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Starting today, the EU could take a further step towards starting vaccination: the pharmaceutical authority EMA presents its opinion on the Biontech / Pfizer vaccine. What’s next after that?
By Alexander Göbel, ARD-Studio Brussels
With the first vaccines around Christmas, it won’t quite work in the EU, but it should start right after. Preparations are in full swing and the roadmap is clear: today the EU Medicines Agency (EMA) in Amsterdam presents its evaluation of the vaccine from Biontech and its US partner Pfizer.
It is expected to give the green light and recommend the new active ingredient BNT162b2 from Biontech. So the final decision rests with the EU Commission. If you agree, the vaccine is formally approved throughout the EU. Only Switzerland would have preceded the EU; other countries like the United States or Great Britain have obtained emergency approvals.
It is not expected that the EU Commission can ultimately vote against such conditional approval, because it is generally based on the recommendations of the Medicines Agency. The path for the vaccine will likely be clear by Christmas at the latest – that is, Wednesday or Thursday.
Special shift at Biontech
Then Biontech can distribute the vaccination doses already produced to the member states. The EU vaccination strategy foresees a key that is determined according to the size of the population. National vaccination campaigns are scheduled to begin on December 27. According to CEO Ugur Sahin, Biontech will also work at Christmas, “so that it is really possible for the vaccine to reach all countries.” But even then, it’s all about safety again: In Germany, for example, the Paul Ehrlich Institute tests all approved batches before they are inoculated.
The EU deliberately did not want emergency approval. This would have sped up the process, but Brussels argued with common ground, the best possible quality and tolerability on a large database, confidence in the vaccine and issues of liability. In the case of emergency approvals, the respective state is responsible in case of problems; In the event of such conditional market approval, this responsibility rests with the manufacturer.
Has the EU asked for too little vaccine?
The “Spiegel” accusation that the EU has ordered too little vaccine is rejected as cheap and negligent. The reason: Until a few weeks ago, no one could know which vaccine worked best, which was particularly effective, and which was ahead of the curve in terms of approval. This is one of the reasons why the EU set the goal of organizing vaccines for all 27 member states from the beginning. This went hand in hand with the intention of not relying on a single vaccine. That is why the EU Commission has signed six contracts with different manufacturers for different types of vaccines; a seventh could soon be signed. The EU has already secured two billion doses of vaccines.
The Biontech / Pfizer vaccine could now be the first to be approved and inoculated; however, it is very demanding when it comes to storage: it must be strongly cooled, which makes it significantly more expensive than “classic” vaccines. Biontech, CureVac and also the American company Moderna use a new method: mRNA technology. No pathogens or their components are required. Rather, some cells in the body receive parts of the virus’ genetic information in the form of RNA with the vaccine – the blueprint for individual virus proteins, also known as antigens, is delivered. These then activate the immune system and are supposed to generate the protective immune response.
Large Orders from Moderna and CureVac
It was therefore clear from the outset in Brussels that the Eastern European EU countries in particular would first rely on a conventional and therefore cheaper vaccine, for example from Astra Zeneca, the approval of which will take some time. However, to also monitor the interests of these countries, the EU Commission had to “distribute” its vaccine purchases, without being able to know which vaccine would be approved and how quickly.
In addition, the doctor Peter Liese (CDU), spokesman for health policy of the PPE group in the EU Parliament, highlights that “Spiegel” omitted important facts in his criticism of the EU vaccine purchase strategy. The Union ordered three times more per capita of the Modern vaccine scheduled for January than Britain, Liese said. ARD studio Brussels. More than 400 million doses of vaccine have been ordered across the EU of the equally innovative vaccine from Tübingen-based manufacturer CureVac.
No quick end in sight for the pandemic
Even if the vaccine is approved, no end to the pandemic is in sight, at least not so soon. To stop the pandemic, between 60 and 70 percent of the population would have to be vaccinated, in Germany that would be up to 58 million people. Depending on the vaccine used, you need two pricks for complete protection from the vaccine. This is the case, for example, of the vaccine from the German company Biontech.
Anyway, the vaccinations will take months. On the one hand, this is due to the logistical challenge. On the other hand, at the moment there are not enough doses of vaccine available worldwide, so it is not even enough for the risk groups defined in the national vaccination plans. So there must still be a long way to go before Corona is defeated. The measure depends on how quickly approved vaccines are available in sufficient quantities. And: if it can be admitted and distributed to other applicants.
MEP and health expert Liese is optimistic that risk groups and medical personnel will be able to get vaccinated across the EU by the end of March 2021. “This will quickly make the pandemic less horrific,” he hopes. He is betting that from April or May at least a “more normal life” is possible. But it is important to quickly vaccinate people who do not belong to the risk group. It cannot be predicted today if this could happen by the fall of 2021. “We have to be patient, but there is definitely light at the end of the tunnel.”
