CDC, FDA see no Pfizer vaccine link to heart problem, eyeing with ‘special interest’
The Centers for Disease Control and Prevention and the Food and Drug Administration said on Monday they have not detected any indication so far that Pfizer-BioNTech’s COVID-19 vaccine causes inflammation of the heart, but are monitoring with “special interest” reports of cases.
Over the weekend, Israel’s pandemic response coordinator said it was a “question mark” whether Pfizer’s vaccine had caused tens of cases of myocarditis, a dangerous condition of heart inflammation, that had been identified there primarily among young men after they had taken their second dose, according to Reuters.
Pfizer, in a statement to McClatchy, said that it was aware of the Israeli observations and that the company has “not observed a higher rate of myocarditis than what would be expected in the general population. A causal link to the vaccine has not been established.”
An FDA official told McClatchy that the agency has not seen “any new safety signals for myocarditis following administration of any of the authorized COVID-19 vaccines.”
Over 220 million doses of vaccine doses produced by Pfizer and Moderna — which use the same biological technology, known as messenger RNA — have been administered nationwide.
A CDC official said that “at this point, there is no safety signal for myocarditis or pericarditis for COVID-19 vaccines in U.S. monitoring systems.” Pericarditis is a condition where the thin membrane that surrounds the heart is inflamed.
The CDC official said that the reports of cases are being closely watched by a safety monitoring board as “an adverse event of special interest for U.S. vaccine safety surveillance of COVID-19 vaccines.”
In the United States, the Pentagon said it was examining 14 cases of a linkage among troops. And a Washington-based reporter wrote on Twitter of his experience with myocarditis shortly after receiving the Pfizer vaccine.
All of these cases have been reported to Pfizer and the FDA.
“To date, FDA and CDC have not seen any new safety signals for myocarditis following administration of any of the authorized COVID-19 vaccines,” the FDA official told McClatchy. “Post-authorization safety monitoring during the COVID-19 pandemic vaccination program will aim to continuously monitor the safety of COVID-19 vaccines to rapidly detect safety problems if they exist.”
“Should any new safety signals be identified by FDA and CDC through this safety surveillance, that information will be communicated to the public,” the official added.
This story was originally published April 26, 2021 at 9:45 PM.
