JAKARTA - The United States Food and Drug Administration (FDA) plans to move quickly to add a warning regarding rare cases of heart inflammation in adolescents and young adults in Pfizer and Moderna's COVID-19 vaccine fact sheets.
The US Centers for Disease Control and Prevention (CDC) advisory group, meeting to discuss reported cases of the heart condition after vaccination, found that inflammation in adolescents and young adults may be vaccine-related.
However, the US Department of Health and Human Services and other health authorities continue to say and believe that vaccinations outweigh the risks.
Pfizer, whose vaccine has been approved for use in the United States from as young as 12 years old, said it was aware of reports of myocarditis and pericarditis following mRNA vaccination. It said the risk-benefit profile of the Pfizer/BioNTech vaccine remains positive.
Meanwhile, Moderna said it was aware of reports of cases of heart inflammation, after administering the mRNA vaccine and working with regulators.
Health regulators in several countries have investigated whether Pfizer and Moderna injections using the new mRNA technology pose a risk and how serious the risk is.
The CDC explains, patients with heart inflammation after COVID-19 vaccination, generally recover from symptoms and recover.
"We strongly encourage all persons 12 years of age and older who are eligible to receive vaccines under the Emergency Use Authorization to be vaccinated," the CDC said.
Doctors and hospitals have been warned by the CDC to watch for symptoms of myocarditis or pericarditis, and the FDA warning will further raise awareness.
"Based on available data, warning statements in fact sheets for healthcare providers and vaccine recipients and caregivers would be warranted," FDA official Doran Fink said at an advisory committee meeting.
Fink, deputy director of the agency's vaccine division, said the FDA expects to move quickly to add a warning after the meeting ends.
The CDC identified cases of heart inflammation increased a week after the second dose of vaccine and in male patients. Of the 309 hospitalizations for inflammation of the heart in people under the age of 30, 295 have been discharged.
Dr. Tom Shimabukuro, deputy director of the CDC's Office of Immunization Safety, explained in a presentation that data from one of the Vaccine Safety Datalink (VSD) safety monitoring systems showed a rate of 12.6 cases per million in the three weeks after the second dose at ages 12 to 39.
"We observed this in younger age groups, especially in people in their teens and early 20s, and observed more in males, compared to females," Shimabukuro said.
"This effect mostly disappears once you get into an older age group, or individuals 50 years of age and over."
The CDC has been investigating cases of heart inflammation especially in young men for several months. Meanwhile, Israel's health ministry earlier this month said it saw a possible link between such cases and Pfizer's COVID-19 vaccine
The CDC said it is still assessing the risk of the condition and has not specifically confirmed a causal link between the vaccine and heart problems.
According to data from the US Vaccine Adverse Event Reporting System (VAERS), there were 347 cases of cardiac inflammation observed in the week after the second dose of vaccine in men aged 12 to 24 years. That compares with estimates of 12 cases or fewer for men that age range based on the background incidence rate of the US population, the CDC said.
For information, as of Monday this week, the CDC noted that 138 million Americans had received the full dose of the COVID-19 vaccine, using Pfizer or Moderna.
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