FDA approves GSK shot for older adults
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 "millions" of doses of the RSV vaccine ready to ship.
The company plans to meet in June with the federal Centers for Disease Control and Prevention's vaccine advisory committee to hash out potential vaccination schedules for the U.S., according to that presentation.
GSK's shot is also inching closer to approval in the European Union. Last week, the European Medicines Agency recommended that the company's vaccine be approved by the EU for older adults.
The shot would help countries combat the next RSV season in the fall.
The U.S. suffered an unusually severe RSV season last year.
Cases of the virus in children and older adults overwhelmed hospitals across the country, largely because the public stopped practicing Covid pandemic health measures that had helped keep the spread of RSV low.
RSV usually causes mild, cold-like symptoms. But each year the virus kills 6,000 to 10,000 seniors and a few hundred children younger than 5, according to the CDC.
Source: CNBC
