Novavax COVID vaccine, new 4th option, approved by FDA

Americans will soon have a fourth COVID vaccine option.

Novavax’s more traditional vaccine was approved Wednesday by the Food and Drug Administration, clearing the way for more shots in arms later this month.

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/)

The Novavax vaccine, which was delayed by production issues, uses a well-established protein-based strategy to attack the virus that causes COVID-19. Public health leaders are hoping that the new vaccine — which is similar to shots for hepatitis B, shingles and HPV, among others — helps convince remaining holdouts to get vaccinated. Some people have cited the novel mRNA technology in the Pfizer and Moderna vaccines as a reason not to get vaccinated.

About 78% of Americans have received at least one vaccine dose, leaving millions still eligible for the two-dose Novavax series, according to Centers for Disease Control data. Shots from Pfizer, Moderna and Johnson & Johnson have been in use for more than a year.

The Novavax vaccine has not yet been approved for “mix-and-match” booster doses, but that approval could come soon. About 49% of Americans have received a booster shot.

FDA officials are also reviewing data that could allow children to get the Novavax shot. Wednesday’s initial approval only applies to people ages 18 and older.

In clinical trials, the Novavax vaccine was 90% effective at preventing infection, but those trials were conducted before the omicron variant became dominant. Novavax has not altered its vaccine to combat the more transmissive variant.

The omicron variant was able to skirt the other vaccines’ infection protection, but the vaccines remained effective at preventing severe disease and death.

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. In the U.S., it will need to be approved by the CDC before shots are in arms.

Also 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