The CDC's vaccine safety group provided very little details about the cases – other than there were "relatively few" reports of the adverse reaction. It added that the myocarditis reports may even be completely unrelated to the vaccine itself.
The vaccine safety group noted that the post-vaccination myocarditis cases occurred mainly in teenagers and young adults four days after they received their second mRNA vaccine dose. Furthermore, it noted that heart muscle inflammation was more prevalent in males than females.
Myocarditis usually occurs following a bout of infection. Its symptoms include fatigue, chest pain, heartbeat problems and cardiac arrest. Around 10 to 20 people out of 100,000 suffer from myocarditis in the general population every year.
Despite these findings, the vaccine safety group said: "Most cases appear to be mild, and follow-up of cases is ongoing." Doctors were first alerted to the reports on May 14: The vaccine safety group then proceeded to review the data on myocarditis three days later. Nevertheless, the group said it is still reviewing the reports and accompanying data.
Meanwhile, the CDC posted guidance on its website alerting doctors of the "unusual" heart condition out of an abundance of caution. According to the public health agency, the myocarditis reports it has received so far are no greater than what would be normally seen in young people. Some doctors have remarked that the risk of myocarditis is smaller than the risk of contracting COVID-19. In its acute stage, the disease caused by the Wuhan coronavirus can even trigger myocarditis.
The reports came as mRNA coronavirus vaccines were set to be authorized for younger Americans
Based on data from the American Association of Pediatricians, more than 3.9 million children in the U.S. have contracted COVID-19 as of May 13. It added that more than 16,000 children had been hospitalized due to the disease and about 300 children had died from it as of the same date.
The Pfizer/BioNTech and Moderna vaccines are the only mRNA shots authorized for emergency use in the U.S. The Food and Drug Administration (FDA) granted both vaccine candidates emergency use approval back in December 2020. The one-dose Johnson & Johnson vaccine, which uses an adenovirus vector to induce immunity against COVID-19, later received emergency approval in February 2021.
According to CDC guidance, Americans 12 years old and above are strongly encouraged to get vaccinated against the Wuhan coronavirus. To accommodate this guidance, the FDA amended the initial emergency use authorization (EUA) issued to the Pfizer/BioNTech vaccine on May 10. Its initial EUA indicated its use for Americans 16 years old and above. The FDA's amendment expanded its use to children 12 to 15 years old.
Acting FDA Commissioner Dr. Janet Woodcock said: "The FDA's expansion of the [EUA] for the Pfizer/BioNTech COVID-19 vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic." She assured parents and guardians that the agency conducted a "rigorous and thorough" review of all data for the vaccine before amending the authorization.
Meanwhile, Moderna also conducted trials of its mRNA COVID-19 vaccine on younger patients. The Massachusetts-based drug company said on May 26 that its COVID-19 vaccine is "safe and effective" for children 12 to 17 years old. In case the FDA expands the Moderna vaccine's authorization, it will be the second vaccine available to younger Americans. Under its original EUA terms, only those 18 years old and above can avail of the vaccine.
Moderna CEO Stephane Bancel said in a statement: "We are encouraged [that the vaccine] was highly effective at preventing COVID-19 in adolescents. It is particularly exciting to see that the Moderna COVID-19 vaccine can prevent SARS-CoV-2 infection."
The Pfizer/BioNTech vaccine has been previously linked to cardiac inflammation
However, this is not the first instance of cardiac inflammation linked to the mRNA vaccines. Health authorities in Israel said they identified more than 60 vaccinated citizens who reported heart lining and heart muscle inflammation. The Israelis received the Pfizer/BioNTech mRNA vaccine, which Israel administered to a large portion of its population.
A study by the Israeli Ministry of Health said there were 62 cases of pericarditis and myocarditis identified by the Israeli government. Two of these cases died, while the rest managed to recover. Israeli health officials are now examining if the incidents are indeed linked to the two-dose Pfizer/BioNTech vaccine.
Pfizer meanwhile confirmed in a statement that it is aware of the myocarditis reports in Israel. However, the New York-based pharmaceutical firm insisted that "there is no evidence … that myocarditis is a risk" associated with the two-dose vaccine. "We have not observed a higher rate of myocarditis than what would be expected in the general population. A causal link [between myocarditis and] the vaccine has not yet been established," the Pfizer statement said.
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