FDA Adds Heart Disease Risk Warning to Pfizer and Moderna Vaccine Information Materials

[Photo by Reuters Yonhap News]

[Asia Economy Reporter Park Byung-hee] The U.S. Food and Drug Administration (FDA) has added a warning to the information sheets for Pfizer-BioNTech and Moderna COVID-19 vaccines, stating that the two vaccines may increase the risk of heart disease, CNN reported on the 26th (local time).

On the 25th, the FDA added a warning about the risk of myocarditis and pericarditis to the information sheets for the Moderna and Pfizer vaccines developed using messenger ribonucleic acid (mRNA) technology. The warning states that reported side effects so far suggest an increased possibility of myocarditis and pericarditis, especially noting that these symptoms may appear within a few days after receiving the second dose of the vaccine. Myocarditis is an inflammation of the heart muscle, and pericarditis is an inflammation of the tissue surrounding the heart.

However, Acting FDA Director Janet Woodcock said, "Considering the number of vaccines administered so far, the risk of myocarditis and pericarditis appears to be very low," and added, "The benefits of COVID-19 vaccination still outweigh the risks."

The FDA stated that the addition of this warning followed a comprehensive review of information and discussions by the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP).

Earlier, the CDC reported to its advisory body ACIP that after administering 300 million doses of Pfizer and Moderna vaccines, it received about 1,200 reports of such heart conditions. The CDC confirmed 300 of these cases, with many occurring in young people, including adolescents. However, patients recovered quickly with only mild treatment.

Combining Pfizer and Moderna vaccines, heart disease occurred at a rate of 12.6 cases per 1 million doses. The FDA recommends that if symptoms such as ▲ chest pain ▲ shortness of breath ▲ rapid, fluttering, or pounding heartbeat occur after receiving Pfizer or Moderna vaccines, individuals should immediately seek medical attention.