FDA issues new heart risk warnings for Pfizer, Moderna COVID vaccines - should you be worried?
The
US Food and Drug Administration
(FDA) has warned that COVID-19 vaccines, which are manufactured by
Pfizer
and Moderna, have the potential for cardiac risks, as per a report.
What's Behind the FDA's New Warning?
These warnings were first proposed in letters, which were sent to both companies in April, providing additional information about the potential risks of myocarditis and/or pericarditis associated with the two vaccines, as reported by the Cardiovascular Business report. Myocarditis and pericarditis have the possibility of leading to long-term heart damage, according to the report.
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Who Faces the Highest Risk?
FDA's latest update covers Pfizer's Comirnaty vaccine and Moderna's Spikevax vaccine, while both companies had mentioned text about myocarditis and pericarditis in the labelling for these vaccines since 2021, but the FDA wanted more information added to these warnings that specifically mentions the increased risks for young men, as per the Cardiovascular Business report.
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What's Changing in the Vaccine Labels?
According to the Cardiovascular Business report, the new labeling for both the vaccines is now required to include the following text, as per FDA's latest update:
"Based on analyses of commercial health insurance claims data from inpatient and outpatient settings, the estimated unadjusted incidence of myocarditis and/or pericarditis during the period 1 through 7 days following administration of the 2023-2024 Formula of mRNA COVID-19 vaccines was approximately 8 cases per million doses in individuals 6 months through 64 years of age and approximately 27 cases per million doses in males 12 through 24 years of age," as quoted in the report.
The label should also include,
"Follow-up information on cardiovascular outcomes in hospitalized patients who had been diagnosed with COVID-19 vaccine-associated myocarditis is available from a longitudinal retrospective observational study. Most of these patients had received a two-dose primary series of an mRNA COVID-19 vaccine prior to their diagnosis. In this study, at a median follow-up of approximately 5 months post-vaccination, persistence of abnormal cardiac magnetic resonance imaging (CMR) findings that are a marker for myocardial injury was common. The clinical and prognostic significance of these CMR findings is not known,"
as quoted by the Cardiovascular Business report.
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What's the FDA Doing Next?
While, FDA has also emphasised that it plans to keep tracking the safety of COVID-19 vaccines from now on, as per the report.
The agency said, 'Continuous monitoring and assessment of the safety of all vaccines, including the mRNA COVID-19 vaccines, is an FDA priority and we remain committed to informing the public when we learn new information about these vaccines,' adding, 'In addition, as part of the approvals of Comirnaty and Spikevax, each manufacturer is required by FDA to conduct a study to assess if there are long-term heart effects in people who have had myocarditis after receiving an mRNA COVID-19 vaccine. These studies are underway,' quoted by the Cardiovascular Business report.
FAQs
Why is the FDA updating warnings now?
The FDA wants the public to have clearer information about rare heart-related risks linked to COVID-19 mRNA vaccines, especially for young men, as per the Cardiovascular Business report.
Are Moderna and Pfizer vaccines still considered safe?
Yes, the FDA continues to support their use, but these warnings are about rare side effects, as per the Cardiovascular Business report.
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