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European citizens can expect millions of additional doses of the Biontech Comirnaty vaccine. According to information from SPIEGEL, the Mainz-based manufacturer has submitted an application to the European Medicines Agency Ema to change the approval conditions. Biontech is committed to ensuring that doctors in the future can take six full doses of vaccine of 0.3 ml each from the vials provided with a total of 2.25 ml of the finished vaccine, provided they can draw six full doses.
In the case of Germany, for example, this would mean that up to 800,000 instead of 670,000 doses of the Biontech vaccine could be available per week in January. By the end of March, more than 1.5 million additional vaccines could be obtained in this country.
On Tuesday, Ema told SPIEGEL that it would “quickly” examine said Biontech application and, in the event of a positive evaluation, would change its approval conditions.
So far, the Ema only allows the extraction of five doses of vaccine (that is, 1.5 ml of vaccine), and instructs doctors several times in the product information for Comirnaty to dispose of the rest. Regulators in Switzerland, the United States and Great Britain, meanwhile, are in favor of obtaining six doses, provided that doctors can do so with the extraction of a single vial. According to several medical professionals, this is not a great feat as long as high-quality syringes and cannulas are used, in which only small amounts remain after injection. It is strictly forbidden to mix the leftovers of several bottles anywhere.
In mid-December, American doctors found that at least six or even seven cans can be obtained from a bottle. Biontech had already informed Ema of the possibility of the sixth dose before approval; however, the EU authority prohibited this option.
Also Spahn for changing the admission requirements.
Now the authority is under increasing pressure. Critics denounce his rigid instructions as a “scandal” and a waste of an extremely rare vaccine. Health experts and politicians like Czech Prime Minister Andrej Babiš are calling for the approval to be increased to six doses.
Federal Health Minister Jens Spahn is now campaigning for the sixth dose. “It is possible to take six doses of vaccine,” the CDU politician in Berlin said on Wednesday. And if doctors manage to get six full doses of 0.3 milliliters each from a vial, it makes “sense” to use the extra dose.
On Tuesday, Ema told SPIEGEL that if Biontech submits a request to change the approval conditions, it will be reviewed “quickly” by its Committee for Human Medicines. “Yes [der Ausschuss] finds that six doses can be reliably drawn, will recommend a change to current approval conditions. “
Additional vaccination protection for five and a half million people
Also in Germany, numerous doctors have managed to extract six or sometimes even seven full doses from the Biontech bottle. The Federal Republic of Germany, which has secured 55.8 million doses of the Biontech vaccine through orders across the EU, could get up to 11 million additional vaccines with the sixth dose and thus protect five million and a half more people from the virus.
The state does not incur additional costs because Biontech does not calculate this sixth dose according to its own information. The Mainz manufacturer also does not want to reduce the filling quantity. Biontech deliberately overfills the vials so that even inexperienced physicians and poor equipment can easily draw all five manufacturer-guaranteed doses.
