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Why is the EU taking so long to OK vaccine?

AMSTERDAM — As Canadians, Britons and Americans begin getting immunized with a German-developed vaccine against coronavirus, pressure is building on the European Medicines Agency to approve the shot made by Pfizer Inc. and the German company BioNTech. German officials have been especially vocal that they want it approved before Christmas. Here’s a look at the EMA approval process:

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WHAT IS THE EUROPEAN MEDICINES AGENCY?

The EMA is Europe’s medicines regulatory agency and approves new treatments and vaccines for all 27 countries across the European Union. It is roughly comparable to the U.S. Food and Drug Administration. The agency is headquartered in Amsterdam and it has nearly 900 employees.

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WHY IS THE EMA TAKING SO LONG TO APPROVE A VACCINE?

Britain, Canada and the U.S. granted approval for the Pfizer-BioNTech vaccine to be used under emergency use provisions earlier this month, meaning the shot is an unlicensed product whose temporary use is justified by the urgency of a pandemic that has already killed over 1.6 million people.

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 will 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 U.S., 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 Dec. 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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HOW WILL THE EMA DECIDE WHETHER TO OK THE VACCINE?

The EMA is convening an “extraordinary” meeting on Dec. 29 — although that date could be moved up sooner — during which their experts will discuss the data behind the Pfizer-BioNTech vaccine. The meeting, which will be closed, will include a presentation by two officials charged with assessing the vaccine and could also include bringing in company representatives to answer questions.

Within hours of the meeting’s conclusion, the EMA will issue a statement on whether or not it is recommending the vaccine be approved. Several days later, they will release their full scientific assessment explaining the decision.

The EMA’s approval is valid in all 27 EU countries and once it is granted, countries can start receiving vaccines for immunization campaigns. An Italian health official says all EU countries want to start vaccinations on the same day.

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WHAT DOES GERMANY THINK?

Germany is increasing the pressure on the agency, with its health minister, a leading hospital association and lawmakers all demanding that it approve a coronavirus vaccine before Christmas.

“Our goal is an approval before Christmas so that we can still start vaccinating this year,” Health Minister Jens Spahn said.

Spahn has expressed impatience with the EMA, noting that Germany has 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 Tuesday as well, demanding that the agency issue emergency authorization 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 are also getting impatient.

“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 Tuesday.

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WILL THE EMA SPEED UP ITS APPROVAL?

Cooke, the agency’s chief, said Monday that EMA staff are working “around the clock” and that if they have sufficient data and have completed their required protocols, the Dec. 29 meeting to consider the Pfizer-BioNTech vaccine could indeed be moved up.

“We feel a huge responsibility to get this right … to make sure that what we deliver in terms of a scientific opinion is robust and reliable,” Cooke told the AP in an interview last week. “It’s already a huge responsibility, I can tell you, without putting a race around it.”

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IS THE AGENCY EXAMINING ANY OTHER CORONAVIRUS VACCINES?

The EMA is also planning to convene a meeting Jan. 12 to consider approving the coronavirus vaccine made by Moderna, but said that discussion too could be moved up earlier.

It is also assessing data from two other vaccines, one made by Oxford University and AstraZeneca and the other by Janssen, but neither of those two companies have yet made a formal request to be licensed in the EU.

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HOW WILL EMA MAKE SURE A VACCINE IS SAFE ONCE IT’S BEING USED?

The agency usually asks companies to deliver data on vaccines’ safety and side effects every six months, but due to the coronavirus pandemic, it will be asking companies for that data every month.

“We need to consider how (these vaccines) perform once they are once they are deployed in a mass vaccination situation,” Cooke said, explaining that the EMA is adopting extra surveillance measures to detect any rare or serious side effects.

Although tests of the Pfizer-BioNTech vaccine suggested the shot is safe and about 95% effective in preventing COVID-19, there is still limited long-term safety data on it.

On the day that Britain started its mass vaccination program last week, severe allergic reactions were reported in two people who got the shot. Officials are now investigating if those reactions were caused by the vaccine and have advised people with severe allergies not to get the shot.

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