EMA on corona vaccine: doubts about postponing the second dose



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Due to initially low reserves, experts have spoken in favor of postponing the second dose of vaccination. The European Medicines Agency is lowering expectations: a change in approval for the procedure would probably be necessary.

The European approval authority EMA has expressed its reluctance to a possible postponement of the second dose of the Biontech / Pfizer corona vaccine. For a few days it has been debated whether the necessary second dose of vaccination should be administered later in order to vaccinate as many people as possible with scarce supplies.

The EMA was skeptical. Although an upper limit for the time interval between doses was not explicitly defined, the proof of effectiveness was based on a study in which the doses were administered at intervals of 19 to 42 days, the EMA told the dpa news agency. . A six-month interval, on the other hand, is not in accordance with the provisions and therefore should be considered as a so-called off-label application. Such a change would also require a change in approval and more clinical data.

Thomas Mertens, chairman of the Robert Koch Institute’s Standing Committee on Immunization, described the postponement of the second dose of vaccination as “definitely worth considering.” Bonn virologist Hendrik Streeck had made a similar statement.

Strategy in the UK

This procedure is recommended in the UK. There, the vaccine from the British-Swedish pharmaceutical company AstraZeneca and the University of Oxford received emergency approval on Wednesday after agent Biontech / Pfizer. At the same time, the Vaccine Committee advocated giving as many people as possible only the first dose of both vaccines. The second dose should be injected within twelve weeks instead of the originally planned two or four weeks.

Many UK experts welcomed the decision as a sensible approach to address the vaccine shortage. However, they also noted that the effectiveness is lower after the first dose and it should be seen if the strategy actually works.

So far more than 160,000 vaccines in Germany

The number of vaccinated people in Germany continues to increase. The Robert Koch Institute (RKI) received a total of 165,575 vaccinations as of noon on Friday. Compared to the previous day, the number of vaccinated people increased by 31,846. However, this number could also contain late registrations and does not reflect the number of people actually vaccinated in one day, the RKI emphasized.

Among those vaccinated there are 71,590 residents of nursing homes. 77,253 people received the vaccine for professional reasons. This includes medical personnel at very high risk of infection and personnel caring for the elderly. A total of 39,214 people were vaccinated due to their old age.


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