"The coincidental removal of the approval documents for the Moderna vaccine is another massive blow to the credibility of the FDA, and I call on the agency to release this document immediately," Rep. Byron Donalds (R-Fla.), a member of the House Oversight Committee, told The Epoch Times via email on Feb. 4.
After The Epoch Times sent questions about critical portions of the document, it disappeared from the agency's website.
Spokespersons have declined to explain what happened.
The FDA has declined so far to provide a copy of the meta-analysis or a copy of another document referred to in the SBRA, a quantitative, age-stratified benefit-risk analysis in males 18 and older to evaluate the benefits and risks of Moderna's vaccine.
At least one portion of the document was altered before it was placed back online.
The initial version of the SBRA said that a scheduled communication and a scheduled meeting between regulators and Moderna were canceled, but did not explain why. The updated version says that Moderna canceled the meetings.
The Epoch Times had asked about the cancellations.
The Epoch Times has submitted Freedom of Information Act requests for the meta-analysis, the other analysis, the original SBRA, and communications regarding the document.
The situation surrounding the document was not mentioned by an FDA official who alerted the Centers for Disease Control and Prevention's (CDC) expert advisory panel on Feb. 5 about the agency's approval of Moderna's vaccine, nor were members apprised of either FDA analysis.
The panel mostly heard presentations from the CDC regarding the vaccine. Those presentations included safety analyses that pegged the rate of post-vaccination heart inflammation as lower than the FDA's meta-analysis found.