Europe Advances Review of Pfizer’s Covid-19 Vaccine as Pressure Pressure Mounts

The head of the European Union’s drug regulator will speed up his review of the Covid-19 vaccine after being pressured by some governments to authorize the shooting as the continent struggles to contain a wave of cases before Christmas.

The European Medicines Agency said on Tuesday it would meet on December 21, eight days earlier than previously scheduled, to consider authorizing the shooting developed by German company BioNTech SE and Pfizer. Inc.

To date, the United States, the United Kingdom and Canada have begun vaccinating their citizens with gunshots. Once the vaccine is phased out in Europe, it would take a few days to transport the doses across the continent, which means vaccinations – at least in some countries – could begin before Christmas.

The agency and several national governments in the bloc have said a careful analysis is needed to ensure public confidence in the shooting at a time when growing skepticism about vaccines in Europe.

However, some EU leaders have been frustrated at the pace of the review as the death toll from the virus rises.

At an EU summit last week, at least three heads of government complained that it was becoming politically unbearable to explain to their citizens why the US and Canada were administering a vaccine made in Europe before the EU, officials familiar with the talks said.

“I hope that the EU will also get the first and bureaucratic approval of the first vaccines, while respecting all scientific standards,” Austrian Chancellor Sebastian Kurz told The Wall Street Journal. “The better we are able to start vaccination in the EU, the better. Because every day of the pandemic in Europe means thousands of deaths, severe economic damage and countless people who have to fear for their job. “

On Monday, more than 50 hospitals and health departments across the country received the new authorized Covid-19 vaccine developed by Pfizer Inc. and BioNTech. Healthcare workers were among the first to be vaccinated in the United States Photo: UPMC

On Tuesday, the Italian Ministry of Health said it hoped the EMA could authorize a vaccine ahead of time. Other nations severely affected by the virus, including France and Spain, have not raised complaints about the speed of the examination.

“We should be very careful about any possibility of being entangled in bureaucracy,” Polish Prime Minister Mateusz Morawiecki told the newspaper. “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, restricting social gatherings and church services after an increase in hospital-threatened cases.

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

The EMA does not have the authority to issue the type of emergency use authorization granted by the United Kingdom and the United States. In the EU, this power rests with national governments. However, not all governments have the ability to quickly review highly specialized clinical data and reach a judgment.

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Mr Spahn 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 that the vaccine doses were ordered centrally in the EU, which makes it easier to start distribution throughout the block on the same day.

EMA officials said they were moving as fast as they could without eroding confidence in vaccines. Instead, some public health officials and medical institutions have warned the agency that hastily authorizing a photograph using new technology would be a difficult sale on a continent where vaccination rates have fallen.

On Friday, the agency’s leaders held a four-hour video conference to assure the public that they are meticulous in reviewing clinical trial data and production information.

“We are working non-stop to license the first Covid-19 vaccine,” EMA Executive Director Emer Cooke said in an email. “European citizens have told us that they want a quick approval, but more importantly, they want a thorough assessment of the benefits and risks of the vaccine so that they can be confident that it is safe, effective and of high quality.”

EMA analyzes the same data as its counterparts in the United Kingdom, Canada and the United States. Regulators analyze patient data from large-scale human studies in rolling stock to see how many infections occurred in those who received a placebo vaccine compared to those who received the vaccine. Because the virus is spreading so much, it took BioNTech only a few weeks to record the number of cases needed to determine how effective its fire is – a process that would usually take years.

But regulators are also asking questions to confirm that the vaccine is generally safe and effective and can be manufactured to a consistent quality. From this point of view, the EMA was slower than the UK, whose lead regulator started asking questions earlier in the process and was quicker to ask further questions, sometimes within minutes of an answer, said people who have recently worked with both agencies. Different regulators also want differently formatted data, creating a delay.

Ugur Sahin, CEO of BioNTech, said in an interview on Friday that the EMA process does not take longer than in the US and the UK for scientific reasons, but rather because the EU agency is following its own procedures.

“We have accelerated everything we could to accelerate our relationship with the EMA,” said Dr. Sahin. “I think the Member States need to give their support to make this 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 of how future batches of vaccine 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 as it does today.

“It’s a double-edged sword. If you do it too fast, there will be people who will say that 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 who say ‘people die, why don’t you approve of it?’ “There is this dilemma.”

The EU has signed a contract to buy 200 million doses from BioNTech and Pfizer – enough to vaccinate 100 million people – with the option of another 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 is not willing to make a decision on the Modern Shooting until January 12th. After that, it could be months before he makes decisions 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 more data to be released before a decision is made.

“Corporate communications will not restore citizens’ confidence in the vaccine system,” Michele Rivasi of France, a member of the European Parliament and his Green Party group, said in a public video call on Friday. “Acceptance of this vaccine, developed so quickly and with new technology, requires a high degree of trust from manufacturers and especially from the approval authorities.”

Write to Drew Hinshaw at [email protected] and Bojan Pancevski at [email protected]

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