The FDA Approves Two New COVID-19 Vaccines As Cases Remain On The Rise

On Thursday, The U.S. Food and Drug Administration announced two new updated COVID-19 vaccines as cases tied to the largest spike in infections within the last two years remain high across the country.

The vaccines, manufactured by Pfizer-BioTech and Moderna, target the KP.2 variant — one of the FLiRT variants — a descendant of the highly contagious JN.1 Omicron variant.

The agency advised manufacturers that the updated vaccines should be monovalent vaccines that attack the selected strain to provide adequate protection against circulating variants after evaluating the recent uptick in infections.

Initially, the FDA suggested they target JN.1, but the agency altered its suggestion after reviewing updated data.

According to the U.S. Centers for Disease Control and Prevention, the current predominant strain of the virus is KP.3.11, another FLiRT variant. It has overtaken its parent lineage, KP.3, and previous dominant KP.2 variants.

Within the first two-week period of August, KP.3.11 accounted for approximately 31 to 43 percent of cases across the country. Although the updated vaccines target KP.2, they’ve been proven to be significantly more effective against the JN lineage than the vaccines currently available.

The CDC recommends that anyone six months and older receive an updated vaccine regardless of their previous vaccination status. Pfizer-BioTech and Moderna’s updated vaccines — Comirnaty and Spikevax — are available for people six months and older.

Novavax is working on a third vaccine that follows the FDA’s original recommendation by aiming to protect against the earlier JN.1 variant. The agency is expected to approve this vaccine soon, and it will be available to people 12 years of age and older.

Pfizer-Biotech and Moderna are expected to begin shipments of the vaccine to distributors within the coming days. The updated vaccines could cost up to $150 per dose for those paying out of pocket. However, most public and private health insurance plans should cover this cost.

Some uninsured adults may have issues accessing the vaccine at no cost or at a lower cost as the CDC’s Bridge Access Program — which covers the costs of some vaccinations for those without coverage — could end in August.

Those who rely on this program can opt to get their vaccines at community health centers or clinics, where they may be free or offered at a reduced rate.