June 15, 2021

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EU eyes Dec 29 approval for 1st virus vaccine, later than US

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EU eyes Dec 29 approval for 1st virus vaccine, later than US

BERLIN (AP) — The EU drug agency said Tuesday it may need another four weeks to decide whether to grant its first approval for a coronavirus vaccine, even as authorities in the United States and Britain continued to aim for a green light before Christmas.
The European Medicines Agency plans to convene a meeting by Dec. 29 to decide if there is enough safety and efficacy data about the vaccine developed by Pfizer and BioNTech for it to be approved, the regulator said. The agency also said it could decide as early as Jan. 12 whether to approve a rival shot by American pharmaceutical company Moderna Inc, which was submitted to U.S. and European regulators this week.
If its vaccine is approved, Germany-based BioNTech said its use in Europe could begin before the end of 2020 — but that seems quite ambitious, given that the EU Commission usually needs to rubber-stamp the regulator’s decision. Still, the regulator has also left open the possibility that the date of that meeting will be brought forward if data comes in faster.
The approval date now being eyed would be later than some European countries had hoped. Germany, which has given BioNTech 375 million euros ($450 million) in funding to develop the vaccine, has been preparing to start immunizing people from mid-December onward.

The EU’s top official said Tuesday around 2 billion doses of potential COVID-19 vaccines have been secured for the bloc’s 27 nations, with the first deliveries likely to start before the end of the year.

“It will be a huge step forward toward our normal life,” EU Commission President Ursula von der Leyen said. “In other words, I just wanted to say there is a light at the end of the tunnel.”

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