European regulator presents decision on Covid vaccine after German pressure | Society


The EU’s drug regulator has issued its decision on the Pfizer / BioNTech Covid vaccine after Germany made it clear it wanted approval before Christmas.
The Amsterdam-based European Medicines Agency’s announcement that it will meet on December 21 instead of December 29 to decide whether or not to authorize the vaccine follows a growing backlash from countries desperate for the EU, German Health Minister Jens Spahn said the agency risks losing the trust of European citizens if it does not act quickly.

“The aim is to get approval before Christmas,” he told a press conference in Berlin. “We want to start vaccinating in Germany before the end of the year. ”

The German government has repeatedly insisted that emergency approval of the type given by the UK and elsewhere could have a negative impact on the public’s willingness to get vaccinated – Germany would have more anti-vaxxers and vaccine skeptics than other countries – but Spahn on Sunday said at a coronavirus summit between government and state leaders that if Germany had gone alone it would have been “significantly faster.”

Responding to criticism that the UK, Canada and the US approved vaccines earlier than the EU, Spahn said the EMA decision would be “the world’s first regular approval” of a vaccine and would involve the participation of experts from the 27 EU member countries.

“We said from the start that we would do this at European level and not at national level… The ‘we’ is stronger than the ‘I’,” said Spahn. “This is good news for the whole of the EU.”

“We took a deeper dive into the data and undertook a more granular investigation of the data … so it took longer to assess it.”

The announcement of the vaccine has been well received by politicians, medical staff and business leaders. Headline writers called it “the best Christmas present.”

Germany enters a strict lockdown on Wednesday that will last at least until January 10, as it struggles to control the spread of the virus. Schools and kindergartens will close, as will non-essential stores and hairdressers.

Until the fall, Germany had done better than many other European countries, with significantly lower infection and death rates. But experts say its advantage was wasted in part due to the widespread perception that the virus was so well under control that people could safely relax their behavior.

On Sunday, political leaders backtracked on a plan to drastically relax the rules on Christmas, causing the seasonal festivities to halt.

Lothar Wieler, president of the Robert Koch Institute, the country’s leading public health body, said the virus has never been so widespread in Germany, with more than 350,000 people infected and a daily death rate consistently above 500.

“The situation is more serious than it has ever been,” Wieler said, pointing to the drastic increase in cases among those over 80. He said he expected the situation to get worse. A growing number of hospitals were close to capacity and the country’s 412 health units were struggling to cope, Wieler said.

Spahn said he acknowledged that some people had doubts about vaccines and that a vaccination program would be debated in parliament on Wednesday and Thursday.

Experts have suggested that the German government hopes that regular rather than emergency approval of vaccines will place responsibility for its safety on manufacturers, not the government.

Klaus-Dieter Zastrow, professor of sanitary hygiene, told German media that he did not expect the vaccination program to have a palpable impact on German life until April or May at the earliest. He said until then “we will have to continue to wear masks and keep our distance”. He added that it was still not known whether those who had been vaccinated were still able to spread the virus.

As countries in Europe work to avoid another surge in coronavirus infections over Christmas and New Years, the Spanish government has called on people to ‘be extra careful’ in the face of a slight increase in the number of new cases .

Infection levels in Spain have fallen in recent weeks, from over 20,000 in October to less than 10,000 in recent weeks. But the latest figures from the weekend show that the number of cases per 100,000 inhabitants rose from 190 on Friday to 194 on Monday.

Coronavirus case in Spain

The country’s health emergency chief Fernando Simón said the drop in new cases appeared to be stabilizing, while government spokeswoman María Jesús Montero called for patience and responsibility over Christmas and the new year.

“We expect the first vaccines to arrive in Spain early next year,” she said on Tuesday. “Caution must be our watchword in the way we move in the days to come. We need to step it up over the next few days if we don’t want to go back to square one. ”

Spain’s Health Minister Salvador Illa said he hoped some people would start getting vaccinated by the end of the year. The government plans to immunize health workers, health center staff and residents, as well as those with serious health problems during the first round of immunizations.

Additional reporting by Sam Jones in Madrid


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