New COVID-19 jabs approved by FDA for 2024-25 season

The FDA has approved new versions of Pfizer/BioNTech's Comirnaty and Moderna's Spikevax COVID-19 vaccines that target the Omicron KP.2 strain of SARS-CoV-2 which was dominant in the US in recent months.

Both new mRNA-based vaccines have been approved for use in people aged 12 and over – and been granted emergency use authorisation for younger people aged 6 months to 11 years – and will be available within the next few days, said the drugmakers.

KP.2 is one of the offshoots of the JN.1 lineage of Omicron but is already being superseded by sister strain KP.3. Still, Pfizer/BioNTech and Moderna say they expect their new vaccines will retain protective efficacy as the two strains are very alike.

The FDA advised manufacturers of licensed and authorised COVID-19 vaccines in June that the shots for the coming vaccination season should target KP.2, reflecting the shift of the COVID-19 vaccine category to annual formulation tweaks like influenza vaccines.

Both Moderna and Pfizer/BioNTech have responded to that shift with the development of combined COVID-19/flu vaccines, with Moderna pitching at a possible approval for its candidate next year or in 2026, while Pfizer/BioNTech recently suffered a setback in a phase 3 trial that delayed their programme.

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

"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."

Vaccination rates in the US and around the world have declined since the COVID-19 pandemic was declared over, and have cratered in Europe since many governments stopped providing free shots to people outside of an increasingly narrow group of vulnerable patients.

Earlier this year, a report suggested that COVID-19 vaccination rates have now fallen to such low levels in Europe that elderly people and those with weakened immune systems could be at risk.

In the US, the Centers for Disease Control and Prevention (CDC) still recommends that everyone over six months old receive an updated COVID-19 vaccine this year, but free shots are also no longer widely accessible outside of federal assistance programmes for those with no or inadequate insurance. Those schemes are due to expire shortly.

A third player in the market, Novavax, filed for approval of a non-mRNA vaccine based on the earlier JN.1 variant before the FDA asked manufacturers to switch to KP.2. However, it said it is working with the FDA on the review and expects "to have authorisation in time for peak vaccination season."