FDA approves emergency use for Novavax COVID-19 vaccine

The U.S. Food and Drug Administration (FDA) has approved emergency use authorization (EUA) for the Novavax COVID-19 vaccine for people aged 18 years and older.

“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 M. Califf, MD, said in the June 13 news release about the EUA.

The 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,” Califf said in the news release. “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.”

The Novavax COVID-19 Vaccine, Adjuvanted is administered as a two-dose primary series, three weeks apart, by intramuscular injection, according to FDA. The vaccine had a 90.4% effectiveness rating in a study conducted with participants aged 18 years and older, in the United States and Mexico. In the subset of participants aged 65 years and older, the vaccine was 78.6% effective, according to FDA.

The vaccine, also known as NVX-CoV2373, is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease, according to Novavax. It is the first approved COVID-19 vaccine designed and manufactured differently than the mRNA COVID-19 vaccines, according to the U.S. Department of Health and Human Services (HHS).

The company announced FDA’s Vaccines and Related Biological Products Advisory Committee on June 7 voted to recommend EUA and followed up June 28 with a vote to recommend inclusion of a SARS-CoV-2 Omicron component for COVID-19 booster vaccines in the United States in fall.

"We are confident that our prototype COVID-19 vaccine generates broad levels of antibodies as a primary series, and that boosting with this prototype vaccine increases the magnitude of the breadth of response," Novavax President of Research and Development Gregory M. Glenn, MD, said in the company’s news release about its FDA request for approval. "While we believe in the strength of our prototype vaccine data, we are prepared to supply an Omicron-based vaccine this fall in accordance with health authority recommendations."

The July 13 FDA approval came two days after HHS announced it had secured 3.2 million doses of the Novavax vaccine, pending approval by FDA and recommendation by the Centers for Disease Control and Prevention, which is pending. In 2020, Novavax secured a $1.6 billion federal contract for vaccine development and 100 million doses of the drug.