The FDA has authorized the use of new vaccines from Pfizer/BioNTech and Moderna which have been designed to defend against the Omicron KP.2 variant of SARS-CoV-2.
The nod comes as word of a new omicron variant, KP.3.1.1, is beginning to eclipse KP.2 as the dominant strain of the virus in the United States. Manufacturers of the adapted vaccines say that the similarities in the strains are such that the new shots will still be effective.
In a statement, a Pfizer spokesperson said the company and its partner BioNTech will “be prepared to develop modified vaccine formulas, as the data support and as regulatory agencies recommend.”
The FDA endorsed both adapted vaccines for people ages 6 months and older. While the shots are fully approved for patients ages 12 and older, the nod for those ages 6 months to 11 years is an emergency authorization. Both should become available in the coming days, the companies said.
“Vaccination continues to be the cornerstone of COVID-19 prevention,” Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research (CBER), said in a release. “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.”
Another COVID-19 vaccine producer, Novavax, said on Thursday that it is expects to gain authorization of its adapted shot “in time for peak vaccination season," once the FDA completes review of its data .
Demonstrating the elusive nature of the virus, in late April the World Health Organization (WHO) recommended that producers of COVID vaccines adapt their shot to the JN.1 strain of the virus. Seven weeks later, the FDA advised that the new shots should be geared to defending against KP.2, which is an offshoot of JN.1.
Acting on the WHO’s guidance, Novavax adapted its protein-based vaccine to JN.1 which provides acceptable coverage against “lineage viruses, including KP.2.3, KP.3, KP.3.1.1 and LB1,” the company said.
The Centers for Disease Control and Prevention (CDC) still recommends that people age 6 months and older get vaccinated with an updated shot. The CDC also recommends that flu shots be received in September/October, with co-administration of the COVID shot encouraged.
“COVID-19 remains a significant health risk and is the leading cause of respiratory illness-related hospitalization, regardless of age or health condition,” Moderna CEO Stéphane Bancel said in a release. “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.”
Moderna is working on a combination flu/COVID vaccine, anticipating approval next year. Last week, Pfizer and BioNTech said that their combo shot came up short on one endpoint in a phase 3 trial and that they were evaluating adjustments to the candidate.