On Tuesday, June 7th, a U.S. Food and Drug Administration (FDA) advisory committee voted to grant Novavax, a Gaithersburg, Maryland-based biotechnology firm, emergency use authorization (EUA) for its COVID-19 vaccine.
Although the panel’s vote has traditionally received great deference, the vaccine must still receive final approval from the FDA. Emergency use authorization would allow adults 18 years old or older to receive the vaccine. In a clinical trial involving 30,000 participants, the Novavax COVID-19 vaccine demonstrated 90.4% efficacy.
The Novavax vaccine differs from its competitors because it is protein-based, meaning it recreates a protein sequence found in the COVID-19 virus, causing the body to develop an immune response. Many regularly administered vaccines, including those combatting the flu and hepatitis, are also protein-based. In a quote reported by Reuters, Peter Marks, director of the Center for Biologics Evaluation and Research (CBER) at the FDA, discussed why a more traditional protein-based vaccine might be beneficial:
‘We do have a problem with vaccine uptake that is very serious in the United States,’ FDA official Peter Marks told the panel. ‘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,’ he added.
According to Reuters, a timeline for the vaccine’s arrival is unavailable, though one Novavax employee estimated a late June arrival.