U.S. FDA greenlights revised COVID-19 vaccines for the upcoming fall and winter

The U.S. Food and Drug Administration approved updated COVID-19 vaccines from Pfizer and Moderna on Thursday, designed to target a recent variant of the disease, ahead of the upcoming fall vaccination campaign.

U.S. FDA greenlights revised COVID-19 vaccines for the upcoming fall and winter
On Thursday, the U.S. Food and Drug Administration (FDA) granted approval for updated COVID-19 vaccines from Pfizer and Moderna, aimed at addressing a recent variant of the virus in preparation for the upcoming fall vaccination campaign.

These updated vaccines specifically target the KP.2 variant that was prevalent earlier this year and are expected to be accessible nationwide in the coming days, according to the companies.

Back in June, the health regulator had urged vaccine manufacturers to focus on this variant if possible.

The newly approved vaccines are formulated to more effectively address currently circulating variants and provide better protection against severe symptoms of the disease. In contrast, the previous vaccines targeted a variant that is no longer active.

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

While KP.2 is not currently the dominant strain, it remains related to other variants circulating in the United States. Health officials are optimistic that by targeting closely related variants such as KP.2, they can enhance protection against these ongoing threats.

The FDA has authorized the use of Moderna's vaccine, marketed as Spikevax, as well as Comirnaty, jointly developed by Pfizer and BioNTech, for individuals aged six months and older, including adults.

For children under 12, the vaccines have received clearance via the agency's emergency use authorization pathway.

However, the regulator did not approve a traditional protein-based vaccine from Novavax, which serves as an alternative for individuals hesitant about the mRNA options from Pfizer and Moderna.

Novavax stated that it is collaborating "productively" with the FDA and anticipates receiving authorization in time for the peak vaccination season.

The company informed Reuters that it has been producing the updated vaccines in anticipation of approval for several months.

Developed using moth cells, Novavax's vaccine requires an extensive manufacturing timeline, with the company having noted that it needed six months in 2023 to ensure an adequate market supply.

These approvals occur amid a recent rise in COVID-19-related hospitalizations and deaths in the United States over the last three months. Despite this, demand for vaccines has significantly decreased since the height of the pandemic.

Emily Johnson contributed to this report for TROIB News