RSV Racing

Amid rising cases of respiratory syncytial virus (RSV) over the winter months, the lack of an approved vaccine was all the more apparent. But within a few days of each other, FDA advisors recommended both Pfizer and GSK’s RSV vaccines for adults aged 60 years and over (1,2).

“In older adults, RSV can result in serious illness, hospitalization, or even death, so there is a significant need to protect this at-risk population,” said Pfizer’s Senior Vice President and Chief Scientific Officer of Vaccine Research and Development, Annaliesa Anderson (1). “We are encouraged by the outcome of today’s [Vaccines and Related Biological Products Advisory Committee] meeting as it is a testament to the strength of our science and dedication to bringing this important vaccine candidate to the market. We look forward to working with the FDA as it completes the review of our application.”

The advisory committee voted 7-4 in favor of the safety and effectiveness of Pfizer’s vaccine, with one member abstaining from the vote (1). For GSK’s vaccine, the committee voted unanimously in favor of the vaccine’s effectiveness and 10-2 in favor of its safety data (2).

“Today’s vote brings us an important step closer to delivering one of the world’s first vaccines for RSV – a respiratory virus that causes potentially debilitating disease and imposes a major burden on healthcare systems,” said Phil Dormitzer, Global Head of Vaccines R&D at GSK (2). “Thousands of older adults in the US are impacted by RSV and those with underlying health conditions, like respiratory and heart diseases and diabetes, are at increased risk of severe complications. We’re delighted that the Advisory Committee recognized the strength of our vaccine’s data and its potential to make a positive public health impact with a unanimous vote on the effectiveness of the vaccine.”

Two’s company, three’s a crowd – nevertheless, Moderna has also entered the race (albeit a little late), announcing at the start of 2023 that its investigational RSV vaccine MRNA-1345 met primacy endpoints in its ConquerRSV Phase III trial (3).

Who will cross the finish line first? Will we need a photo finish? We’ll be watching from the stands.