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To quickly immunize a larger part of the population against the coronavirus, the Federal Ministry of Health is examining an extension of the interval between the first and second vaccination doses. This stems from a ministry document that SPIEGEL has received.
By extending the period between the two individual vaccinations, the availability of the vaccine could be increased in the short term. The ministry asked the Standing Commission on Immunization of the Robert Koch Institute to review the procedure, the document says. The department of Health Minister Jens Spahn (CDU) is based on the British procedure, where an extension of the period between vaccinations well beyond the expected maximum time of 42 days is already possible.
So far, 1.34 million doses of vaccines from joint manufacturers Biontech and Pfizer have been delivered in Germany. Since it has been discovered in practice that, due to “overfilling” of the vials, six doses can be withdrawn instead of the planned five vaccination doses, the ministry also advocates this procedure, according to the document.
According to the report, this had already been defended in consultation with the Paul Ehrlich Institute and the manufacturer on December 27, 2020 against the federal states “in compliance with all due diligence requirements.” A request has been submitted for the corresponding approval change. According to the ministry, this could increase the number of vaccine doses available by up to 20 percent and allow “up to 1.6 million vaccines” instead of 1.34 million.
Biontech wants to double capacities
In addition, the federal government wants to support the manufacturer Biontech in expanding its capabilities. The Paul Ehrlich Institute, as the top federal authority, will accompany the start of production at a newly purchased and renovated plant in Marburg, which is scheduled for February, together with the state of Hesse. Therefore, Biontech aims to double its production capacity.
The approval of the vaccine developed by the American company Moderna, for which the European Medicines Agency Ema is responsible, could also help alleviate the situation. The Ministry of Health assumes that the final opinion of the scientific committee of Ema and the subsequent approval expire “very soon”, probably on January 6.
In the first weeks “you can expect at least 1.5 million doses of this vaccine.” In total, Germany has secured 50 million doses of vaccines by 2021 from Moderna through European treaties. Also with this preparation, two doses are necessary for the best possible protection from vaccination.
Spahn’s ministry also relies on a rapid test of the vaccine from AstraZeneca and the University of Oxford, which has already been approved in the UK. Ema has also received a request for the so-called continuous review, an expedited approval process. This is being evaluated by the German Paul Ehrlich Institute and the other national pharmaceutical authorities of the EU “with high pressure”, it says in the document of the Ministry of Health. The aim is to »quickly decide on the path and scope of an approval«.
The heads of country criticize the distribution
Spahn is under pressure with the Health Ministry in procuring vaccines, as the EU Commission’s ordering and purchasing strategy, which he supported, has contributed to the current shortage in Germany. Biontech boss Uğur Şahin also criticized this in an interview with SPIEGEL.
On Monday, the conference of ministers of health of the federal states will discuss the vaccination strategy. Several heads of country recently complained about the shortage of vaccines and distribution by the Federal Ministry of Health, including the first mayor of Hamburg, Peter Tschentscher (SPD). He sees the city-state at a disadvantage when it comes to the allocation of vaccinations for medical personnel. For Hamburg, the doses are estimated for 1.85 million people, while the Hanseatic city also takes care of the health care of the surrounding area and therefore about five million people, according to Tschentscher. Consequently, the need in the health sector is greater.