The Centers for Disease Control and Prevention on Tuesday recommended the use of a newly licensed vaccine from Novavax as an option for adults seeking primary immunity to the coronavirus.
Dr. Rochelle Walensky, director of the CDC, approved the recommendation of a committee of vaccine experts who unanimously approved the vaccine on Tuesday afternoon. This decision removes the final regulatory hurdle for the fourth Covid-19 shot approved in the United States.
The Novavax vaccine is expected to play a limited role in national immunization campaigns, at least initially. Last week, the Food and Drug Administration approved it as primary immunity for adults, but has not yet considered booster shots.
Maryland’s pharmaceutical company Novavax received a large amount of federal funding to develop the shot, but was far behind in the vaccine race. Still, I hope the shot will appeal to Americans who have previously refused to vaccinate.
According to survey data released at the conference by CDC Dr. Katherine Fleming-Dutra, 26 to 37 million adults in the United States have not yet been vaccinated with the coronavirus vaccine.
But in countries where it has been available for months, Novavax shots have not yet had a significant impact on vaccination coverage. In a presentation to the panel on Tuesday, Novavax said that by the end of June, more than one million vaccines had been given worldwide. This is negligible compared to the reach of competing shots.
The Biden administration announced last week that it would buy 3.2 million doses of Novavax two-shot vaccine, enough to fully vaccinate 1.6 million people in the United States. The vaccine is not yet available at pharmacies or other clinics that administer shots. In a post-voting news release, Novavax said the FDA has approved the first dose to the United States and the company plans to ship the vaccine to distribution centers “in the next few days.”
The vaccine, given twice at 3-week intervals, has been found in clinical trials to be very protective against coronavirus infections and serious illnesses. However, these were performed prior to the emergence of Omicron variants, which significantly reduced the effectiveness of other licensed vaccines in infection prevention.
The Novavax vaccine behaves differently than the three previously approved Covid vaccines in the United States. It provokes an immune response with nanoparticles composed of proteins from the surface of the coronavirus that causes Covid-19. Similar protein-based vaccines have been used worldwide for decades.
CDC’s Dr. Evelyn Twentyman published the results of a study suggesting that unvaccinated Americans are relatively less likely to choose Novavax. Only 16% of unvaccinated respondents said they would “probably” or “certainly” receive a protein-based Covid vaccine, and 50% of unvaccinated respondents “probably” or “certainly” vaccinated. I answered that I would not.
At a meeting on Tuesday, CDC officials reviewed clinical trial data linking the vaccine to a higher but lower risk of developing a form of heart inflammation known as myocarditis or pericarditis.
Dr. Filip Dubovsky, Chief Medical Officer of Novavax, said at a meeting that the company is monitoring cases of carditis in countries where vaccines have already been approved. He said the company investigated over a million doses and identified 17 distinct or possible cases of myocarditis and pericarditis.
