Novavax Seeks FDA Authorization for Emergency Use of COVID-19 Vaccine Booster

Vials with a sticker reading, "COVID-19 / Coronavirus vaccine / Injection only" and a medical syringe are seen in front of a displayed Novavax logo in this illustration taken Oct. 31, 2020. Dado Ruvic/Illustration/Reuters

Novavax is seeking emergency authorization of its COVID-19 booster shot in adults aged 18 and older from U.S. regulators, the company announced on Monday.

In a press release, the biotechnology company based in Maryland said it has submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for its protein-based booster shot.

If authorized, the Novavax vaccine would be the first protein-based COVID-19 booster for adults.

“It’s important for people to have a choice as they evaluate how to stay protected against COVID-19, and boosters are an invaluable tool to build upon immunity obtained from previous vaccinations,” said Novavax President and CEO Stanley Erck in a statement.

“Based on the data presented to the FDA’s VRBPAC [Vaccines and Related Biological Products Advisory Committee] and the CDC ACIP [Advisory Committee on Immunization Practices], we believe our vaccine offers a broad, long-lasting immune response against a range of variants.”

The vaccine is different from the mRNA and viral-vector COVID-19 vaccines, and the protein-based technology used within it has been utilized for decades to combat diseases like shingles and hepatitis.

The Novavax vaccine delivers proteins along with immunity-stimulating adjuvants—a substance that enhances the body’s immune response to a vaccine—directly to a person’s cells, rather than via mRNA, to spur an immune response.

“The Novavax COVID-19 Vaccine, Adjuvanted contains purified protein antigen and can neither replicate nor can it cause COVID-19,” the company states.

Phase 3 Trials

Novavax’s application for EUA is supported by data from its phase 3 trial of over 25,000 adults in the United States and Mexico, during which researchers found that the vaccine was 90.4 percent effective against COVID-19, and its UK-sponsored COV-BOOST Phase 2 trial.

“As part of an open-label booster phase of the [phase 3] PREVENT-19 trial, a single booster dose of the Novavax COVID-19 Vaccine, Adjuvanted was administered to healthy adult participants at least six months after their primary two-dose vaccination series of the Novavax COVID-19 Vaccine, Adjuvanted,” the company said.

“The third dose produced robust antibody responses comparable to or exceeding levels associated with the efficacy data in the primary series Phase 3 clinical trials. In the COV-BOOST trial, the Novavax COVID-19 Vaccine, Adjuvanted induced a significant antibody response when used as a heterologous third booster dose.”

Following the booster shot, “local and systemic reactions had a median duration of approximately two days,” according to Novavax, while “medically attended adverse events, potentially immune-mediated medical conditions, and severe adverse events occurred infrequently following the booster dose.”

The booster shot would be available to individuals who received two doses of the Novavax vaccines, as well as to those who got another vaccine.

The FDA granted EUA for the initial two-shot Novavax vaccine for adults 18 and over in July and the Biden administration promptly announced a deal with the company to purchase 3.2 million doses of the vaccine.

Novavax had hoped that individuals who had declined to take Pfizer and Moderna mRNA vaccines over the risk of heart inflammation would opt to take theirs instead, Reuters reported.

However, the European Medicines Agency (EMA) earlier this month recommended adding a warning for two types of heart inflammation: myocarditis and pericarditis, to Novavax’s shot—marketed under the name Nuvaxovid—owing to a small number of cases reported in those who received the vaccine.

The EMA’s Pharmacovigilance Risk Assessment Committee also requested the “marketing authorization holder of Nuvaxovid provides additional data on the risk of side effects occurring.”

Novavax on Aug. 8 halved its full-year revenue forecast saying it does not anticipate significant sales of its COVID-19 shot this year in the United States amid dwindling demand.