A committee of Independent consultant, expert give Food and Drug Administration voted overwhelmingly to allow Novavax two doses Covid-19 vaccine yesterday, with 21 of the 22 committee members voting in favor of the vaccine and one abstaining.
The endorsement is for the adult two-dose main series only, not for the booster. FDA is under no obligation to follow the committee’s advice – the Advisory Committee on Vaccines and Related Biological Products (VRBPAC) —but the agency generally follows its advice. If the FDA approves the vaccine, Centers for Disease Control and Prevention will need to register to use it before it is available.
The decision regarding the Novavax vaccine, which has been licensed in dozens of other countries, is not a simple one in the US. This vaccine has some advantages over currently approved vaccines but has some effects against it.
In terms of design, this vaccine follows a more traditional formulation than Johnson & Johnson’s two mRNA-based Covid-19 vaccines or the adenovirus vector-based design. Both of these designs are relatively new and work by delivering the genetic code for the SARS-CoV-2 mutant protein to our cells, which they then translate. Novavax vaccine, on the other hand, is a protein subunit based vaccine that delivers the SARS-CoV-2 spike protein directly to cells, along with an adjuvant – which is an additive used in vaccines to enhance the immune response to vaccines. In this case, excipients Derived from saponin compounds found in the Chilean soap tree, which has been used in previously FDA-approved vaccines.
In general, the protein subunit vaccine design has been tested and is reliable; It has been used in vaccines against influenza, pertussis (whooping cough), and meningococcal infections, for example.
Who will get it?
Novavax has a strong focus on traditional design to tout the FDA. Now that we are more than two years into the pandemic and an mRNA vaccine is available in the US, most of the people who want to get vaccinated are already vaccinated. This raises a key question about the role of the Novavax vaccine and how it ensures “emergency use” with the availability of other vaccines.
The company resolutely targets its traditional injections at vaccine stockpiles, which the CDC estimates at around 27 million. They may be wary of mRNA vaccine but could ultimately be swayed to vaccination if offered an alternative that is considered more conventional, Novavax argues.
“Millions of Americans today are still unvaccinated,” said Greg Poland, director of the Mayo Vaccine Research Group who represents the Novavax vaccine. “For individuals who are not fully immunized and are waiting for another option, having a vaccine platform that many stakeholders — including regulators, physicians, and the public — are familiar with could help mitigate some of the challenges we face today.”
Although some committee members doubted that another option would affect viability, Peter Marks, the FDA’s top vaccine administrator, is likely to buy it. “We really have a very serious vaccine uptake problem in the United States, and anything we can do to make it more comfortable for people to accept potentially medical products. Saving lives is something we feel compelled to do,” says Marks. He also noted that some Americans are unable to get the mRNA vaccine due to adverse reactions, so a protein-based vaccine would be a welcome new option.
Efficacy, Variation and Safety
Novavax’s vaccine had solid efficacy estimates in a clinical trial published in February. New England Journal of Medicine. In the trial with more than 29,000 participants, the vaccine had an overall efficacy estimate of 90.4 percent against symptomatic Covid-19. The vaccine’s safety data suggest it is generally safe and well-tolerated, although there may be an association with the rare cases of heart inflammation (myocarditis) seen with mRNA vaccines.