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Why does the EU take longer than the UK to approve a COVID-19 vaccine?

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By Darren McCaffrey
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European Medicines Agency in Amsterdam, Holland
European Medicines Agency in Amsterdam, Holland   -   Copyright  Peter Dejong/Copyright 2021 The Associated Press. All rights reserved
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The EU approved its second COVID-19 vaccine this week, giving the green light to the Moderna jab.

But the bloc's authorisation process has not been as fast as other countries, such as the UK, who approved its first vaccine on December 2.

By contrast, the EU's first approved vaccine did not come until December 21.

London has since added a further two vaccines to its portfolio: the Oxford–AstraZeneca one on December 30 and Moderna today (January 8).

So, why has the EU been slower in approving a vaccine?

The Amsterdam-based European Medicines Agency (EMA) is responsible for approving all new drugs and vaccines across the 27 EU member states, Iceland, Liechtenstein and Norway. It is roughly equivalent to the US Food and Drug Administration.

Professor Stephen Evans, a former independent expert member of the drug safety and risk assessment committee at the EMA, the answer for its slower approach comes down to two things: the science and the administration.

He told Euronews on Friday that the science involves looking at all the data from basic laboratory data — including animal studies and the first few human volunteers — up to the more advanced phase three.

"Those processes tend to be almost exactly the same, whether they are done in Europe or the US or anywhere else," he said.

But under EMA rules, Prof Evans added, a vaccine still needs to be approved by representatives of every EU member state — and the European Commission — before it can enter general circulation in the bloc.

That means it is "probably fair to say" that administrative delays are the reason the EMA is taking longer to approve vaccines — rather than, for example, because their process is more or less robust.

"There's no doubt that the EMA process is rigorous," said Prof Evans. "But it is inevitable that in sharing out the workload among the 27 member states that, in order to involve all of them in all the decisions, they divide it up so that there will be two member states that take the principal load of assessing the data. But the authorisation and the advice on authorisation has to be shared by all 27 member states."

Prof Evans explained that the EMA's vaccine approval process involves scientific experts in two countries reviewing the lion's share of the data.

Before Brexit, the UK — as part of the EU and its medicine agency — "might have been a member state that did the scientific assessment", Evans said.

In the case of the Pfizer-BioNtech vaccine, it was Sweden and France who were the two member states that did the major scientific assessment.

How are the vaccination programmes going?

London revealed on Friday that it had now given the first dose of a COVID-19 vaccine to 1.29 million people in the UK.

With a three-week headstart on EU countries, it has inoculated more than Germany, who had administered around 476,000 jabs, as of Thursday, January 7. France, by contrast, has vaccinated around 44,500 citizens.

In December, before the EU's first vaccine approval, Germany's health minister, Jens Spahn, expressed impatience with the EMA.

He said Germany had already created some 440 vaccination centres, activated about 10,000 doctors and medical staff and was ready to start mass vaccinations.

The German Hospital Association chipped in as well, demanding that the agency issue emergency authorisation for the Pfizer-BioNTech vaccine. That way, it says, workers can go into nursing homes to vaccinate those most at risk of dying from the virus.

Other EU nations were also getting impatient at the time.

“My hope is that the EMA, in compliance with all safety procedures, will be able to approve the Pfizer-BioNTech vaccine earlier than expected and that vaccinations can also begin in the countries of the European Union as soon as possible,” Italian health minister Roberto Speranza said.

Belgium criticises the UK's approach

While the UK may be ahead in the race to get its population vaccinated, it has not been immune from criticism.

Petra De Sutter, Belgium's deputy prime minister, said on Tuesday that London was taking fewer precautions.

She said the UK, like Russia and China, was "in the process of vaccinating people with vaccines not having the same standards as those we use".

"We must not forget that people need to be confident in vaccines," she said.

Meanwhile, Australian Prime Minister Scott Morrison, said he would not take "unnecessary risks" by imitating the United Kingdom for urgent approval of the vaccines.

"Australia is not in an emergency situation like the United Kingdom. So we do not need to rush," said Morrison, whose government does not plan to administer the first COVID-19 vaccines until the end of March.

The UK, however, has defended its approach.

"We did not rush into authorising vaccines," a spokesman for Prime Minister Boris Johnson told reporters. "The public should trust them and take them when asked."

He cited statements from the British health regulator (the Medicines and Healthcare Regulatory Agency) that said the vaccines from Pfizer-BioNTech and Oxford-AstraZeneca had been authorised after a rigorous and exhaustive review.

How does EMA's approach compare with the UK and other countries?

The UK, Canada and the US granted approval for the Pfizer-BioNTech vaccine to be used under emergency use provisions in December, meaning the shot is an unlicensed product whose temporary use is justified by the urgency of a pandemic.

But the EMA's approval process for coronavirus vaccines is largely similar to the standard licensing procedure that would be granted to any new vaccine, only on an accelerated schedule. The companies still need to submit follow-up data to the EU regulator and the approval will need to be renewed after one year.

EMA executive director Emer Cooke told The Associated Press that while all of the regulatory agencies in the US, Britain and Canada are largely looking at the same data, “we may not have all gotten it at the same time.”

EMA began its expedited approval process of the Pfizer-BioNTech vaccine in October and the companies formally asked for their shot to be licensed on December 1.

Using its expedited approval process, the EMA says the time for assessing a new drug or vaccine has been shortened from about 210 days to fewer than 150.

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