Health
EU regulators meet to discuss COVID-19 vaccine approval
The European Medicines Agency is meeting to consider approval of the coronavirus vaccine developed by BioNTech and Pfizer. It will be the first to be approved for use in the European Union.
The private meeting will take place weeks after the UK and US regulators have approved the shot under urgent regulations.
If EMA scientists conclude that the vaccine is safe, officials from an Amsterdam-based agency are expected to conditionally approve the use of the vaccine across blocks in 27 countries. I will. The European Commission needs to rubber stamp the decision before deploying the vaccine. According to German authorities, this process may begin on December 27th. Pharmaceutical companies also need to submit follow-up data on vaccines next year.
European regulators were under great pressure last week from countries calling for approval of vaccine use as soon as possible. Initially, the EMA set December 29 as the evaluation date for vaccines manufactured by Germany-based BioNTech, but the meeting proceeded after a prompt response from Berlin and others.
Vaccines have already been given some form of regulatory approval in more than 12 countries.
According to Johns Hopkins University, the United Kingdom, Canada and the United States have approved the use of vaccines in accordance with urgent regulations. In short, this shot is an unlicensed product whose temporary use is justified by a pandemic that has killed about 1.7 million people worldwide so far.
However, EMA approval is similar to the normal licensing process for new vaccines, but with an accelerated schedule.
In a statement last week, authorities emphasized that the vaccine would only be approved after a scientific assessment showed that its overall benefit outweighed the risk.
“The benefits of a vaccine that protects people from COVID-19 must outweigh the side effects and potential risks,” he said.
So far, the US Centers for Disease Control and Prevention said it had seen six severe allergic reactions from more than 250,000 injections of the given BioNTech-Pfizer vaccine, including one with a history of vaccination reactions. I am.
BioNTech and Pfizer provided the EU with 400 million doses of vaccine, but Brock’s executive committee chose to buy 200 million doses and could also buy an additional 100 million doses. ..
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