FDA votes for COVID vaccines targeting XBB variants, Pfizer aims for July production

Pfizer Inc. has said that it can produce COVID-19 vaccines that target the XBB.1.5 strain by the end of July, provided government regulators recommend it. The pharmaceutical giant, in collaboration with BioNTech SE, also stated that the development of a vaccine for the XBB.1.16 strain would take a bit longer, with an estimated delivery time of August.

These announcements were made by Kena Swanson, Pfizer's vice president for viral vaccines, during a meeting of the US Food and Drug Administration's vaccine advisers on Thursday.

The committee also unanimously voted for monovalent COVID shots in the fall and winter targeting the XBB variants, which are now the dominant strains of the SARS-CoV-2 virus in the world.

Initially designed to combat the original strain of COVID-19 that originated in Wuhan, China, vaccines have undergone adaptations to address emerging variants.

Updated vaccines are necessary to address the ongoing evolution of the SARS-CoV-2 virus and its emerging variants. As the virus mutates over time, new strains with different characteristics can emerge, potentially rendering existing vaccines less effective.

By developing updated vaccines that specifically target these new strains, we can enhance protection against the latest variants, reduce the likelihood of breakthrough infections and maintain the effectiveness of vaccination campaigns in mitigating the spread of the virus and preventing severe illness.

Pfizer's presentation at the FDA meeting indicated that targeting a single strain of XBB, a highly contagious version of the omicron variant, would be the most effective approach based on the latest data.

In line with these findings, a panel from the World Health Organization recommended in May that vaccine manufacturers focus on developing shots for the XBB.1 strains. Moderna Inc. also expressed its ability to supply a new vaccine later this year, supporting the WHO's recommendation.

Novavax, a biotechnology company, shared its plans to have a vaccine targeting the XBB.1.5 strain ready for distribution in the fall. However, any potential delay in production may occur if the FDA advises a different formulation

For instance, vaccines directed at the XBB.1.16 strain would likely require an additional eight weeks of development, as explained by Filip Dubovsky, Novavax's president of research and development, during the meeting.