The Food and Drug Administration (FDA) has granted approval for the first vaccine designed to protect infants from infections. This groundbreaking vaccine, named Abrysvo, is administered to pregnant mothers during their third trimester to ensure that newborns are protected from the moment they are born. Developed by Pfizer, Abrysvo is a single-dose injection that is recommended for use between 32 and 36 weeks of pregnancy. The FDA’s Vaccines and Related Biological Products Advisory Committee voted in favor of this drug in May.
Abrysvo has already received approval for preventing respiratory syncytial virus (RSV) in older adults. RSV is a common cause of illness in children, especially infants, who are at a higher risk of severe disease and hospitalization. By approving Abrysvo, the FDA offers healthcare providers and pregnant individuals an option to protect infants from this potentially life-threatening disease.
Pfizer presented data during the advisory committee review, demonstrating that infants whose mothers received the vaccine had higher levels of neutralizing antibodies against RSV up to 6 months of age. Infants below 6 months face an increased risk of severe RSV cases. According to the FDA, Abrysvo reduced the risk of lower respiratory tract disease by approximately 82% in the first 90 days after birth and about 70% in the first 180 days, based on one clinical study.
Pfizer’s Senior Vice President, Annaliesa Anderson, expressed gratitude to the clinical trial participants and study investigator teams worldwide for their contribution in making this vaccine available. She stated that the achievement of delivering a maternal vaccine for infants younger than six months, when they are most vulnerable to serious consequences from RSV, was a long-awaited goal.
RSV cases tend to increase during the fall and peak in the winter, similar to other respiratory viruses. Last winter, a significant number of infants and toddlers were hospitalized due to RSV, leading to capacity challenges in hospitals. The pandemic and COVID-19 quarantines may have contributed to the harsher RSV season, although higher case rates were observed even before the global health crisis.
Until this year, there were no specific treatments targeting RSV, apart from a monoclonal antibody for extremely high-risk cases. However, two RSV vaccines for older adults and a preventive monoclonal antibody for infants and toddlers were approved by the FDA this year.
Abrysvo’s approval for older adults was announced earlier this year, with Pfizer expecting it to be available before the anticipated RSV season in the third quarter of this year.
Common side effects of Abrysvo reported during trials included injection site pain, headache, muscle pain, and nausea. The FDA panel discussed the observation that preterm births were slightly higher among those who received the vaccine, but this difference was not deemed statistically meaningful. Preeclampsia was also slightly more common among vaccine recipients. It is important to note that the FDA states that the available data is insufficient to establish or exclude a causal relationship between preterm birth and Abrysvo. As a result, Pfizer will be required to conduct postmarketing studies to further evaluate the serious risk of preterm birth and conditions like preeclampsia.
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