The European Union’s main drug regulator will accelerate the review of a Covid-19 vaccine after it has come under pressure from some governments to approve the shot as the continent struggles to cope with a wave of cases before the Christmas season to contain.
The European Medicines Agency said Tuesday that it would meet on December 21, eight days earlier than previously planned, to consider approving the shot developed by Germany’s BioNTech SE and Pfizer. Inc.
So far the US, UK and Canada have started vaccinating their citizens with the shot. Once the vaccine is released in Europe, it would take several days to ship the doses across the continent, meaning vaccinations – at least in some countries – can begin before Christmas.
The agency and several national governments in the bloc had said a careful review was needed to ensure public confidence in the shot at a time of growing skepticism about vaccines in Europe.
However, some EU leaders have become frustrated with the pace of the review as the death toll from the virus rises.
At an EU summit last week, at least three government leaders complained that it was becoming politically untenable to explain to their citizens why the US and Canada administered a European-made vaccine before the EU, officials familiar with the discussions.
“I hope that the EU will also get a swift and unbureaucratic approval of the first vaccines in compliance with all scientific standards,” Austrian Chancellor Sebastian Kurz told The Wall Street Journal. “The sooner we can start vaccinating in the EU, the better. Because every day of the pandemic in Europe, thousands are killed, serious economic damage and countless people fear for their jobs. “
On Tuesday, the Italian Ministry of Health said it hoped the EMA could approve a vaccine ahead of schedule. Other countries badly affected by the virus, including France and Spain, have not filed any complaints about the speed of the assessment.
“We must be very alert to any possibility of getting caught up in the red tape,” Polish Prime Minister Mateusz Morawiecki told the Journal. “Some Western and Asian countries outside the EU have already started vaccinations. Meanwhile, millions of EU citizens are still waiting. “
Germany and several neighboring countries – including Poland, the Czech Republic and Austria – are asking residents to stay home until Christmas, limiting social gatherings and church services after a wave of cases threatening to overwhelm hospitals.
On Monday, German Health Minister Jens Spahn defended his government’s decision not to grant emergency authorization for the vaccine – as the UK had done and as any EU member could do on its own – and instead to wait for full EU permission. But he told national radio his government was pushing to speed up the timetable.
The EMA has no authority to issue the type of emergency use permit issued by the UK and US. In the EU, that power rests with national governments. Yet not all governments have the capacity to quickly review and reach a judgment of highly specialized clinical trial data.
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Mr Spahn has said in the past that EU governments had agreed not to start a race for emergency permit so as not to create tensions within the bloc. He also said vaccine doses have been ordered centrally in the EU, making it easier to distribute across the block on the same day.
EMA officials have said they are moving as quickly as possible without undermining confidence in vaccines. Conversely, some public health officials and medical institutions have warned the agency that hasty approval of a shot that uses new technology would be difficult to sell on a continent where vaccination coverage has fallen.
On Friday, the bureau’s leaders held a four-hour video conference to assure the public that they are rigorously reviewing clinical trial data and manufacturing data.
“We are working around the clock to approve the first Covid-19 vaccine,” said Emer Cooke, EMA director, in an emailed statement. “European citizens have told us they want a speedy approval, but more importantly, they want a thorough evaluation of the benefits and risks of the vaccine so that they can be confident that it is safe, effective and of high quality.”
The EMA is studying the same data that its counterparts in the UK, Canada and the US did. Regulators analyze patient data from large-scale human trials submitted in rolling batches to see how many infections occurred in those who received a placebo-like injection compared to those who received the vaccine. Because the virus is so widespread, it took BioNTech only a few weeks to document the number of cases it took to determine how effective its injection is – a process that would typically take years.
But regulators are also asking questions to confirm that the vaccine is generally safe, effective and can be manufactured with consistent quality. In this regard, the EMA has been slower than the UK, whose chief regulator started asking questions earlier in the process and was able to ask follow-up questions more quickly, sometimes within minutes of a response, said people who recently worked with both agencies. The various regulators also want data to be formatted differently, which causes delays.
Ugur Sahin, BioNTech’s CEO, said in an interview on Friday that for scientific reasons, the EMA process did not take longer than that in the US and UK, but rather because the EU agency followed its own procedures.
“We’ve accelerated everything we could in dealing with EMA,” said Dr. Sahin. “I think that Member States should now lend their support to make this happen quickly.”
The EMA can release a vaccine for wide commercial use, through what it calls a conditional marketing authorization, but that doesn’t give the agency much of an overview of how future batches of a vaccine will be produced. Accordingly, EMA officials say they need a higher level of assurance that BioNTech’s manufacturing process will continue to maintain the same consistent quality as it currently does.
‘It’s a double-edged sword. If you make it too fast, there will be people who say ‘you moved too fast, I don’t trust it,’ ”said Nikolas Dietis, assistant professor of pharmacology at the University of Cyprus. “If you put it off, people will say ‘people are dying, why don’t you approve?’ There is a dilemma. “
The EU has signed a contract to purchase 200 million doses of BioNTech and Pfizer – enough to vaccinate 100 million people – with the option of an additional 100 million doses. Last month, it agreed to buy 160 million doses of a second vaccine developed by Moderna Inc.,
using the same mRNA technology.
The EMA will not make a decision on the Moderna shot until January 12. After that, it can take months to make decisions about other candidates, such as a Johnson & Johnson vaccine, which is being conducted in large-scale clinical trials. , and another developed by AstraZeneca PLC. Some prominent officials are pushing for more information to be disclosed before a decision is made.
“It is not corporate communication that will restore citizens’ confidence in the vaccine system,” Michèle Rivasi of France, a member of the European Parliament and his Green Party group, told the EMA during a public video call on Friday. “The adoption of this vaccine, developed so quickly and through new technology, requires a high degree of confidence in the manufacturers and especially the approval authorities.”
—Laurence Norman contributed to this article.
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