By IDSE News Staff
The FDA approved and granted emergency use authorization (EUA) for updated mRNA COVID-19 vaccines (2024-2025 formula), which include a monovalent component that corresponds to the omicron variant KP.2 strain of SARS-CoV-2.
The mRNA COVID-19 vaccines by Moderna and Pfizer-BioNTech have updated the formula to more closely target circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death, the FDA said in a statement.
“Vaccination continues to be the cornerstone of COVID-19 prevention,” said Peter Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation and Research. “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.”
In early June, the FDA advised manufacturers the COVID-19 vaccines (2024-2025 formula) should be monovalent JN.1 vaccines. Based on the further evolution of SARS-CoV-2 and a rise in cases of COVID-19, the agency subsequently advised manufacturers that the preferred JN.1 lineage for the COVID-19 vaccines (2024-2025 formula) is the KP.2 strain.
“Even if you’ve already received a previous COVID-19 vaccine, getting the latest version helps your immune system keep pace with the everchanging characteristics of the virus, which is crucial to prevent severe consequences of an acute infection and protect you from the lasting and often devastating impacts, such as long COVID,” said Phillip Levy, MD, a professor of emergency medicine and the associate vice president of translational science at Wayne State University, in Detroit.
The updated mRNA COVID-19 vaccines include Comirnaty (Pfizer-BioNTech) and Spikevax (Moderna), both of which are approved for people 12 years of age and older and mRNA vaccines for children 6 months through 11 years of age, which have an EUA.
Here are the current recommendations for receipt of COVID-19 vaccines among children:
- Unvaccinated children 6 months through 4 years of age are 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.
- Children 6 months through 4 years of age who have been vaccinated previously against COVID-19 are eligible to receive one or two doses of either updated, authorized COVID-19 vaccine (timing and number of doses to administer depends on the previous COVID-19 vaccine received).
- Children 5 through 11 years of age regardless of previous vaccination are eligible to receive a single dose of the updated, authorized Moderna or Pfizer-BioNTech COVID-19 vaccine; if previously vaccinated, the dose is administered at least two months after the last dose of any COVID-19 vaccine.
- Children 12 years of age and older are eligible to receive a single dose of the updated, approved Comirnaty or the updated, approved Spikevax; if previously vaccinated, the dose is administered at least two months since the last dose of any COVID-19 vaccine.
- Additional doses are authorized for certain immunocompromised individuals ages 6 months through 11 years of age as described in the Moderna COVID-19 vaccine and Pfizer-BioNTech COVID-19 vaccine fact sheets.
The updated vaccines are expected to provide protection against COVID-19 caused by the currently circulating variants. Barring the emergence of a markedly more infectious variant of SARS-CoV-2, the FDA anticipates that the composition of COVID-19 vaccines should be assessed annually, as occurs for seasonal influenza vaccines.
“With the upcoming fall respiratory season just around the corner, 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. “Keep in mind that your local pharmacist is here to help. Getting vaccinated isn’t just about self-protection; it’s also about protecting those who can’t and are not vaccinated.”
The FDA’s decision is based on a combination of manufacturing and preclinical data, as well as previous clinical, nonclinical and real-world evidence supporting the efficacy and safety of mRNA vaccines. The mRNA COVID-19 vaccines have been administered to hundreds of millions of people in the United States, and the benefits of these vaccines continue to outweigh their risks, the FDA said.
“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 U.S. 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, the CEO of Moderna (Preprints 2024 May 30).
Regulators in other countries have recommended a vaccine that targets the JN.1 variant; Moderna is simultaneously manufacturing an updated COVID-19 vaccine targeting the JN.1 variant of SARS-CoV-2. Additional regulatory applications for Moderna’s updated COVID-19 vaccines targeting KP.2 or JN.1 are under review by other regulatory agencies, with decisions anticipated in the coming weeks.
Pfizer said its vaccines will start shipping immediately.
