EU agency to approve COVID-19 vaccine before December 23, says German health minister



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BERLIN: After days of lobbying the European Union’s medical regulator, Germany’s health minister said on Tuesday (December 15) that it had received assurances that the European Medicines Agency will approve a COVID-19 vaccine by 23 December. December.

Health Minister Jens Spahn told reporters in Berlin on Tuesday that he “welcomed” German media reports that the EMA would finalize its approval process for the Pfizer-BioNTech coronavirus vaccine for the December 23, rather than a meeting on December 29.

“Our goal is approval before Christmas,” said Spahn. “We want to start vaccinating this year.”

When asked by The Associated Press later if he had received direct confirmation that the vaccine would be approved by then, Spahn said yes, “otherwise he would not have said that.”

However, he added, “the EU has to announce it.”

READ: Pressure Mounts on EU Medicines Regulator to Approve Pfizer COVID-19 Vaccine

Spahn did not say from whom he had received confirmation and the EMA could not immediately be reached for comment on exactly when it would release its findings on the approval process.

The EMA said later on Tuesday that it had moved the meeting up from December 29 to December 21.

In announcing the change, he said that after receiving additional data “an exceptional meeting … has been scheduled for December 21 to conclude if possible.”

Spahn has expressed impatience with the EMA for days, noting that Germany has created some 440 vaccination centers, activated about 10,000 doctors and medical personnel, and was ready to begin mass vaccinations immediately.

Virus outbreak in Germany

People walk at the Old Town Christmas market in front of the town hall in Duesseldorf, Germany, on December 14, 2020 (Photo: AP / Martin Meissner)

Italy, where the coronavirus outbreak broke out in Europe in February and now leads the continent in COVID-19 death counts, is also pushing for a safe and expedited approval process.

“My hope is that the EMA, complying with all safety procedures, can approve the Pfizer-BioNTech vaccine earlier than expected and that vaccinations can also start in the countries of the European Union as soon as possible,” said the Minister of Italian health. Roberto Speranza said in a statement.

READ: Why us again? Italy suffers a disproportionate toll in the second wave of COVID-19

The new vaccine developed by the German BioNTech and the American pharmaceutical company Pfizer is already being used in Great Britain, the United States, Canada and other countries. But Germany cannot start vaccines because it is still awaiting approval from the EMA, which evaluates drugs and vaccines for all 27 EU nations.

Seeing the vaccine being administered to thousands of people elsewhere was irritating to many Germans.

“It cannot be that a vaccine that has been developed in Germany will only be approved and vaccinated (here) in January,” said Christine Aschenberg-Dugnus, federal lawmaker for the pro-business Free Democrats.

The German Hospital Association intervened on Tuesday, demanding that the EU shorten its lengthy approval process and issue an emergency authorization for the Pfizer-BioNTech vaccine.

“I wonder if we really need time until December 29 to get the vaccination approved in Europe; Europe should try to get an emergency authorization sooner, ”Gerald Gass, president of the hospital association, told the RND media group. “That way, we could still go to nursing homes with mobile teams before Christmas and vaccinate the residents.”

Virus outbreak in Germany

People wearing masks pass a Christmas stall in the city center of Duesseldorf, Germany, on Dec. 14, 2020 (Photo: AP / Martin Meissner)

EMA chief Emer Cooke said Monday that her team is already working “around the clock,” but added that the vaccine’s approval schedule is constantly being reviewed, suggesting the date could change.

Part of the problem could be that the EU is looking to start vaccines in all its nations at the same time, and Germany could be more prepared than others.

READ: Poor countries face long wait for COVID-19 vaccines despite promises

Spahn’s growing anxiety comes as Germany has been hitting records for new daily infections and deaths from viruses in recent weeks. Germany’s hospitals and medical groups have also repeatedly warned that they are reaching their limits in caring for COVID-19 patients. On Tuesday, 4,670 COVID-19 patients were being treated in German ICUs.

The nation will enter a harsh lockdown on Wednesday and schools and most stores will close through at least January 10 to stem the exponential rise in COVID-19 cases.

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

The country could vaccinate up to 60 percent of Germany’s citizens by late summer, Spahn said Monday night on public broadcaster ZDF. The World Health Organization says that around 60% to 70% of the population needs to be vaccinated to successfully suppress 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 tallied over 22,600 virus deaths overall, which is still a third of the figure for Italy or Britain.

The director of the Institute warned that the number of cases will continue to rise for some time after Germany closes on Wednesday.

“Those over 80 are increasingly affected, and those are the people who become seriously ill or die.” Lothar Wieler warned.

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