PRAC investigates heart inflammation reports with Pfizer vaccine

Regulatory NewsRegulatory News | 07 May 2021 |  By 

During an early May meeting, the European Medicines Agency’s safety committee concluded two reviews of safety signals related to COVID-19 vaccines, while it continued following other vaccine-related “topics of interest.” These included reports of heart muscle inflammation after receipt of the Pfizer-BioNTech vaccine.
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) wrapped up a review of reports of facial swelling in recipients of Pfizer’s COVID-19 vaccine, known at Comirnaty in the EU. For people who have received dermal fillers, “at least a reasonable possibility” exists that facial swelling after vaccination may be related to the vaccine. The information will be included as a side effect in the summary of product characteristics and the patient information leaflet for the vaccine; the benefit-risk assessment for Comirnaty is unchanged, wrote PRAC.
The benefits still outweigh the risks of receiving the COVID-19 vaccine from Janssen, Johnson & Johnson’s vaccine division, judged PRAC. The vaccine’s product information will now include advice that individuals who develop low blood platelets within 3 weeks of vaccination with the Janssen vaccine should be investigated for blood clots; likewise, patients who develop thromboembolism within the 3-week window should be assessed for thrombocytopenia. PRAC has tasked Janssen with providing a plan to further study the mechanism for the very rare syndrome of thrombosis with thrombocytopenia that may develop after vaccination, and the risk management plan will be updated with the syndrome as an “important identified risk.”
Despite PRAC’s ongoing surveillance and review, no safety signal is being found for the low platelet and clotting syndrome with either of the two authorized messenger RNA (mRNA) vaccines. Neither Comirnaty nor the mRNA vaccine developed by Pfizer and BioNTech are thus far associated with a higher rate than would be seen in the background population of the condition; also, “these cases do not seem to present the specific clinical pattern” seen with Janssen or the AstraZeneca vaccine where the syndrome is more common, wrote EMA. “Overall, the current evidence does not suggest a causal relation.”
PRAC is also following rare reports of Guillain-Barre syndrome, an immune disorder that causes ascending paralysis, seen following administration of AstraZeneca’s COVID-19 vaccine. The regulator has asked AstraZeneca for a detailed analysis of these cases when the firm submits its next required monthly safety report.
Finally, EMA has received reports of Comirnaty recipients developing myocarditis and pericarditis. “There is no indication at the moment that these cases are due to the vaccine,” wrote PRAC. An analysis of any reported cases should be included in the next safety summary report for Comirnaty, said the committee; Moderna is also being asked to look for similar cases in those who have received its mRNA vaccine and report back.
Separately, EMA’s human medicines committee has begun a rolling review of another monoclonal antibody to treat COVID-19.
Sotrovimab, developed by GlaxoSmithKline and Vir Biotechnology, joins four other antibody treatments for COVID-19 that are in EMA’s rolling review process. The procedure allows ongoing evaluation of a therapeutic or vaccine candidate; EMA will consider data as they are made available by the sponsor during the development process, rather than waiting for a full submission packet.
Currently, EMA is evaluating “the first batch of data” for sotrovimab, including laboratory and animal studies and quality-related data, said the agency.
 PRAC report


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Tags: CHMP, coronavirus, EMA, EU, PRAC

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