With 21 committee members voting in favor and one abstaining, the decision cleared the way for the United States to have a new immunization option for protection against the novel coronavirus. The Pfizer-BioNTech and Moderna vaccines rely on a relatively new technology that uses mRNA, whereas the Novavax shot is a protein-based vaccine (similar to the flu shot); public health advisers hope its proven development technique will persuade many who are unvaccinated to finally get their shots. The Centers for Disease Control and Prevention (CDC) estimates that about 27 million U.S. adults have not yet received any form of COVID-19 vaccination. “The Novavax COVID vaccine is created using very traditional vaccine production methods,” says William Schaffner, MD, an infectious-disease specialist and a professor of preventive medicine and health policy at the Vanderbilt University School of Medicine in Nashville, Tennessee. “As such, I hope that it will provide reassurance to some people who have so far been hesitant to be vaccinated. It will protect them as individuals and also contribute to making their families and communities safer.”
Promising Results in Study
Given in two doses three weeks apart, the vaccine appears to provide a high level of protection. A study involving about 30,000 participants published in the New England Journal of Medicine in February this year found the product demonstrated a 90.4 percent efficacy rate in preventing symptomatic COVID-19. None of the participants experienced moderate or severe virus symptoms. An FDA briefing document pointed out that the research was conducted when the original alpha strain of the virus was predominant, prior to the emergence of the more contagious delta and omicron variants. Although existing vaccinations have demonstrated decreased effectiveness against circulating omicron variants, the paper said that, judging by the efficacy estimate in the clinical trial of this vaccine, “it is more likely than not that the vaccine will provide some meaningful level of protection against COVID-19 due to omicron, in particular against more severe disease.” Whether a booster of the Novavax product will provide additional protection remains a question to be further evaluated, according to advisory committee members.
Some Side Effects Reported
While very few serious side effects were reported during study of the vaccine, five instances of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane surrounding the heart) were identified within two weeks of vaccination. FDA materials said these rare heart events are “concerning for a causal association,” and written materials accompanying the vaccine should flag such a risk. While the World Health Organization granted emergency use of the Novavax shot in December 2021, and it is currently available in at least 170 countries, The Washington Post noted June 7 that a decision to authorize the vaccine may not happen immediately because a review of the manufacturing process is ongoing. Stanley Erck, the president and chief executive officer of Novavax, said in a statement, however: “Consistent with submissions to regulatory authorities worldwide, we have already submitted an amendment with updated manufacturing information for the EUA to the FDA for review.” Novavax is currently investigating a seasonal influenza–COVID combination vaccination and an omicron-strain-specific inoculation as well.
