15 December 2020

Germany demands EU approval of vaccine before Christmas

15 December 2020

Germany has increased the pressure on the European Union’s regulatory agency to approve a coronavirus vaccine before Christmas.

Health Minister Jens Spahn, other politicians and a hospital association have all made the demand.

He said he “welcomed” German media reports that the European Medicines Agency, or EMA, will finalise its approval process of the Pfizer-BioNTech coronavirus vaccine by December 23 instead of at a December 29 meeting.

The EMA could not immediately be reached for comment on exactly when it will release its findings on the approval process.

Our goal is an approval before Christmas so that we can 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, 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.

Mr Spahn has expressed impatience with the EMA for days, noting Germany has created some 440 vaccination centres, activated about 10,000 doctors and medical staff and is ready to start mass vaccinations as early as Tuesday.

“Our goal is an approval before Christmas so that we can still start vaccinating this year,” he told the dpa news agency on Tuesday.

Mr Spahn is pushing for a quick approval of the vaccine developed by Germany’s BioNTech and American drug-maker Pfizer that has already been authorised for use in the UK, US, Canada and other countries.

But Germany cannot use it because it is still waiting for approval by the EMA, which evaluates drugs and vaccines for the EU’s 27 nations.

Virus Outbreak Germany BioNTech (AP)

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 Tuesday as well, demanding the EU shorten its lengthy approval process and issue emergency authorisation for the Pfizer-BioNTech vaccine.

EMA chief Emer Cooke said on Monday that her team is already working “around the clock”.

Ms Cooke added, however, that the timeline for vaccine approval is constantly under review, which suggests the date could change.

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.”

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.

Virus Outbreak Germany (AP)

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 ICUs.

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.

Germany has counted more than 22,600 virus deaths overall, which is still a third of the toll in the UK and Italy.

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