Officials look to tie Covid-19 vaccine to risks in pregnancy, kids while weighing narrower recommendation for older adults

By Meg Tirrell, Brenda Goodman, CNN

(CNN) — Health officials under US Health and Human Services Secretary Robert F. Kennedy Jr. are preparing analyses that may tie safety risks in pregnant women and children to the Covid-19 vaccine, while considering whether to narrow recommendations for elderly people to receive the shot, according to a person familiar with the matter.

US Food and Drug Administration officials are scouring datasets for case reports of congenital deformities in babies after their mothers received the Covid-19 vaccine during pregnancy, said the person, who declined to be named because they’re not authorized to speak on the matter.

Dr. Tracy Beth Hoeg, a senior science adviser at the FDA, is also preparing a presentation for next week’s meeting of vaccine advisers to the US Centers for Disease Control and Prevention on children who died after receiving the Covid-19 vaccine, the person said.

The Washington Post and the New York Times first reported on the plans, which have been met with alarm by public health researchers who are concerned that the analyses use datasets that aren’t set up to prove causation – such as the Vaccine Adverse Event Reporting System, or VAERS – and may be misrepresenting events.

“VAERS is a system that generates hypotheses,” wrote Dr. Demetre Daskalakis, who resigned late last month as director of the CDC’s National Center for Immunization and Respiratory Diseases, in a post on X. “It is designed to be a very low threshold system for everyone, patients and providers, to submit adverse events for additional review and to generate more study.”

Events included in that database are likely to have been analyzed by the CDC and FDA already, he pointed out. A presentation in June by CDC staff detailed how the public health agency monitors the safety of Covid-19 vaccines through VAERS as well as other databases.

The safety monitoring turned up the rare risk of myocarditis, or heart inflammation, which was highest in teenage boys. Follow-up CDC studies show that most adolescents and young adults who developed that condition have recovered and found no known deaths or heart transplants.

The CDC has also monitored the safety of the vaccines during pregnancy through a registry that includes more than 23,000 pregnant women as well as through a database called the Vaccine Safety Datalink, or VSD, which it said included more than 45,000 pregnant women. Its studies showed no increased risk of major birth defects, miscarriage or other adverse events.

Pfizer posted data about its Covid-19 vaccine in pregnant women this week, noting that in addition to other studies, it ran a placebo-controlled randomized trial of its immunization in healthy pregnant women. It found congenital anomalies in eight of 156 vaccinated participants and two of 159 unvaccinated participants, an incidence “within the range observed in the general population, and events were not deemed to be vaccine related.”

The analyses have been signaled by FDA Commissioner Dr. Marty Makary in recent interviews, including on CNN this week.

“We are getting the data that was never made available before, including adverse event data,” Makary told CNN’s Kate Bolduan on Wednesday. “That is, young people who have died from the Covid vaccine. And we’re going to make that available to the medical community in full transparency, because this is the question that Americans are asking.”

In May, Kennedy, who helmed an anti-vaccine advocacy group before President Donald Trump nominated him for HHS secretary, announced that the Covid-19 vaccine would no longer be recommended for pregnant women and healthy children on the CDC’s immunization schedule.

Public health experts were concerned with the change, both because they said it would make vaccines harder to access for those groups, who have been shown in studies to benefit from vaccines, and because the process bypassed the government’s normal procedures for evaluating and recommending vaccines for Americans.

In June, Kennedy replaced all 17 experts on the CDC’s vaccine advisory group, the Advisory Committee on Immunization Practices, or ACIP, and replaced them with several members who have made false or misleading statements about the safety of vaccines. The group is scheduled to meet for the second time September 18 and 19, when these presentations on vaccine risk are expected to be made.

“FDA and CDC staff routinely analyze VAERS and other safety monitoring data, and those reviews are being shared publicly through the established ACIP process,” HHS Communications Director Andrew Nixon told CNN on Friday. “Any recommendations on updated Covid-19 vaccines will be based on gold standard science and deliberated transparently at ACIP next week.”

The committee is also considering whether to narrow the age recommendation for Covid-19 vaccines for older adults, pushing it up to 75 from 65, a move that could affect a group more likely to get vaccinated. In that scenario, vaccination would be recommended for people under the age of 75 only if they have a higher risk of severe Covid-19.

It wasn’t clear whether the committee would pursue a narrowing of the recommendation in that way, according to the person familiar with the discussions.

In late August, the FDA approved updated Covid-19 vaccines for people over the age of 65 and for people under 65 who have health conditions putting them at higher risk – already a narrowing of approvals from the previous administration.

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