What Would a Novavax Covid-19 Vaccine Mean in the US?

A committee of independent, expert advisers for the Food and Drug Administration voted to approve the two-dose Novavax Covid-19 vaccine, with 21 of 22 committee members voting in favor of the vaccine and one member abstaining.

The endorsement only applies to the two-dose primary series. The FDA doesn't have to follow the advice of the Vaccines and Related Biological Products Advisory Committee, but it usually listens to it. The vaccine will need to be approved by the CDC before it can be used.

It is not easy to make a decision about the Novavax vaccine in the US. The vaccine has a number of strikes against it.

The design is traditional.

The vaccine is a more traditional recipe than the two Covid-19 vaccines or the adenoviruses design. Both of those designs work by delivering genetic code to our cells, which then translate the code. The saponin compounds used in the vaccine have been used in FDA-approved vaccines before.

The design of the vaccine is usually tried and trusted; it's already used in vaccines against flu and meningococcal infections.

Who would get the item?

The traditional design was used in the pitch to the FDA. Most people who want to get vaccine have already gotten it, since it's easy to get in the US. This raises a question of what role Novavax's vaccine has left to play and how it should be used given the availability of other vaccines.

According to the CDC, there are 27 million vaccine holdouts. If an alternative that is perceived to be more conventional is offered, they could finally be swayed to get vaccine.

Poland spoke on behalf of the Novavax vaccine at yesterday's meeting. Having a vaccine platform that multiple stakeholders are familiar with can help mitigate some of the challenges we are facing today.

Peter Marks, the top FDA vaccine regulator, seemed to think that another option would hold out. Marks said that there is a problem with vaccine take-up that is very serious in the United States and that anything we can do to get people more comfortable to be able to accept these potentially life-saving medical products is something that we are compelled to do. There are some Americans who aren't able to get a vaccine due to adverse reactions, which is a good thing.

Efficacy, variations, and safety.

In February, Novavax's vaccine had solid efficacy estimates in a clinical trial. The vaccine had an efficacy estimate of 90.4 percent against Covid-19. There may be a link between the vaccine and rare cases of heart inflammation.

The trial was finished last year before Delta and Omicron arrived. The vaccine's efficacy is not certain.