- Pregnant women and young children were excluded from the U.S. clinical trials of the vaccines, as is typical in experimental vaccine research.
- That’s led to some concerns that there’s not enough data to be sure that the vaccines are safe among pregnant women.
- But Fauci said the Food and Drug Administration has not seen reason to worry so far.
There have been “no red flags” seen in the more than 10,000 pregnant women who have received Covid-19 vaccine shots so far, White House health advisor Dr. Anthony Fauci said Wednesday.
Pregnant women and young children were excluded from the original U.S. clinical trials of the vaccines, as is typical in experimental vaccine research. That’s led to some concerns that there’s not enough data to be sure that the vaccines are safe among pregnant women, but Fauci said the Food and Drug Administration has not seen reason to worry yet.
“The FDA, as part of the typical follow up you have following the initial issuing of any [emergency use authorization] have found, thus far, and we’ve got to be careful, but thus far, no red flags about that, about pregnant women,” Fauci said Wednesday in an interview with The Journal of the American Medical Association’s Dr. Howard Bauchner.
Since the authorization of the Moderna and Pfizer-BioNTech vaccines in December, over 10,000 pregnant women, many of whom were health-care workers, have gotten the shots, Fauci said. He noted that there is evidence that a coronavirus infection can lead to heightened risk of an adverse outcome in pregnancy, which might be why many pregnant health-care workers decided to get the vaccine.
The Centers for Disease Control and Prevention has advised that pregnant women should consult their health-care provider on whether or not to get vaccinated against Covid-19. But the World Health Organization has struck a more cautious tone, saying last week that only pregnant women who are at high risk of being exposed to Covid-19 should get vaccinated.
As for young children, the FDA has only authorized Pfizer’s Covid-19 vaccine for use in people 16 and older in the U.S. Moderna’s vaccine is only authorized for use in people 18 and older in the country.
Fauci said “de-escalation studies” for younger children are underway. Such studies will look at the safety and effectiveness of the vaccines in progressively younger and younger children. Data from those studies should be available in “the next few months,” Fauci said.
“We will not have to do 30,000-to-44,000-person efficacy trials at each age group,” he noted.