August 20, 2021
New data has prompted US health officials to investigate whether a serious adverse effect associated with Moderna’s Covid-19 vaccine may be more widespread than previously thought, according to the Washington Post.
The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are studying if myocarditis, a disease that causes heart inflammation, is potentially more common among young adults who got the Moderna vaccine than originally estimated, two people familiar with the probe told the Post.
The US health authorities are examining data from Canada that suggests the Moderna shot may be more dangerous for young people than the Pfizer variant, particularly among men aged 30 and younger. The figures, provided by the Canadian government, purportedly show that there might be a 2.5-times higher incidence of myocarditis in those who get the Moderna vaccine compared with the Pfizer shot.
The FDA and CDC are poring over US data to see if similar conclusions can be made about the vaccine’s effect on young Americans, WaPo said.
One source who spoke with the outlet stressed that it was still too early to say if the issue had been understated. The FDA and CDC did not comment on the alleged probe, but both agencies stressed that they were committed to reviewing new safety data as it becomes available. Moderna did not provide the Post with a comment about the purported investigation.
In June, the FDA issued new warning labels for both the Pfizer and Moderna mNRA vaccines, stating that they were likely associated with an increased risk of myocarditis.
The CDC issued a report a month later stating that although there is an “elevated risk” for myocarditis from the Pfizer and Moderna shots, particularly among males ages 12 to 29, the benefits of vaccination against Covid-19 “clearly outweigh” any potential side effects.
As of August 11, the agency has received 1,306 unverified reports of myocarditis or pericarditis (another form of heart inflammation) among individuals ages 30 and younger. Most of the cases involved Pfizer or Moderna vaccines. To date, the CDC and FDA have confirmed 762 cases of myocarditis or pericarditis developing in young people following vaccination.
Around 57% of Americans between the ages of 18 and 24 have received at least one vaccine dose, according to the Mayo Clinic, with the figure increasing to 60.5% for 25- to 39-year-olds.
Health authorities continue to stress that serious adverse effects are rare.
As governments around the world rolled out nationwide inoculation programs, reports emerged linking the AstraZeneca shot to rare blood clots. But in recent weeks, safety concerns have focused more on mNRA vaccines. The European Medicines Agency (EMA) announced earlier this month that it was investigating reports that the Pfizer and Moderna shots were causing allergic skin reactions and kidney disorders. A month earlier, the EMA recommended adding myocarditis and pericarditis to the list of possible adverse effects associated with the two mRNA vaccines. However, Europe’s medicines watchdog insisted that the benefits of the drugs outweighed the potential rare risks.