The director of the National Institute for Allergies and Infectious Diseases, Dr. Anthony Fauci, speaks during a White House press conference led by White House Press Secretary Jen Psaki in the James Brady Press Briefing Room at the White House January 21, 2021 in Washington, DC.
Alex Wong | Getty Images
“No red flags” have been seen in the more than 10,000 pregnant women who have received Covid-19 vaccinations so far, said White House health advisor Dr. Anthony Fauci, on Wednesday.
Pregnant women and young children were excluded from the original US clinical trials of the vaccines, as is typical in experimental vaccine research. This has raised some concerns that there isn’t enough data to ensure that the vaccines are safe in pregnant women, but Fauci said the Food and Drug Administration hadn’t seen any cause for concern.
“The FDA, as part of the typical follow-up you have after the initial issue of any [emergency use authorization] have found so far and we have to be careful, but so far no red flags about it, about pregnant women, “said Fauci on Wednesday in an interview with Dr. Howard Bauchner of the Journal of the American Medical Association.
Since the approval of the Moderna and Pfizer-BioNTech vaccines in December, over 10,000 pregnant women, many of whom were healthcare workers, have had the chance, Fauci said. He noted that there is evidence that coronavirus infection may lead to an increased risk of an undesirable outcome in pregnancy, which is why many pregnant healthcare workers may have chosen the vaccine.
The Centers for Disease Control and Prevention has recommended that pregnant women should consult their doctor about whether or not to get vaccinated against Covid-19. However, the World Health Organization chose a cautious tone and stated last week that only pregnant women who are at high risk of being exposed to Covid-19 should be vaccinated.
For young children, the FDA has only approved Pfizer’s Covid-19 vaccine for use in people aged 16 and over in the United States. Moderna’s vaccine is only approved for use in people aged 18 and over in the country.
Fauci said “de-escalation studies” for younger children are underway. Such studies will examine the safety and effectiveness of the vaccines in increasingly younger children. Data from these studies should be available “in the next few months,” said Fauci.
“We don’t need to do efficacy studies with 30,000 to 44,000 people in every age group,” he noted.