- Standing Commission on Vaccination recommends Astrazeneca's vaccine only for people 18 to 64 years old
- Astrazeneca's vaccine is expected to be approved in the EU on Friday.
- Further, there is also no solution on how Astrazeneca will bridge supply shortages of its Corona vaccine and fulfill contracts with the EU
- Limited recommendation could throw German vaccination strategy into turmoil. Does the vaccination order need to be changed?
In the fight against Corona, it should be a strong signal of hope for all Europeans: This Friday, the European Medicines Agency (EMA) in Amsterdam will finally approve the vaccine produced by the British-Swedish pharmaceutical company Astrazeneca.
The vaccine is considered relatively easy to handle, because it requires only refrigerator temperatures for storage instead of extreme deep-freezing, and at 1.78 euros per dose it costs only one-seventh of the price Biontech-Pfizer charges for a syringe. But hopes for a quick turnaround in the pandemic were dashed several times this week.
Astrazeneca vaccine: only limited recommendation and supply problems
In addition to the dispute over supply levels, one piece of news in particular is likely to have a major impact on vaccination strategy Although the Standing Commission on Vaccination also recommends the Corona vaccine with the vaccine from the British-Swedish manufacturer Astrazeneca, the vaccination sequence in Germany is limited Astrazeneca – however with a decisive restriction. Based on currently available data, this vaccine would only be recommended for individuals aged 18 to 64 years recommended, it was said on Thursday in the Federal Ministry of Health.
The clinical trials for the vaccine had been made mainly with younger people, only three percent of the subjects were over 70 years old. Experts in Brussels and in Berlin government circles have therefore feared for some time that the EU authority would use this as a basis for its Market approval The EMA said that the vaccine would only be given to younger people, but that it was allowed to be used in older people aged 65 and over.
Federal Minister of Health Jens Spahn (CDU) made it clear that the final recommendation the Stiko only after the EMA has approved the vaccine. At the same time, he pointed out that the smaller data base in older people has been known since fall. It was "not bad data, but too little data," said the minister's.
Problems with Astrazeneca: Must vaccination sequence be changed?
In Germany, even before the EMA could decide, the Standing Commission on Vaccination now made a decision. Since Germany's vaccination strategy is based on first Patients at risk, i.e., mainly seniors, should be immunized against the coronavirus, the planning will probably now have to be significantly adjusted. The German government had secured 60 million doses of the inexpensive vaccine from the British-Swedish company – a comparatively large amount.
The Prioritization in vaccination in Germany should not change for the time being: Due to limited availability, vaccination should initially be offered only to certain population groups. The requirement is still a particularly high risk of severe or fatal courses of COVID-19 disease or occupational contact risk, for example among doctors or nursing staff.
Lauterbach: Vaccination with Biontech or Moderna vaccine only for over 65s
SPD health expert Karl Lauterbach, on the other hand, argued for a change in the vaccination sequence. "Now, the many under 65-year-olds in the vaccination groups I, II and III get the vaccine from Astrazeneca," the epidemiologist told this newsroom.
In his view, it makes no sense "to use the vaccine from Moderna and Biontech, which is more valuable for the elderly, for nursing staff, police officers, judicial officials, members of the government or members of parliament". For those groups, he said, Astrazeneca's vector vaccine is good enough. To implement this would probably need the ministerial regulation on the Vaccination sequence are being changed.
Effectiveness of Astrazeneca's vaccine lower
Adding to the problem is the fact that the effectiveness of the vaccine with 70 percent significantly lower than that tested by Biontech and Moderna. However, the World Health Organization, like regulatory agencies in the EU and U.S., has set a threshold of 50 percent for the required vaccine efficacy.
This is therefore no obstacle to the introduction of the vaccine. Nevertheless, the low efficacy of the mRNA vaccine, which was effective in well over 90 percent of subjects, raises questions.
Astrazeneca, meanwhile, emphasized the reliability of its product, even in the elderly. The latest clinical data showed that the vaccine, produced in collaboration with Oxford University, was effective even in people over 65, a spokesman for the British-Swedish company said Thursday.
Crisis meeting between EU and Astrazeneca probably failed to bring about a rapprochement
So far, the ordered doses of the Astrazeneca vaccine are not yet ready for vaccination anyway. Despite EU protests, the manufacturer is sticking to its announcement that planned deliveries to EU states in the first quarter will be cut by 60 percent, to just 31 million doses, is cut. Also a third Crisis meeting on Wednesday evening between company management, the EU Commission and representatives of the EU states brought no rapprochement – only the prospect that Astrazeneca may yet expand deliveries somewhat in the first quarter, and after the launch on 7. February in any case.
EU won't take the cut, invoking the treaty. The company also. It's testimony against testimony. That's why calls are growing louder for the agreement to be made public. The EU Commission is in favor, prere in the EU Parliament is growing. Now the company is also giving in, wants a Disclosure with redaction of certain bodies agree, as EU circles said on Thursday.
If the EU is right, it could sue the company. But does that help? "It's not about money, it's about vaccination," warns EU Parliament Vice President Katarina Barley (SPD).
Vaccination summit with countries and pharmaceutical companies should bring clarity
That's why both Brussels and Berlin are now looking for ways to have the approved vaccines produced by other pharmaceutical companies as well. The German government, at the urging of coalition politicians, announced a vaccination summit with the states and pharmaceutical companies, which would also discuss how industry cooperation could be used. Europe, demands health minister Spahn, must "make its fair share Get." Read about it: Spahn wants vaccination summit – and reckons with ten tough weeks
Astrazeneca itself shows how it could work. The company has its vaccine manufactured by Indian pharmaceutical giant SII, among others, and production is booming: Morocco about received from India last Friday two million doses of vaccine from Astrazeneca vaccine, on Thursday King Mohammed VI gave the go-ahead for the major vaccination campaign in his country.