EU regulator brings forward Covid vaccine ruling after German pressure | Society

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The EU drug regulator has brought forward its ruling 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 21 December instead of 29 December to decide whether to authorise the shot followed a growing backlash 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 press 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 “will be able to approve the Pfizer BioNTech vaccine ahead of schedule”.

Addressing criticism that the UK, Canada and the US approved vaccines sooner than the EU, Spahn said the EMA’s ruling would be “the world’s first regular approval” of a vaccine.

The German government has repeatedly insisted an emergency approval of the type given by the UK and elsewhere might have a negative impact on the public’s willingness to be vaccinated. Germany is believed to have more anti-vaxxers and vaccine sceptics than other countries.

The approval process involved the participation of experts from all 27 EU member countries, which Spahn said meant it was taking longer.

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

“We dug deeper into the data, and undertook a more granular investigation of the data … so it took additional time to evaluate it.”

The vaccine announcement was welcomed by politicians, medical staff and business leaders. Headline-writers referred to it as “the best Christmas present”.

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

Until the autumn Germany had fared better than many other European countries, with considerably lower infection and death rates. But experts say its advantage has been squandered in part due to the widespread perception that the virus was so well under control people could safely relax their behaviour.

On Sunday, political leaders rowed back on a plan to considerably relax rules over Christmas, causing seasonal festivities to grind to a halt..

Lothar Wieler, the president of the Robert Koch Institute, the country’s leading public health body, said the virus had 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 at the drastic rise in cases among the over-80s. He said he expected the situation to worsen. An increasing number of hospitals were close to capacity and the country’s 412 health offices were struggling to cope, Wieler said.

Spahn said he recognised some people had misgivings about vaccines, and that a vaccination programme would be debated in parliament on Wednesday and Thursday.

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

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

As countries around Europe grapple with how to avoid a fresh surge in coronavirus infections over Christmas and new year, the Spanish government called on people “to step up their prudence” amid a small increase in the number of new cases.

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

Spain coronavirus cases

The country’s health emergencies chief, Fernando Simón, said the fall in new cases appeared to be levelling out, while the government’s spokeswoman, María Jesús Montero, appealed for patience and responsibility over Christmas and the new year

“We’re expecting the first vaccines to arrive in Spain at the beginning of next year,” she said on Tuesday. “Prudence has to be our watchword for the way we move around over the coming days. We have to step it right up over the coming days if we don’t want to go back to square one.”

Spain’s health minister, Salvador Illa, said he hoped some people would begin being vaccinated by the end of the year. The government plans to vaccinate health workers, care home staff and residents, and those with serious health problems in the first round of vaccinations.

Additional reporting by Sam Jones in Madrid

Hafta Ichi
Source: The Guardian
Keyword: EU regulator brings forward Covid vaccine ruling after German pressure | Society

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