Novavax's
The FDA's Vaccine and Related Biological Products Advisory Committee voted 21 to 0, with one abstention, to recommend authorizing the shot for use in adults ages 18 years and older after discussing the shot's safety and efficacy data. Following this recommendation, the FDA will need to make its own decision; the agency usually follows the committee's recommendations, but is not required to do so. The U.S. Centers for Disease Control and Prevention (CDC) will also need to back the vaccine before pharmacies and other health-care providers can begin administering the shot to the public.
If authorized for emergency use, Novavax's vaccine would be the fourth vaccine available to Americans and the first cleared since Johnson & Johnson's
Novavax was an early frontrunner in the race to create a COVID vaccine in 2020, being one of the early participants on the former Trump administration's Operation Warp Speed. However, the biotech was impacted by manufacturing setbacks.
The biotech's vaccine demonstrated 90% effectiveness at preventing illness and 100% effective at preventing severe infection, according to Novavax's clinical trials. However, those studies were conducted before the Omicron variant emerged and became the dominant global strain, with the clinical trials concluding in September 2021. Like other current-generation COVID vaccines, Novavax's shot was designed to target the original SARS-CoV-2 virus that first emerged in Wuhan, China, in 2019. FDA officials noted in briefing documents on Tuesday that no data is available on the effectiveness of the Novavax vaccine against Omicron, but it is still likely to protect against severe disease and hospitalization like other approved vaccines.
Novavax's safety profile is similar to other COVID vaccines, with common side effects being injection site pain, fatigue, headache and muscle pain, according to the FDA. However, the vaccine may be linked to risk of heart inflammation like Pfizer and Moderna's shots. Still, the CDC has found that the risk of myocarditis is higher from COVID infection than vaccination.
The company's vaccine is based on established protein technology, differing from the messenger RNA technology used in the vaccines developed by Pfizer
More than 75% of U.S. adults ages 18 and older have already received two doses of COVID vaccine, primarily those developed by Pfizer and Moderna, according to data compiled by the CDC. However, about 27 million U.S. adults have yet to receive their first dose.
Novavax's shot may appeal to those who have been hesitant to receive the new genetic-based technology used by Pfizer and Moderna, for its underlying technology has been used for decades to prevent infections like hepatitis B and HPV. Johnson & Johnson's shot also uses technology similar to common influenza vaccines, but its use has been restricted by the CDC due to increased risks of blood clots, especially in women.
Another reason Novavax's vaccine could appeal to those who have been hesitant to get inoculated is that the shot has no connection to abortions, which has held some religious communities back from receiving other vaccines. Early-stage testing for Pfizer and Moderna's vaccines used laboratory-grown cell lines descended from fetuses that were aborted decades ago and Johnson & Johnson used similar cell lines to grow the viruses used to manufacture its vaccine. None of these vaccine contain fetal cells. Novavax's says "no human fetal-derived cell line sor tissue" were used in the development, manufacturing or production of its vaccine, the Associated Press reports.
