FDA Grants EUA for Novavax COVID-19 Vaccine

American adults have another COVID-19 vaccine option after the FDA granted emergency use authorization (EUA) for Novavax’s COVID-19 vaccine.

Robert M. Califf, M.D.

“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,” said FDA Commissioner Robert M. Califf, M.D., in a statement. “This authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”

Anticipating the EUA, the Department of Health and Human Services (HHS) and the Department of Defense already secured an initial 3.2 million doses of the vaccine, Novavax said in a statementearlier this week.

Novavax’ protein-based vaccine will be made available for free to states, jurisdictions, federal pharmacy partners, and federally qualified health centers.

In early June, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 21 to 0, with one abstention, to recommend the FDA grant EUA for the vaccine.

At the June 7, 2022, VRBPAC meeting, Novavax “heard the overwhelming support for our vaccine from physicians, healthcare organizations, and consumers who are eagerly anticipating a protein-based vaccine option,” Stanley C. Erck, president and CEO of Novavax, said in a statement.

Novavax’s COVID-19 vaccine has already received authorization for use in people 18 and over from more than 40 countries, in addition to emergency use listing from the World Health Organization.

However, the FDA said in June it would not make a decision the approval of the vaccine until it has an opportunity to review Novavax’s manufacturing process, per CNBC.

Novavax informed the agency of changes to its manufacturing process on June 3, days before the committee was scheduled to review its vaccine's safety and efficacy data, Abby Capobianco, an FDA spokesperson, told CNBC.

"FDA will carefully review this and any additional information submitted by the firm as part of its ongoing assessment and prior to authorizing the vaccine for emergency use," she said.

The Novavax COVID-19 vaccine is administered as a two-dose primary series, three weeks apart. The vaccine contains the SARS-CoV-2 spike protein and Matrix-M adjuvant.

Adjuvants are incorporated into some vaccines to enhance the immune response of the vaccinated individual, the FDA said. The spike protein in this vaccine is produced in insect cells; the Matrix M-adjuvant contains saponin extracts from the bark of the Soapbark tree that is native to Chile.