Germany calling for earlier jab approval
FACING strong pressure from Germany and other EU nations, the European Medicines Agency (EMA) has brought forward a meeting to assess the Pfizer/BioNTech coronavirus vaccine to December 21.
It brings vaccinations a step closer for millions of EU citizens.
The agency said it made the decision after receiving additional data from the vaccine makers.
The announcement came after Germany’s health minister and others had publicly demanded the agency move quicker than its previously planned December 29 meeting, at which it was to discuss approving the vaccine.
The vaccine is already being given daily to thousands of people in the UK, US and Canada.
The EMA said its 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 authorisation, 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.
“Our goal is an approval before Christmas,” German health minister Jens Spahn told reporters yesterday in Berlin.
“We want to still start vaccinating this year.”
Mr Spahn has expressed impatience with the EMA for days, noting Germany has created 440 vaccination centres, activated about 10,000 doctors and medical staff, and is ready to start mass vaccinations immediately.
Italy, where Europe’s coronavirus outbreak erupted in February and which now leads the continent in the Covid-19 death count, is also 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 firm Pfizer is already being used in the UK, US, Canada and other countries.
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.
Christine Aschenberg-Dugnus, a politician with the pro-business Free Democrats, said: “It cannot be that a vaccine that has been developed in Germany is only approved and vaccinated here in January.”
EMA chief Emer Cooke said that her team is already working “around the clock” but added the vaccine approval timeline is constantly under review, which suggests the date could change.
Part of the problem could be that the EU is seeking to begin vaccinations in all of its nations at the same time, and Germany could be more prepared than others.
Mr Spahn’s growing anxiety comes as Germany has been hitting records of new daily infections and virus deaths in recent weeks.