EU regulators advance assessment of Pfizer vaccine until 21 December

BERLIN (AP) – In the face of strong pressure from Germany and other European Union countries, the bloc’s drug agency on Tuesday presented a meeting to evaluate the Pfizer-BioNTech coronavirus vaccine until December 21, which would probably bring vaccines closer to millions of EU citizens.

The agency said it made the decision after receiving additional data from vaccine manufacturers. The announcement came after the German health minister and others had publicly demanded that the agency move faster than the December 29 meeting at which the vaccine was to be approved.

The vaccine is already being given daily to thousands of people in Britain, Canada and the United States, affecting some Europeans who note that BioNTech is a German company.

The European Medicines Agency said its human medicines committee “will conclude its evaluation as soon as possible and only once the data on vaccine quality, safety and efficacy are strong and complete enough to determine if the benefits of the vaccine outweigh their risks. “

After the committee recommends a marketing authorization, the EU Executive Committee will “speed up the decision-making process” until the vaccine is approved for all 27 EU countries and some others in a few days, say the EMA.

“Our goal is an approval before Christmas,” German Health Minister Jens Spahn told reporters in Berlin on Tuesday. “We want to start vaccinating this year.”

Asked by The Associated Press if he had received direct confirmation that the vaccine would be approved before Dec. 23, Spahn said “if not, I wouldn’t have said so.”

He added, however, that “the EU must announce it.”

Spahn has expressed impatience with the EMA for days, noting that Germany has set up about 440 vaccination centers, activated about 10,000 doctors and medical staff and is ready to start mass vaccinations immediately.

Italy, where the European coronavirus outbreak broke out in February and now leading the continent in COVID-19 death toll, was also pushing for an accelerated and secure approval process.

“My hope is that the EMA, in compliance with all safety procedures, will be able to approve the Pfizer-BioNTech vaccine ahead of schedule and that vaccinations can also start in European Union countries as soon as possible,” he said. Italian Health Minister Roberto Speranza said in a statement.

The new vaccine developed by Germany-based BioNTech and US pharmacist Pfizer is already being used in Britain, the United States, Canada and other countries. But Germany cannot start vaccines because it is still awaiting approval from the EMA, which evaluates medicines and vaccines for the 27 EU nations.

“It can’t be that a vaccine that has been developed in Germany is only approved and vaccinated (here) in January,” said Christine Aschenberg-Dugnus, a federal lawmaker with pro-business Free Democrats.

The German hospital association on Tuesday demanded that the EU shorten its lengthy approval process and issue emergency clearance for the Pfizer-BioNTech vaccine.

“I wonder if we really need time until December 29 to get approval for vaccination in Europe: Europe should try to get an emergency permit first,” said Gerald Gass, president of the hospital association. in the RND media group. “That way, we could still get into residences with mobile equipment before Christmas and vaccinate residents.”

Part of the problem could be that the EU is trying to start vaccinations in all its nations at once, and Germany could be more prepared than others.

Spahn’s growing anxiety comes as Germany has been recording records of new daily infections and virus deaths in recent weeks. Hospitals and medical groups across Germany have also repeatedly warned that they are reaching their limits to treat patients with COVID-19. On Tuesday, 4,670 patients with COVID-19 were treated in German ICUs.

The nation will go into a tough blockade on Wednesday with schools and most stores closing at least until Jan. 10 to stop the exponential rise in COVID-19 cases.

Spahn’s ministry says Germany is ready to administer 3 to 4 million doses of BioNTech vaccination in January and up to 11 million doses in the first quarter of 2021.

The country would be able to vaccinate up to 60 percent of German citizens by the end of the summer, Spahn said Monday night on public broadcaster ZDF. The World Health Organization says that between 60% and 70% of the population need to be vaccinated to successfully fight the pandemic.

The Robert Koch Institute, Germany’s central disease control center, reported 14,432 new confirmed cases and 500 new deaths on Tuesday, the third highest number of daily deaths since the pandemic began. Germany has accounted for more than 22,600 deaths from viruses in general, which is still a third of the toll in Italy or Britain.

The head of the institute warned that the numbers of cases would still increase for some time despite the new closure of Germany.

“People over the age of 80 are increasingly affected and it’s the people who get seriously ill or die.” Lothar Wieler warned.

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Mike Corder in The Hague, Nicole Winfield in Rome and Maria Cheng in Toronto contributed to this report.

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Follow AP pandemic coverage at https://apnews.com/hub/coronavirus-pandemic at and https://apnews.com/UnderstandingtheOutbreak

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