FDA Clears 4th COVID Vaccine Option

Novavax shot has been approved for adults
By Newser Editors and Wire Services
Posted Jun 8, 2022 1:41 AM CDT
Updated Jul 13, 2022 5:15 PM CDT
US Could Soon Have a 4th COVID Vaccine Option
In this image provided by the Serum Institute of India, vials of freshly manufactured Novavax COVID-19 vaccines wait to be labeled in 2022, in Pune, India.   (Serum Institute of India for Novavax via AP, File)

Update: The US is getting another COVID-19 vaccine choice. The Food and Drug Administration on Wednesday cleared Novavax shots for adults. Novavax makes a more traditional type of shot than the three other COVID-19 vaccines available for use in the US and the company hopes the protein-based vaccine will become a top choice for boosters as well as for primary vaccinations, the AP reports. For now, the FDA authorized Novavax's initial two-dose series for people 18 and older. Novavax CEO Stanley Erck says he expects the US to expand use of the vaccine beyond unvaccinated adults fairly quickly. The FDA is already evaluating it for those as young as 12. Our story from June 7 follows:

Maybe fourth time is the charm for American adults who haven’t yet gotten vaccinated against COVID-19, as advisers to the Food and Drug Administration on Tuesday backed a more traditional type of shot, the AP reports. Next, the FDA must decide whether to authorize the protein vaccine made by latecomer Novavax as the nation's fourth coronavirus shot for adults. It's made with more conventional technology than today's dominant Pfizer and Moderna shots and the lesser-used Johnson & Johnson option. Novavax shots are already available in Australia, Canada, parts of Europe and multiple other countries, either for initial vaccinations or as mix-and-match boosters. But US clearance is a key hurdle for the Maryland-based company.

FDA's vaccine chief Dr. Peter Marks said another choice in the US may entice at least some vaccine holdouts—whatever their reason—to consider rolling up their sleeves. “We do have a problem with vaccine uptake that is very serious in the United States," Marks said. "Anything we can do to get people more comfortable to accept these potentially life-saving products is something that we feel we are compelled to do.” A final FDA decision isn't expected immediately, as the agency finishes combing through the data. The FDA advisory panel voted that the benefits of two primary Novavax doses outweigh its risks—but they had a lot of questions about the shots' role at this point in the pandemic. “This vaccine does indeed fill some unmet needs,” such as an option for people with allergies to competing shots, said Dr. Michael Nelson of the University of Virginia.

It's not clear how widely a Novavax vaccine would be used, at least right away. Only about 27 million US adults remain unvaccinated, according to the Centers for Disease Control and Prevention. Eventually, Novavax hopes also to become a choice for the millions more who haven’t yet had a booster dose of today’s vaccines, regardless of which shot people got originally. But the FDA is considering two adult doses for now, when other COVID-19 vaccines have needed a third dose, Nelson said. And while “this vaccine has incredible potential,” there’s no clear evidence yet of how well it works against the more contagious omicron variant and its siblings, added fellow adviser Dr. Bruce Gellin of the Rockefeller Foundation. (Click for more on side effects and the type of vaccine tech used.)

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