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FDA approves GSK's RSV vaccine for older adults, world's first shot against virus

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[ad_1] A GSK lab in London. Oli Scarff | Getty Images The Food and Drug Administration on Wednesday approved an RSV vaccine produced by GlaxoSmithKline for use on adults ages 60 and older. The approval, the first ever globally by a regulatory body for an RSV vaccine , is a decisive victory for GSK in a race against drugmakers Pfizer and Moderna to bring to market a shot that targets the respiratory syncytial virus . Shares of GSK rose nearly 2% Wednesday following the approval. GSK's chief scientific officer Tony Wood said in a statement the decision "marks a turning point" in the company's effort to reduce the "significant burden" of RSV. The company will now focus on ensuring eligible older adults in the U.S. can access the vaccine "as quickly as possible," he said. GSK will also work toward regulatory review and approval of the shot in other countries. London-based GSK during an earnings presentation last week said it has "mil...

Pfizer RSV vaccine for infants has 'generally favorable' safety data, FDA staff say

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[ad_1] Blood sample for respiratory syncytial virus (RSV) test Jarun011 | Istock | Getty Images U.S. Food and Drug Administration staff on Tuesday said Pfizer's vaccine that protects infants from respiratory syncytial virus has "generally favorable" safety data. The FDA staff made the conclusion in briefing documents ahead of a meeting on Thursday when a panel of external advisors to the agency will discuss whether to recommend full approval of the RSV shot . The advisors will vote on whether Pfizer's late-stage clinical trial data on the vaccine supports its safety and efficacy. The FDA typically follows the advice of its advisory committees, but is not required to do so. The agency is slated to make a decision on whether to clear the shot in August before RSV season in the fall. If approved, Pfizer's jab would become the world's first vaccine that protects infants against RSV.  RSV usually causes mild, cold-like symptoms. But infants and older ad...

Pfizer, GSK RSV shots for older adults may prevent thousands of hospitalizations, CDC analysis says

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[ad_1] Respiratory syncytial virus vial. Manjurul | Istock | Getty Images Vaccinating one million adults ages 65 and above with a single RSV shot from Pfizer or GSK may prevent thousands of hospitalizations over two seasons of the virus, according to a Centers for Disease Control and Prevention analysis .  A CDC medical officer presented the analysis, conducted by researchers at the University of Michigan, at an advisory committee meeting on Wednesday. The committee recommended that adults ages 60 and older may receive one dose of Pfizer's or GSK's respiratory syncytial virus shot after consulting their doctor.  The analysis found that vaccinating one million adults 65 and older with a single dose of Pfizer's shot may prevent 2,500 hospitalizations and 25,000 outpatient visits over two seasons of the virus. RSV season typically lasts from October to March in the Northern Hemisphere.   The analysis also found that vaccinating one million adults in the same age gr...