Tuesday, September 21

EU regulator advances ruling on Covid vaccine after German pressure Society


The EU drug regulator has issued its ruling on the Pfizer / BioNTech Covid vaccine after Germany made it clear that it wanted approval before Christmas.

The announcement by the Amsterdam-based European Medicines Agency that it will meet on December 21 instead of December 29 to decide whether to authorize the injection followed a growing reaction from desperate EU countries.

Germany and Italy joined Hungary and Poland in pressuring the EMA to speed up the process on Tuesday. “The goal is to get approval before Christmas,” Health Minister Jens Spahn told a news conference in Berlin. “We want to start vaccinating in Germany before the end of the year.”

Italy’s health minister, Roberto Speranza, said he hoped the EMA “can approve the Pfizer BioNTech vaccine ahead of schedule.”

Referring to criticism that the UK, Canada and the US approved vaccines before the EU, Spahn said the EMA’s decision would be “the world’s first regular approval” of a vaccine.

The German government has repeatedly insisted that an emergency approval of the kind given by the UK and elsewhere could have a negative impact on the public’s willingness to get vaccinated. Germany is believed to have more anti-vaccine and vaccine skeptics than other countries.

The approval process involved the participation of experts from all 27 EU member countries, which, according to Spahn, means it is taking longer.

“We have said from the beginning that we will do this at the European level and not at the national level… The ‘we’ is stronger than the ‘me’,” said Spahn. “This is good news for the entire EU.”

“We delved into the data and did a more granular investigation of the data … so it took longer to evaluate.”

The announcement of the vaccine was well received by politicians, medical personnel and business leaders. The headline writers referred to it as “the best Christmas present.”

Germany enters a strict lockdown on Wednesday that will last until at least January 10, as it struggles to control the spread of the virus. Schools and kindergartens will close, as will nonessential shops and hair salons.

Until the fall, Germany had fared better than many other European countries, with considerably lower infection and mortality rates. But experts say its advantage has been wasted in part due to the widespread perception that the virus was so well controlled that people could safely relax their behavior.

On Sunday, political leaders traced back to a plan to significantly relax the rules around Christmas, causing the seasonal festivities to come to a 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 dire than ever,” Wieler said, noting the dramatic increase in cases among those over 80. He said he expected the situation to get worse. An increasing number of hospitals were nearing capacity and the country’s 412 health offices were struggling to cope, Wieler said.

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

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

Klaus-Dieter Zastrow, professor of health hygiene, told German media that he did not expect the vaccine program to have a palpable impact on German life until April or May at the earliest. He said that until then “we will have to keep wearing masks and keep our distance.” He added that it was unclear if those who had been vaccinated could still transmit the virus.

As European countries grapple with how to avoid a further increase in coronavirus infections during Christmas and New Years, the Spanish government called on people “to intensify their caution” amid a small increase in the number of new cases. .

Infection levels in Spain have fallen in recent weeks, from daily highs of more than 20,000 in October to less than 10,000 in recent weeks. But the latest figures for the weekend showed that the number of cases per 100,000 people rose from 190 on Friday to 194 on Monday.

Coronavirus cases in Spain

The country’s health emergencies chief, Fernando Simón, said that the drop in new cases seems to be stabilizing, while the government spokesperson, María Jesús Montero, called for patience and responsibility for Christmas and the new year.

“We hope that the first vaccines will arrive in Spain early next year,” he said Tuesday. “Prudence has to be our watchword for the way we move in the coming days. We have to improve in the next few days if we don’t want to go back to where we started. “

Spain’s Health Minister Salvador Illa said he expected some people to start getting vaccinated by the end of the year. The government plans to vaccinate healthcare workers, nursing home staff and residents, and those with serious health problems in the first round of vaccinations.

Additional information on Sam Jones in Madrid


www.theguardian.com

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