Pregnant Women Should Talk to Their Doctors About COVID-19 Vaccines: FDA Commissioner

Dr. Marty Makary’s agency recently approved a vaccine for all adults with at least one risk condition, including pregnancy.

Dr. Marty Makary, the Food and Drug Administration's commissioner, in a file photograph. Madalina Vasiliu/The Epoch Times

Pregnant women should consult their doctors about COVID-19 vaccines, the commissioner of the Food and Drug Administration said on June 1.

“In the absence of data, they should talk to their doctor, and their doctor will use their best wisdom and judgment,” Dr. Marty Makary, the commissioner, said on CBS’s “Face the Nation.”

The Centers for Disease Control and Prevention had said that getting a COVID-19 vaccine was “especially important” for pregnant women, but now no longer recommends COVID-19 vaccines for the population, an update implemented in late May.

Health Secretary Robert F. Kennedy Jr. and Makary announced the change in a video on May 27.

Earlier in May, Makary and Dr. Vinay Prasad, the FDA’s top vaccine official, said that they expected the benefits to outweigh the risks with regard to COVID-19 vaccines for children and adults with at least one factor placing them at higher risk of severe outcomes, as defined by the CDC.

One of those risk factors is pregnancy.

The FDA later approved a new COVID-19 vaccine for people aged 65 and up, and individuals from 12 to 64 with at least one of the risk factors.

Makary was pressed on Sunday on the discrepancy between the FDA and the CDC on pregnant women receiving COVID-19 vaccines. He said that he and Prasad had “simply list[ed] what the CDC has traditionally defined as high risk, and we’re just saying, decide with your doctor.”

Makary noted that Moderna’s clinical trial for pregnant women was terminated. Pfizer, on the other hand, completed its trial for pregnant women after ending it early. The results for 175 women showed slightly lower COVID-19 incidence among the vaccinated when compared to those who received a placebo, according to results posted on clinicaltrials.gov.

A systematic review of studies through January 2023 involving pregnant women who received a COVID-19 vaccine concluded that the vaccines effectively prevented COVID-19 infection.

The American College of Obstetricians and Gynecologists has criticized the change in CDC guidance, saying that “the COVID-19 vaccine is safe during pregnancy, and vaccination can protect our patients and their infants after birth.”

Kennedy and Makary also said that COVID-19 vaccines would be removed from the immunization schedule for healthy children. In its update, the CDC said that children with compromised immune systems should get a vaccine, and that healthy children should check with their parents and doctors as they decide on whether or not to receive a COVID-19 vaccine.

“Where the parent presents with a desire for their child to be vaccinated, children 6 months and older may receive COVID-19 vaccination, informed by the clinical judgment of a healthcare provider and personal preference and circumstances,” the CDC said.

“We don’t have the data to support that repeat vaccination booster strategy every year in perpetuity,” Makary said on PBS' “Newshour” over the weekend. He added later: “We’re going to turn this decision back to patients and their doctors. We’re going to get more in line with where the public is.”

Just 13 percent of children and 14 percent of pregnant women have received one of the currently available COVID-19 vaccines, according to the CDC.

“The old COVID-19 vaccine recommendations for healthy children under 18 and for pregnant women have been removed from the CDC vaccine schedule,” a spokesperson for the Department of Health and Human Services, the parent agency of the CDC and FDA, told The Epoch Times in an email after the changes were implemented.

“The CDC and HHS encourage individuals to talk with their healthcare provider about any personal medical decision. Under the leadership of Secretary Kennedy, HHS is restoring the doctor-patient relationship,“ the spokesperson added. ”If a parent desires their healthy child to be vaccinated, their decision should be based on informed consent through the clinical judgement of their healthcare provider.”