FDA authorizes protein-based Novavax Covid vaccine for adults

The Food and Drug Administration (FDA) on Wednesday authorized Novavax’s Covid-19 vaccine for emergency use in people 18 years of age or older, widening vaccine options in the US against the virus as the fourth vaccine to get approval by the agency.

The Centers for Disease Control and Prevention (CDC) will meet next week to decide whether to sign off on the vaccine and determine who should get the shot before pharmacies and other healthcare providers can start administering them. Novavax is also expected to finish its quality testing “in the next few weeks” before the doses are provided.

Officials authorized the vaccine as a primary immunization series as opposed to a booster, which will probably limit its initial use.

“Covid-19 vaccines remain the best preventive measure against severe disease caused by Covid-19 and I encourage anyone who is eligible for, but has not yet received a Covid-19 vaccine, to consider doing so,” said FDA Commissioner Robert M Califf in a statement.

The move comes after the Biden administration announced on Monday that it had secured 3.2m doses of the Novavax vaccine through an agreement with the Maryland-based company, US Department of Health and Human Services, and the Department of Defense.

Novavax’s protein-based vaccine, given in doses spread three weeks apart, will be made available for free to states, jurisdictions, federal pharmacy partners, and federally qualified health centers, according to a statement by the company.

In June, the FDA voted to recommend that the agency grant an emergency use authorization for the Novavax Covid-19 vaccine for individuals aged 18 and over. The company’s vaccine approval from the FDA was delayed for weeks amid a review of Novavax’s manufacturing process.

The authorization for the vaccine was approved as the emergence of another fast-spreading Omicron variant has become dominant among new coronavirus cases. In the UK, healthcare professionals are calling for the return of infection control measures as cases of the new subvariant emerge.