As the next big meeting of the CDC’s vaccine advisory group approaches on September 18–19, federal health officials are closely reviewing safety data related to COVID-19 vaccines — especially for pregnant women, children, and older adults.
The U.S. Food and Drug Administration (FDA) is focusing on reports of birth defects after vaccination during pregnancy, as well as rare deaths in children following COVID vaccination.
This review is not meant to cause alarm, say experts, but rather to ensure public trust through transparency and scientific analysis.
Why Are COVID Vaccines Being Reviewed Again?
The FDA’s latest safety checks come at a time when public concern around vaccine safety, particularly for vulnerable groups, remains high. As part of this review:
- The FDA is analyzing reports of possible birth defects linked to vaccination during pregnancy.
- Officials are preparing data presentations on rare child deaths that occurred after vaccination.
- The CDC advisory panel will consider updating COVID vaccine guidelines for seniors.
Importantly, the data is being reviewed ahead of an official discussion by the CDC’s Advisory Committee on Immunization Practices (ACIP), which helps shape national vaccine policy.
Understanding the Role of VAERS in Vaccine Monitoring
A large part of the review includes data from VAERS — the Vaccine Adverse Event Reporting System — which collects reports of side effects and complications following vaccination. However, it’s important to understand that:
- VAERS is not proof of a link between a vaccine and a health problem.
- It’s a tool used to flag potential safety concerns, which then need further scientific investigation.
Dr. Demetre Daskalakis, former head of the CDC’s immunization division, explained: “VAERS is a system that generates hypotheses,” meaning it raises questions but doesn’t provide final answers.
What Do the Studies Show So Far?
According to the CDC and independent researchers, large-scale studies continue to support the safety of COVID vaccines in pregnancy.
Here’s what the data shows:
- One CDC registry tracked over 23,000 pregnant women.
- Another CDC-linked database included more than 45,000 pregnant participants.
- Neither study found a higher risk of miscarriage, major birth defects, or complications.
- Pfizer’s clinical trials also showed no significant difference in birth defect rates between vaccinated and unvaccinated pregnant women.
These results align with the global scientific consensus that COVID vaccines are safe during pregnancy and help protect both the mother and the baby from severe illness.
What About Children and Vaccine-Related Deaths?
Another focus of the upcoming CDC meeting is the rare deaths in children reported after receiving the COVID vaccine. The FDA is expected to present detailed data on these cases.
While any report of a child’s death is deeply concerning, health experts stress that:
- The total number of such cases is extremely low.
- Investigations are needed to understand the exact causes.
- No confirmed pattern has shown vaccines directly caused these deaths.
Experts say reviewing these cases openly is key to maintaining public confidence.
Possible Changes in Vaccine Guidance for Older Adults
Currently, COVID vaccines are recommended for:
- Adults aged 65 and older
- Younger adults with high-risk medical conditions
However, the CDC may revise this guidance after reviewing new data. One possibility is narrowing recommendations to focus on:
- Adults aged 75 and older
- Younger people with specific underlying health issues
This would align with a more targeted approach, ensuring that those most at risk receive ongoing protection while avoiding unnecessary doses for others.
Transparency Remains the Top Priority
FDA Commissioner Dr. Marty Makary assured the public that all findings would be shared openly. “We’re going to make that available to the medical community in full transparency,” he told CNN. “This is the question that Americans are asking.”
By providing all available data, the FDA and CDC hope to support informed decisions among doctors, patients, and parents.
As the COVID vaccine conversation evolves, especially around its use in pregnancy, children, and older adults, federal health agencies are working to ensure safety remains the top priority.
With more data being analyzed and shared, public health officials aim to build trust through transparency. The upcoming CDC advisory meeting may lead to updated recommendations — but for now, major studies continue to show that the benefits of vaccination outweigh the risks, especially for those most vulnerable to severe illness.
