FDA Approves Updated COVID-19 Vaccines for Current Variants

The US Food and Drug Administration (FDA) has recently approved updated COVID-19 vaccines from Pfizer/BioNTech and Moderna. These new vaccines are specifically designed to provide better protection against currently circulating variants of the virus. The updated versions target the KP.2 strain, a descendant of the JN.1 variant, which was prevalent in the US earlier this year. The vaccines are anticipated to be available to the public in the coming days.

Both Pfizer/BioNTech and Moderna's mRNA vaccines have received approval for use in individuals aged 12 years and older. Additionally, they have been granted emergency use authorization for children aged six months to 11 years. This move follows recent FDA guidance from June, which advised COVID-19 vaccine manufacturers to target the KP.2 strain for the upcoming autumn and winter vaccination programs if possible.

Although KP.2 is no longer the dominant strain, currently accounting for only 3.2% of COVID-19 cases in the country based on recent data from the Centers for Disease Control and Prevention (CDC), it remains related to other circulating variants. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, highlighted the importance of the updated vaccines. He stated that these vaccines meet the FDA’s rigorous standards for safety, effectiveness, and manufacturing quality. Marks emphasized that, due to the waning immunity from previous virus exposure and prior vaccinations, eligible individuals are strongly encouraged to receive the updated COVID-19 vaccine for enhanced protection against the currently circulating variants.

The FDA also indicated that the composition of COVID-19 vaccines will likely need annual evaluations, similar to the process for seasonal influenza vaccines. In line with this, both Pfizer/BioNTech and Moderna have been working on combination vaccines for flu and COVID-19.

Notably, Pfizer and BioNTech recently announced the top-line results from a late-stage study of their combination vaccine candidate. The trial met one of its two primary immunogenicity endpoints. Although the combination vaccine elicited higher immune responses against influenza A compared to a standard flu vaccine, it showed weaker results against the influenza B strain.

Similarly, Moderna recently shared positive phase 3 results for its own flu/COVID-19 combination vaccine candidate. The company stated that it plans to engage with regulators to discuss the next steps in the development and approval process for their combination vaccine.

In summary, the FDA has approved updated COVID-19 vaccines from Pfizer/BioNTech and Moderna that target the KP.2 strain. These vaccines are intended to offer better protection against current virus variants and are expected to be available soon. The vaccines have been approved for individuals aged 12 and older, with emergency use authorization granted for younger children. The approval follows FDA guidance and underscores the importance of annual evaluations for COVID-19 vaccine compositions, similar to seasonal flu vaccines. Both companies are also making progress in developing combination vaccines for flu and COVID-19, with ongoing studies showing promise and plans for further regulatory engagement.