FDA Grants Emergency Authorization for Novavax COVID-19 Vaccine

A vial of the Phase 3 Novavax coronavirus vaccine is seen ready for use in the trial at St. George's University hospital in London on Oct. 7, 2020. Alastair Grant/AP Photo

The Food and Drug Administration (FDA) on Wednesday issued an emergency use authorization for Novavax’s protein-based COVID-19 vaccine.

“Authorizing an additional COVID-19 vaccine expands the available vaccine options for the prevention of COVID-19, including the most severe outcomes that can occur such as hospitalization and death,” FDA Commissioner Robert Califf said in a statement.

The agency said the vaccine, under the emergency use authorization, can be given to adults aged 18 and older. The vaccine, which is given in two doses several weeks apart, can become available once the U.S. Centers for Disease Control and Prevention signs off on the FDA’s authorization.

Califf added that Wednesday’s move gives people “another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency-use authorization.”

Novavax uses different technology than the vaccines that are currently available. Pfizer and Moderna both use mRNA technology, whereas the Johnson & Johnson shot uses an adenovirus.

Novavax uses a protein-based vaccine that places parts of the COVID-19 spike protein directly in the body. That technology is commonplace in older vaccines such as the ones for shingles and hepatitis.

But clinical trials that were used to authorize the vaccine were carried out in early 2021, coming months before the Delta and Omicron variants spread across the world, according to the FDA’s statement Wednesday.

Studies from across the world have shown Omicron and the latest sub-variants can evade COVID-19 vaccines. Numerous public officials, including White House COVID-19 adviser Anthony Fauci, have contracted the virus in recent months despite having received two booster shots.

Novavax, of Maryland, previously said that its vaccine could appeal to people who have been reluctant to get the Pfizer, Moderna, or J&J vaccines. According to the CDC’s most recent data, about 22 percent of Americans have not received any vaccine.

“This authorization reflects the strength of our COVID-19 vaccine’s efficacy and safety data, and it underscores the critical need to offer another vaccine option for the U.S. population while the pandemic continues,” Novavax Chief Executive Stanley Erck said in a statement after the FDA’s authorization.

Like the Moderna and Pfizer shots, the fact sheets for the Novavax vaccine say that it increases the risk of myocarditis and pericarditis, two types of heart-inflammation conditions, according to the FDA.

The agency said that symptoms of heart inflammation started within 10 days following the administration of the vaccine. Individuals who experience shortness of breath, chest pain, and other serious symptoms should seek immediate medical attention, the agency warned.

The CDC’s Advisory Committee on Immunization Practices is slated to meet on July 19, where they will likely discuss the Novavax emergency use authorization. On Monday, the Biden administration announced the United States has obtained 3.2 million doses of the vaccine.

The FDA’s authorization took “longer than we wanted,” Erck told NBC News. “But we’re there and we have gotten the company’s first approval with the FDA for a vaccine in the United States.”