COVID-19: FDA Approves, Grants EUA to Moderna, Pfizer 2024-2025 Vaccine Formulations
Novavax is still awaiting FDA authorization for their protein-based COVID-19 vaccine.
The FDA has approved and granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines manufactured by Moderna and Pfizer to include a monovalent component corresponding to the KP.2 variant of the Omicron strain of SARS-CoV-2. These vaccines, the FDA noted in a news release, now “more closely target currently circulating variants and provide better protection against serious consequences of COVID-19.”1
On June 5, 2025, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met and, in a unanimous vote, recommended a monovalent JN.1-lineage vaccine composition for the 2024-2025 COVID-19 vaccine; the FDA advised manufacturers of licensed and authorized vaccines of this decision the following day. Shortly thereafter, the FDA updated their guidance to manufacturers, advising that “the preferred JN.1 lineage for the COVID-19 vaccines (2024-2025 formula) is the KP.2 strain, if feasible.”2
Updated COVID-19 vaccines for the 2024-2025 respiratory virus season will be available at pharmacies in the coming days. | Image credt: phonlamaiphoto - stock.adobe.com
The US is currently experiencing a wave of COVID-19 infections: Viral activity levels in wastewater are the highest they’ve been during a summer surge since July 2022.3 According to the CDC, who runs the National Wastewater Surveillance System, the western region of the US has been hit hardest by this spike in viral activity. Of note, this year’s summer COVID-19 wave is taking place earlier this year compared to 2024, which saw a wave in late August/early September.3,4
Updated mRNA COVID-19 vaccines include Pfizer’s Comirnaty and Moderna’s Spikevax, both approved by the FDA for use in individuals aged 12 years and older. Both the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine are authorized for emergency use in individuals aged 6 months through 11 years.1
“Vaccination continues to be the cornerstone of COVID-19 prevention,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.1 “These updated vaccines meet the agency’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality.”
“Given waning immunity of the population from previous exposure to the virus and from prior vaccination, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants,” Marks continued.
READ MORE: Slideshow: COVID-19’s Impact on the Leading Causes of Death in the US
Crucially, the agency does not anticipate that the change to the KP.2 strain will delay vaccine availability. In an emailed statement, David Jimenez, senior vice president and general manager of North America at Moderna, noted that the company has focused on building a robust supply chain in the US and “expect[s] Spikevax to be at pharmacies and care settings in the coming days.”
Novavax, which manufactures the only non–mRNA COVID-19 vaccine option (NVX-CoV2705), filed an EUA for their 2024-2025 vaccine formula in June.5 In a news release, the company noted that they are working with the FDA to complete the review, with authorization expected “in time for peak vaccination season.”6 The 2024-2025 formulation of NVX-CoV2705 targets JN.1 and provides protection and cross-reactivity against JN.1 and “numerous JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1, and LB.1.”
On June 27, 2024, the CDC recommended that all individuals aged 6 months and older receive an updated 2024-2025 COVID-19 vaccine to protect themselves during the fall and winter respiratory virus season, “whether or not they have ever previously been vaccinated with a COVID-19 vaccine.”7
Despite the availability of updated immunizations, public health experts remain concerned that not enough Americans will get the shot. According to CDC data, as of May 11, 2024, only 22.5% of adults had reported that they received a 2023-2024 COVID-19 vaccine since September 14, 2023. Those same data show that only 14.4% of children received the updated 2023-2024 vaccine.8
A survey from the Pew Research Center showed that currently, only 1 in 5 Americans view COVID-19 as a major health threat in the US.9 Similarly, only 27% of Americans are very or somewhat concerned about getting a COVID-19 infection that would require hospitalization, and only 40% are very or somewhat concerned that they may unknowingly spread COVID-19 to others.
In addition to these attitude changes, logistical concerns—such as the lack of federal funding to vaccinate uninsured Americans—have also decreased rates of vaccination across the board.
But, “It’s important for families to stay up to date on their routine vaccines, including COVID-19, to reduce the spread of respiratory illness and protect their individual health,” said Mitchel Rothholz, RPh, MBA, FAPhA, a consultant to the profession of pharmacy and globally recognized expert on pharmacy-based immunization delivery. “Getting vaccinated isn’t just about self-protection, it’s also about protecting those who can’t and are not vaccinated.”
READ MORE: COVID-19 Resource Center
References
FDA approves and authorizes updated mRNA COVID-19 vaccines to better protect against currently circulating variants. News release. FDA. August 22, 2024. Accessed August 22, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-and-authorizes-updated-mrna-covid-19-vaccines-better-protect-against-currently
FDA updates advice to manufacturers of COVID-19 vaccines (2024-2025 Formula): If feasible use KP.2 strain of JN.1-lineage. FDA. Reviewed August 13, 2024. Accessed August 22, 2024. https://www.fda.gov/vaccines-blood-biologics/updated-covid-19-vaccines-use-united-states-beginning-fall-2024
Goodman B. The US is experiencing its largest summer COVID wave in at least two years. CNN. Updated August 16, 2024. Accessed August 22, 2024. https://www.cnn.com/2024/08/16/health/covid-largest-summer-wave/index.html
Wastewater COVID-19 national and regional trends. CDC. National Wastewater Surveillance System. Updated August 15, 2024. Accessed August 22, 2024. https://www.cdc.gov/nwss/rv/COVID19-nationaltrend.html
Novavax continues to work with the US FDA on authorization of 2024-2025 formula COVID-19 vaccine. News release. Novavax. August 22, 2024. Accessed August 22, 2024. https://ir.novavax.com/press-releases/Novavax-Continues-to-Work-with-the-U-S-FDA-on-Authorization-of-2024-2025-Formula-COVID-19-Vaccine
Novavax submits application to US FDA for updated protein-based 2024-2025 Formula COVID-19 vaccine. News release. Novavax. June 14, 2024. Accessed August 22, 2024. https://ir.novavax.com/press-releases/2024-06-14-Novavax-Submits-Application-to-U-S-FDA-for-Updated-Protein-based-2024-2025-Formula-COVID-19-Vaccine
CDC recommends updated 2024-2025 COVID-19 and flu vaccines for fall/winter virus season. News release. CDC. June 27, 2024. Accessed August 22, 2024. https://www.cdc.gov/media/releases/2024/s-t0627-vaccine-recommendations.html
Weekly dashboard. COVIDVaxView. CDC. Updated May 22, 2024. Accessed August 22, 2024. https://www.cdc.gov/vaccines/imz-managers/coverage/covidvaxview/interactive/vaccination-dashboard.html
Tyson A, Pasquini G. How Americans view the coronavirus, COVID-19 vaccines amid declining levels of concern. Pew Research Center. March 7, 2024. Accessed August 22, 2024. https://www.pewresearch.org/science/2024/03/07/how-americans-view-the-coronavirus-covid-19-vaccines-amid-declining-levels-of-concern/
