FDA Issues Myocarditis Warning for Non-mRNA Novavax COVID-19 Shot

In its review of the Novavax COVID-19 shot, the FDA issued a warning about the risk of myocarditis for the non-mRNA injection.

The company is seeking FDA emergency use authorization for the shot, positioning it both as a booster for the vaccinated and an alternative first shot for those who rejected the mRNA jabs.

But Novavax is pure garbage just like every single other COVID-19 shot.

Although the mRNA COVID-19 shots (Pfizer & Moderna) carry the risk of heart inflammation, the FDA made a blunt warning of myocarditis for the Novavax shot.

“US FDA issues warning of myocarditis for Novavax's COVID vaccine, suggesting a common factor being the spike protein across all vaccine platforms.” Via ⁦@Mod_Disc⁩ https://t.co/6SSsQEwuqK

— Sharell Cook (@AboutIndia) June 3, 2022

#Novavax vaccine is already authorised in other countries, particularly in Europe. https://t.co/iGmYs6HbZw

— WION (@WIONews) June 4, 2022

The Novavax COVID-19 shot is stated to be 90% effective at preventing new cases in a clinical trial, but nobody with common sense can take these pharmaceutical companies seriously.

AXIOS reported:

The staff evaluation comes days before an FDA advisory panel will decide whether to green-light the shot for use in adults 18 and over.

• The review noted instances in which people who took the vaccine had an increased risk of the heart conditions myocarditis and pericarditis, especially within seven days of the second shot.
• Four of the events occurred in young men, a subject population known to be at higher risk for mRNA COVID-19 vaccine-associated myocarditis.
• The study was conducted before the emergence of the Delta and Omicron variants, raising questions about the vaccine’s overall effectiveness.
• FDA staff said the shot is likely to provide some meaningful protection against severe disease from Omicron but that its utility as a booster needs to be evaluated further.
• There is not enough data to evaluate the safety of the vaccine in children, pregnant women and immunocompromised people, FDA staff said.

Catch up quick: Novavax was one of America’s first big bets under Operation Warp Speed, winning $1.6 billion in federal backing in 2020.

• The vaccine uses a protein from the target virus combined with what’s called an adjuvant which enhances the body’s immune response. It’s easier to store than Moderna and Pfizer’s vaccines.
• The company ran into early production problems and struggled to meet FDA standards. But it has won approval from regulators overseas, along with the World Health Organization and the European Commission for primary vaccination of adults 18 and older.

The FDA stated in its briefing document of the Novavax COVID-19 shot:

In clinical evaluation, local and systemic adverse reactions, usually lasting 1 to 3 days, were reported at higher frequencies among NVX-CoV2373 recipients as compared to placebo recipients. The most common solicited adverse reactions were injection site pain/tenderness, fatigue, headache, and myalgia. Overall, solicited reactions were reported more commonly in younger participants. Hypersensitivity reactions and lymphadenopathy were observed post vaccination. Reporting rates of medically attended adverse events, serious adverse events, and potential immune-mediated medical conditions in the clinical trials were generally low and balanced between NVX-CoV-2373 and placebo arms.

Myocarditis events were identified across the clinical development program, including four events of myocarditis (and one additional event that in FDA’s assessment is clinically consistent with myocarditis) within the 20-day window post vaccination. There were no myocarditis cases in the placebo arm within 0-20 days post vaccination. These events raise the concern for a causal association with this vaccine, similar to the association documented with mRNA COVID19 vaccines. Data from passive surveillance during post-authorization use in other countries also indicate a higher than expected rate of myocarditis and pericarditis (mainly pericarditis) associated with the vaccine. However, interpretation of these passive surveillance data is not straightforward, and further evaluation is needed to inform the risk of myocarditis and pericarditis associated with this vaccine, and their outcomes, as additional data emerge over time.

One case of Guillain-Barre syndrome was observed in the clinical development program, in temporal association post-vaccination and without an identified alternative cause. Guillain-Barre syndrome is known to be associated with other vaccines.

