- Studies indicated COVID-19 and shingles vaccines have good safety profile
- FDA blocked publication of those studies, which were paid for by taxpayers.
- CDC previously didn't publish its study showing COVID vaccine reduced hospitalization and emergency visits.
Although large studies of the COVID-19 and shingles vaccines found few risks and overall safety, the U.S. Food and Drug Administration has blocked their publication, even as millions of dollars in taxpayer money was spent on them.
Critics believe the studies weren’t blocked because they were flawed, but rather because they found value in the vaccines.
The shingles and COVID vaccine studies in question were conducted by federal employee scientists who looked at millions of patient records and only rarely found serious side effects, as The Guardian reported.
The New York Times reported that one of the studies of the COVID-19 vaccine reviewed medical records for 7.5 million Medicare enrollees to determine if the COVID-19 vaccine is safe for those over 65. It found the vaccine is safe.
The researchers, per the Times, looked at outcomes starting on the 21st day and extending an additional 20, to see if there was any elevation of 14 different outcomes, including heart attack and stroke, among others. They also considered Guillain-Barré syndrome, which is a rare autoimmune disorder.
The only “concerning outcome,” which appeared in about 1 in 1 million people who received the Pfizer COVID-19 vaccine, was anaphylaxis, a rare and severe allergic reaction. The Times reported the study was accepted by the peer-reviewed journal Drug Safety, but was withdrawn.
Questioning decision to block studies
Former FDA principal deputy commissioner Janet Woodcock told The Guardian that “there is a pattern here for not letting information out that might support the general safety of vaccines, with methodological rationales given by non-scientist spokespersons”, reportedly a thinly veiled reference to Health and Human Services spokesman Andrew Nixon.
Nixon had issued a statement confirming the studies were withdrawn despite the large taxpayer investment. He said the decision was made “because the authors drew broad conclusions that were not supported by the underlying data. The FDA acted to protect the integrity of its scientific process and ensure that any work associated with the agency meets its high standards.”
Critics of the decision question the motive.
A different study that was withdrawn looked at COVID-19 vaccine safety among 4.2 million people ages 6 months to 64 years, considering a dozen health conditions like blood clots and brain swelling. It found rare cases of fever-related seizures and heart muscle inflammation, per the Times.
Cutting funding and research
Reuters reported that the “withdrawal of these studies is the latest attempt by the health regulator and the administration to limit access to vaccines, reflecting broader policy changes under U.S. Health Services Secretary Robert F. Kennedy Jr., a staunch critic of vaccines."
Federal funding for both vaccine research and vaccines themselves have been drastically cut by the Trump administration this term and many of the recommendations have changed, including advice for vaccinating infants and children, as Deseret News has reported.
Several months ago, as Health and Human Services changed recommendations for a number of vaccines, Kennedy said more research would be done to vet vaccines for safety.
Per The Washington Post, this batch of studies isn’t the first denied publication. Several weeks ago, the Centers for Disease Control and Prevention opted not to publish a study that found the COVID-19 vaccine cut the likelihood of needing to be hospitalized last winter and also reduced emergency department visits.
The Post wrote that “attention on how HHS agencies have been handling such reports comes as the Trump administration has sought to soften its public stance on vaccine actions ahead of the midterm elections. Republican pollsters have warned that policies supporting vaccine skepticism carry political risks amid Health Secretary Robert F. Kennedy Jr.’s efforts to overhaul the vaccine schedule."