FDA Reveals Why It Changed End Date of Study of Heart Inflammation After COVID Vaccination – TheEpochTimes 2/14/23

Source: TheEpochTimes.com

The U.S. Food and Drug Administration (FDA) changed the end date of a study it is requiring Pfizer to conduct because Pfizer requested a delay, the agency says.

“The company requested an extension from FDA for completion, which the agency granted,” an FDA spokesperson told The Epoch Times via email.

When the FDA approved Pfizer’s vaccine in August 2021, it said Pfizer was required to conduct postmarketing studies to evaluate the safety of the vaccine.

One of the studies was meant to assess post-vaccination subclinical myocarditis, or heart inflammation, following a third dose of the vaccine in people aged 16 to 30.

That study was going to be completed on June 30, 2022, with Pfizer submitting a final report on the results to the FDA by Dec. 31, 2022.

After the deadline passed, the FDA quietly changed the end date to June 30, 2023.

The FDA declined to say whether it knows why Pfizer wanted an extension and, if so, what the rationale was….

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