FDA Advisers Recommend Novavax’s Covid-19 Vaccine for Use in Adults

After a unanimous vote, vaccine advisers to the U.S. Food and Drug Administration (FDA) on June 6 recommended that the agency authorize Novavax's Covid-19 vaccine for emergency use in adults, reports Science's Meredith Wadman.

While Novavax is late to the vaccine race, the two-dose shot’s recommendation is opening the way for the first protein-based Covid-19 vaccine to become available in the United States. Novavax's vaccine can also be stored at refrigerator temperatures for months, making it easier to store and transport. This is unlike the mRNA vaccines from Pfizer and Moderna, which make up the vast majority of vaccinations in the U.S. and require temperatures as low as -75 to -130 degrees Fahrenheit to be stored long-term.

If the FDA accepts the committee’s 21-0 vote (with one abstention) and recommendation, the new Covid-19 vaccine will be the fourth to receive clearance for use in adults in the United States, report Carl Zimmer and Rebecca Robbins for the New York Times. However, before the FDA officially authorizes the shots, the agency must approve Novavax’s manufacturing process, and the Centers for Disease Control and Prevention (CDC) would also need to endorse the shots. If approved, the vaccine will be manufactured at the Serum Institute of India, per Science.

After receiving a joint $2 billion from the U.S. government and the international nonprofit organization Coalition for Epidemic Preparedness Innovations, Novavax was saved from delisting by the NASDAQ stock index and began to develop a vaccine against SARS-CoV-2, Science's Meredith Wadman reported in 2020.

Unlike the other three vaccines (mRNA Pfizer and Moderna vaccines, and the DNA-based Janssen/Johnson & Johnson vaccine) currently available in the U.S., Novavax’s vaccine is made from small nanoparticles made of the actual spike proteins from the coronavirus's surface mixed with an immune-reaction boosting adjuvant, the New York Times reports. This is instead of having pieces of genetic code instruct the body’s cells to make the spike protein to cue an immune response like mRNA and DNA vaccines do, Science reports. Vaccines for shingles, hepatitis B, and influenza use technology similar to Novavax’s protein-based vaccine.

The FDA found that the Novavax vaccine has a 90 percent efficacy in protecting individuals against mild, moderate and severe Covid-19 cases, reports NPR’s Scott Hensley and Rob Stein. Published in the New England Journal of Medicine, the study used by the FDA to evaluate the vaccine included about 30,000 participants in the United States and Mexico. However, data collection ended in the fall of 2021 before Omicron, a SARS-CoV-2 variant, was detected in the U.S.

Some evidence found that the Novavax vaccine may cause myocarditis or pericarditis, two forms of heart disease, which have also been seen in some people who received the Pfizer or Moderna Covid-19 vaccines. 

In a database of 40,000 Novavax vaccine recipients in the United States and the United Kingdom, four cases of myocarditis or pericarditis were identified after they received the vaccine. Still, Novavax officials stated that the risks of side effects were balanced across volunteers who received a placebo and those who received the vaccine, reports CNBC’s Spencer Kimball. 

Currently, the Novavax vaccine is authorized in over 40 countries, including, India, South Africa and Britain, and has received clearance from the European Union and the World Health Organization, the New York Times reports. 

Peter Marks, director of the Center for Biologics Evaluation and Research who leads the FDA in reviewing vaccine safety and effectiveness, said that the vaccine could appeal to those who are hesitant to receive an mRNA vaccine. “We do have a problem with vaccine uptake that is very serious in the United States, and anything we can do to get people more comfortable to be able to accept these potentially life-saving medical products is something that we feel we are compelled to do,” said Marks.

Elizabeth Gamillo | | READ MORE

Elizabeth Gamillo is a correspondent for Smithsonian and a science journalist based in Milwaukee, Wisconsin. She has written for Science magazine as their 2018 AAAS Diverse Voices in Science Journalism Intern.