The Food and Drug Administration (FDA) announced on Wednesday, July 13, that it had authorized Novavax's protein-based COVID vaccine for adults. This is great news for Americans, who now have an alternative to the mRNA-based shots from Pfizer-BioNTech and Moderna.
The Novavax primary series is given in two doses, which are administered 21 days apart, according to CNN. FDA Commissioner Dr. Robert Califf issued a statement, saying that the authorization offers adults in the United States, who have not yet received a COVID-19 vaccine, another option that meets the agency's rigorous standards for effectiveness, manufacturing quality, and safety that are needed to support an emergency use authorization.
The FDA's signoff is not the last step. The decision will now go to the Centers for Disease Control and Prevention (CDC) and its advisory committee to issue their own recommendation on how the Novavax shots should be used. The CDC's Advisory Committee on Immunization Practices is scheduled to hold a meeting on July 19.
Biden administration secures 3.2 million doses of Novavax COVID vaccine
On Monday, July 11, the Biden administration announced that the United States has already secured 3.2 million doses of the Novavax COVID vaccine. They are ready to be shipped to states once the said shot receives the green light.
The Department of Health and Human Services (HHS) and Novavax said in a statement that the company is expected to complete all necessary quality testing in the next few weeks, which would support the final release of the COVID shots. The company announced last month that the initial doses of the COVID vaccine would be manufactured by its partner Serum Institute of India, according to Reuters.
Wednesday's much-awaited authorization comes more than a month after the FDA's vaccine advisory committee overwhelmingly recommended that the agency authorize the use of the shots and five months since Novavax first submitted its application to the FDA.
Novavax's COVID shot has already been cleared for use in more than 40 countries, including the European Union (EU), but manufacturing problems have impeded the company's efforts to be authorized in the United States.
Novavax's COVID vaccine important to the vaccination campaign
Novavax CEO Stanley Erck told NBC News that the FDA authorization took longer than they wanted, but they are there. They had gotten the company's first approval with the agency for a vaccine in the United States.
Novavax's COVID vaccine uses an older technology found in other widely used vaccines, including the shots for shingles and hepatitis. The company's COVID vaccine uses synthetic coronavirus proteins to teach the body's immune system to recognize bits of the virus.
Erck and outside experts said that Novavax's COVID shot is important to the country's vaccination campaign because it may persuade people unwilling or unable to get the mRNA shots to finally get vaccinated. According to data from the CDC, about 22 percent of people in the U.S. have still not received a single dose of a COVID shot.
