EU eyes Dec. 29 approval for 1st virus vaccine; US will be later
BERLIN – 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 rubberstamp 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 $450 million in funding to develop the vaccine, has been preparing to start immunizing people from mid-december onward.
On Tuesday, officials in Germany, France and the Netherlands cautioned that vaccine programs likely won’t start until the end of the year.
“With the information we got in recent days we have to assume that approval will only happen around the turn of the year,” German Health Minister Jens Spahn said.
“It has moved because some studies obviously need a little longer to be submitted,” he said. “What’s important is to be prepared.”
His comments were echoed by French President Emmanuel Macron and Dutch Health Minister Hugo de Jonge, who said authorities in those countries are working to begin vaccinating people in the first week of January.
“It won’t be a vaccination policy for the broader public” during the first few months, Macron said in a news conference at the Elysee presidential palace.
Biontech and Pfizer have said that clinical trials showed their vaccine is 95% effective. The two companies have already submitted data to regulators in the United States and Britain, and approval might come from them first.
Hospitals in England have been told they could receive the first doses of the Pfizer shot as early as the week of Dec. 7 if it receives the OK, the Guardian and Financial Times reported. The U.S. Food and Drug Administration’s scientific advisers are holding a public meeting Dec. 10 to review Pfizer’s request, and approval could come shortly thereafter.
British regulators also are assessing another vaccine developed by researchers from Oxford University and Astrazeneca.
Whichever of the regulators acts earliest would be giving the first approval of a COVID-19 vaccine that has been rigorously tested by tens of thousands of people in trials.