FDA Issues Emergency Use Authorization to Novavax’s COVID-19 Vaccine 2023-24 Formula

The FDA has granted Emergency Use Authorization (EUA) to NVX-CoV2601, Novavax’s COVID-19 vaccine adjuvanted 2023-2024 formula, for the prevention of COVID-19 in those 12 years of age and older. In the coming days, NVX-CoV2601 is expected to be available at thousands of locations nationwide, including national and local community pharmacies, after the Center for Biologics Evaluation and Research releases the vaccine batches, the company announced in a press release.¹

"COVID-19 is once again on the rise with infections and hospitalizations increasing, so it's important that individuals get vaccinated to protect themselves and their loved ones," John C. Jacobs, Novavax president and chief executive officer, said in the release. "Novavax's authorization today means people will now have the choice of a protein-based non-mRNA option to help protect themselves against COVID-19, which is now the fourth leading cause of death in the US In the coming days, individuals in the US can go to pharmacies, physicians' offices, clinics and various government entities to receive an updated Novavax vaccine."¹

The FDA based its decision on non-clinical data, which indicate that Novavax's COVID-19 vaccine produced functional immune responses against the XBB.1.5, XBB.1.16 and XBB.2.3 variants. Last month, the CDC Advisory Committee on Immunization Practices (ACIP) voted 13 to 1 in favor of a universal recommendation for the use of the 2023-2024 monovalent, XBB containing COVID-19 vaccines authorized via EUA or approved by biologics license applications. After the vote, the CDC endorsed the ACIP decision.²

During the meeting, Novavax presented non-clinical data showing that the COVID-19 adjuvanted vaccine with the 2023-2024 formulation induced neutralizing antibody responses. This included a broad range of circulating variants, such as the new data on the FL.1.5.1 subvariant.¹

Additionally, there was robust CD4+ polyfunctional cellular responses against the EG.5.1 and XBB.1.16.6 variants, which are becoming more prominent in the United States. The data indicate that the vaccine can stimulate the immune system and is capable of inducing a broad response against circulating variants.¹

In clinical trials, the most common adverse effects (AEs) associated with the prototype COVID-19 vaccine, NVX-CoV2373, included headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness, injection site pain, fatigue, and malaise.

Earlier in September, the FDA approved updated COVID-19 vaccination formulations for emergency use, including mRNA vaccines for the 2023-2024 season. The updated formulations are currently targeting the circulating COVID-19 variants to better protect against serious infection.

The vaccines were updated to include monovalent components against the XVV.1.5 variant, supported by evidence from clinical trials and input from FDA expert advisors.³

The FDA approved the updated formulations for those aged 12 years and older and are authorized under EUA for individuals aged 6 months through 11 years. The agency reported that individuals who receive the updated vaccine could experience similar AEs as were previously reported from the previous COVID-19 vaccines.

Furthermore, the FDA expects the COVID-19 vaccines may need to be updated annually, similarly to the season influenza vaccines, because of the continuous circulation of variants.

References

1. Novavax 2023-2024 COVID-19 Vaccine Now Authorized and Recommended for Use in the U.S. News release. Novavax. October 3, 2023. https://ir.novavax.com/press-releases/2023-10-03-Novavax-2023-2024-COVID-19-Vaccine-Now-Authorized-and-Recommended-for-Use-in-the-U-S

2. US CDC and Advisory Committee recommend use of authorized and approved 2023-2024 monovalent XBB COVID-19 vaccines. News release. Novavax. September 12, 2023. Accessed September 13, 2023. https://ir.novavax.com/press-releases/US-CDC-and-Advisory-Committee-Recommend-Use-of-Authorized-and-Approved-2023-2024-Monovalent-XBB-COVID-19-Vaccines

3. Gallagher A. FDA authorizes updated COVID-19 vaccine formulation for current variants. Pharmacy Times. September 11, 2023. Accessed September 13, 2023. https://www.pharmacytimes.com/view/fda-authorizes-updated-covid-19-vaccine-formulations-for-current-variants