CDC’s ACIP Votes in Favor of Universal Recommendation for 2023-2024 Monovalent COVID-19 Vaccines

The CDC Advisory Committee on Immunization Practices (ACIP) voted in favor (13 to 1) of the universal recommendation for the use of the 2023-2024 monovalent, XBB containing COVID-19 vaccines authorized via Emergency Use Authorization (EUA) or approved by biologics license applications. After the vote, the CDC endorsed the ACIP decision.¹

“Novavax is pleased that discussions at today’s ACIP meeting showed broad support for COVID vaccination this season via a universal recommendation and highlighted the urgent need for a protein-based option. Based on today’s discussion and upon authorization from the FDA, we anticipate that Novavax’s XBB COVID vaccine will be included in the ACIP’s recommendations in accordance with our label,” John C. Jacobs, president and CEO of Novavax, said in a statement. “Doses of Novavax’s vaccine are already in the [United States] and once authorized, will be the only protein-based non-mRNA vaccine option available for individuals aged 12 and older.”¹

The updated version of the Novavax COVID-19 vaccine, targeting the XBB strain, is currently under review by the FDA for EUA to prevent COVID-19 in those aged 12 years and older.¹

The company presented non-clinical data at the ACIP meeting, demonstrating that the COVID-19 Adjuvanted Vaccine with the 2023-2024 formulation induced neutralizing antibody responses. This included a broad range of circulating variants, including new data on the FL.1.5.1 subvariant.¹

Additionally, there was robust CD4+ polyfunctional cellular responses against 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

Following FDA authorization, the vaccine will be available across the United States, including community pharmacies, physician offices, public health clinics, and government entities, such as the Vaccine for Children and the US Department of Defense.¹

The company will also submit for authorization to other global regulatory agencies, including the European Medicines Agency, Health Canada, and the World Health Organization.¹

Early in September, the FDA approved updated COVID-19 vaccination formulations for emergency use, including mRNA vaccines for the 2023-2024 season by Moderna Inc (Spikevax; 2023-2024 formulation) and Pfizer-BioNTech (Comirnaty; 2023-2024 formulation).² 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.²

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 adverse effects as were previously reported from the previous COVID-19 vaccines.²

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. The manufacturers of the updated vaccines anticipate the rollout to be ready for the fall season.²

As of the new authorization and FDA action, the bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.²

References

1. 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
2. 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