Pfizer, BioNTech Seek EU Clearance for Covid-19 Vaccine

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  • Bloomberg Quicktake: Now published this video item, entitled “Pfizer, BioNTech Seek EU Clearance for Covid-19 Vaccine” – below is their description.

    Pfizer Inc. and partner BioNTech SE sought regulatory clearance for their Covid-19 vaccine in the European Union, putting the shot on track for potential approval there before the end of the year.

    The European Medicines Agency said on Tuesday it could issue an opinion within weeks, with a meeting on the assessment scheduled for Dec. 29 at the latest. Submitted on Monday, the formal application caps a rolling review process that started on Oct. 6 and allowed Europe’s drugs regulator to examine data on the vaccine as it emerged.

    Governments around the world are eager to start vaccinating their populations to curb the pandemic. Rival Moderna Inc. requested clearance in the U.S. and Europe on Monday. The U.K. invoked a special rule to allow its regulator to bypass its EU counterpart and may be the first to sign off on the Pfizer-BioNTech product. The U.S. isn’t far behind, with a Food and Drug Administration panel set to meet on Dec. 10 to discuss the vaccine.

    BioNTech can start shipping the first doses “within hours” after regulatory clearance, Chief Financial Officer Sierk Poetting said at a press conference. BioNTech shares rose 2.3% in German trading.

    In November, a study of almost 44,000 people showed the shot prevented 95% of symptomatic coronavirus cases.

    If the EMA concludes that the benefits of the Pfizer-BioNTech shot outweigh its risks, it will recommend granting a conditional clearance that could enable the shot to be rolled out in Europe before the end of the year, the companies said in a statement. The agency said it would work “over the Christmas period” on the assessment.

    Pfizer and BioNTech also started regulatory submissions in other countries including Australia, Canada and Japan, they said. The partners have signed deals to deliver hundreds of millions of doses of the vaccine, including an agreement with the EU for 200 million doses, with an option for an additional 100 million.

    A conditional clearance is issued when European authorities want to get a drug to patients quickly without waiting for as comprehensive a data package as would normally be required for standard authorization. It’s valid for one year and can be renewed — and eventually converted into a standard approval.

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    In This Story: Canada

    Canada is a country in the northern part of North America. It extends from the Atlantic to the Pacific and northward into the Arctic Ocean, covering 9.98 million square kilometres (3.85 million square miles), making it the world’s second-largest country by total area.

    Its southern and western border with the United States, stretching 8,891 kilometres (5,525 mi), is the world’s longest bi-national land border. Canada’s capital is Ottawa, and its three largest metropolitan areas are Toronto, Montreal, and Vancouver.

    Various Indigenous peoples inhabited what is now Canada for thousands of years before European colonization. The Canada Act 1982, which severed the vestiges of legal dependence on the British Parliament. Canada is a parliamentary democracy and a constitutional monarchy in the Westminster tradition, with a monarch and a prime minister who serves as the chair of the Cabinet and head of government.

    As a highly developed country, Canada has the seventeenth-highest nominal per-capita income globally as well as the thirteenth-highest ranking in the Human Development Index. Its advanced economy is the tenth-largest in the world, relying chiefly upon its abundant natural resources and well-developed international trade networks.

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