On Tuesday, the FDA’s vaccine advisors will meet to decide whether to approve the Novavax COVID-19 vaccine. The committee will decide as to whether the benefits of the two-dose vaccination outweigh the risks for people aged 18 and up, according to an 80-page briefing report published on Friday.
An FDA inspection determined that the vaccine was effective against severe, moderate, or mild COVID-19 for approx. 2.5 months after the two doses were completed based on the data in the document. Adults aged 65 and up had a 78.6 percent effectiveness rate.
These figures, according to CNN, were gathered prior to the Omicron variant. The efficacy and duration of protection against the most recent subvariants of the vaccine are unknown. Novavax’s vaccine has “broad cross-creativity against Omicron and its variants in a primary two – dose treatment plan, with increased responses following a 3rd dose at 6 months,” as per a late December announcement.
The FDA would also take into account Novavax vaccine side effects such as fatigue, muscle aches, headaches, and injection site pain. The vast majority of reported reactions were mild and moderate in severity and only lasted for few days. In contrast, the FDA defined rare cases of pericarditis and myocarditis, both of which involve inflammation of heart muscle and surrounding tissue.
6 cases of pericarditis and myocarditis occurred after receiving the Novavax vaccine, according to the briefing document. There were five among males between the ages of 16 and 67. Five of the 6 patients were admitted to the hospital. They have now recovered.
Novavax stated in a remark released on Friday that the rate of myocarditis is “within the expected level” and comparable to the group who received a placebo. Furthermore, the company claimed that there really is “insufficient evidence” to link the vaccine to myocarditis or pericarditis.
“We’ve learned that in any large enough database, we can anticipate natural background myocarditis events, and the young men are at a higher risk,” the organisation said. “The most common cause of myocarditis is nonspecific viral infections.”
The “known advantages” over placebo of Novavax vaccine recipients, according to the FDA briefing document, include a “reduced risk of severe COVID-19 infection occurring at least seven days after the 2nd primary vaccinations.” The committee hearing will be live streamed on the FDA’s website or on YouTube.
Novavax, according to CNN, applied for FDA approval in January end. The EU, Austria, the UK, Canada, India, New Zealand, Philippines and the South Korea were the first to give the Novavax vaccine emergency approval in November.
Despite the fact that the majority of adults in the US have already had coronavirus vaccination, the Novavax vaccine is being considered for booster doses, irrespective of the initial vaccine series received.
Furthermore, the vaccine is viewed as a supplement for those who have not previously been immunised. Novavax created a protein subunit vaccine, that is more traditional than Moderna and Pfizer’s mRNA vaccines. Other well-known subunit vaccines, according to CNN, include the pertussis and hepatitis B vaccines. Protein-based vaccines, according to CNN, cause the body’s immune system to recognise modified pieces of the virus. Coronavirus spike protein fragments are included in the Novavax vaccine.
In a January statement, Novavax CEO Stanley Erck said, “We believe that the vaccine we has a offers a distinct option built on a well-studied protein-based vaccine platform that is a substitute to the portfolio of currently offered vaccines to help fight the COVID-19 pandemic.”
Novavax is working on a vaccine for the Omicron variant. Last week, the organization announced the start of a Phase 3 clinical trial in Australia with 1,340 participants. The vaccine is now being evaluated as a booster dose for people who have earlier received mRNA vaccines. According to the company, the trial would last ten months, with preliminary results likely in the “second half of 2022.”