Federal health officials are taking a fresh look at safety data on COVID-19 vaccines, with a particular focus on pregnant women, children, and older adults. The review will be presented during a joint meeting of the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention’s (CDC) vaccine advisory group on Sept. 18–19, according to CNN.
Examining Reports in Pregnancy and Children
The FDA is analyzing reports of possible birth defects following vaccination during pregnancy. At the same time, officials are reviewing reports of deaths in children after receiving COVID-19 vaccines.
Health experts caution that these reviews are part of ongoing monitoring efforts and do not indicate confirmed safety problems. Much of the data under review comes from the Vaccine Adverse Event Reporting System (VAERS), a federal program designed to flag potential safety signals.
“VAERS is a system that generates hypotheses,” said Dr. Demetre Daskalakis, former director of the CDC’s National Center for Immunization and Respiratory Diseases. “It is not designed to prove causation.”
Evidence on COVID Vaccines in Pregnancy
So far, large-scale studies have found COVID-19 vaccines to be safe for pregnant women. CDC monitoring has included more than 23,000 participants in one registry and more than 45,000 in another database. Neither study found an increased risk of miscarriage, birth defects, or other serious complications.
Pfizer has also reported that its clinical trial in pregnant women showed no higher rate of birth defects compared with the general population.
FDA Commissioner Dr. Marty Makary emphasized that the agency intends to make all available data public.
“We’re going to share that with the medical community in full transparency, because these are the questions Americans are asking,” he said.
Possible Updates for Older Adults
The CDC advisory committee will also consider whether vaccine recommendations for older adults should be refined. One option under discussion is focusing boosters on people 75 and older or younger adults with certain health conditions.
Currently, COVID-19 vaccines remain authorized for adults 65 and older, as well as younger adults at higher risk for severe illness.
YOU MAY ALSO LIKE
FDA Warns Hims & Hers Over Weight-Loss Drug Marketing
