The probe is being led by the FDA’s Center for Drug Evaluation and Research
The Food and Drug Administration is reviewing the safety of antibodies against respiratory syncytial virus (RSV) that have been cleared for use in babies and toddlers.
The probe is being conducted by the FDA’s Center for Drug Evaluation and Research (CDER), according to the government.
“FDA routinely evaluates emerging safety information and will update product labeling if warranted by the totality of the evidence,” a spokesperson for the Department of Health and Human Services, the FDA’s parent agency, told news outlets in a statement on Dec. 9.
“CDER’s team is rigorously reviewing the available data, as it does for all products, to ensure decisions remain rooted in evidence-based science.”
The federal government recommends two antibodies for young children: Beyfortus, also known as nirsevimab, from Sanofi and AstraZeneca, and Enflonsia from Merck.
“At this time, no safety issue has been identified from clinical studies of nirsevimab or from post-marketing experience with more than six million babies immunized worldwide,” a Sanofi spokesperson told The Epoch Times in an email.
The spokesperson also said available data show the antibody prevents hospitalizations and emergency room vis
A spokesperson for Merck told news outlets in a statement, “We believe deeply in the importance of transparency and we value the FDA’s rigorous review of our clinical data of all of our products.”
Dr. Tracy Beth Hoeg, the new acting director of CDER, told a meeting of the Advisory Committee on Immunization Practices (ACIP) earlier in December that, compared with the United States, Denmark generally does not recommend RSV antibodies.
She also highlighted how in clinical trials of Beyfortus and Enflonsia, there were more instances of mortality from any cause in vaccine recipients versus placebo recipients.
The imbalance was “not quite statistically significant, but yet this is very concerning to see in all four randomized trials, to see that there’s actually a higher death rate, and so I think that this is something that could also be revisited [by] ACIP,” she said.
Retsef Levi, one of the members who voted no, pointed to the data on mortality in the trials and how there were more serious adverse events among the vaccinated.
“Should we not be concerned that maybe there are some potential safety signals?” he asked.
A representative for Merck told the meeting that none of the deaths were determined to be related to RSV or the antibodies.
“We did review all of these narratives very carefully, and we did not observe any trends or clusterings and causes of death and nothing that seemed suggestive of a drug-related cause of death in any of these cases,” an FDA official added at the time.
The advice was adopted in August, and the CDC began recommending Enflonsia, also known as clesrovimab, for infants younger than 8 months of age to protect against severe disease and hospitalization. It also recommends Beyfortus for young children aged 8 months to 19 months who are deemed at increased risk for severe RSV.