A new study published in the Journal of the American Medical Association (JAMA) found that serious safety concerns persist in the Fertility Technology for Assisted Reproductive Technologies (FETAR) trial.
Researchers say that even after many of the trial participants have had the FETAR vaccine, there is still a “significant risk of adverse events” and the vaccine has only been administered to about a third of the participants.
The study, which followed nearly 2,000 women over two years, found that the risk of a vaccine-related adverse event in the trial’s first year was 4.3 percent, compared to just 1.1 percent for the placebo group.
Researchers also noted that there were “significant differences in the types of adverse event reported for each dose” and that women who had been on the vaccine and then stopped were at higher risk of experiencing adverse events.
The vaccine is still being tested, and the researchers said they’re still evaluating other safety data, including how it might impact the overall trial.
But it seems the FDA is taking a dim view of the FST study, noting that the FDA did not approve the vaccine for use in clinical trials until just last week.
“Although the trial was not approved, there was no indication of a serious adverse event at this time,” a spokesperson for the agency said.
“The FDA does not recommend that anyone discontinue a trial of a drug or device based on a positive FST results.
The FDA is actively reviewing this trial to assess the safety and efficacy of the vaccine.”