Regulatory Novavax COVID-19 moves one step closer to FDA approval 

Novavax COVID-19 moves one step closer to FDA approval 

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The U.S. Food and Drug Authority’s (FDA) committee has unanimously voted to recommend Novavax’s Covid vaccine for authorized use in the U.S. The vaccine is two-dose and is to be administered to adults. 

FDA’s committee approval for the Novavax vaccine could soon lead to the vaccine being distributed across the country. The FDA is not under an obligation to follow committee recommendations although mostly it does. 

Another major approval would need to come from the Centers for Disease Control (CDC). After the CDC approves the vaccine shots the healthcare workers can begin the process to administrate the vaccine to the population.

With Novavax’s approval, the country would have a total of 4 approved COVID-19 shots, however, this would be the first vaccine approved in over a year. The last vaccine that was cleared was Johnson & Johnson’s. 

While Novavax was in the vaccine race since the pandemic began, it wasn’t able to produce its clinical data at the same time as other companies such as Moderna. Novavax’s vaccine was developed with funding from Operation Warp Speed totaling almost $2 billion. 

This vaccine is different from the ones developed by Moderna and Pfizer as it uses protein technology as opposed to messenger RNA technology. The protein technology used by Novavax is similar to the vaccines developed for HPV and hepatitis B.

Thus, the Novavax vaccine after receiving FDA approval can be an option for U.S. citizens who do not want to opt for messenger RNA-based vaccines. While Johnson & Johnson’s vaccine is an option as well, due to the risk of blood clots associated with the vaccine its use is limited. 

Only 24% of the U.S. population has not received two complete doses of COVID-19 vaccine. The company believes that it can appeal to some of this 27 million population as people may want to opt for a vaccine like Novavax that has been developed on technology that has existed for many years now, as opposed to the newer mRNA technology.

The clinical trial for Novavax revealed 90% effectiveness at preventing COVID-19-related illness with a 100% effectiveness against severe disease. The trial was conducted in both the U.S. and Mexico, however as the trial ended by September 2021, the vaccine’s efficacy against the Omicron variant has not been studied as Omicron had not spread across North America at that time. 

A company representative commented that “It’s factual that we don’t have efficacy data against omicron, what we do have is a technology that we think generates a broad immune response, demonstrated against a broad array of variants.”

Novavax Chief Medial Officer explained to the FDA panel that to reach a similar efficacy against Omicron that was achieved by the vaccine in the trial against the initial, Wuhan based strain of the virus, three doses of Novavax have to be administered. The company will be asking the FDA to authorize the third dose after the first two are approved.

The side effects of the vaccine include soreness at the injection site, headache, muscle pain, and fatigue. 

4 out of 40,000 of those vaccinated reported myocarditis or pericarditis shortly after the vaccine dose, which the FDA raised as a possible concern. 

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