EU drug regulator to use UK data on adverse effects in assessment of Pfizer vaccine

EU drug regulator to use UK data on adverse effects in assessment of Pfizer vaccine
  • Country:
  • Belgium

The European Union drug regulator will use data from Britain and other countries outside the EU on the safety of Pfizer-BioNTech's COVID-19 vaccine before deciding whether to approve it, it said in a statement on Wednesday.

Britain's medicine regulator has advised that people with a history of significant allergies do not get the Pfizer-BioNTech vaccine after two people reported adverse reactions on the first day of rollout on Wednesday.

Asked whether this new information could be used in the assessment of the vaccine in Europe, the European Medicines Agency said: "All available information on the quality, safety and efficacy of the vaccine will be taken into account. This will include safety data generated from the use of the vaccine outside the EU."

Give Feedback

Use this form for editorial or site feedback. We usually reply within 2 to 3 working days.

By submitting, you agree that we may use your email address to respond.