Coronavirus vaccine assessment brought forward by EU amid rising pressure

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 earlier on Tuesday 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.”

The German Hospital Association chipped in on Tuesday as well, demanding the EU shorten its lengthy approval process and issue emergency authorisation for the Pfizer/BioNTech vaccine.

Gerad Gass, president of the hospital association, told the RND media group: “I am asking myself if we really need time until December 29 to reach the approval of the vaccination in Europe – Europe should try to get an emergency authorisation earlier.

“That way we could still go into nursing homes with mobile teams before Christmas and vaccinate the residents.”

EMA chief Emer Cooke said on Monday 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.

Hospitals and medical groups across Germany have also repeatedly warned they are reaching their limits in caring for coronavirus patients.

On Tuesday, 4,670 Covid-19 patients were being treated in German intensive care units.

The nation is going into a hard lockdown on Wednesday, with schools and most stores shutting down at least until January 10 to stop the exponential rise of cases.

Mr Spahn’s ministry said Germany is ready to give three million to four million Pfizer/BioNTech vaccination doses in January and up to 11 million doses in the first quarter of 2021.

The country would be able to vaccinate up to 60% of Germany’s citizens by the end of the summer, Mr Spahn said on Monday night on public broadcaster ZDF.

The World Health Organisation said around 60% to 70% of a population needs to be vaccinated to successfully curtail the pandemic.

On Tuesday, the Robert Koch Institute – Germany’s central disease control centre – reported 14,432 new confirmed cases and 500 new deaths, the third-highest number of daily deaths since the pandemic began.

The Institute’s chief warned that the case numbers would still go up for some time after Germany heads into lockdown on Wednesday.

“Those older than 80 are getting more and more affected, and those are the people who get severely ill or die.” Lothar Wieler warned.