FDA to Decide in June on Next Booster Compostion
FDA officials told the agency’s Vaccines and Related Biological Products Advisory Committee 4/6 that a decision will likely be made in June on whether a new Covid-19 booster composition is needed by November for what some health experts predict could be another Covid infection wave as people remain indoors again during the winter months. They are expecting new clinical data from some of the manufacturers in the next couple of months to help drive discussions and decisions.
In a briefing document released in advance of the meeting, FDA officials noted that observational studies show that the primary Covid-19 vaccinations have decreased effectiveness against the Omicron variants and waning effectiveness over time. They say that while the first booster doses restored waning vaccine effectiveness (VE), “observational studies have also indicated waning effectiveness of the first booster dose over time, mainly against mild disease, with some studies also suggesting waning effectiveness against hospitalization… The Israeli experience with second booster dose of the Pfizer-BioNTech Covid-19 vaccine in adults 60 years of age and older indicates that a second booster dose improves VE overall, including through a reduction in mortality, … although effectiveness against mild disease decreased during a 10-week follow-up period.”
During the panel discussion, Children’s Hospital of Philadelphia professor Paul Offitt suggested that companies should have less control on deciding vaccine composition. He said once it is determined that the current vaccine no longer protects against serious illness, there then needs to be a coordinated effort between FDA, NIH, other agencies, and the companies on how to best move forward. “I feel like at some level, the companies kind of dictate the conversation there. You love to hear that the company now has an Omicron-specific vaccine or a vaccine that can now link with the influenza vaccine, and it shouldn't come from them. It really has to come from us.”
CDC National Center for Immunizations and Respiratory Diseases chief medical officer Amanda Cohn agreed with other panel members that it would be “incredibly helpful for the companies or for FDA to at least bring to the committee some of the different approaches the companies are thinking about taking and allowing us to comment on specific proposals or concepts so that we can better inform the direction moving forward.”