US FDA Requires New Label For COVID-19 Vaccine Related To Heart Risk In 16'25 Years Old Men

JAKARTA - The United States Food and Drug Administration (FDA) ordered Pfizer and Moderna to expand warning labels on the COVID-19 vaccine, regarding the risk of side effects of a heart injury that may result from mRNA vaccine injections.

This risk was mainly found in teenage boys and young men, based on studies published last year and recent data from the agency.

The order to expand this warning was announced by the FDA on Wednesday via a letter dated April 17 to Pfizer and BioNTech for the Comirnaty vaccine, as well as to Moderna for the Spikevax vaccine.

The two vaccines have previously included a risk warning that side effects in the form of inflammation of the heart muscle (miocarditis) and inflammation of the cardiac membrane (pericarditis) tend to be higher in young men, generally in the first week after vaccination.

Previously, the commemoration stated that the age range for 18'24 years was for Moderna vaccines and 12'17's for Pfizer vaccines. Now, the new warning applies to men aged 16'25 years in both vaccines.

"After administering the COVID-19 mRNA formula 2023 2024, the highest incidence of myocarditis or pericarditis is expected to occur in men aged 16 to 25 years," the FDA said in a new warning that must be included in the two vaccines, quoted from the CBS News page.

The FDA noted that the rate of myocarditis and pericarditis events was around 8 cases per million doses for children and adults under the age of 65. However, in the 16'25 year age group, this figure jumped to 38 cases per million doses.

The Centers for Disease Control and Prevention (CDC) previously stated that myocarditis and pericarditis events after the COVID-19 vaccination were relatively rare.

CDC officials also told vaccine advisers that acute myocarditis cases tend to improve soon and no increased risk seen in recent data for the 12 to 39 year age group.

It is unclear whether Pfizer or Moderna rejected this order. Both companies have 30 calendar days from the date of the letter to object. Until this news was written, a spokesman for Pfizer and Moderna had not yet responded.

The American people are entitled to radical transparency about the safety and effectiveness of the COVID-19 vaccine, and the FDA is keeping their promise to make it happen. Moderna and Pfizer must ensure that the public is aware of side effects such as myocarditis and pericarditis related to the COVID-19 vaccine, "said Andrew Nixon, spokesman for the US Department of Health and Humanitarian Services via email.

The letters were published on the FDA website hours before a hearing held by the US Senate Security and Government Affairs Committee, chaired by Republicans. The hearing discussed how health officials were deemed to have underestimated and hidden the incidence of myocarditis and other side effects related to the COVID-19 vaccine.

The FDA said the expansion of this warning was driven by new data from their security surveillance system and the results of the study were published last October, thus tracing the development of patients experiencing myocarditis after the COVID-19 vaccination.

The discussion about changing this warning label actually started before high-ranking FDA vaccine officials, Dr. Peter Marks left his position on April 5. However, the debate over how to present the data accurately made the decision not yet finalized at that time.

The scientists in the study monitored patients, mostly teenage boys who had chest pain and increased levels of leptonin in their blood, an indicator of heart damage. They found that although the symptoms are usually mild with low heart function disorders, heart muscle injuries remain common.

A new warning from the FDA also stated that the findings of heart MRI in most patients showed improvement over time. However, it remains unknown whether the MRI findings can predict the long-term impact of myocarditis.

Further studies are underway to find out if there are long-term effects for people who experience myocarditis after receiving the COVID-19 mRNA vaccine.