Corona vaccination: December 21st is Europe's pain threshold

display

The redeeming message burst in the middle of the press conference by Federal Health Minister Jens Spahn (CDU): On December 23, the European Medicines Agency (EMA) wanted to decide on the approval of the vaccine from Biontech and Pfizer.

Several media reported it initially unanimously.

Spahn had already hinted at the start of the press conference.

But while the minister was visibly pleased that the coveted vaccine could be approved before Christmas, the shock came from Amsterdam, where the authority is based:

One could not confirm that the corona vaccine will be approved for the EU on December 23.

An earlier date cannot be ruled out, but the previously communicated date of December 29 is still assumed.

display

Two hours later came the next - and now definitive - announcement from the EMA: On December 21, the supervisors will present their report on the approval of the corona vaccine BNT162b2 in the EU.

The EU Commission then has to decide.

The public back and forth about the date of the meeting of a previously little-known authority outside the pharmaceutical sector shows how tense the situation among decision-makers in health policy has become.

And how great the pressure must have been on the supervisors to move forward communicatively in view of the dramatic situation.

On December 21st, the EMA will, so to speak, go to its pain limit.

"It can not be"

The corona pandemic is raging with undiminished force in many European countries.

According to the Robert Koch Institute, 325,000 people in Germany are currently infected with Sars-CoV-2, and from tomorrow the whole country will shut down in the second major lockdown since the outbreak of the pandemic.

display

However, a vaccine that could protect high-risk patients and medical staff in particular is not yet available.

Not because it doesn't exist.

But because the vaccine produced at record speed by the Mainz company Biontech and the US company Pfizer is simply not yet approved in the EU.

The vaccine BNT162b2 is already being used in the UK.

The USA, Canada and a few other countries have also already granted emergency approval, and the first vaccine doses have also already been administered there.

The fact that the vaccine was developed in Germany and is not yet available here of all places has been causing heavy criticism for days.

"It cannot be that a vaccine developed in Germany can only be approved and vaccinated in January," said the health policy spokeswoman for the FDP in the Bundestag, Christine Aschenberg-Dugnus.

"Every day counts to save human lives."

display

The German Hospital Association had previously criticized the delay and demanded emergency approval based on the example of other countries.

Confidence in the vaccine

However, this instrument is not intended to be used across the EU; it can only be used at national level.

However, Spahn had categorically ruled out emergency approval for Germany.

“We have pre-ordered vaccines together in Europe, invested together in research at the companies and are now getting approval together.

We are stronger than I, ”he also emphasized during the press conference.

One cannot first talk a lot about Europe and then draw the national card in the crisis: "It is a matter of continuing on this European path together, that creates trust together."

Trust in the vaccine is also what makes the European approach so important.

He received emails all the time, reported Spahn, in which people pointed out that they did not want to be guinea pigs for a new type of vaccine.

"If we had been the first to vaccinate with an emergency license in Germany, then we would have had exactly this debate," said the Minister of Health.

In fact, the question of which makes more sense now - an emergency approval based on the British and American models or a conditional marketing approval as the EMA provides - has been a matter of dispute for weeks.

Immediately after its emergency approval at the beginning of December - the first in the world - the British authority MHRA was accused of not having worked thoroughly enough.

"It goes deeper into the data"

The EMA, on the other hand, is in the crossfire because of its much more lengthy procedure of conditional marketing authorization.

“The conditional market approval is about a product authorized according to strict rules.

Emergency approval, on the other hand, is the permission to temporarily use a product that has not yet been officially approved, ”EMA boss Emer Cooke explained in an interview with WELT last week.

display

That also has legal consequences.

In the case of an emergency approval, such as the one issued by the USA, manufacturers are not liable for unforeseen side effects that only occur after approval.

The emergency approval is only valid as long as the corresponding emergency situation persists.

It can therefore be revoked at any time, and each individual vaccine batch must also be assessed and approved.

On the other hand, the EMA's conditional marketing authorization will initially apply for one year, and it will apply to the then authorized vaccine as a whole, not just to individual batches.

The procedure also differs.

At the EMA, experts from all 27 member states are involved in vaccine approval.

The vaccines - in this case the one from Biontech and that from the US manufacturer Moderna, which has also applied for approval in the EU - are sometimes examined very granularly by experts from several countries.

"We go deeper into the data, the data are checked more finely," said Spahn on Monday.

The additional time that this takes up is made up for by a decisive added value: “In Europe, we will have the world's first proper approval.

The question of how vaccination is approved is something that inspires confidence. "

Vaccination in Germany - this year

The major disadvantage of the European route, however, is the loss of time.

Because even the British MHRA and the American FDA with their large and very experienced teams of experts are unlikely to want to accuse anyone of sloppy testing work.

And there the vaccine doses are already being vaccinated.

But in Germany too, things should go fast as soon as the EMA and the EU Commission have given their blessings.

First of all, there must be a batch release by the Paul Ehrlich Institute so that, according to Spahn, “we can be sure that what is delivered also corresponds to what is approved”.

The federal government will then take care of the "fastest possible delivery" to the federal states, where the vaccine will then be distributed to the prioritized groups.

"After approval, we can expect a vaccination to start a maximum of two to four days later," said the Minister of Health.

"The vaccination logistics are ready from today."

If nothing comes up, vaccination against corona could also start in Germany this year.