In February 2023, a few days after the FDA requested further studies into the link between GBS and its RSV vaccine candidate, Pfizer announced that the FDA had voted that available data supports the “safety and effectiveness” of the vaccine. The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 7 to 4 on safety and 7 to 4 on effectiveness.  

What does the vote mean? 

Although the VRBPAC provides recommendations to the FDA, Pfizer emphasises that they “are not binding” and the FDA is still considering the approval of RSVpreF with a decision expected in May 2023.  

The vote was based on available evidence from Pfizer, including data from the RENOIR study last year. However, some of the members of the committee expressed concerns about the safety of the candidate, particularly in light of the perceived connection between the vaccine and GBS. Dr Hana El Sahly, Committee Chair, described the risk as “concerning”, voting in favour of the vaccine based on efficacy but against its safety profile.  

A step forward for Pfizer with GSK following 

Dr Annaliesa Anderson, Senior Vice President and Chief Scientific Officer, Vaccine Research and Development at Pfizer, described the “significant need” to protect older adults from “serious illness, hospitalisation, or even death” from RSV. 

“We are encouraged by the outcome of today’s VRBPAC meeting as it is a testament to the strength of our science and dedication to bringing this important vaccine candidate to the market.” 

Dr Anderson looks forward to “working with the FDA” to complete the application.  

Closely following Pfizer in the ‘race’ to secure approval for its RSV vaccine is GSK. The Committee meets again today, on the 1st March, to evaluate its candidate following “positive” results last year.  

For more updates on RSV vaccine developments and the timeline to success, join us for discussions with representatives of these key participants in the efforts to achieve it at the World Vaccine Congress in Washington this April.