BERLIN (AP) – Faced with strong pressure from Germany and other European Union countries, the bloc’s drug agency on Tuesday moved a meeting to review the Pfizer-BioNTech coronavirus vaccine to December 21, likely bringing vaccinations one step closer to millions EU citizens.
The agency said it made the decision after receiving additional data from the vaccine manufacturers. The announcement came after Germany’s health minister and others publicly demanded that the agency act faster than its previously scheduled December 29 meeting at which it would discuss approval of the vaccine.
The vaccine is already being given to thousands of people in Britain, Canada and the United States every day, irritating some Europeans who comment that BioNTech is a German company.
The European Medicines Agency said the Committee for Medicinal Products for Human Use “will complete its review as early as possible and only when data on the quality, safety and effectiveness of the vaccine are sufficiently robust and complete to determine whether the benefits of the vaccine outweigh against the risks. “
After the committee recommends a marketing authorization, the EU Executive Committee will “speed up its decision-making process” to approve the vaccine within days for all 27 EU countries and a few others, the EMA said.
“Our goal is approval for Christmas,” German Health Minister Jens Spahn told reporters in Berlin earlier on Tuesday. “We want to start vaccinating this year.”
Asked by The Associated Press if he had received immediate confirmation that the vaccine would be approved on December 23, Spahn said he had, “otherwise I wouldn’t have said so.”
However, he added, “the EU must announce it.”
Spahn has expressed impatience at the EMA for days, noting that Germany has set up some 440 vaccination centers, activated about 10,000 doctors and medical personnel, and was ready to begin mass vaccinations immediately.
Italy, where the European coronavirus outbreak erupted in February and now leads the continent in the COVID-19 death count, also pushed for a safe, expedited approval process.
“I hope that, in accordance with all safety procedures, the EMA can approve the Pfizer-BioNTech vaccine earlier than expected and that vaccinations can also start as soon as possible in the countries of the European Union,” said Italian Health Minister Roberto. Speranza said in a statement.
The new vaccine developed by the German BioNTech and the American drug manufacturer Pfizer is already being used in Great Britain, the United States, Canada and other countries. But Germany cannot start vaccinations because it is still awaiting approval from the EMA, which is evaluating drugs and vaccines for the 27 countries of the EU.
“It cannot be that a vaccine developed in Germany will not be approved and vaccinated until January (here),” said Christine Aschenberg-Dugnus, a federal lawmaker with the pro-business Free Democrats.
The German Hospital Association voted in heart on Tuesday, demanding that the EU shorten its lengthy approval process and issue an emergency permit for the Pfizer-BioNTech vaccine.
“I wonder if we really need time until December 29 to get vaccination approval in Europe – Europe should try to get an emergency permit sooner,” Gerald Gass, president of the hospital association, told the report. RND media group. “That way we could enter nursing homes with mobile teams before Christmas and vaccinate the residents.”
Part of the problem could be that the EU is trying to start vaccinations in all its countries at the same time, and Germany could be better prepared than others.
Spahn’s growing concern comes as Germany has recorded 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 in caring for COVID-19 patients. On Tuesday, 4,670 COVID-19 patients were treated in German ICUs.
The nation will go into a hard lockdown on Wednesday, with schools and most stores closing at least until January 10 to stop the exponential rise in COVID-19 cases.
Spahn’s ministry says Germany is ready to give 3 to 4 million BioNTech vaccination doses in January and up to 11 million doses in the first quarter of 2021.
By the end of the summer, the country could vaccinate up to 60% of German citizens, Spahn said on public broadcaster ZDF Monday evening. The World Health Organization says that about 60% to 70% of the population must be vaccinated to successfully combat 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 start of the pandemic. Germany has counted more than 22,600 virus deaths in total, which is still a third of the toll taken by Italy or Great Britain.
The institute’s chief warned that the number of cases would continue to rise for a while despite Germany’s new closure.
“Those over 80 are increasingly affected, and those are the people who become seriously ill or die.” Lothar Wieler warned.
Mike Corder in The Hague, Nicole Winfield in Rome and Maria Cheng in Toronto contributed to this report.
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