Third COVID Vaccine Gets Approved for Adults 65 and Over

The U.S. Food and Drug Administration (FDA) has officially approved a COVID-19 vaccine from Novavax for adults 65 and older and for individuals ages 12 to 64 who have an underlying health condition that puts them at higher risk for serious illness from a coronavirus infection.

The vaccine, Nuvaxovid, is the third coronavirus shot to gain full approval, joining vaccines from Pfizer and Moderna. It has been available under emergency use authorization for people 12 and older since 2022.

Unlike the other two FDA-approved COVID-19 vaccines, however, Nuvaxovid’s approval is limited to older adults and some people at higher risk for severe illness. Both Moderna and Pfizer’s COVID-19 vaccines are approved for people 12 and older and are available under emergency use authorization for kids as young as 6 months old.

“Market research and U.S. CDC [Centers for Disease Control and Prevention] statistics indicate that older individuals and those with underlying conditions are the populations most likely to seek out COVID-19 vaccination seasonally,” Novavax President and Chief Executive Officer John C. Jacobs said in a statement. “This significant milestone demonstrates our commitment to these populations and is a significant step towards availability of our protein-based vaccine option."

According to federal data, older adults represent 94 percent of all COVID-19 deaths. And while hospitalizations are lower now than they were during peak periods, the hospitalization rate for adults 65 and older towers over the rates for younger populations.

How Nuvaxovid differs from mRNA vaccines

Novavax’s vaccine is based on a more traditional platform than the mRNA vaccines from Pfizer and Moderna are. It’s a protein subunit vaccine, meaning it contains harmless copies of the COVID-19 spike protein and trains the immune system to recognize and attack this protein. Doctors have seen it as an alternative for people who remain skeptical about the mRNA vaccines or who may be allergic to them.

The FDA approval did not specify what health conditions make someone age 12 to 64 eligible for Nuvaxovid. But according to the CDC, more than 20 categories of conditions, such as chronic lung disease, cancer and heart issues, can increase a person’s risk for severe illness from a coronavirus infection. 

The FDA is requiring Novavax to conduct post-marketing trials to continue studying the vaccine’s safety and effectiveness. Novavax says it expects to be ready for the commercial delivery of the 2025-2026 COVID-19 vaccine formula in the U.S. this fall, pending vaccine strain recommendations from FDA advisers.

A meeting to discuss updates to the COVID-19 vaccine is scheduled for May 22. A group of vaccine experts that advises the CDC on vaccine recommendations is scheduled to meet in late June.