The FDA’s independent advisory panel voted in favor of two vaccines for respiratory syncytial virus (RSV). The vaccines, developed by GSK and Pfizer for people 60 years and older, would be the first for RSV if approved by the FDA. Large clinical trials demonstrated GSK’s vaccine to be 82.6% effective at preventing disease in the lower respiratory tract, while Pfizer’s vaccine was 66.7% effective. The committee of outside experts showed higher confidence in GSK’s vaccine compared to the one produced by Pfizer on safety and effectiveness. The panel unanimously voted in favor of GSK vaccines effectiveness and voted 10-2 in favor of its safety profile. The committee voted in favor of Pfizer’s vaccine 7 to 4 on separate votes of safety and effectiveness. If authorized by the FDA, the vaccines could save thousands of lives and prevent hundreds of thousands of hospitalizations per year. The virus causes 6,000 to 10,000 deaths and 60,000 to 160,000 hospitalizations every year.
The scientists critically reviewed data on several cases of nervous system disorders that may be connected to the vaccines. Committee chair Dr. Hana El Sahly, along with 3 other members, believe more safety data is needed for approval. Among the 15,000 participants in the GSK study, one woman was diagnosed with Guillain-Barre syndrome 9 days after receiving the vaccine. Research studies cited by the FDA show that Guillain-Barre syndrome typically affects 1 in 100,00 people 60 years and older. Dr. Nicholas Geagan, an FDA official, said that “it does seem concerning to have observed these cases in the context of clinical development program”, and called on the agency to conduct further safety analyses. Two people were diagnosed with condition called acute disseminated encephalomyelitis after receiving the RSV and flu vaccines simultaneously, one of whom died. During Pfizer’s trial two people developed Guillain-Barre syndrome. According to Adam Berger of the National Institutes of Health, acute disseminated encephalomyelitis cases are likely a result of getting the RSV and flu shot at the same time, as opposed to a problem with GSK’s vaccine. “Our obligation is to do what’s right for the public,” said Dr. David Kim, an officer in the U.S. public health service and an FDA committee member. “And in this case, we have bad disease, we have a good vaccine. The vaccine could be used to prevent a disease”.
Full Story: CNBC, Reuters, New York Times