FDA Approves Nuvaxovid for the Prevention of COVID-19
Novavax’s COVID-19 vaccine has been available in the US under emergency use authorization since July 2022.
The FDA approved Novavax’s COVID-19 vaccine for the prevention of the virus in adults 65 years and older and individuals aged 12 to 64 years with at least 1 underlying condition that is associated with a high risk of severe outcomes of COVID-19. Nuvaxovid has been available in the US under emergency use authorization since July 2022.1
Novavax’s COVID-19 vaccine has been available in the US under emergency use authorization since July 2022. | Image Credit: lubero - stock.adobe.com
"Today's approval solidifies a pathway for Americans aged 65 and older and those aged 12 through 64 with an underlying condition that puts them at high risk for severe outcomes from COVID-19 to have access to a protein-based, non-mRNA COVID-19 vaccine," John C. Jacobs, president and CEO at Novavax, said in a news release.1 "Market research and US CDC statistics indicate that older individuals and those with underlying conditions are the populations most likely to seek out COVID-19 vaccination seasonally. This significant milestone demonstrates our commitment to these populations and is a significant step towards availability of our protein-based vaccine option."
The biologic license application was based on 4 phase 3 clinical trials (NCT04611802, NCT04368988, NCT05463068, NCT05372588), showing that the vaccine was safe and effective for the prevention of COVID-19.2
In one study (NCT05463068), investigators evaluated the immunogenicity and safety of the vaccine for previously vaccinated adults aged 18 to 49 years in the United States. Individuals received randomized treatment (1:1:1) of the intramuscular injection from 1 of 3 manufacturing lots, according to the study authors. Immunogenicity was assessed with immunoglobulin G (IgG) and neutralizing antibodies (NAb). Investigators also analyzed the response for individuals vaccinated with the primary series with or without a prior booster of the mRNA-1273, BNT162b2, Ad26.COV2.s, or NVX-CoV2373 vaccines.3
They found that the immunogenicity met the prespecified equivalence criteria and the booster dose was well tolerated. Further, the vaccine had robust IgG and NAb responses when used as a first dose or later, regardless of the primary series vaccine type.3
In another trial (NCT05372588), investigators randomized treatment to individuals aged 18 to 64 years with 3 doses of the prototype vaccine. They received a single dose of NVX-CoV2515, NVX-CoV2373, or a bivalent mixture. They measured immunogenicity 14 and 28 days after vaccination, and the safety data were assessed.4
Patients who received NVX-CoV2515 had superior NAb responses compared with NVX-CoV2373 at day 14. The seroresponse rates were 73.4% for NVX-CoV2515 compared with 50.9% for NVX-CoV2373, according to the study investigators.4
In July 2022, the FDA granted emergency use authorization for the vaccine as a 2-dose primary series to prevent COVID-19 for patients 18 years and older. In the trial for emergency use, investigators found adverse reactions of injection site pain, fatigue, muscle pain, headache, joint pain, nausea or vomiting, injection site redness, injection site swelling, and fever.5
READ MORE: Immunization Resource Center
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