FDA Approves Pfizer's RSV Vaccine for Pregnant Women 

– The FDA has approved Pfizer's RSV vaccine for use in women during the middle of the third trimester of pregnancy.

– The vaccine can be given to women 32 to 36 weeks into a pregnancy to prevent lower respiratory tract infection and severe disease in infants until they are six months old.

– The vaccine is already approved for use in adults aged 60 and older.

– Infants are at greatest risk for severe illness from RSV.

– The CDC still needs to sign off on the use of the vaccine.

– The FDA's decision was based on data from a late-stage trial with more than 7,000 participants.

– The most common side effects in pregnant women were fatigue, headache, pain at the injection site, muscle pain, nausea, joint pain and diarrhoea.

– Some experts raised concerns during an advisory committee meeting over the higher number of pre-term births among those who received the vaccine in the clinical trial compared with pregnant women in the placebo group.

– Sanofi and partner AstraZeneca have also received US approval for their antibody therapy, nirsevimab, to prevent lower respiratory tract disease in infants and toddlers.

– GSK is not seeking approval for its RSV vaccine in expectant mothers.