FDA Said to Delay Publication of Study on Safe COVID-19 Vaccine

JAKARTA - The United States Food and Drug Administration or FDA is said to have withheld the publication of a number of studies that found the COVID-19 and herpes zoster vaccines to be safe. The research used data from millions of patients and was funded by US taxpayers.

Citing The Guardian, Friday, May 8, FDA scientists analyzed millions of patient medical records. The results, serious side effects from the vaccine are said to be rare.

Spokesperson for the US Department of Health and Human Services or HHS, Andrew Nixon, confirmed that the studies were withdrawn. He said the withdrawal was made because the conclusions of the authors were considered too broad and not supported by basic data.

"The FDA is acting to protect the integrity of its scientific process," Nixon said, quoted by The Guardian.

One study examined the safety of the COVID-19 vaccine in people over 65 years of age. The research reviewed the medical records of 7.5 million Medicare recipients, as first reported by the New York Times.

Researchers compared health conditions in the 21 days after vaccination and the following 20 days. They assessed 14 risks, including heart attacks, strokes, and Guillain-Barré syndrome.

The only result considered alarming was anaphylaxis, with a case of about one in a million Pfizer vaccine recipients. The study said there was no statistically significant increase in other risks.

Although it has been accepted by the journal Drug Safety, the study was later retracted.

Dorit Reiss, a law professor at UC Law San Francisco, said the retraction was striking because the study had been accepted by the journal and its conclusions appeared to be uncontroversial.

Former top FDA official Janet Woodcock also highlighted a pattern of withholding information that might support the general safety of the vaccine.

Another study examined the safety of the COVID-19 vaccine in 4.2 million people aged six months to 64 years. The study found rare cases of fever-related seizures and myocarditis, but still stated that the benefits of vaccination outweigh the risks.

In addition to the COVID-19 study, a number of studies on the Shingrix herpes zoster vaccine were also said not to be continued. FDA officials were said to have not given timely approval for the abstracts of the two studies to be sent to a drug safety conference.

Nixon said the study design was outside the FDA's purview.

The Guardian reported that the decision to stop publication did not reach FDA Commissioner Marty Makary or HHS Secretary Robert F. Kennedy Jr.

The report comes amid criticism of HHS and vaccine policy in the US. At the same time, FDA employees have also voiced concerns about the agency's management under Makary.