The approval on Wednesday by the European Commission, which follows a recent endorsement from the European Medicines Agency, comes about a month after the U.S. health regulator gave the drug Arexvy the green light.
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The FDA’s advisory committee voted unanimously that available data supported the vaccine’s efficacy for giving the shot to women in their second or third trimesters of pregnancy to prevent lower respiratory tract infection and severe disease in infants up to 6 months of age.
Pfizer Inc and GSK are close to bringing the first two vaccines for RSV to the United States after gaining the backing of a panel of advisers to the FDA.
The company is discontinuing the late-stage study of its experimental respiratory syncytial virus adult vaccine, weeks after rivals Pfizer and GSK gained a lead in the race for the first vaccine against the virus.
The frontrunners in a crowded race to develop the first respiratory syncytial virus vaccine – Pfizer Inc and GSK – will face scrutiny from a panel of experts to the U.S. Food and Drug Administration this week.
The European Commission has approved Sanofi and AstraZeneca’s Beyfortus for the prevention of a common and highly contagious type of respiratory infection in infants.
Data recently unveiled showed GSK’s respiratory syncytial virus (RSV) vaccine was 82.6% effective in a keenly watched late-stage study involving older adults.
There are no U.S. approved vaccines for RSV, a common virus that typically causes mild cold-like symptoms but can be fatal for young kids and older adults. RSV is estimated to cause about 14,000 annual deaths among older adults in the United States.