Pfizer’s RSV Vaccine: US FDA Panel Wants Robust Safety Program With Public Accountability
Advisory committee offers strong support for approval of Pfizer’s RSV vaccine to protect infants while simultaneously offering the agency a handful of suggestions that were directed towards the review and post-market surveillance of all vaccinations.
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The vaccine, already approved for adults, was approved for pregnant women to protect infants from birth up to six months from complications caused by respiratory syncytial virus.
The prospect of a game-changing approval of Pfizer’s maternal RSV vaccine hung over CDC committee’s vote on AstraZeneca/Sanofi’s Beyfortus, even though the pending product could not be addressed.
Claiming Pfizer’s Abrysvo infringes four of its patents, GSK asks court to permanently enjoin Pfizer from making or selling the vaccine in the US but would exempt the pending maternal indication.