EU regulator brings forward Covid vaccine ruling after German pressure
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, with the German health minister, Jens Spahn, saying that the agency risked losing the trust of EU citizens if it did not act fast.
“The goal 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.” Italy’s health minister, Roberto Speranza, said he hoped the EMA “will be able to approve the Pfizer BioNTech vaccine ahead of schedule”.
The German government has previously 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 – but Spahn on Sunday told a coronavirus summit between the government and state leaders that had Germany gone it alone it would have been “markedly quicker”.
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 and involve the participation of experts from all 27 EU member countries.
“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 nonessential 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 that 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 to 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.
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 the new year, Denmark announced it was extending a partial lockdown already in force in major cities to the nation as a whole and the Swedish prime minister, Stefan Lofven, said it had misjudged the strength of the second wave.
Sweden has stood out in Europe for relying on a sense civic duty rather than lockdowns to control the virus but since experiencing a rapid increase in new cases that strained its healthcare system has banned gatherings of more than eight people and alcohol sales after 10pm. “I think that most people in the profession didn’t see such a wave in front of them, they talked about different clusters,” he told the Aftonbladet newspaper.
An independent inquiry meanwhile said Sweden had failed to protect the elderly in the first wave of the pandemic, saying the government and its predecessors bore ultimate responsibility for structural shortcomings in its healthcare system.
In Spain, where there has been a small increase in the number of new cases, the national government called on people “to step up their prudence” .
Infection levels in Spain have fallen 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.
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 vaccinations would begin by the end of the year. The government plans to vaccinate health workers, care home staff and residents, and those with serious health problems first.