The European Union’s medicines agency said on Tuesday that it has moved up a meeting to assess the Pfizer-BioNTech coronavirus vaccine for provisional approval in the 27-nation bloc to December 21.
The agency said it decided after receiving additional data from the vaccine makers. The announcement came after Germany’s health minister and others had publicly demanded that the agency move quicker than its previously planned December 29 meeting at which it was to discuss approving the vaccine.
The European Medicines Agency said it’s human medicines committee “will conclude its assessment at the earliest possible timepoint and only once the data on the quality, safety and effectiveness of the vaccine are sufficiently robust and complete to determine whether the vaccine’s benefits outweigh its risks.”
After the committee recommends a marketing authorization, the EU’s Executive Commission will “fast track its decision-making process” to giving the vaccine approval for all 27 EU nations and a few others within days, the EMA said.
German Health Minister Jens Spahn has expressed impatience with the EMA for days, noting that Germany has created some 440 vaccination centers, activated about 10,000 doctors and medical staff and was ready to start mass vaccinations immediately. He told reporters earlier Tuesday in Berlin. “We want to still start vaccinating this year.”
Italy, where Europe’s coronavirus outbreak erupted in February and which now leads the continent in the COVID-19 death count, also was pressing for a safe, accelerated approval process.
“My hope is that the EMA, in compliance with all safety procedures, will be able to approve the Pfizer-BioNTech vaccine earlier than expected and that vaccinations can also begin in the countries of the European Union as soon as possible,” Italian Health Minister Roberto Speranza said in a statement. The new vaccine developed by Germany’s BioNTech and American drugmaker Pfizer is already being used in Britain, the United States, Canada and other countries. But Germany cannot start vaccinations because it is still waiting for approval by the EMA, which evaluates drugs and vaccines for the EU’s 27 nations. Part of the problem could be that the EU is seeking to kick off vaccinations in all of its nations at the same time, and Germany could be more prepared than others.
