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GRAMBritain was once again quicker: the second vaccine against Covid-19 has already been approved there with the product of the British manufacturer Astra Zeneca. In early December, Britain became the first country in the world to approve a vaccine against the new corona virus.
The Biontech and Pfizer vaccine has been available there ever since, as has Astra Zeneca’s now, thanks to an emergency approval. Germany and Europe still have to be patient. However, there are already many questions about the new vaccine.
When will the Astra Zeneca vaccine arrive in Germany?
Not even the Federal Minister of Health, Jens Spahn, knows at this time. Astra Zeneca has not yet submitted an application for approval to the European Medicines Agency (EMA) in Amsterdam. However, a positive decision by the EMA, and a subsequent approval by the EU Commission, is the entry ticket for manufacturers to market their product within the EU.
Therefore, the EU approval for the Astra-Zeneca vaccine appears questionable even in January. Especially since the information that the EMA has received so far is obviously still not sufficient for an evaluation of the vaccine. “We need additional data on the quality of the vaccine,” EMA Deputy Director Noël Wathion recently emphasized.
However, if this, together with the app, were to become available at some point, similar to the Biotech and Pfizer vaccine, it could be approved very quickly in Germany and the EU as well. The vaccine is also not approved yet in the US There, too, FDA supervisors are demanding more data on the vaccine.
When can the next approval be expected here?
The American manufacturer Moderna will get EU approval long before Astra Zeneca. The EMA wants to make its decision on January 6, after which the EU Commission must give its approval. Federal Minister of Health Jens Spahn urges a speedy procedure. “The more vaccines that are approved, the faster you can make an offer to anyone who wants to get vaccinated,” he told a news conference Wednesday.
Moderna’s vaccine is “at the door”, that of Astra Zeneca is still “on the way to the door.” When this could be approved at this time cannot be predicted with certainty because data is still lacking.
What are the benefits of the Astra Zeneca vaccine?
The big advantage is the logistics. Unlike the product from Biontech and Pfizer, the British manufacturer’s vaccine does not require an elaborate cold chain with almost sub-zero Antarctic temperatures, but can be stored and transported under normal refrigeration conditions of two to eight degrees. This makes production and transportation much easier.
The manufacturer Astra Zeneca and scientists at the University of Oxford in the UK, who jointly developed the product, call their vaccine the “vaccine for the world.” In fact, this vaccine is likely to be much easier to distribute, especially in emerging countries with insufficient infrastructure. Especially since Astra Zeneca claims to be marketing the vaccine during the pandemic at cost and deliberately giving up profits.
How effective is the vaccine?
Bankruptcies, bad luck and setbacks: this was the impression that those who followed the development of the Astra-Zeneca vaccine had to win at times. For example, the manufacturer temporarily suspended its clinical study in September after a test person in Britain became seriously ill.
This is generally standard in drug development. At the time, however, some scientists criticized the sometimes contradictory communication about the incident. Information about the vaccine’s effectiveness 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: 90 percent only refer to a relatively small group of around 2,700 test people who received only half the dose rather than the full dose as the initial vaccination. There are conflicting statements about whether this modified vaccination schedule was an error or a deliberate variance compared to the standard procedure.
And other manufacturers?
For comparison: Biontech / Pfizer and American manufacturer Moderna achieved an effectiveness rate of 95 percent and 94.5 percent, respectively, with their vaccines in clinical studies.
It is also still unclear which vaccination scheme should be implemented in Britain as soon as vaccinations with the Astra Zeneca vaccine start: Just half the dose or the full dose? The manufacturer and the university have yet to provide any information. But the start of vaccination is safe: next Monday it should start in Great Britain.
How many doses are available?
The UK has ordered 100 million doses of Astra Zeneca vaccine, the manufacturer’s largest order in a single country. There are 30 million cans from Biontech and Pfizer. British Health Secretary Matt Hancock told the BBC that the government had ordered enough vaccines to be able to offer a vaccine to all adult citizens in the UK.
No vaccine against Covid-19 for children has yet been approved. The EU also signed a lengthy contract for 300 million cans and an option for 100 million more with Astra Zeneca months ago. The EU will receive a total of 300 million cans from Biontech and Pfizer, and the delivery of 80 million and the option of another 80 million have been agreed with the American manufacturer Moderna.
There are also other contracts with manufacturers CureVac, Johnson & Johnson and Sanofi, which are still in the middle of clinical studies.
How much does Germany get from it?
So far, only the Biontech and Pfizer vaccine has been approved in this country. Of the quantity of vaccine ordered by the EU, Germany receives 55.8 million doses, as specified by a spokesman for the Federal Ministry of Health at the request of WELT.
There is also the option of 30 million additional doses, which the government has agreed bilaterally with Biontech / Pfizer. With the Moderna vaccine, which has not yet been approved, Germany will receive 50.5 million doses. “Furthermore, additional doses are being negotiated here at the national level,” the spokesperson said. Of these two vaccines, Germany will have 136.3 million safe doses next year.
Which vaccine is preferable?
So far, those who are willing to vaccinate have no other choice: With the Biontech and Pfizer vaccine, only one Covid-19 vaccine is currently approved here. As soon as other products become available, the Permanent Vaccination Commission will make the corresponding recommendation and, if necessary, adjust the groups of indications, according to the Federal Ministry of Health.
Moderna and Biontech / Pfizer vaccines are based on new mRNA technology. Astra Zeneca, on the other hand, has developed a so-called vector vaccine based on an attenuated chimpanzee adenovirus. This procedure is still relatively new and was first used as an approved vaccine for an Ebola vaccine. All three manufacturers emphasize that their products are effective and safe, and have been thoroughly tested in large clinical studies.
Why do vaccines take so long in Germany?
Britain is fast, Israel even faster. In the small country, 600,000 of the nine million inhabitants are already vaccinated. According to a ranking by the University of Oxford, Israel ranks first in the world. Britain, where 800,000 have already been punctured, is closely following in third place.
According to the Robert Koch Institute, 78,109 citizens have been vaccinated in Germany. The country ranks eighth in the world. You can understand that people are frustrated that they still have to wait for the vaccination appointment, even though one of the vaccines was developed here, Spahn said.
However, Germany made the 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,” Spahn said.
But sometimes these products took years to reach Croatia: “This is a situation that we did not want to accept in this pandemic.” Also, the mRNA vaccine is a completely new product that is not available worldwide. the corresponding production capacities. However, Spahn hopes that everyone in Germany can get vaccinated “by summer”, at least if they are approved and enough vaccines are available by then.