The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the Novavax COVID-19 vaccine, adjuvanted in individuals aged 18 years and older, as a two-dose primary series.
The authorisation was based on data from a phase 3 clinical trial, PREVENT-19, which revealed the vaccine was 90.4% effective in preventing mild, moderate or severe COVID-19.
Vaccinations will begin upon a product release and once a policy recommendation from the Centers for Disease Control and Prevention (CDC) is received.
The effectiveness of the vaccine was assessed in clinical trial participants aged 18 years and older, who did not have evidence of SARS-CoV-2 infection six days after receiving the second vaccine dose. Among this group, approximately 17,200 received the vaccine, and 8,300 received the placebo.
Overall, 17 cases of COVID-19 occurred in the vaccine group and 79 cases in the placebo group. No cases of moderate or severe COVID-19 were reported in participants who received the vaccine, compared with nine cases of moderate COVID-19 and four cases of severe COVID-19 reported in the placebo group
In the subset of participants 65 years of age and older, the vaccine was 78.6% effective.
Novavax’s protein-based vaccine, given in doses spread three weeks apart, contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. Adjuvants are used in some vaccines to enhance immune response.
The most commonly reported side effects by vaccine recipients included pain and tenderness, redness and swelling at the injection site, fatigue, muscle pain, headache, joint pain, nausea and vomiting and fever.
Commenting on the authorisation, FDA commissioner, Robert Califf, said: “Authorising an additional COVID-19 vaccine expands the available vaccine options for the prevention of COVID-19, including the most severe outcomes that can occur such as hospitalisation and death.
“Today’s authorisation offers adults in the US 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 authorisation.”
In addition to the FDA EUA, the Novavax COVID-19 vaccine has received conditional authorisation for use in individuals aged 18 and over from multiple regulatory agencies worldwide, including the European Commission, and an emergency use listing from the World Health Organization (WHO).