A committee of the European Medicines Agency (EMA) determined that the mRNA COVID-19 vaccines could possibly be linked to “very rare” cases of heart inflammation among vaccine recipients.
The safety committee, Pharmacovigilance Risk Assessment Committee (PRAC), of the European Union’s health body concluded in a Friday release that types of heart inflammation called myocarditis and pericarditis “can occur in very rare cases following vaccination” with the Pfizer-BioNTech and Moderna vaccines.
The EMA identified and analyzed 145 cases of myocarditis among Pfizer-BioNTech recipients and 19 among Moderna recipients. The committee looked into 138 pericarditis cases among patients who got Pfizer-BioNTech and another 19 for Moderna.
These cases occurred out of 177 million Pfizer doses and 20 million Moderna doses in the European Economic Area, with the conditions occurring in 0.00016 percent and 0.00019 percent of Pfizer and Moderna vaccinations, respectively.
The PRAC still recommended listing myocarditis and pericarditis as new side effects in the product information for both vaccines in order to ensure health professionals and patients know about the infrequent cases.
“EMA confirms that the benefits of all authorised COVID-19 vaccines continue to outweigh their risks, given the risk of COVID-19 illness and related complications and as scientific evidence shows that they reduce deaths and hospitalisations due to COVID-19,” the release said.
The heart inflammation conditions produce symptoms such as breathlessness, palpitations and chest pain. Those who experience these symptoms were instructed to seek immediate medical attention.
“The chance of these conditions occurring is very low, but you should be aware of the symptoms so that you can get prompt medical treatment to help recovery and avoid complications,” the committee said in a release.
The EMA noted its guidance for the heart inflammation side effects was based on “all currently available evidence.”
The PRAC determined that these cases occurred “primarily” within 14 days after vaccination, most typically after the second dose and among young adult men. Five of the 321 cases documented resulted in deaths with the patients being either older or having pre-existing conditions.
Keanna Ghazvini, a spokesperson for Pfizer, told The Hill in a statement that the heart inflammation cases are “generally mild,” noting individuals usually recover “within a short time following standard treatment and rest.”
“Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis in vaccine recipients,” she said.
“With hundreds of millions of doses of the Pfizer-BioNTech COVID-19 vaccine administered globally, the benefit risk profile of our vaccine remains positive for all approved indications and age groups,” Ghazvini added.
Moderna did not immediately return a request for comment on the committee’s conclusion.
Last month, a Centers for Disease Control and Prevention safety panel ruled there is a “likely association” of mild heart inflammation in adolescents and young adults after receiving an mRNA vaccine, but concluded the vaccine does more good than harm.
The World Health Organization’s (WHO) Global Advisory Committee on Vaccine Safety (GACVS) also issued an updated statement on the heart inflammation cases on Friday, noting that “current evidence suggests a likely causal association between myocarditis and the mRNA vaccines.”
The committee also pointed out the benefits of the mRNA vaccines still “outweigh the risks” that COVID-19 presents.
The EMA’s safety committee noted that “at this point in time” there is “no causal relationship” between myocarditis or pericarditis and the Johnson & Johnson and AstraZeneca vaccines.
In a separate release, the PRAC also suggested those who previously had capillary leak syndrome not get the Johnson & Johnson vaccine due to concerns over three cases of fluid leaks in small blood vessels. Two of the three patients who had cases recorded by the EMA died.
Updated: 1:05 p.m.