Novavax COVID vaccine, potential 4th option, approved by FDA panel

A potential fourth COVID vaccine was approved by a Food and Drug Administration advisory panel on Tuesday.

The Novavax vaccine was 90% effective in clinical trials, but those tests were done in early 2021, before the omicron variant emerged and decreased vaccines’ ability to prevent infection.

Some on the FDA advisory panel also questioned the need for a fourth vaccine when 78% of the U.S. population already got at least one shot of the Pfizer, Moderna and Johnson & Johnson vaccines. However, only 47% of people have received a booster shot.

A vial of the Phase 3 Novavax coronavirus vaccine prepared for use in a trial at St. George's University hospital in London. (Alastair Grant/)

“We do have a problem with vaccine uptake that is very serious in the United States,” FDA vaccine honcho Dr. Peter Marks said. “Anything we can do to get people more comfortable to accept these potentially lifesaving products is something that we feel we are compelled to do.”

The panel approved the Novavax vaccine for two initial doses. Novavax said it’s working on securing approval for a booster dose.

Before the Novavax shot can be used in the U.S., it must be approved by FDA Commissioner Robert Califf, a Centers for Disease Control panel and then CDC Director Rochelle Walensky. The delay between the clinical trial and the FDA approval was caused by supply issues, which Novavax says it has solved.

The Novavax shot is already available in more than 40 other countries, including Canada and Australia, and can be used for initial doses or mix-and-match booster doses in most places. It’s a more traditional, protein-based shot similar to those used for hepatitis B and shingles, among other diseases.

“This vaccine does indeed fill some unmet needs,” said Dr. Michael Nelson, of the University of Virginia, noting that some people are allergic to the current vaccines.

In clinical trials, six of 40,000 people showed signs of heart inflammation, also known as myocarditis. The condition has also been linked to other vaccines and has been more common in young men. However, the CDC found that COVID itself was much more likely to cause heart problems.

With News Wire Services