EMA ‘Firmly Convinced’ of AZ Vaccine Safety Ahead of Official Review Results

Date: March 17, 2021 | Country: BELGIUMNETHERLANDS | Region: EUROPE | Type: Regulation | Keywords: #astrazeneca #covid19 #ema #review #safety #vaccine

PRICENTRIC BRIEF:

  • The European Medicines Agency (EMA) has stated that it is “firmly convinced” that the benefits of AstraZeneca’s COVID-19 vaccine outweigh the risks
  • EMA head Emer Cooke explained that “While the investigation is ongoing, currently, we are still firmly convinced that the benefits of the AstraZeneca vaccine in preventing Covid-19, with its associated risks of hospitalization and death, outweigh the risks
  • The official outcome of the EMA’s safety review is expected to be released on Thursday

 

THE DETAILS

AMSTERDAM, The Netherlands – The European Medicines Agency (EMA) has stated that it is “firmly convinced” that the benefits of AstraZeneca’s COVID-19 vaccine outweigh the risks.

EMA head Emer Cooke explained that “While the investigation is ongoing, currently, we are still firmly convinced that the benefits of the AstraZeneca vaccine in preventing Covid-19, with its associated risks of hospitalization and death, outweigh the risks.

“We know that many thousands of people develop blood clots in the EU so what we want is to establish whether these events are caused by the vaccine or by other causes.”

The official outcome of the EMA’s safety review is expected to be released on Thursday.

 

AZ Vs. EU

More than a dozen European countries have now temporarily suspended the use of AstraZeneca’s COVID-19 vaccine following reports from the Danish Medicines Agency of blood clots post-administration.

There was one report of a death, but the Danish Agency confirmed that there is no evidence to conclude that there is an association between the vaccine and the blood clots.

The European Medicines Agency also noted at the time that it was aware of Denmark’s move, and issued a release stating that “there is currently no indication that vaccination has caused these conditions, which are not listed as side effects with this vaccine.

Germany, Italy, France, Spain, Germany, Denmark, Norway, Iceland, Austria and The Netherlands are among the hoard of countries that have chosen to pause the use of the Anglo-Swedish made vaccine, but people in the UK have been urged to “still go and get their COVID-19 vaccine when asked to do so,” as the UK is standing by the vaccine.

The European Medicines Agency (EMA) is working closely with the company, with experts in blood disorders, and with other health authorities including the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) based on its experience with around 11 million administered doses of the vaccine.

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