Covid-19 vaccines: And then came the question that concerns the whole of Europe

GRAMBritain, Canada and a few other countries have already done so. America is on the brink of this. In the EU alone, it is not yet clear whether and when the Biontech and Pfizer vaccine will receive approval and can be vaccinated millions of times.

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

However, it took over an hour before it really turned into some kind of exchange of views. Because in the first place, representatives of the EMA took the opportunity to present the work of their authority in the field of vaccine approval in a kind of virtual seminar.

A lot is about security, transparency, and review processes.

“Despite the rapid pace of development and approval, Covid-19 vaccines will be approved according to the same high standards that apply to all medicines in the EU,” was the most important message from the head of the EMA, Emer. Cooke, at the beginning of the conference. In the roughly 75 minutes that followed, during which various authority experts voiced their opinion, much was about security, accountability, transparency, and clear review processes.

In no case, that was one of the most important messages, will safety be neglected when new vaccines against the pandemic are approved.

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

“So do us a favor: let your national supervisors or manufacturers know if you notice any side effects after such a vaccine,” Arlett continues.

However, the confidence-building measure was clouded by the fact that the EMA, of all places, had recently been the target of a hacker attack in which cybercriminals had gained access to the company’s documents. Biontech vaccine approval request.

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“I can assure you that this will not affect the vaccine approval schedule and that we are fully operational,” Cooke said. One question came up with particular frequency in the following question and answer session with representatives from a wide variety of stakeholders: How will the EMA ensure that potential side effects of vaccines are actually reported in a transparent manner?

Earlier, Britain’s MHRA, where the Biontech vaccine has been inoculated since this week, had issued a warning. Consequently, MHRA experts advise people with a significant allergic history against Covid-19 vaccination.

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Previously, two people who had been vaccinated with a history in the UK had severe allergic reactions after vaccination. The incident has created additional uncertainty amid the ongoing debate over the pace and diligence to approve Covid-19 vaccines.

Critics of the EMA accuse the agency of being too slow compared to other supervisors and thus delaying urgently needed vaccines and risking human lives. On the other hand, proponents of the European style have their judgment confirmed that British supervisors may have moved too fast.

Vaccine approval is also pending in the US.

Meanwhile, there are signs in the US that an emergency approval of the vaccine from Biontech and its US partner Pfizer is imminent. On Thursday night, the FDA’s independent Vaccine Advisory Committee voted overwhelmingly to support 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 abstained. Experts expect the FDA to approve the vaccine based on this recommendation in the coming days. It would be the first Covid-19 vaccine available in the US.

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

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

In the run-up to the event, all interested EU citizens were asked to contribute their questions. The criteria by which the 15 invited speakers were ultimately selected remained largely obscure.

For a long time, the dialogue seemed oddly static and hardly lived up to its name. The contributions of individual speakers’ speeches, some of which lasted minutes, in which critical questions were more marginal, were followed almost without exception by a short response from EMA Vice President Noël Wathion, who moderated the virtual event. .

In his brief rebuttals, he repeatedly noted that more studies are needed on individual topics, such as the effects of vaccines on the very old: “We are just at the beginning of this journey.

Therefore, it was primarily up to the invited scientists to speak in plain text. “We need vaccines that are optimally adapted to the respective vaccination groups,” warned Carlos Guzmán, head of the vaccination department at the Helmholtz Institute for Infection Studies, for example.

In previous pandemics, like the 2009 swine flu, mass vaccination sometimes had rare side effects that were not expected. And that although the vaccines that were used were well-known vaccines.

Only the connected audience brought speed to the debate

“Therefore, we need absolute transparency about the frequency of side effects,” warned the researcher. Comprehensive data on the advantages and disadvantages of corona vaccines in children is also required, as they are generally less ill with Covid-19 than adults.

It was only when the EMA finally launched the debate for the roughly 3,500 connected viewers that the event saw significantly more momentum.

For example, one bystander asked how great the risk was that after a vaccine, contact with the pathogen could cause serious immunopathological side effects, as demonstrated in an animal model with the first corona outbreak with Sars-CoV-1 .

The most important question from the EU perspective was also asked

“That is definitely a very important question, and we have it absolutely in view,” said Marco Cavaleri, head of the department of biological risks and vaccination strategies at the EMA.

However, so far 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 similar has been shown.

And finally there was also the question that is particularly pressing for some observers this week: Why does the EMA take longer to pass than its supervisory body in the US, Great Britain or Canada?

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Britain is rushing forward

“We don’t like being so fast,” replied EMA Vice President Wathion. “But that is because we chose a different legal instrument.”

While the aforementioned countries are concerned about 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, such as that from Great Britain, Canada and probably soon also in the United States is the case.

“We have to be very sure of our decision and weigh the advantages of vaccination against its possible disadvantages. This is why we analyze the data very carefully, ”Wathion emphasized. “Our decision will be efficient and solid.”