Spahn defends late approval: Europe gives itself BNT162b2 for Christmas

Tuesday, December 15, 2020

Spahn defends late admission
Europe is giving itself BNT162b2 for Christmas

From Sebastian Huld

Some countries are already busy injecting. Germany expects the EU approval of Biontech's corona vaccine on December 21. Federal Health Minister Spahn sees no cause for criticism: The "first proper approval of a vaccine worldwide" creates trust.

If the lockdown and the strict contact rules still ruined the anticipation of Christmas, a hopeful star is now rising from Amsterdam: The European Medicines Agency (Ema) based there will decide on a recommendation for the corona vaccine from Biontech on December 21. Approval is expected, as is the European Commission, which has the final say on approval for all EU countries.

Federal Health Minister Spahn speaks at noon at a joint press conference with Lothar Wieler, President of the Robert Koch Institute, of "good news for the European Union". He is still assuming December 23rd as the approval date. "This will be the first proper approval of a vaccine worldwide." Spahn expects a start-up time of two to four days for the vaccination campaign. After the approval, the batch delivered to Germany is checked. Then the extradition to the federal states will begin, whose vaccination centers should be operational from today.

The Ema had previously communicated that the approval should take place by December 29 or earlier. Because several hundred people die every day in Germany alone in connection with Covid-19, every day of waiting for approval makes a difference.

Europe checks "fine-grained"

Especially since the active ingredient BNT162b2 from Biontech and Pfizer has been injected in several countries for days, in Great Britain, Israel, Canada and the USA. However, emergency approvals have been issued in these countries. The difference to the EU: In Europe, the data are "digested deeper", they are "checked more finely," explains Spahn. The European authorities would look "where there may be additional risks for certain groups". Spahn wants to create trust by emphasizing the particular prudence of the European test procedure.

The federal government was recently criticized for waiting for the slower European approval process. After all, Spahn could have pushed ahead with national emergency approval single-handedly. The basis would have been Section 3 of the "Ordinance to ensure the supply of the population with medical products in the event of the epidemic caused by the Sars-CoV-2 coronavirus". The Federal Ministry of Health could have commissioned the Paul Ehrlich Institute to examine an emergency approval. That might have made sense a few weeks ago. Now the German authority can no longer overtake the Ema, which is supported by the Paul Ehrlich Institute.

The doubters in view

For Spahn, however, that would not have been an option either, as he asserts: "That is now a difference of two weeks between an emergency approval and a proper approval, which can be absolutely accounted for." And for two reasons: because of the greater confidence of the population in a properly licensed vaccine and because of the fact that a race for the vaccine within Europe would have been poison for the cohesion of the European Union. Smaller and poorer countries would presumably have been inferior here. The CDU politician now sees this averted and rebukes his critics: "In the crisis, when it really matters, some brutally draw the national card."

Spahn says that he has his eyes above all on the doubters, i.e. those citizens who generally want to be vaccinated but are still skeptical about the completely new vaccine. "This is exactly what we are doing this way," he says. It is about the "added value that this first proper approval brings worldwide for trust and reliability".

Wieler adds that according to the RKI's Cosmo study, 70 percent of people who find out about a vaccine wanted to know something about the side effects. "This is why checking the documents is so important," says Wieler. "We will also show the undesirable side effects such as fever and pain at the injection site transparently. All of this is important so that the public can trust." Spahn also points out that it is a strength that 27 national approval authorities are involved in the test with all their expertise.

Admission for one year

What Spahn does not mention: The packaging of the vaccine will have a black triangle on it. This symbol indicates that a medicinal product has only received conditional marketing authorization. That means: the examination is not completed and the admission is limited to one year. All users are therefore requested to report any abnormalities. This does not mean that the admission was not made properly. But it is also the result of an accelerated test procedure which, according to the Paul Ehrlich Institute, was completed in 150 instead of 210 days.

The black triangle will appear on the packaging of BNT162b2 for another reason: The conditional approval results not only from the speed of the test procedure, but also from the still limited knowledge about the long-term effects of the vaccine. In addition to possible damage, the likelihood of which the experts now seem to be significantly lower than the benefit of the product, two things are still unclear: the duration of an immunization and the question of whether immune vaccinated persons can still be carriers. This will probably only become apparent over time in practice. That vaccinated people will not be a little guinea pig, which Spahn vehemently denies, is therefore also only partly true.