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FDA Working Towards Warning for MRNA COVID-19 Vaccines

With a small number of heart-related adverse effects in younger people, the US Food and Drug Administration (FDA) will move towards a warning statement for Pfizer and Moderna vaccines.

In recent weeks, US federal agencies have met to discuss the safety of the mRNA COVID-19 vaccines, specifically reports of myocarditis or pericarditis in younger people after being vaccinated with the Pfizer and Moderna vaccines.

Yesterday, the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) met to discuss these adverse effects in people aged 30 and younger.

From that meeting, the FDA stated it will work towards developing a warning for these vaccines.

"Based on the available data, a warning statement in the factsheets for both healthcare providers and vaccine recipients and caregivers would be warranted," FDA Deputy Director-Clinical, Division of Vaccines and Related Products Applications Doran Fink, MD said at the ACIP meeting yesterday.

In yesterday’s meeting, presenters said there have been over 1200 cases of myocarditis or pericarditis reported after a second dose of a mRNA COVID-19 vaccine in the Vaccine Adverse Event Reporting System (VAERS).

It is also important to note that presenters have pointed out VAERS is open to the public to disclose any adverse effects, and CDC vets VAERS reports to define and establish if they are working cases of heart inflammation.

In its most recent reporting, 323 cases were established cases, and 309 people were hospitalized.

This is a continuation of a discussion on the topic that has been ongoing for some weeks now.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met two weeks ago to discuss COVID-19 vaccines in the pediatric population. The data reported during that meeting showed the agency was able to establish that young men (n=595) suffered more frequently from myocarditis than young women (n=186). The onset of myocarditis would typically occur 4 days to 1 week after vaccine administration. CDC said 226 people met the definition of a working case at that time. The federal agency is still reporting on active cases. These numbers represent an age population of 30 years and younger.

In yesterday’s ACIP meeting, committee members discussed a benefit-risk analysis and said the benefits of mRNA vaccinations still outweighed the risks in adolescents and young adults.

In addition, the committee offered the following recommendations:

  • Those with pericarditis prior to vaccination can receive any FDA authorized COVID-19 vaccine.
  • Those with pericarditis after the first dose of an mRNA COVID-19 vaccine but prior to a second dose should proceed with a second dose of mRNA COVID-19 vaccine after resolution of symptoms.
  • Those with myocarditis prior to a COVID-19 vaccination can receive any FDA-authorized COVID-19 vaccine if their heart has recovered.
  • Those with myocarditis after the first dose of an mRNA COVID-19 vaccine but prior to a second dose should defer a second dose of mRNA COVID-19 vaccine until more information is known. However, if their heart has recovered, they should consider proceeding with a second dose under certain circumstances.

No timetable has been set for FDA’s warning statement yet.