Europe Advances Review of Pfizer Vaccine as Pressure Mounts

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Europe Advances Review of Pfizer Vaccine as Pressure Mounts

Medical personnel take throat swab samples at a testing station in Berlin.

Photo: Sean Gallup/Getty Images

The European Union’s chief drug regulator will accelerate its review of a Covid-19 vaccine after coming under pressure from some governments to authorize the shot, as the continent struggles to contain a wave of cases ahead of the Christmas period.

The European Medicines Agency said on Tuesday it would meet on Dec. 21, eight days earlier than previously scheduled, to consider authorizing the shot developed by Germany’s BioNTech SE and Pfizer Inc.

So far, the U.S., U.K. and Canada have begun vaccinating their citizens with the shot. Once the vaccine is cleared in Europe, it would take several days to ferry the doses across the entire continent, meaning vaccinations—in some countries at least—could start 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 mounting skepticism about vaccines in Europe.

Some EU leaders, however, had been growing frustrated at the pace of the review as the death toll from the virus ticks higher.

At an EU summit last week, at least three heads of government complained that it was becoming politically untenable to explain to their citizens why the U.S. and Canada were administering a Europe-made vaccine ahead of the EU, officials familiar with the discussions said.

“I hope that the EU too will get quick and unbureaucratic approval of the first vaccines while observing all scientific standards,” Austrian Chancellor Sebastian Kurz told The Wall Street Journal. “The earlier we in the EU are able to start vaccinating, the better. Because every day of the pandemic in Europe means thousands of deaths, severe economic damage and innumerable people who must fear for their jobs.”

On Monday, over 50 hospitals and health departments across the country received the newly authorized Covid-19 vaccine developed by Pfizer Inc. and BioNTech. Health-care workers were among the first to be vaccinated in the U.S. Photo: UPMC

On Tuesday, Italy’s Health Ministry said it hoped the EMA could authorize a vaccine ahead of schedule. Other nations badly affected by the virus, including France and Spain, haven’t raised complaints about the speed of the review.

“We should be very alert to any possibility of being tangled up in the red tape,” Polish Prime Minister Mateusz Morawiecki told the Journal. “Some non-EU Western and Asian countries have already started vaccinations. Meanwhile, millions of EU citizens are still waiting.”

Germany and several neighboring countries—including Poland, Czech Republic and Austria—are asking residents to stay at home through Christmas, restricting social gatherings and church services, after a surge in cases threatened to overwhelm hospitals.

On Monday, German Health Minister Jens Spahn defended his government’s decision not to grant the vaccine emergency authorization—as the U.K. had done and as any EU member could do on its own—and wait instead for full EU authorization. But he told national radio that his government was pushing for the timetable to be accelerated.

The EMA has no authority to issue the type of emergency-use authorization that the U.K. and U.S. have given. In the EU, that power falls to national governments. Yet not all governments have the capacity to swiftly review highly specialized clinical-trial data and reach a judgment.

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Mr. Spahn has said in the past that EU governments had agreed not to start a race for emergency authorization 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 start distribution across the bloc on the same day.

EMA officials have said they are moving as fast as they can without eroding trust in vaccines. Conversely, some public-health officials and medical institutions have warned the agency that hasty authorization of a shot that uses novel technology would be a difficult sell on a continent where vaccination rates have declined.

On Friday, the agency’s leaders held a four-hour videoconference to assure the public that they are being meticulous in reviewing clinical-trial data and the manufacturing particulars.

“We are working around the clock towards the licensing of the first Covid-19 vaccine,” EMA Executive Director Emer Cooke said in an emailed statement. “European citizens have told us they want a fast approval, but more importantly they want a thorough evaluation of the benefits and the risks of the vaccine, so that they can be confident it is safe, effective and of high quality.”

The EMA is poring over the same data as its counterparts in the U.K., Canada and the U.S. 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 shot compared with those who were given the vaccine. Because the virus is spreading so widely, it took BioNTech only weeks to record the number of cases necessary to determine how effective its shot is—a process that would typically take years.

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But regulators also ask questions to confirm the vaccine is generally safe and effective, and can be manufactured at a consistent quality. On this front, the EMA has been slower than the U.K., whose chief regulator started posing questions earlier in the process and was quicker to make follow-up queries, sometimes within minutes of an answer, said people who worked with both agencies recently. The different regulators also want data formatted differently, creating a delay.

Ugur Sahin, BioNTech’s chief executive, said in an interview Friday that the EMA process wasn’t taking longer than those in the U.S. and the U.K. because of scientific reasons, but rather because the EU agency was following its own procedures.

“We have accelerated everything that we could accelerate in the dealing with EMA,” Dr. Sahin said. “I think the member states must now lend their support for this to go quickly.”

The EMA can clear a vaccine for broad commercial use, through what it calls a conditional marketing authorization, but that doesn’t give the agency much oversight over how future batches of a vaccine are produced. Accordingly, EMA officials say they need a higher level of certainty that BioNTech’s manufacturing process will continue to adhere to the same consistent quality as it currently does.

“It’s a double-edged sword. If you make it too fast there will be people saying ‘you moved too fast, I don’t trust it,’” said Nikolas Dietis, assistant professor of pharmacology at the University of Cyprus. “If you delay it, you will have those saying ‘people are dying, why don’t you approve it?’ There is 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 for another 100 million doses. Last month, it agreed to purchase 160 million doses of a second vaccine, developed by Moderna Inc., that uses the same mRNA technology.

The EMA isn’t set to make a decision on the Moderna shot until Jan. 12. After that, it could be months before it makes decisions on 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 disclosure of more data before a decision is made.

“It’s not corporate communications that will restore the confidence of citizens in the vaccine system,” Michèle Rivasi of France, a member of the European Parliament and its Green Party group, told the EMA during a public video call Friday. “The acceptance of this vaccine, developed so rapidly and by new technology, requires a high degree of confidence in the manufacturers and especially the approval authorities.”

Write to Drew Hinshaw at drew.hinshaw@wsj.com and Bojan Pancevski at bojan.pancevski@wsj.com

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