FDA Withholds Some COVID-19 and Shingles Vaccine Studies Citing Scientific Standards

The Food and Drug Administration blocked publication of studies finding that COVID-19 and shingles vaccines were safe, The New York Times reported. FDA scientists and data contractors reviewed millions of patient records for the studies that were pulled back before release.

The Department of Health and Human Services confirmed that the FDA blocked the publication of studies showing the safety and efficacy of vaccines against COVID-19 and shingles.

The Centers for Disease Control and Prevention scrapped a scientifically vetted study previously scheduled for publication that found COVID-19 vaccines sharply cut the risk of emergency care and hospitalization among healthy adults. The CDC study was rejected by Robert F. Kennedy’s acting CDC director.

Two studies on COVID-19 vaccines by FDA scientists were accepted for publication at medical journals before unnamed FDA officials directed the agency scientists to withdraw them. A preliminary abstract of one of the COVID-19 vaccine studies was presented at a conference last fall and remains online. The New York Times obtained a copy of the full manuscript of one of the COVID-19 vaccine studies.

FDA officials did not allow agency scientists to submit two abstracts for studies on Shingrix to a major drug safety conference. The two Shingrix studies bolstered known efficacy and safety data of the vaccines. ” Andrew Nixon stated that the FDA acted to protect the integrity of its scientific process and ensure that any work associated with the agency meets its high standards.

Andrew Nixon stated that the design of the Shingrix efficacy study fell outside the agency’s purview. Andrew Nixon did not address why the Shingrix safety study was withheld. Health Secretary Robert F.

The actions come despite Kennedy’s public commitment to openness on scientific matters under his oversight at HHS. At the FDA, the withdrawal orders overrode acceptance decisions already made by independent medical journals.