The U.S. Food and Drug Administration (FDA) on Monday approved Pfizer's respiratory syncytial virus (RSV) vaccine for use in women during the second trimester of pregnancy to protect their babies. their baby.
The company said the approval allows the vaccine to be given to women 32 to 36 weeks pregnant to prevent lower respiratory tract infections and serious illness in babies up to six months of age.
A group of experts outside the FDA endorsed the safety and effectiveness of Pfizer's RSV vaccine for women during the second and third trimesters in early May.
A Pfizer spokesperson could not comment on the FDA's rationale for the more limited period for vaccines but said the company was confident the vaccine would have a positive impact on public health. and RSV infection rates.
RSV is a common respiratory virus that often causes mild cold-like symptoms, but can also lead to severe illness and hospitalization. The vaccine, sold under the brand name Abrysvo, has been approved for use in adults 60 years of age and older to prevent infection with a disease that kills about 1,60,000 people worldwide each year.
Newborns are at greatest risk for serious illness from RSV. According to government data, between 58,000 and 80,000 children under the age of 5 are hospitalized each year with RSV infections in the United States.
The U.S. Centers for Disease Control and Prevention has yet to approve the vaccine, making it the first maternal RSV vaccine to be widely available in the country. That will happen shortly after the approval announcement on Monday. The FDA's decision was based on data from a late-stage trial with more than 7,000 participants that found the vaccine was 82 percent effective at preventing serious infections in infants when given to women. pregnancy in the second half of pregnancy.
Pfizer says the most common side effects in pregnant women are fatigue, headache, injection site pain, muscle aches, nausea, joint pain, and diarrhea.
Some experts raised concerns at an advisory committee meeting about a higher number of premature births among those vaccinated in the clinical trial compared with pregnant women in the placebo group. medicine.
Sanofi and partner AstraZeneca received US approval in July for their antibody treatment, nirsevimab, to prevent lower respiratory tract disease in infants and toddlers.
In May, the FDA also gave the green light to GSK's elderly RSV vaccine, helping the company and Pfizer cement their presence in the multi-billion dollar market. GSK does not ask for permission to give injections to pregnant women.
