EMA's PRAC weighs in on more vaccine side effects

Regulatory NewsRegulatory News | 09 July 2021 |  By 

The European Medicines Agency (EMA) has weighed in on several rare adverse events for COVID-19 vaccines and one gene therapy for treating thalassemia in their latest Pharmacovigilance Risk Assessment Committee (PRAC) meeting.
At its July meeting, EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) found mRNA-based COVID-19 vaccines, like Pfizer’s Comirnaty and the Moderna vaccine marketed in the EU as Spikevax, carry a small risk of myocarditis and pericarditis.
The evidence for this increased risk comes from a review of 145 cases of myocarditis in individuals who received Comirnaty and 19 cases in individuals who received Spikevax within the European Economic Area (EEA). PRAC also reviewed 138 cases of pericarditis developed after individuals received Comirnaty and 19 cases developed after individuals received Spikevax in the EEA. To date, countries in the EEA have administered than 177 million doses of Comirnaty and 20 million doses of Spikevax.
After review of these new cases of myocarditis and pericarditis, PRAC is recommending the product information for these vaccines include the conditions as new side effects.
Individuals who have a history of capillary leak syndrome should avoid receiving COVID-19 Vaccine Janssen, a recommendation based on 3 cases that developed shortly after individuals received the vaccine. Globally, more than 18 million doses of COVID-19 Vaccine Janssen have been administered, EMA said.
In addition, a direct provider health communication (DPHC) warned of “very rare” side effects of thrombosis and thrombocytopenia following vaccination with COVID-19 Vaccine Janssen, the one-dose vaccine commonly referred to the US as the Johnson & Johnson vaccine.
“Individuals diagnosed with thrombocytopenia within three weeks after vaccination with COVID-19 Vaccine Janssen should be actively investigated for signs of thrombosis. Similarly, individuals who present with thrombosis within three weeks of vaccination should be evaluated for thrombocytopenia,” EMA said.
PRAC also recommended the risk of capillary leak syndrome be added to COVID-19 Vaccine Janssen’s product label. “Healthcare professionals should be aware of the signs and symptoms of capillary leak syndrome and of its risk of recurrence in people who have previously been diagnosed with the condition,” EMA noted in the PRAC meeting highlights.
EMA warned about the possible risk for developing Guillain-Barre syndrome (GBS) among individuals who received AstraZeneca’s COVID-19 vaccine Vaxzevria. A change to the product information was recommended by PRAC, but the committee noted that “at this stage the available data neither confirms nor rules out a possible association with the vaccine.”
PRAC also found that a gene therapy for thalassemia does not cause acute myeloid leukemia (AML). The committee investigated bluebird bio’s thalassemia treatment Zynteglo (betibeglogene autotemcel) because a similar treatment for sickle cell disease led to two cases of AML that emerged during clinical trials.
Although both treatments share a similar viral vector, PRAC found no cases of AML attributed to Zynteglo in its investigation. “The review found that the viral vector was unlikely to be the cause,” EMA said.
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC)


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