell the $   July 19, 2022 at 10:20 pm

    Do they really believe we would take this 💉💉. ?
    If we didn’t trust the MRNA that FDA approved, we don’t trust FDA .

    GAME OVER.

    Reply
  2. MrsB   July 20, 2022 at 1:22 pm

    I agree! The toxic element (the spike protein) is in this experimental injection as well.

    Reply
  3. covIDIOTS   July 20, 2022 at 3:28 pm

    And why is this still being called a “vaccine”?? It’s not! it’s gene “therapy”, which is going to create a huge amount of havoc in the future.

    Reply

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