Investing.com — Pfizer and BioNTech, following Moderna, have requested conditional approval from EU regulators for the use of the COVID-19 vaccine, writes Bloomberg.
>> Moderna has applied for vaccine approval
The European Medicines Agency said on Tuesday that it could reach an opinion within a few weeks and intends to work on the assessment «during the Christmas period». The evaluation meeting is scheduled no later than December 29. The official filing, presented on Monday, completes an ongoing review process that began on October 6 and allowed the European regulator to examine the vaccine data as it emerges..
Meanwhile, the UK has introduced a special rule to allow its regulator to bypass the EU regulator and may be the first country to authorize the use of Pfizer-BioNTech. However, the United States is not far behind: on December 10, the FDA will hold a meeting to discuss the vaccine.
As CFO Sirk Poetting said at a press conference, BioNTech may start shipping the first doses «during few hours» after obtaining regulatory approval. BioNTech shares rose 2.3% in Germany. Pfizer adds 2.19% at the premarket of the New York Stock Exchange.
In November, a study of nearly 44,000 people found the vaccine prevented 95% of coronavirus cases.
Pfizer and BioNTech have also started filing regulations in other countries, including Australia, Canada and Japan. Partners signed deals to supply hundreds of millions of vaccine doses, including an agreement with the EU for 200 million doses with the option of another 100 million.
A conditional authorization is issued when the European authorities want to quickly deliver a drug to patients without waiting for the complete data package normally required for a standard authorization. It is valid for one year and can be renewed or converted to standard definition.
— Written using Bloomberg materials
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