admin 
(CNN) — Health officials under US Health and Human Services Secretary Robert F. Kennedy Jr. are preparing analyses that may link safety risks in pregnant women and children to the COVID-19 vaccine, while also considering whether to narrow recommendations for elderly people to receive the jab, according to a person familiar with the matter.
US Food and Drug Administration (FDA) officials are reviewing datasets for case reports of congenital deformities in babies whose mothers received the COVID-19 vaccine during pregnancy, said the source, who declined to be named as they were not authorised 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 Centres for Disease Control and Prevention (CDC) on children who died after receiving the COVID-19 vaccine, the person added.
The Washington Post and The New York Times first reported on the plans, which have alarmed public health researchers concerned that the analyses rely on datasets not designed to prove causation – such as the Vaccine Adverse Event Reporting System (VAERS) – and may risk 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 Centre for Immunisation 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.”
He pointed out that events included in that database are likely to have already been analysed by the CDC and FDA. A presentation in June by CDC staff detailed how the agency monitors the safety of COVID-19 vaccines through VAERS as well as other databases.
Safety monitoring identified the rare risk of myocarditis, or heart inflammation, which was highest among teenage boys. Follow-up CDC studies show that most adolescents and young adults who developed the condition have recovered, with no known deaths or heart transplants.
The CDC has also tracked vaccine safety during pregnancy through a registry including more than 23,000 pregnant women, as well as through the Vaccine Safety Datalink (VSD), which has monitored over 45,000 pregnant women. Its studies found no increased risk of major birth defects, miscarriage or other adverse events.
Pfizer this week released data about its COVID-19 vaccine in pregnancy, noting that alongside other studies, it had conducted a placebo-controlled randomised trial in healthy pregnant women. It reported 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 forthcoming analyses were flagged 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 Americans are asking.”
In May, Kennedy – who led an anti-vaccine advocacy group before being nominated by President Donald Trump as HHS Secretary – announced that the COVID-19 vaccine would no longer be recommended for pregnant women and healthy children on the CDC’s immunisation schedule.
Public health experts raised concerns about the change, arguing both that it would make vaccines harder to access for those groups, who have been shown in studies to benefit from them, and that the move bypassed the government’s normal processes for evaluating and recommending vaccines.
In June, Kennedy dismissed all 17 experts on the CDC’s vaccine advisory group, the Advisory Committee on Immunisation Practices (ACIP), and replaced them with several individuals who have made false or misleading statements about vaccine safety. The group is scheduled to meet for the second time on 18–19 September, when these new presentations on vaccine risk are expected.
“FDA and CDC staff routinely analyse 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 weighing whether to raise the recommended vaccination age threshold for older adults, from 65 to 75, a shift that could affect a group more likely to take up the jab. Under such a change, vaccination would only be recommended for people under 75 if they are at higher risk of severe COVID-19.
It was not clear whether the committee would pursue such a narrowing of recommendations, according to the source familiar with discussions.
In late August, the FDA approved updated COVID-19 vaccines for people over 65 and for those under 65 with underlying health conditions – already a narrower approval than under the previous administration.
