Covid vaccine trials on pregnant women will start in January, according to White House health advisor Dr. Anthony Fauci.
The director of the National Institute of Allergy and Infectious Diseases said that drug manufacturers and U.S. regulators will conduct clinical trials in January testing the safety of Covid-19 vaccines on pregnant women and young children.
Those vulnerable groups were not involved in the initial coronavirus vaccine clinical trials until researchers could affirm that the vaccine was safe in healthy adults before testing it in more vulnerable populations.
Dr. Fauci confirmed that pregnant women have not yet been included in any Covid vaccine clinical trials. However, studies on pregnant women will be focused on in later trials, he said.
“That will not necessarily be looking at efficacy, but we’ll be looking at safety and immunogenicity to bridge to the efficacy in the adult non-pregnant population,” he said at Columbia University’s Grand Rounds 2020 event. “The same holds true for the pediatric population. Those studies will probably start in mid-to late-January.”
Aron Hall, Covid response chief at the CDC, stressed that physicians have identified an increased risk of complications for pregnant women who were diagnosed with Covid-19.
“The early indication is there might be a higher risk of pre-term delivery,” he said Thursday at the FDA’s Vaccines and Related Biological Products Advisory Committee.
Dr. Doran Fink, deputy director of the FDA’s division of vaccines and related products, said that there is “very limited data on use in pregnancy.”
“We recognize that among the groups first prioritized for vaccine use under an EUA, there will be many women of childbearing potential, including women who are pregnant either knowingly or unknowingly,” he said at a meeting. “We really have no data to speak to risks specific to the pregnant women or the fetus, but also no data that would warrant a contraindication to use in pregnancy at this time.”
He explained that pregnant women and women of childbearing years will be “free to make their own decision" under a so-called emergency use authorization.
“Pfizer recognizes that developing a potential SARS-CoV-2 vaccine for broad use is critically important to help stop the pandemic, including for potential use in pregnant women,” Pfizer spokeswoman Jerica Pitts said in a statement. “Pfizer is in the process of conducting DART studies and plans to submit available data to the agency.”
Vaccine distribution
CVS Health announced that it is set to distribute vaccines to vulnerable populations within 24 to 48 hours upon receiving its stocks.
Larry Merlo, the company’s chief executive, is prepared to administer “vaccines into the arms of some of our most vulnerable populations.”
“We’re ready to go. We’re in great shape and as I mentioned, people are excited to be an important part of this solution,” Merlo said Thursday in an interview on CNBC’s “Squawk Box.”
The Centers for Disease Control and Prevention said that health-care workers and residents and staff at long-term care facilities must be prioritized for the Covid-19 vaccines.
Merlo explained that the company’s 10,000 health care professionals will distribute vaccines in nursing homes and assisted living centers. He added that the company “has been hiring individuals since this pandemic began” to assist with coronavirus testing. Moreover, he said it is experienced with giving seasonal flu shots at long-term care facilities.
