A committee of independent, expert advisers for the Food and Drug Administration voted overwhelmingly to authorize the two-dose Novavax Covid-19 vaccine yesterday, with 21 of twenty-two committee members voting in favor of the vaccine and one member abstaining.
The endorsement is just for a two-dose major sequence in adults, not for boosters. The FDA isn’t obligated to observe the recommendation of its committee—the Vaccines and Related Biological Products Advisory Committee (VRBPAC)—however the company usually heeds its recommendation. If the FDA authorizes the vaccine, the Centers for Disease Control and Prevention might want to log out on use earlier than it turns into obtainable.
The choice relating to the Novavax vaccine, which is already approved in dozens of different nations, isn’t a simple one within the US. The vaccine has some benefits over presently authorized vaccines however has a number of strikes towards it.
When it comes to design, the vaccine follows a extra conventional recipe than the 2 mRNA-based Covid-19 vaccines or Johnson & Johnson’s adenovirus vector-based design. Each of these designs are comparatively new and work by delivering genetic code for the SARS-CoV-2 spike protein to our cells, which then translate the code. The Novavax vaccine, alternatively, is a protein subunit-based vaccine that instantly delivers the SARS-CoV-2 spike protein to cells, together with an adjuvant—which is an additive utilized in vaccines to boost immune responses to the vaccine. On this case, the adjuvant is derived from saponin compounds discovered within the Chilean soapbark tree, which have been utilized in FDA-approved vaccines beforehand.
Typically, the protein-subunit vaccine design is tried and trusted; it is already utilized in vaccines towards flu, pertussis (whooping cough), and meningococcal an infection, for instance.
Who Would Get It?
Novavax leaned onerous into the standard design in its pitch to the FDA. Now that we’re greater than two years into the pandemic and mRNA vaccines are available within the US, most individuals who need to get vaccinated have already gotten their pictures. This raises a key query of what position Novavax’s vaccine has left to play and the way it warrants “emergency use” authorization given the supply of different vaccines.
The corporate firmly aimed its conventional pictures at vaccine holdouts, which the CDC estimates to quantity round 27 million. They could be cautious of the extra progressive mRNA vaccines however may lastly be swayed to get vaccinated if supplied another that’s perceived as extra typical, Novavax argued.
“Tens of millions of People right now are nonetheless unvaccinated,” mentioned Greg Poland, director of the Mayo Vaccine Analysis Group, who spoke on behalf of the Novavax vaccine at yesterday’s assembly. “For these people who should not totally vaccinated and are ready for an additional possibility, having a vaccine platform that a number of stakeholders—together with regulators, physicians, and the general public—are aware of may help mitigate among the challenges we’re going through right now.”
Although some committee members had been skeptical that another choice would sway holdouts, prime FDA vaccine regulator Peter Marks appeared to purchase it. “We do have an issue with vaccine uptake that could be very critical in the USA, and something we are able to do to get individuals extra snug to have the ability to settle for these probably life-saving medical merchandise is one thing that we really feel we’re compelled to do,” Marks mentioned. He additionally famous that some People aren’t capable of get mRNA vaccines on account of adversarial reactions, thus the protein-based vaccine could be a welcome new possibility.
Efficacy, Variants, and Security
Novavax’s vaccine had stable efficacy estimates in a medical trial printed in February in The New England Journal of Medicine. Within the trial of greater than 29,000 individuals, the vaccine had an total efficacy estimate of 90.4 p.c towards symptomatic Covid-19. Security information for the vaccine suggests it is usually secure and properly tolerated, although there could also be a hyperlink to uncommon instances of coronary heart irritation (myocarditis) seen with the mRNA vaccines.
That mentioned, the trial was accomplished final yr earlier than Delta and Omicron (with all its subvariants) got here alongside. It is unclear how the vaccine’s efficacy will stand as much as these newer variants.