Modern Discontent explained the technology behind the Novavax shot:

Novavax’s vaccine, named Nuvaxovid or Covavax (NVX-CoV2373) follows a more traditional vaccine design with a few bells and whistles added. This vaccine is considered a protein/antigen-based vaccine, as it utilizes the actually spike protein of the SARS-COV2 virus rather than utilizing mRNA technology to produce the spike.

While mRNA vaccines are the “Blue Aprons” of the vaccine world- order the vaccine and assemble it yourself- Novavax’s vaccine is the takeout version- order it, pick it up, and you’re done. No assembly needed.

But the spike protein can’t quite exist on its own. It needs some help in its presentation. Here, Novavax utilizes an interesting technology called an Immune Stimulating COMplex, or ISCOM for short. ISCOMs are comprised of a compound that is intended to stimulate an immune response (called an adjuvant) as well as a good mix of cholesterol and phospholipids. It essentially mimics a cell membrane studded with the antigen and serves as a way to present the antigen to the immune system. For Novavax, their ISCOM is a propriety formulation called Matrix-M and contains all of the agents indicated above.

The overall ISCOM structure supposedly looks similar to that of an antigen-studded tennis ball:

*Source – Modern Discontent*

This structure is quite unique, as it doesn’t have to present with only one antigen. Instead, this ISCOM structure can present with several antigens including those from other respiratory viruses. Just a few days ago Novavax reported the initial results of a Phase I/II clinical trial of a vaccine utilizing both SARS-COV2 and Influenza antigens. This “antigen cocktail” is intended to provide several vaccines in one go rather than the multiple typically needed.

The immune-stimulating adjuvant that makes up this ISCOM is a saponin called Quillaja saponins and are derived from the Quillaja saponaria Molina plant found in South American countries such as Peru and Chile.

Saponins derive their name from the latin root sapon which means soap1. When added to water saponins form bubbles. This comes from the amphiphilic nature of saponins which are comprised of polar, water-loving groups as well as nonpolar, lipid-loving groups. This allows them to serve as good emulsifiers by interacting with both water and lipid-based structures, allowing for the formation of the ISCOM structure while aiding in the structure’s overall solubility. Because of this, Q. saponins have been used extensively in many foods and cosmetics (from Fleck et. al.2):

As far as the spike protein, the spike utilized in Novavax’s COVID-19 shot is the full-length spike glycoprotein…of the Wuhan strain.

The report also noted that “this vaccine is likely to suffer from the same issues that the Adenovirus and mRNA vaccines suffer from as they are presenting an old antigen that is no longer circulating among the population4. Keep in mind that we don’t have any data of Nuvaxovid against Omicron aside from evidence about a booster’s effectiveness.”

In other words, expect the Novavax COVID-19 shot to have similar side effects to the mRNA and adenovirus injections.

They belong in the garbage like the others.

After the FDA’s myocarditis warning, Novavax’s stocks took a major hit.

Is it the end of COVID vaccine stocks?
Novavax shares are down 17% early Friday – after the FDA published some briefing documents on its COVID vaccine.
FDA expressed concern over four cases of myocarditis after administration of the shot in pivotal trials.https://t.co/obtS3zoQ9M

— Ran Israeli (@RanIsraeli) June 3, 2022

Seeking Alpha wrote:

Novavax (NASDAQ:NVAX) shares are down 17% in early Friday trading after U.S. FDA briefing documents on its COVID-19 vaccine expressed concern over four cases of myocarditis — a rare heart inflammation — after administration of the shot in pivotal trials.

There was one case of myocarditis observed 20 days post vaccination in the placebo arm of the pivotal studies, though the FDA said that it was unrelated to the placebo vaccination. Two cases of pericarditis were also associated in the treatment arm. The FDA said the results “raise a concern for a causal association” between the vaccine, NVX-CoV2373, and myocarditis.

“Data from passive surveillance during post-authorization use in other countries also indicate a higher than expected rate of myocarditis and pericarditis (mainly pericarditis) associated with the vaccine,” according to U.S. FDA briefing documents ahead of an advisory committee meeting.