AMSTERDAM: The European Medicines Agency says no new side effects linked to the coronavirus vaccine made by BioNTech and Pfizer were identified in the regulator’s first safety update on COVID-19 vaccines.
In a statement published Friday, the European regulator said its expert committee assessed reports of people who died after getting the vaccine and said their review “did not suggest a safety concern.” Earlier this month, Norwegian officials amended their vaccination advice to say that doctors should assess frail and severely ill elderly people to decide if they should be immunized.
The EMA concluded that safety data collected on the Pfizer vaccine are “consistent with the known safety profile of the vaccine” and noted that severe allergic reactions are a known, rare side effect. It said the frequency of such allergic reactions was about 11 cases per million doses in the U.S. but that there was no comparable European estimate yet.
The EMA authorized the Pfizer vaccine on December 21 and granted it a conditional license; Pfizer and BioNTech must submit safety reports every month in line with a heightened monitoring process. The agency said “there are no recommended changes regarding the use of the vaccine.”