FDA Approves Updated Novavax COVID-19 Vaccine
The protein-based vaccine includes a monovalent component corresponding to the Omicron variant JN.1 strain.
The FDA has granted emergency use authorization (EUA) to an updated COVID-19 vaccine from Novavax to prevent the disease in individuals aged 12 years and older, the company announced in a release.1 Novavax said the vaccine will be available in thousands of pharmacies and grocers across the United States after batches are released by the Center for Biologics Evaluation and Research.
FDA Approves Updated Novavax COVID-19 Vaccine / Tom - stock.adobe.com
The protein-based vaccine, called NVX-CoV2705, is an updated 2024-2025 formula that includes a monovalent component corresponding to the Omicron variant JN.1 strain. The EUA was based on non-clinical data that showed the vaccine provides cross-reactivity against JN.1 and lineage viruses, including numerous variants that are currently circulating. The most common adverse reactions associated with the vaccine include headache, nausea, vomiting, muscle and joint pain, injection site tenderness or pain, fatigue, and malaise.
READ MORE: Q&A: How Health Care Providers Can Help Increase COVID-19 Vaccine Uptake
"[This] authorization enables Novavax to launch our updated COVID-19 vaccine in the US in pre-filled syringes, and we have worked hard to ensure consumers have access in thousands of locations nationwide," John C. Jacobs, president and CEO of Novavax, said in a release.1 "Our updated vaccine targets JN.1, the 'parent strain' of currently circulating variants, and has shown robust cross-reactivity against JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1 and LB.1."
According to data from the CDC, COVID-19 infections are growing or likely growing in 20 states and are stable or uncertain in 18.2 The increased viral activity in many parts of the country is due largely to the KP.3.1.1 Omicron variant, which is the only major variant increasing in proportion nationally. KP.3.1.1 is now the predominant variant circulating in the country after overtaking the KP.3 and KP.2 variants.3 For the 2 week period ending August 17, the variant accounts for 31% to 43% of COVID-19 clinical specimens.
The CDC recommends that all people aged 6 months and older get vaccinated against COVID-19 to protect against serious illness. The agency said that individuals who are considering getting a 2023-2024 COVID-19 vaccine formula should talk with their health care provider to determine if it would delay their ability to get the updated 2024-2025 vaccines. Data has shown that those who are up to date on COVID-19 vaccines have lower risk of severe illness, hospitalization, and death compared to unvaccinated individuals.
The EUA for Novavax’s updated COVID-19 vaccine comes shortly after the FDA granted approval to updated shots from Pfizer and Moderna. Pfizer’s Comirnaty and Moderna’s Spikevax, which are based on mRNA technology, include a monovalent component that corresponds to the Omicron variant KP.2 strain and are approved for use in individuals aged 12 years and older. The Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine also are authorized for emergency use in individuals aged 6 months through 11 years.
“The COVID-19 vaccines have had a tremendous positive impact on public health and vaccination continues to be the most effective method for COVID-19 prevention,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a release.4 “COVID-19 continues to be a very real risk for many people, and we encourage individuals to consider getting an updated COVID-19 vaccine when eligible. [This] authorization provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”
READ MORE: COVID-19 Resource Center
Don’t get left behind: Sign up today for our free Drug Topics newsletter and get the latest drug information, industry trends, and patient care tips delivered straight to your inbox.
