FDA approves updated mRNA COVID-19 vaccines

Last week, the FDA approved updated mRNA COVID-19 vaccines that included a monovalent component to protect against the KP.2 SARS-CoV-2 strain, an omicron variant currently circulating across the U.S. and other countries.

These updated vaccines offer an additional public health tool for protecting the nation against circulating strains of SARS-CoV-2, addressing gaps in the coverage that previously available and approved vaccines provided.

"Vaccination continues to be the cornerstone of COVID-19 prevention," said Peter Marks, MD, Ph.D., director of the FDA's Center for Biologics Evaluation and Research. "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."

There are four updated vaccines that have been approved by the FDA -- the Comirnaty, Spikevax, Moderna, and Pfizer-BioNTech vaccines.

According to the FDA, the Moderna and the Pfizer- BioNTech COVID-19 vaccines are available to kids six months and older. For unvaccinated individuals between six months and four years, providers can administer three doses of the updated, authorized Pfizer-BioNTech COVID-19 vaccine or two doses of the updated Moderna vaccine. Those in the same age bracket who were previously vaccinated are eligible to receive one or two doses of the updated, authorized Pfizer-BioNTech or Moderna COVID vaccines. However, they should consult their healthcare provider for the exact number of doses and administration guidelines.

Individuals 5-11 years old can receive a single dose of updated, authorized Pfizer-BioNTech or Moderna COVID-19 vaccines, irrespective of their current vaccination status; however, individuals who have been vaccinated should wait at least two months before getting one of these vaccines.

Finally, individuals 12 and older can receive a single dose of the updated, approved Comirnaty or Spikevax vaccines. Again, those who have been vaccinated in the past should wait at least two months before getting an additional dose.

Like the standard vaccine series and previously approved booster, these vaccines might result in side effects such as injection site pain and flu-like symptoms.

The availability of new vaccines might help combat the rising rates and impacts of COVID-19. According to the CDC COVID Data Tracker, 18.0% of COVID-19 samples tested during the week of August 17, 2024, were positive. Additionally, 2.5% of COVID-19 patients required an emergency department visit during that week. Across the same period, 1.8% of all deaths in the U.S. were attributed to COVID-19.

Throughout the week of August 3, 2024, COVID-19 contributed to 4.4 hospitalizations per 100,000 individuals.

Although COVID-19 rates and survival outcomes have improved significantly since the height of the pandemic with the help of respiratory health practices and vaccines, the public health threat persists as the variants mutate, forcing pharmaceutical companies and regulatory bodies to reformulate their vaccines to address emerging strains.

For example, the 2023 updated vaccines predominantly addressed the XBB.1.5 COVID-19 strain. However, throughout the past year, KP.2, also called the FLiRT COVID strain, has emerged as a leading variant nationwide.

The hope is that newly approved vaccines will offer protection against this strain, protecting the population from infections and the longitudinal impacts of COVID-19.

Veronica Salib has covered news related to the pharmaceutical and life sciences industry since 2022.