vaccines

The Food and Drug Administration on Wednesday authorized Novavax’s COVID-19 vaccine for emergency use in adults aged 18 years and older. 

The vaccine is adjuvanted to boost recipients’ immune responses, the FDA said in a statement. Unlike other available COVID-19 prophylactics, it is made using an older protein-based technology that has been long used against other diseases such as influenza, according to a report by Reuters.

An option for the vaccine-hesitant? 

There is hope that the drug’s use of established technology will encourage vaccination in those who are wary of newer methods used to make COVID-19 vaccines manufactured by Pfizer-BioNTech, Moderna and Johnson & Johnson.

“Today’s 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,” said FDA Commissioner Robert M. Califf, M.D., in the statement.

The Centers for Disease Control and Prevention must also greenlight the vaccine before it is made fully available, Reuters has reported.

Efficacy in older adults

Novavax’s vaccine is already approved in Europe. In clinical studies, it was 79% effective in participants aged 65 years and older. But those trials were conducted prior to the advent of the delta and omicron variants, Califf noted.

A fact sheet for vaccination providers warns that clinical trial data show evidence for a small increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of tissue surrounding the heart) following receipt of the drug. The same risks have been linked to receipt of the Pfizer-BioNTech and Moderna vaccines, which use an mRNA technology.

Vaccines remain the “best preventive measure against severe disease caused by COVID-19,” Califf said. “And I encourage anyone who is eligible for, but has not yet received a COVID-19 vaccine, to consider doing so.”

The federal government has secured 3.2 million cases of the Novavax vaccine in anticipation of possible authorization, it announced earlier this week.