Pfizer’s RSV Vaccine Becomes First To Gain FDA Panel’s Recommendation
News outlets report on the vote by an FDA panel, which assessed Pfizer's data on the safety and effectiveness of Pfizer's vaccine for respiratory syncytial virus. The panel concluded it was safe for adults 60 and over. The FDA is set to make a formal decision on the drug soon.
AP:
FDA Panel Narrowly Backs Pfizer RSV Vaccine For Older Adults
Federal health advisers on Tuesday narrowly backed an experimental vaccine from Pfizer that could soon become the first shot to protect older adults against the respiratory illness known as RSV. The Food and Drug Administration panel voted 7-4 on two separate questions of whether Pfizer’s data showed the vaccine was safe and effective against the respiratory virus for people 60 and older. One panelist abstained from voting. The recommendation is non-binding and the FDA will make its own decision on the vaccine in the coming months. (Perrone, 2/28)
Bloomberg:
Pfizer’s RSV Vaccine Wins US Panel’s Backing For Safety In Older People
As it did with its messenger RNA Covid-19 vaccine, Pfizer gained the coveted spot of being first to pass a key barrier to the US market for a lung illness that affects thousand of people each year. Pfizer has been vying with the UK’s GSK Plc over what is estimated to become a $10 billion RSV market. GSK will face its own advisory committee hearing on Wednesday for what infectious disease specialists call the last big respiratory virus without a vaccine. (Cattan, 2/28)
USA Today:
FDA Experts Recommends RSV Vaccine For Adults 60 And Over. What's Next?
The vaccine still needs final say from the FDA commissioner and recommendations by an advisory panel at the Centers for Disease Control and Prevention, which will require another sign-off from the CDC director. If that happens, the vaccine will likely become available by the next RSV season. Then on Wednesday, the FDA’s Vaccines and Related Biological Products Advisory Committee will consider a second RSV vaccine for older adults by GlaxoSmithKline, which would follow the same CDC process if recommended. (Rodriguez, 2/28)
Reuters:
Pfizer Gets FDA Panel's Backing In RSV Vaccine Race
GSK, which is another forerunner in a crowded race to develop the first RSV vaccine, will face scrutiny from a panel of experts to the FDA on Wednesday. Companies such as Johnson & Johnson, Moderna Inc and Merck are also looming on the horizon. (Mandowara and Esunny, 2/28)
