FDA Approves Updated Moderna, Pfizer COVID-19 Vaccines for Omicron KP.2 Variant

Image Credit: Adobe Stock Images/JeromeCronenberger

The FDA has approved and authorized updated mRNA COVID-19 vaccines for the 2024-2025 season that target the Omicron KP.2 variant of SARS-CoV-2. Applying to Moderna's Spikevax and Pfizer's Comirnaty, the vaccines focus on a single strain for more effective immunity, according to the FDA. Emergency Use Authorizations will cover both the Moderna and Pfizer-BioNTech vaccines for individuals as young as 6 months of age.¹

“Vaccination continues to be the cornerstone of COVID-19 prevention,” said Peter Marks, MD, PhD, director, FDA’s Center for Biologics Evaluation and Research, in a press release. “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.”

The FDA stated that unvaccinated individuals aged six months through four years will be eligible to receive three doses of the updated, authorized Pfizer-BioNTech COVID-19 vaccine or two doses of the updated, authorized Moderna COVID-19 vaccine. Additionally, those in this age group who have previously been vaccinated against COVID-19 are eligible to receive one or two doses of the updated vaccines, with dosage depending on previous vaccination numbers and timing.

Those aged five to 11 years, regardless of previous vaccination, are eligible to receive a single dose of the updated, authorized Moderna or Pfizer-BioNTech COVID-19 vaccines. If previously vaccinated, the dose is administered at least two months after the last dose of any COVID-19 vaccine. People over 12 years of age are now eligible to receive a single dose of the updated vaccines.¹

"COVID-19 remains a significant health risk and is the leading cause of respiratory illness-related hospitalization, regardless of age or health condition. In the 2023-24 season, we saw more than 600,000 hospitalizations due to COVID in the US. Staying up to date with your COVID-19 vaccine remains one of the best ways for people to be protected and prevent severe illness," said Stéphane Bancel, CEO, Moderna, in a press release. "We appreciate the US FDA's timely review and encourage individuals to speak to their healthcare providers about receiving their updated COVID-19 vaccine alongside their flu shot this fall."²

The FDA warns that the updated vaccines may lead to the same adverse events that were previously reported by individuals who received earlier versions of the vaccines. However, the new vaccines are expected to provide protection against COVID-19 caused by the currently circulating variants. The agency also expects an annual evaluation of the composition of COVID-19 vaccines, similar to seasonal influenza.¹

Pfizer also warned that individuals who have previously experienced allergic reactions to Comirnaty should not take the updated formulation. Signs of an allergic reaction included difficulty breathing, swelling of the face or throat, fast heartbeat, bad rashes all over the body, dizziness, and weakness. Inflammation of the heart muscle and lining outside the heart have also occurred, most commonly in adolescent males 12 through 17 years of age.³

The approval of the new formulations comes as the Department of Health and Human Services has launched a national campaign titled Risk Less, Do More to inform the public about common respiratory viruses and available vaccines. According to the government agency, the campaign aims to increase awareness of vaccines that reduce serious illness from influenza, COVID-19, and RSV in high-risk populations and to limit the spread of these viruses.⁴

"Vaccines for COVID-19 and RSV have helped to save millions of lives, keep countless people out of the hospital, and provide peace of mind for the country. As fall approaches and people spend more time indoors, I encourage everyone who is eligible to get their vaccines to protect themselves and their loved ones," said HHS Secretary Xavier Becerra, in a press release. "The Biden-Harris Administration will continue working every day to provide accurate and up-to-date health information for everyone living in the United States, across age, geography, and race/ethnicity. I hope everyone takes this opportunity to stay healthy."

References

1. FDA Approves and Authorizes Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants. FDA. August 22, 2024. Accessed August 23, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-and-authorizes-updated-mrna-covid-19-vaccines-better-protect-against-currently

2. Moderna Receives U.S. FDA Approval for Updated COVID-19 Vaccine Targeting KP.2 Variant of SARS-CoV-2. Moderna. August 22, 2024. Accessed August 23, 2024. https://investors.modernatx.com/news/news-details/2024/Moderna-Receives-U.S.-FDA-Approval-for-Updated-COVID-19-Vaccine-Targeting-KP.2-Variant-of-SARS-CoV-2/default.aspx

3. Pfizer and BioNTech Receive U.S. FDA Approval & Authorization for Omicron KP.2-adapted COVID-19 Vaccine. Pfizer. August 22, 2024. Accessed August 23, 2024. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-us-fda-approval-authorization

4. HHS Launches National Public Education Campaign Ahead of Respiratory Virus Season. PR Newswire. August 22, 2024. Accessed August 23, 2024. https://www.prnewswire.com/news-releases/hhs-launches-national-public-education-campaign-ahead-of-respiratory-virus-season-302227983.html