FDA to place rare heart inflammation warning on Pfizer and Moderna vaccines

• Rare cases of heart inflammation in adolescents and young adults have been linked to the Pfizer/BioNTech and Moderna COVID-19 vaccines.
• Still, health officials assure everyone that the vaccine benefits outweigh the risks.
• They added that the heart inflammation side-effect is “extremely rare” and temporary, and that patients generally recover from the symptoms.

A warning about rare cases of heart inflammation in adolescents and young adults will be placed on Pfizer/BioNTech and Moderna vaccines, the US Food and Drug Administration (FDA) announced on Wednesday.

Still, the US Centers for Disease Control and Prevention (CDC), the US Department of Health And Human Services (HHS), along with leading US doctors groups and public health officials, maintain that the vaccines are safe and effective and that benefits clearly outweigh the risk.

Health officials added that the heart side-effect is “extremely rare” and that patients who experienced heart inflammation after vaccination generally recovered from the symptoms.

Meanwhile, the FDA warning aims to further raise awareness for the heart inflammation side effect, and the CDC has informed doctors and hospitals to watch out for symptoms.

Pfizer previously reported that they have not observed a higher rate of heart inflammation than normally expected in the general population. Their vaccines have been authorized for use in Americans as young as 12.

Moderna, which has acknowledged the reports, said that it is currently working with public health and regulatory authorities to assess the issue.

Heart inflammation cases, particularly found in young men, have been investigated by the CDC for the past months. Earlier this month, the Israeli health ministry reported on the potential link between such cases and Pfizer’s Covid vaccine.

The risk is still currently being assessed, so far with no confirmation of a causal relationship between the vaccines and the heart issue.

Still, the US Vaccine Adverse Event Reporting System (VAERS) observed 347 heart inflammation cases in the week after the second vaccine dose in males aged 12 to 24. The CDC stated that it is much higher than the expected rate for males in that age range, based on US population background incidence rates, which is only 12 or fewer cases.

But with the vaccination effort slowing down amid concerns about the highly transmissible Delta strain, HHS continues to encourage “everyone age 12 and older who are eligible to receive the vaccine under Emergency Use Authorization to get vaccinated.”

The more contagious Delta variant is fast becoming the dominant strain globally, according to the World Health Organization.

Source: The Guardian