FDA Panel Backs GSK ’s RSV Vaccine for Older People

GSK Plc’s vaccine for respiratory syncytial virus won the support of a key panel of U.S. regulatory advisers for use in people aged 60 and older, as the drugmaker races against Pfizer Inc. to bring to market the first vaccine for RSV. The panel of 12 outside advisers to the Food and Drug Administration voted unanimously on Wednesday that GSK’s data show the Arexvy vaccine is effective. The same committee voted 10-2 that company data show the shot is safe. By contrast, it had voted 7-4 with one abstention to recommend Pfizer’s vaccine as both safe and effective in preventing RSV. [time-brightcove not-tgx=”true”] The Vaccines and Related Biological Products Advisory Committee’s recommendations aren’t binding, but are often followed by the FDA. “It’s a very strong vote for GSK,” Adam Barker, an analyst at Goodbody, said in an email. “The stronger efficacy profile in those at very high risk will be the dominant factor.” Shares of GSK were up 0.2% in London on Thursday morning. GSK has been vying with Pfizer over which drugmaker will become the first to reach the U.S. market with vaccines for the lung illness. The maker of the blockbuster shingles vaccine Shingrix, GSK is counting on new products like Arexvy as Chief Executive Officer Emma Walmsley narrows the pharmaceutical company’s focus on cutting-edge drugs and vaccines. “Across the board data presented suggest both vaccines offer broadly simi...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized bloomberg wire Drugs healthscienceclimate News Source Type: news