EMA finds no safety concerns with Pfizer/BioNTech COVID-19 vaccine

  • World
  • Saturday, 30 Jan 2021

BRUSSELS. Jan. 29 (Xinhua) -- The European Medicines Agency (EMA) said on Friday that it found no safety concerns with the COVID-19 vaccine jointly developed by Pfizer and BioNTech, after the reported deaths of elderly people in Norway arose such concerns.

On Jan. 15, the Norwegian Medicines Agency said an adverse reaction to the first dose of the vaccine may have been responsible for 23 reported deaths among frail and elderly patients in nursing homes in Norway.

In its first safety update on the COVID-19 vaccine, the EMA concluded on Friday that data collected in vaccination campaigns were consistent with the known safety profile of the vaccine and that no new side effects were identified.

The conclusion was reached after evaluating data from EudraVigilance, the European Union's centralized database of suspected side effects, and the company's monthly safety report required for COVID-19 vaccines.

The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) assessed the deaths reported in Norway after vaccination, including the deaths of frail, elderly people. It also considered the presence of other medical conditions and the death rate for corresponding age groups.

"PRAC concluded that the data did not show a link to vaccination with Comirnaty (Pfizer/BioNTech vaccine) and the cases do not raise a safety concern," it said, adding that it would continue to monitor further reports.

The EMA said in a statement that it will publish monthly safety updates for all authorized COVID-19 vaccines.

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