Zachary Brennan
Senior Editor
The European Medicines Agency’s safety committee said Friday that it’s aware of cases of inflammation of the heart muscle and inflammation of the membrane around the heart, mainly reported following vaccination with Pfizer’s Covid-19 vaccine, known in Europe as Comirnaty.
“There is no indication that these cases are due to the vaccine,” the EMA’s Pharmacovigilance Risk Assessment Committee said.
But PRAC has asked Pfizer to provide more detailed analyses of the events by age and gender, and said it will consider if any regulatory action is necessary. Late last month, Israel’s Health Ministry also said it examined tens of cases of heart inflammation among more than 5 million people there who had received Pfizer’s vaccine.
But the US Centers for Disease Control and Prevention said in late April that it has not found a link between heart inflammation and Covid-19 vaccines. CDC director Rochelle Walensky said she is in touch with the US Department of Defense over its investigation of 14 cases of heart inflammation or myocarditis among people who were vaccinated through the military’s health services.
“We have not seen a signal, and we’ve actually looked intentionally for the signal in the over 200 million doses we’ve given,” Walensky said.
Pfizer said in an emailed statement:
Pfizer and BioNTech are supporting PRAC on the review of myocarditis. As the PRAC notes, there is no indication at this time that these cases are due to the vaccine.
Adverse events are regularly and thoroughly reviewed and we have not observed a higher rate of myocarditis than what would be expected in the general population. There is no evidence at this time to conclude that myocarditis is a risk associated with the use of Pfizer/BNT COVID-19 vaccine.
More than 450 million doses of the Pfizer-BioNTech COVID-19 vaccine have been administered globally as of May 6. Serious adverse events unrelated to, but close in timing to vaccination, are expected to occur at a similar rate in vaccinated individuals as they would in the overall population. With a vast number of people vaccinated to date, the benefit risk profile of our vaccine remains positive.
EMA’s committee also asked Moderna to monitor for similar cases of heart inflammation and provide a detailed analysis in its next pandemic summary safety report on its mRNA vaccine.
In addition to seeking more data on heart inflammation, PRAC added a new side effect to Pfizer’s vaccine label for facial swelling in people with a history of injections with dermal fillers.
“PRAC considered that there is at least a reasonable possibility of a causal association between the vaccine and the reported cases of facial swelling in people with a history of injections with dermal fillers (soft, gel-like substances injected under the skin),” the agency said.
Meanwhile, the committee also said it’s looking into cases of Guillain-Barré syndrome (GBS) reported following vaccination with AstraZeneca’s shot. GBS, which was identified earlier as a possible adverse event requiring specific monitoring, is an immune system disorder that causes nerve inflammation and can result in pain, numbness, muscle weakness and difficulty walking.
The committee also said it’s updating its warning on the J&J vaccine and links to thrombosis (formation of blood clots) with thrombocytopenia (low blood platelets) syndrome, advising patients who are diagnosed with thrombocytopenia within three weeks of vaccination to be actively investigated for signs of thrombosis.
“Similarly, patients who present with thromboembolism within three weeks of vaccination should be evaluated for thrombocytopenia. Lastly, thrombosis with thrombocytopenia syndrome will be added as an ‘important identified risk’ in the risk management plan for the vaccine,” the committee said.
PRAC also noted that it’s not seeing links between the mRNA vaccines and these cases of rare, unusual blood clots with low blood platelets.
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