EU EYEING DEC. 29 FOR VACCINE OK

Drug agency needs more time; EU panel must also sign off

The European Union drug agency said Tuesday it may need four more weeks to approve its f irst coronavirus vaccine, even as authorities in the United States and Britain continue 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 eff icacy data about the vaccine developed by Pfizer and BioNTech for it to be approved. The regulator also said it could decide as early as Jan. 12 whether to approve a rival shot by American pharmaceutical company Moderna, which submitted its request to U.S. and European regulators this week.

If its vaccine is approved, Germany-based BioNTech said the shot’s 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 agency has also left open the possibility that the date of that meeting will be brought forward if data comes in faster.

Any approval granted by the European regulator will be conditional on companies submitting further information to confirm that the vaccine’s benefits outweigh the risks.

The 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 at a news conference.

BioNTech and U.S. partner Pfizer have said that clinical trials showed their vaccine is 95 percent effective. The two companies have already submitted data to regulators in the United States and Britain, and approval might come from them first.