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# FDA Plans Pfizer, Moderna Vaccine Heart Warning
- URL: https://www.fdaweb.com/fda-plans-pfizer-moderna-vaccine-heart-warning/
- Published: 2021-06-23T12:00:00.000Z
- Updated: 2026-09-14T17:04:28.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5149608

FDA plans to “move rapidly” to add a Warning to fact sheets for the Pfizer and Moderna Covid-19 vaccines about the rare risk of developing inflammatory heart conditions. *Politico* reports that CBER vaccine division deputy director **Doran Fink** told a 6/23 meeting of a Centers for Disease Control (CDC) advisory committee meeting on Covid vaccines that the Warning is warranted based on the available data.

A CDC safety panel has found there is a “likely association” between the two vaccines and cases of myocarditis and pericarditis in vaccine recipients, the report says.

There reportedly are more than 1,200 cases under investigation as of 6/11 among more than 150 million people who received either of the mRNA vaccines. CDC says more cases occur after the vaccines’ second shots. More cases have been reported among Pfizer vaccine recipients, possibly because that shot is approved for patients age 12 and up, while Moderna is only for adults.

Officials reportedly are especially focused on cases in those age 30 and younger.