The European Union’s top drug regulator will speed up the review of a Covid-19 vaccine after being pressured by some governments to authorize the shot, as the continent struggles to contain a wave of cases before the Christmas period.
The European Medicines Agency said on Tuesday it would meet on December 21, eight days earlier than expected, to consider clearing the shooting developed by Germany’s BioNTech SE and Pfizer. Inc.
So far, the United States, the United Kingdom and Canada have begun vaccinating their citizens with the shot. Once the vaccine is eliminated in Europe, it would take a few days to transmit the doses across the continent, which means that vaccinations – at least in some countries – could start before Christmas.
The agency and several national governments of the bloc had said a careful review was needed to ensure public confidence in the shooting at a time of growing skepticism about vaccines in Europe.
However, some EU leaders had been frustrated at the pace of the review, as the number of deaths from the virus is rising.
At an EU summit last week, at least three heads of government complained that it was becoming politically unsustainable to explain to their citizens why the United States and Canada were administering a vaccine made in Europe before the EU, familiar officials said. with the discussions.
“I hope that the EU will also get the quick and bureaucratic approval of the first vaccines by observing all scientific standards,” Austrian Chancellor Sebastian Kurz told the Wall Street Journal. “The sooner we are able to start vaccinating in the EU, the better. Because every day of a pandemic in Europe means thousands of deaths, serious economic damage and countless people who have to fear for their jobs.
On Monday, more than 50 hospitals and health departments across the country received the newly authorized Covid-19 vaccine developed by Pfizer Inc. and BioNTech. Healthcare workers were among the first to be vaccinated in the US Photo: UPMC
On Tuesday, the Italian Ministry of Health said it hoped the EMA could authorize a vaccine earlier than planned. Other countries heavily affected by the virus, including France and Spain, have not filed complaints about the speed of the review.
“We should be very alert to any possibility of getting involved in administrative procedures,” Polish Prime Minister Mateusz Morawiecki told the newspaper. “Some Asian and Western EU countries have already started vaccinating. 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 over Christmas, restricting social gatherings and religious services, following an increase in cases threatening to overflow hospitals.
On Monday, German Health Minister Jens Spahn defended his government’s decision not to grant the emergency vaccination permit – as the UK had done and as any EU member could do on its own – and, instead, wait for full EU authorization. But he told national radio that his government was pushing for the schedule to be speeded up.
The EMA has no authority to issue the type of emergency use permit issued by the United Kingdom and the United States. In the EU, this power belongs to national governments. However, not all governments have the ability to quickly review highly specialized clinical trial data and reach a trial.
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Spahn has said in the past that EU governments had agreed not to start a race for emergency clearance so as not to create tensions within the bloc. He also said vaccine doses had been ordered centrally in the EU, making it easier to distribute throughout the block on the same day.
EMA officials have said they are moving forward as quickly as possible without eroding confidence in vaccines. By contrast, some public health officials and medical institutions have warned the agency that hasty authorization of a shot using new technology would be a difficult sale on a continent where vaccination rates have declined.
On Friday, the agency’s leaders held a four-hour video conference to assure the public that they are being thorough in reviewing clinical trial data and manufacturing details.
“We are working 24 hours a day to get the license for the first Covid-19 vaccine,” EMA Executive Director Emer Cooke said in an emailed statement. “European citizens have told us they want a quick approval, but more importantly they want a thorough assessment of the benefits and risks of the vaccine, so they can trust that it is safe, effective and of high quality.”
The EMA analyzes the same data as its counterparts in the United Kingdom, Canada, and the United States. Regulators analyze data from patients tested in large-scale human trials presented in rolling batches to see how many infections occurred in those who received a placebo-like trait compared to those who received the vaccine. Because the virus spreads so widely, BioNTech took just weeks to record the number of cases needed to determine the effectiveness of its shot, a process that would normally take years.
But regulators also ask questions to confirm that the vaccine is generally safe and effective and that it can be manufactured with consistent quality. In this regard, the EMA has been slower than the UK, whose main regulator began asking questions before the process and made follow-up consultations more quickly, sometimes within minutes after a response, according to people who recently worked with the two agencies. Different regulators also want the data to have a different format, which creates a delay.
Ugur Sahin, chief executive of BioNTech, said in an interview on Friday that the EMA process took no longer than the US and UK for scientific reasons, but because the EU agency was following its own procedures.
“We have accelerated everything we could accelerate in dealing with EMA,” Dr. Sahin said. “I think member states now need to give their support for this to happen quickly.”
The EMA can eliminate a vaccine for widespread commercial use, through what it calls a conditional marketing authorization, but this does not give the agency much oversight over how future batches of vaccines are produced. Consequently, EMA officials say they need a higher level of certainty that BioNTech’s manufacturing process will continue to adhere to the same consistent quality that it currently does.
“It’s a double-edged sword. If you do it too fast, there will be people who say, “You went too fast, I don’t trust you,” said Nikolas Dietis, an assistant professor of pharmacology at the University of Cyprus. “If you delay it, you’ll have those who say,” People are dying, why don’t you approve? “There’s this dilemma.”
The EU signed a contract to buy 200 million doses from BioNTech and Pfizer, enough to vaccinate 100 million people, with the option of 100 million more doses. Last month he agreed to buy 160 million doses of a second vaccine, developed by Moderna Inc.,
which uses the same mRNA technology.
The EMA is not scheduled to make a decision on firing Moderna until Jan. 12. After that, it could be months before decisions are made about other candidates, such as a Johnson & Johnson vaccine, which is in large-scale clinical trials. , and another developed by AstraZeneca PLC. Some prominent officials are pushing for the release of more data before making a decision.
“It is not corporate communications that will restore citizens’ confidence in the vaccine system,” Michèle Rivasi of France, a member of the European Parliament and her Green Party group, told the EMA during a public video call on Friday. “Acceptance of this vaccine, developed so quickly and by new technology, requires a high degree of confidence in manufacturers and especially in approval authorities.”
—Laurence Norman contributed to this article.
Write to Drew Hinshaw at [email protected] and Bojan Pancevski at [email protected]
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