A committee of impartial, skilled advisors for the Meals and Drug Administration voted overwhelmingly to authorize the two-dose Novavax COVID-19 vaccine Tuesday, 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 main sequence in adults, not for boosters. The FDA is just not obligated to observe the recommendation of its committee—the Vaccines and Associated Organic Merchandise Advisory Committee (VRBPAC)—however the company sometimes heeds its recommendation. If the FDA authorizes the vaccine, the Facilities for Illness Management and Prevention might want to log off on use earlier than it turns into obtainable.
The choice concerning the Novavax vaccine, which is already approved in dozens of different international locations, is just not a simple one within the US. The vaccine has some benefits over presently permitted vaccines however has a number of strikes in opposition to it.
By way of 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 in opposition to flu, pertussis (whooping cough), and meningococcal an infection, for instance.
Who would get it?
Novavax leaned exhausting into the normal 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 photographs. 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 photographs at vaccine holdouts, which the CDC estimates to quantity round 27 million. They could be cautious of the extra progressive mRNA vaccines however might lastly be swayed to get vaccinated if provided an alternate that’s perceived as extra typical, Novavax argued.
“Hundreds of thousands of Individuals at this time are nonetheless unvaccinated,” mentioned Greg Poland, director of the Mayo Vaccine Analysis Group, who spoke on behalf of the Novavax at Tuesday’s assembly. “For these people who are usually not totally vaccinated and are ready for one more choice, having a vaccine platform that a number of stakeholders—together with regulators, physicians, and the general public—are conversant in can assist mitigate a number of the challenges we’re going through at this time.”
Although some committee members have been skeptical that another choice would sway holdouts, high FDA vaccine regulator Peter Marks appeared to purchase it. “We do have an issue with vaccine uptake that could be very severe in the USA, and something we will do to get folks 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 Individuals aren’t in a position to get mRNA vaccines resulting from antagonistic reactions, thus the protein-based can be a welcome new choice.
Efficacy, variants, and security
Novavax’s vaccine had strong efficacy estimates in a scientific trial printed in February in the New England Journal of Medication. Within the trial of greater than 29,000 individuals, the vaccine had an general efficacy estimate of 90.4 p.c in opposition to symptomatic COVID-19. Security information for the vaccine suggests it is typically secure and well-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 12 months 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.
The one abstention vote Tuesday—solid by committee member Bruce Gellin, chief of world public well being technique at The Rockefeller Basis—was associated to the variant downside. “The information that we have heard at this time and seen at this time has been spectacular,” Gellin mentioned, notably in opposition to extreme outcomes. “However we do not know whether or not that attribute continues to be related at this time… we do not actually know whether or not it is more likely to be efficient going ahead and what the period of that safety is perhaps.”
He clarified that he did not need to vote in opposition to the vaccine however would solely supply a conditional vote in favor, given the restricted information.
Storage and manufacturing
The Novavax vaccine has a bonus over mRNA vaccines by way of storage. The vaccine doesn’t should be saved frozen; as an alternative, it may be saved at fridge temperatures.
However, Novavax has had intensive manufacturing setbacks, which can imply any future rollout will likely be gradual. Final summer season, its Texas-based subcontractor, Fujifilm Diosynth Biotechnologies, stopped making the vaccine after the FDA discovered issues on the facility. Novavax then switched to the Serum Institute of India. The problems got here up in Tuesday’s FDA assembly, with the company noting that it successfully needed to ignore a number of the firm’s scientific trial information as a result of the manufacturing processes for the doses modified over time.