GGreat Britain was once again faster: the second vaccine against Covid-19 has now been approved there with the product of the British manufacturer Astra Zeneca. In early December, Great Britain became the first country in the world to approve a vaccine against the novel corona virus.
The vaccine from Biontech and Pfizer has since been available there – just like that from Astra Zeneca now – thanks to an emergency approval. Germany and Europe still have to be patient. Nevertheless, there are already many questions about the new vaccine.
When will the Astra Zeneca vaccine come to Germany?
Not even Federal Minister of Health Jens Spahn knows that at the moment. Astra Zeneca has not yet submitted an application for approval to the European Medicines Agency (EMA) in Amsterdam. A positive decision from the EMA – and a subsequent approval by the EU Commission – is, however, the entry ticket for manufacturers to be able to market their product within the EU at all.
EU approval for the Astra-Zeneca vaccine therefore appears questionable even for January. Especially since the information that the EMA has received so far is apparently not yet sufficient for an assessment of the vaccine. “We need additional data on the quality of the vaccine,” EMA Deputy Director Noel Wathion recently emphasized.
Should this – along with the application – be available at some point, however, similar to the vaccine from Biotech and Pfizer, it could go very quickly with approval also in Germany and the EU. The vaccine is also not yet approved in the USA. There, too, the FDA supervisors are demanding more data on the vaccine.
When can the next approval be expected here?
The US manufacturer Moderna will get approval in the EU well before Astra Zeneca. The EMA wants to make its decision on January 6th, after which the EU Commission has to give its approval. Federal Minister of Health Jens Spahn is pushing for a speedy procedure. “The more vaccines are approved, the faster an offer can be made to anyone who wants to be vaccinated,” he said at a press conference on Wednesday.
The vaccine from Moderna is “at the door”, that from Astra Zeneca is still “on the way to the door”. When this could be approved cannot be predicted with any certainty at the moment because there is still a lack of data.
What are the benefits of the Astra Zeneca vaccine?
The big advantage is the logistics. In contrast to the product from Biontech and Pfizer, the vaccine from the British manufacturer does not require an elaborate cold chain with almost Antarctic sub-zero temperatures, but can be stored and transported under normal refrigerator conditions of two to eight degrees. This makes production and transport much easier.
The manufacturer Astra Zeneca and the scientists from Oxford University in the UK who jointly developed the product have therefore called their vaccine the “vaccine for the world”. In fact, it should become much easier to distribute this vaccine, especially in emerging countries with inadequate infrastructure. Especially since Astra Zeneca claims to be marketing the vaccine for the duration of the pandemic at cost price and deliberately foregoing profits.
How effective is the vaccine?
Bankruptcies, bad luck and mishaps – this was the impression who had to gain at times those who followed the development of the Astra-Zeneca vaccine. The manufacturer temporarily suspended its clinical study in September after a test person in Great Britain became seriously ill.
This is in principle standard in drug development. At the time, however, some scientists criticized the sometimes contradicting communication around the incident. The information on the effectiveness of the vaccine also caused confusion later.
The manufacturer and the scientists involved named three figures: 90 percent, 70 percent and 62 percent. Only later did it become clear: the 90 percent only refer to a relatively small group of around 2700 test persons who received only half the dose instead of the full dose as an initial vaccination. There are contradicting statements as to whether this modified vaccination schedule was a mistake or a deliberate variant compared to the standard procedure.
What about other manufacturers?
For comparison: Biontech / Pfizer and the US manufacturer Moderna achieved an effectiveness rate of 95 percent and 94.5 percent, respectively, in the clinical studies with their vaccines.
It is currently also unclear which vaccination scheme should be implemented in Great Britain as soon as vaccinations with the vaccine from Astra Zeneca start: Only half the dose or the full dose? The manufacturer and the university have not yet provided any information. But the start of the vaccination is certain: next Monday it should start in Great Britain.
How many doses are available?
The UK has ordered 100 million doses of vaccine from Astra Zeneca, the largest single country order from the manufacturer. There are 30 million cans from Biontech and Pfizer. British Health Secretary Matt Hancock told the BBC that the government had ordered enough vaccine to be able to offer a vaccine to every adult citizen in the UK.
No vaccine against Covid-19 has yet been approved for children. The EU also signed an extensive contract for 300 million cans and an option for 100 million more with Astra Zeneca months ago. The EU is to receive a total of 300 million cans from Biontech and Pfizer, and the delivery of 80 million and the option for a further 80 million have been agreed with the US manufacturer Moderna.
There are also other contracts with the manufacturers Curevac, Johnson & Johnson and Sanofi, which are still in the middle of the clinical studies.
How much does Germany get from it?
So far, only the vaccine from Biontech and Pfizer has been approved in this country. From the amount of vaccine ordered by the EU, Germany receives 55.8 million doses, as a spokesman for the Federal Ministry of Health specified at WELT’s request.
There is also an option for an additional 30 million doses, which the government has agreed bilaterally with Biontech / Pfizer. With the Moderna vaccine, which has not yet been approved, Germany is to receive 50.5 million doses. “In addition, additional doses are being negotiated here at national level,” said the spokesman. Of these two vaccines, Germany will have 136.3 million doses safe in the coming year.
Which vaccine is preferable?
So far, those willing to vaccinate have no other choice: With the vaccine from Biontech and Pfizer, only one vaccine against Covid-19 is currently approved here. As soon as other products are available, the Standing Vaccination Commission will make a corresponding recommendation and, if necessary, adapt groups of indications, according to the Federal Ministry of Health.
The vaccines from Moderna and Biontech / Pfizer are based on the novel mRNA technology. Astra Zeneca, on the other hand, has developed a so-called vector vaccine based on an attenuated chimpanzee adenovirus. This procedure is also still relatively new and was first used as an approved vaccine for a vaccine against Ebola. All three manufacturers emphasize that their products are effective and safe – and that they have been extensively tested in the large clinical studies.
Why does it take so long for vaccinations in Germany?
Britain is fast, Israel even faster. In the small country, 600,000 of the nine million inhabitants have now been vaccinated. According to a ranking by Oxford University, Israel ranks first in the world. Great Britain, where 800,000 have already received the prick, is close behind in third place.
According to the Robert Koch Institute, 78,109 citizens have now been vaccinated in Germany. The country ranks eighth in the world. He can understand that people are frustrated because they still have to wait for their vaccination appointment, although one of the vaccines was developed here, said Spahn.
However, Germany made a conscious decision to procure the vaccines together with its EU partners so that vaccinations can also be carried out in other smaller EU countries at the same time. “New drugs are always immediately available in Germany because this is an attractive market,” said Spahn.
But it sometimes took years for these products to arrive in Croatia: “That is a situation that we did not want to accept in this pandemic.” In addition, the mRNA vaccine is a completely new product that is not already available all over the world the corresponding production capacities. Nevertheless, Spahn expects that everyone in Germany can get vaccinated “towards summer” – at least if enough vaccines are approved and available by then.