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The UK, Canada and a few other countries have already done it.

The US is on the verge of it.

Only in the EU is it still unclear whether and when the vaccine from Biontech and Pfizer will receive approval and can be vaccinated millions of times.

In order to dispel concerns of the citizens, but also to explain its own approach, the European Medicines Agency (EMA) invited to a rather rare public dialogue with various interest groups in Amsterdam on Friday.

However, it took over an hour before it actually turned into some kind of exchange of views.

Because first, representatives of the EMA took the opportunity to present the work of their authority in the field of vaccine approval in detail in a kind of virtual seminar.

A lot was about security, transparency and review processes

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“Despite the fast pace of development and approval, the vaccines against Covid-19 will be approved according to the same high standards that apply to all drugs throughout the EU,” was the most important message from EMA boss Emer Cooke at the beginning of the conference.

In the following 75 minutes, in which various experts from the authority had their say, a lot was about security, responsibilities, transparency and clear review processes.

Under no circumstances, that was one of the most important messages, would safety be neglected when the new vaccines against the pandemic are approved.

Number of new infections rises to a new all-time high

The RKI reported almost 30,000 new corona infections within one day.

The number of free intensive care beds is steadily decreasing.

Intensive care physicians fear dramatic consequences if the trend continues.

Source: WELT / Isabell Finzel

The EMA relies on the participation of all citizens, because the collection of data on possible side effects continues even in the event of approval, said Peter Arlett, head of the data analysis and methods department at the EMA.

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“So do us a favor: Report it to your national supervisors or the manufacturers if you notice any side effects after such a vaccination,” continues Arlett.

The confidence-building measure, however, was clouded by the fact that the EMA, of all places, had recently become the target of a hacker attack in which cyber criminals had gained access to documents from the application for approval for the Biontech vaccine.

"I can assure you that this will not affect the vaccine approval schedule and that we are fully operational," said Cooke.

One question arose particularly frequently in the subsequent question and answer session with representatives from a wide range of interest groups: How will the EMA ensure that possible side effects of vaccinations are actually reported transparently?

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Previously, the MHRA in Great Britain, where the Biontech vaccine has been inoculated since this week, had published a warning.

Accordingly, the MHRA experts advise people with a significant allergic history against the Covid-19 vaccination.

Previously, two people who had been vaccinated with a previous history in the UK had severe allergic reactions after vaccination.

The incident has created additional uncertainty amid the ongoing debate about the pace and diligence in approving Covid-19 vaccinations.

Critics of the EMA accuse the agency of being too slow compared to other supervisors and thereby delaying the urgently needed vaccinations and risking human lives.

In contrast, the advocates of the European way see their judgment confirmed that the British overseers may have rushed forward too quickly.

Vaccine approval is also pending in the USA

Meanwhile, there are also indications in the USA that an emergency approval of the vaccine from Biontech and its US partner Pfizer is imminent.

Late Thursday, the FDA's independent Vaccine Advisory Committee voted overwhelmingly in favor of supporting such approval.

The committee voted 17 to four that the benefits of vaccination outweigh the risks in patients 16 years of age and older.

One member of the committee abstained.

Experts expect the FDA to approve the vaccine based on this recommendation in the next few days.

It would be the first Covid-19 vaccination available in the US.

The fact that Europe is falling behind in view of the increasing number of approvals worldwide, while at the same time the pandemic is rampant in many European countries, including Germany, did not play a major role in the public dialogue of the EMA on Friday.

“I have no questions for the EMA, but would like to take the opportunity to express my thanks to the industry,” said Sue Middleton from the Belgium-based lobby organization Vaccines Europe during her speech and thus almost stood for the character of the relatively tame event.

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In the run-up to the event, all interested citizens in the EU were called on to contribute their questions.

The criteria according to which the 15 invited speakers were ultimately selected remained largely in the dark.

For a long time, the dialogue appeared strangely static and hardly lived up to its name.

The speech contributions of the individual speakers, some of which lasted minutes, in which critical questions were more marginal, were followed almost without exception by a short answer from EMA Vice Noel Wathion, who moderated the virtual event.

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In his brief replicas, he pointed out several times that further studies on individual issues, such as the effects of vaccinations on the very old, are necessary: ​​"We are only at the beginning of this journey."

And so it was mainly up to the invited scientists to speak plain text.

“We need vaccinations that are optimally suited to the respective vaccination groups,” warned Carlos Guzmán, head of the vaccinology department at the Helmholtz Institute for Infection Studies, for example.

In previous pandemics, such as the swine flu in 2009, the mass vaccination sometimes had rare side effects that were not expected.

And that although the vaccines used were well-known vaccines.

Only the connected audience brought speed into the debate

"We therefore need absolute transparency about the frequency of side effects," warned the researcher.

Comprehensive data on the advantages and disadvantages of corona vaccinations in children are also necessary, as they are generally less likely to contract Covid-19 than adults.

It was only when the EMA finally released the debate for the approximately 3,500 connected spectators that the event was significantly more crowded.

For example, one viewer asked how great the risk was that after a vaccination, contact with the pathogen could lead to severe immunopathological side effects, as was demonstrated in an animal model with the first corona outbreak with Sars-Cov-1.

The most important question from an EU perspective was also asked

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"That is definitely a very important question, and we have that absolutely in view," said Marco Cavaleri, head of the department for biological hazards and vaccination strategies at the EMA.

So far, however, there has been no indication that this effect could occur with Sars-Cov-2, especially since in all animal models, unlike Sars-Cov-1, nothing of the kind has been shown.

And finally there was also the question that is particularly urgent for many observers this week: Why the EMA takes longer for its approval than its supervisory colleagues in the USA, Great Britain or ne.

"We don't like to be that fast," replied EMA Vice Wathion.

"But that's because we chose a different legal instrument."

While the countries mentioned are concerned with an emergency permit for an unlicensed product, the EMA is granting market approval for an authorized product, for all batches of the vaccine and not just for individual batches like the one in Great Britain, Canada and soon also in the USA is the case.

“We have to be very sure of our decision and weigh the advantages of vaccination against its possible disadvantages.

That's why we look at the data very carefully, ”emphasized Wathion.

"Our decision will be efficient and it will be robust."

The use of vaccines against Covid-19 is also approaching in Germany

Source: Getty Images / Westend61