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

BERLIN: After several days of pressure on the European Union’s medical regulator, the German health minister said on Tuesday (December 15th) that he had received assurances that the European Medicines Agency would approve a COVID-19 vaccine by December 23rd.

Health Minister Jens Spahn told reporters in Berlin on Tuesday that he “welcomed” German media reports that the EMA would complete the process of approving the Pfizer-BioNTech coronavirus vaccine by December 23, instead of a meeting on December 29. .

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

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

He added, however, “the EU needs to announce it.”

READ: Pressure on EU medicines regulator to approve Pfizer COVID-19 vaccine

Spahn did not say from whom he received the confirmation, and the EMA could not be contacted immediately to comment on exactly when it will publish its findings on the approval process.

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

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

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

Several people go to the Christmas market in the old town in front of Duesseldorf City Hall, Germany, December 14, 2020. (Photo: AP / Martin Meissner)

Italy, where the coronavirus outbreak in Europe broke out in February and is now leading the continent in COVID-19 deaths, is also pushing for a safe, accelerated approval process.

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

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

The new vaccine developed by the German company BioNTech and the American doctor Pfizer is already used in the United Kingdom, the United States, Canada and other countries. But Germany cannot start vaccinations because it is still waiting for approval from the EMA, which evaluates medicines and vaccines for the 27 EU nations.

The sight of the vaccine given to thousands of people elsewhere has been gargling for many Germans.

“A vaccine that was developed in Germany cannot be approved and vaccinated (here) until January,” said Christine Aschenberg-Dugnus, a federal pro-business MP for the Free Democrats.

The German Hospitals Association intervened on Tuesday, demanding that the EU shorten its long approval process and issue an emergency authorization 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 sooner,” Gerald Gass, president of the hospital’s association, told the newsgroup. RND. “In this way, we could continue to go to nursing homes with mobile teams before Christmas and vaccinate residents.”

Virus Outbreak Germany

People with masks pass a Christmas stand in the center of Duesseldorf, Germany, December 14, 2020. (Photo: AP / Martin Meissner)

EMA chief Emer Cooke said Monday that her team is already working 24 hours a day, but added that the vaccine approval schedule is under review, suggesting that the date may change.

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

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

Spahn’s growing anxiety comes as Germany has recorded new daily infections and virus deaths in recent weeks. Hospitals and medical groups in Germany have repeatedly warned that they are reaching their limits in the care of patients with COVID-19. On Tuesday, 4,670 patients with COVID-19 were treated in the German ICU.

The nation enters a heavy blockade on Wednesday, with schools and most stores closing at least until January 10 to stop the exponential growth of COVID-19 cases.

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

The country will be able to vaccinate up to 60% of Germany’s citizens by the end of the summer, Spahn told public broadcaster ZDF on Monday night. The World Health Organization says that about 60% to 70% of the population needs to be vaccinated to successfully reduce 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 recorded more than 22,600 deaths caused by viruses, which is another third of Italy or the United Kingdom.

The head of the institute warned that the number of cases will continue to increase for a period of time after Germany enters the blockade on Wednesday.

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

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