The Comirnaty Covid-19 vaccine by Pfizer-BioNTech is not linked to post-vaccination deaths with no new side effects being identified, according to the European Medicines Agency.

The EMA on Friday published its first safety update on the vaccine, based on the first data from the rollout.

“It concludes that safety data collected on Comirnaty use in vaccination campaigns is consistent with the known safety profile of the vaccine, and no new side effects were identified,” EMA said in its update.

The safety update is based on data collected and assessed since Comirnaty’s authorisation, including data from the EU’s centralised database of suspected side effects, EudraVigilance and that from other sources, including the company’s monthly safety report required for Covid-19 vaccines.

The update also includes the assessment of post-jab deaths of deaths with Comirnaty by the EU regulator’s Pharmacovigilance Risk Assessment Committee (PRAC), including deaths in frail, elderly people.

“PRAC carried out an analysis of the cases and took into account the presence of other medical conditions and the death rate for corresponding age groups in the general population. PRAC concluded that the data did not show a link to vaccination with Comirnaty and the cases do not raise a safety concern,” EMA said in the update.

It will monitor further reports coming in, it said.

Multiple countries in the EU including Norway, Sweden, Denmark, Finland and Iceland have reported deaths of people shortly after Pfizer’s Covid-19 vaccine shot. However, no direct link to the vaccine has been established so far, as per reports.

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