Novavax’s Covid-19 Vaccine Wins CDC Advisers’ Backing

The Food and Drug Administration authorized use of the vaccine in adults 18 years and older last week, but most vaccine providers wait until the CDC signs off before giving the shots.

The advisory committee is composed of medical and public health experts and advises the CDC and develops recommendations for vaccine use generally in the U.S.

If the CDC adopts its advisers’ recommendation, Novavax’s long-delayed vaccine will be available at no charge at pharmacies and through state and local government vaccine programs. The CDC is expected to make a decision shortly.

The vaccine requires two doses given three weeks apart. It would provide a new option for people who have avoided vaccination with gene-based messenger RNA vaccines made by

Moderna Inc.

and

Pfizer Inc.

and partner

BioNTech SE.

Novavax’s protein-based vaccine uses a relatively older and more tested technology that is used as the backbone of vaccines for hepatitis B and the human papillomavirus, or HPV.

The U.S. government said last week that it had bought 3.2 million doses of Novavax’s vaccine, but it isn’t known how much demand there will be for it in the U.S.

The FDA has authorized Novavax’s as an initial inoculation for people who haven’t been vaccinated. About a third of U.S. adults haven’t been fully vaccinated, and about 10% have only received one dose, according to CDC data.

The FDA hasn’t yet authorized it as a so-called booster shot to enhance immunity to Covid-19. Nearly half of U.S. adults haven’t yet received a third or fourth booster shot, providing a far larger market that Novavax has said it hopes to win authorization for.

Novavax has struggled with manufacturing issues that have delayed its vaccine getting on the market.

Testing found the shot was 90.4% effective at preventing Covid-19 symptoms in clinical trials. However, the studies were conducted before the Omicron variant became dominant.

Novavax has said that its vaccine loses some potency against the Omicron variant after two doses, but that a third booster shot should provide strong protection.

The shot also carries an increased risk of heart-inflammation conditions myocarditis and pericarditis, with symptoms usually appearing within 10 days following vaccination, the FDA has said. An increased risk of heart inflammation has also been linked to the Moderna and Pfizer-BioNtech vaccines.

National health officials in Europe, Asia and elsewhere have authorized Novavax’s shot over the past several months. As of June 30, 1.07 million Novavax vaccine doses have been administered globally, Novavax said in a presentation to the advisory committee.

Write to Joseph Walker at [email protected]

The Food and Drug Administration authorized use of the vaccine in adults 18 years and older last week, but most vaccine providers wait until the CDC signs off before giving the shots.

The advisory committee is composed of medical and public health experts and advises the CDC and develops recommendations for vaccine use generally in the U.S.

If the CDC adopts its advisers’ recommendation, Novavax’s long-delayed vaccine will be available at no charge at pharmacies and through state and local government vaccine programs. The CDC is expected to make a decision shortly.

The vaccine requires two doses given three weeks apart. It would provide a new option for people who have avoided vaccination with gene-based messenger RNA vaccines made by

Moderna Inc.

and

Pfizer Inc.

and partner

BioNTech SE.

Novavax’s protein-based vaccine uses a relatively older and more tested technology that is used as the backbone of vaccines for hepatitis B and the human papillomavirus, or HPV.

The U.S. government said last week that it had bought 3.2 million doses of Novavax’s vaccine, but it isn’t known how much demand there will be for it in the U.S.

The FDA has authorized Novavax’s as an initial inoculation for people who haven’t been vaccinated. About a third of U.S. adults haven’t been fully vaccinated, and about 10% have only received one dose, according to CDC data.

The FDA hasn’t yet authorized it as a so-called booster shot to enhance immunity to Covid-19. Nearly half of U.S. adults haven’t yet received a third or fourth booster shot, providing a far larger market that Novavax has said it hopes to win authorization for.

Novavax has struggled with manufacturing issues that have delayed its vaccine getting on the market.

Testing found the shot was 90.4% effective at preventing Covid-19 symptoms in clinical trials. However, the studies were conducted before the Omicron variant became dominant.

Novavax has said that its vaccine loses some potency against the Omicron variant after two doses, but that a third booster shot should provide strong protection.

The shot also carries an increased risk of heart-inflammation conditions myocarditis and pericarditis, with symptoms usually appearing within 10 days following vaccination, the FDA has said. An increased risk of heart inflammation has also been linked to the Moderna and Pfizer-BioNtech vaccines.

National health officials in Europe, Asia and elsewhere have authorized Novavax’s shot over the past several months. As of June 30, 1.07 million Novavax vaccine doses have been administered globally, Novavax said in a presentation to the advisory committee.

Write to Joseph Walker at [email protected]