FDA authorizes Novavax’s updated Covid-19 vaccine

The Food and Drug Administration on Tuesday authorized Novavax’s updated Covid-19 vaccine, giving Americans seeking to update their protection against the SARS-CoV-2 virus another option.

Though the FDA’s green light came three weeks after the approvals for the updated Moderna and Pfizer-BioNTech shots, it contained some welcome news for the Gaithersburg, Md.-based company, which has struggled to claim a share of the now dwindling Covid vaccine market — globally and within the United States.

Previous rules established by the FDA and the Centers for Disease Control and Prevention limited use of this vaccine to people aged 12 and older who had either not had a primary series of Covid vaccinations or who had a primary series and only one booster, and who would not agree to get additional messenger RNA boosters, the technology used by Pfizer and Moderna.

Though the age restriction remains in place, the other limitations have now been lifted, making the Novavax vaccine available to anyone who wants to use it — as long as they have gone at least two months since they had a previous Covid vaccination.

“Today’s authorization provides an additional Covid-19 vaccine option that meets the FDA’s standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization. As we head into the fall season and transition into 2024, we strongly encourage those who are eligible to consider receiving an updated Covid-19 vaccine to provide better protection against currently circulating variants,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.

In an unusual move, the CDC’s expert vaccines panel, the Advisory Committee on Immunization Practices, has already assessed the vaccine, and recommended at a Sept. 12 meeting that all Covid boosters that the FDA approves or authorizes should be used in the U.S. CDC Director Mandy Cohen accepted that recommendation, meaning that the FDA clearance open the door for Novavax’s vaccine to make its way to pharmacies and doctors’ offices immediately.

“Novavax’s authorization today means people will now have the choice of a protein-based non-MRNA option to help protect themselves against Covid-19, which is now the fourth leading cause of death in the U.S.,” John Jacobs, Novavax’s president and CEO, said in a statement. “In the coming days, individuals in the U.S. can go to major pharmacies, physicians’ offices, clinics and various government entities to receive an updated Novavax vaccine.”

The company said it expects the vaccine to be available in thousands of locations across the country, including CVS and Rite Aid pharmacies. Locations stocking the vaccine can be located using the Vaccines.Gov website or via Novavax’s website.

In clinical trials, the most common side effects associated with Novavax’s vaccine included headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness, injection site pain, fatigue, and malaise.

Like the Moderna and Pfizer vaccines, the Novavax jab is a monovalent, protecting against a single strain of SARS-2. Though the virus has evolved since the vaccine strain was selected by the FDA in June, these vaccines are expected to offer protection against severe disease and death caused by Covid.

Novavax, which did not own its own production facilities when it began its quest to make a Covid vaccine, has struggled to compete with other more established or nimble manufacturers. Among other issues its vaccine — which uses a sub-unit protein platform — takes longer to make and update than the mRNA vaccines. That will remain a challenge as SARS-2 continues to evolve and vaccine targets are changed to try to keep up.

Novavax’s solvency depends entirely on the commercial success of its updated vaccine. Due to repeated delays in development and manufacturing, the company all but missed out on the peak of demand for Covid shots, and it has warned shareholders that it might not survive the next 12 months if sales don’t pick up.

The company’s shares rose about 12% on the news Tuesday, as the FDA’s authorization suggests Novavax might still play a role in the fall booster campaign.

Damian Garde contributed reporting.