The Food and Drug Administration (FDA) has launched a safety review of two injectable drugs that offer protection against respiratory syncytial virus (RSV) for babies and toddlers. RSV is a virus that sends thousands of children to the hospital each year. The long-acting drugs, produced by Merck and Sanofi, are not vaccines, but the review is timely as health officials under Health Secretary Robert F. Kennedy Jr. reconsider routine childhood vaccination guidelines. Representatives from both companies reported no new safety signals for their medications, which have been recently approved for infants and young children facing RSV.
These injectable drugs are laboratory-engineered versions of natural antibodies that bolster the immune system against RSV. While the FDA has approved vaccines for older individuals and pregnant women, these injections are critical for newborns and young children due to their high vulnerability.
Merck’s product is designed to safeguard infants either before or during their first RSV season. Sanofi has indicated that it regularly submits potential safety concerns to the FDA but has seen no new issues across over 50 studies of their drug.
Though RSV is generally a mild illness for healthy adults, it can pose significant risks to infants and the elderly. Current recommendations from CDC advisers suggest administering the antibody shots to infants born near or during RSV season, particularly if their mothers have not been vaccinated in late pregnancy. Kennedy's administration has made significant changes to vaccine advisory committees, creating controversy by overturning established vaccination recommendations, including routine hepatitis B vaccinations for newborns. These changes have led to widespread criticism from medical and scientific communities.
The FDA’s examination of vaccine safety, especially in regard to COVID-19 immunizations, indicates an ongoing scrutiny and possible reform within the agency’s traditional vaccine approval process.
These injectable drugs are laboratory-engineered versions of natural antibodies that bolster the immune system against RSV. While the FDA has approved vaccines for older individuals and pregnant women, these injections are critical for newborns and young children due to their high vulnerability.
Merck’s product is designed to safeguard infants either before or during their first RSV season. Sanofi has indicated that it regularly submits potential safety concerns to the FDA but has seen no new issues across over 50 studies of their drug.
Though RSV is generally a mild illness for healthy adults, it can pose significant risks to infants and the elderly. Current recommendations from CDC advisers suggest administering the antibody shots to infants born near or during RSV season, particularly if their mothers have not been vaccinated in late pregnancy. Kennedy's administration has made significant changes to vaccine advisory committees, creating controversy by overturning established vaccination recommendations, including routine hepatitis B vaccinations for newborns. These changes have led to widespread criticism from medical and scientific communities.
The FDA’s examination of vaccine safety, especially in regard to COVID-19 immunizations, indicates an ongoing scrutiny and possible reform within the agency’s traditional vaccine approval process.
