The U.S. Food and Drug Administration (FDA) on Thursday approved Pfizer and Moderna's updated COVID-19 vaccines amid a summer wave of "very high" coronavirus levels in wastewater, according to the Centers for Disease Control and Prevention (CDC).
The approval allows the pharmaceutical giants to begin shipping out millions of doses that "more closely target currently circulating variants," according to the FDA, including the KP.2 strain.
"Shipping will begin immediately to ensure robust supply and rapid access of this season's vaccine in pharmacies, hospitals, and clinics across the country," a spokesperson for Pfizer told Newsweek in an email.
Moderna said in a news release that the "approval is timely, as COVID-19 remains a significant health risk and is the leading cause of respiratory illness-related hospitalization, regardless of age or health condition." It noted that the updated vaccines should appear in "pharmacies and care settings in the coming days."
An FDA press officer told Newsweek that the "FDA approves or authorizes a product when FDA's standards have been met," and noted that the agency "will review any additional COVID-19 vaccine applications submitted to the agency and take appropriate regulatory action," on an ongoing basis.
The statement noted that, "Novavax has announced it anticipates that the Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) to be available sometime this fall."
Newsweek reached out to Moderna's press team for comment via email on Thursday.
COVID-19 infections have surged this summer, with the CDC reporting "very high" viral activity in national wastewater, which can detect traces of the virus.
According to recent CDC data, KP.3.1.1 Omicron strain accounts for over a third of infections in the U.S. The analysis also reveals that the highest rates of infection in the past two weeks are found in five Southern/Southwestern states, with nearly 1 in 4 COVID tests coming out positive across the region comprised of Arkansas, Louisiana, New Mexico, Oklahoma and Texas.
In a Thursday news release announcing the approval, Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said, "Vaccination continues to be the cornerstone of COVID-19 prevention." He urged eligible individuals to get the updated vaccines and noted a "waning immunity of the population."
The FDA said individuals who receive the updated vaccines "may experience similar side effects" as previous coronavirus vaccines. "The FDA anticipates that the composition of COVID-19 vaccines will need to be assessed annually, as occurs for seasonal influenza vaccines," the agency said.
It approved the vaccines for people age 12 and older, and granted emergency use authorization for those age 6 months through 11 years old.
The statement sought to assuage concerns over the vaccines: "The mRNA COVID-19 vaccines have been administered to hundreds of millions of people in the U.S., and the benefits of these vaccines continue to outweigh their risks." CDC officials have previously stated that while vaccines don't completely protect against the virus, they can prevent severe cases and hospitalization.
The virus is expected to surge in winter as people gather indoors. The CDC previously stated that "It is safe to receive COVID-19 and flu vaccines at the same visit."
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