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Friday, January 1, 2021
Ema invalidates the postponement debate
The second subsequent vaccination jeopardizes approval
To vaccinate more people against the coronavirus, some scientists are currently calling for the second prescribed vaccination dose to be given later than scheduled. The European Medicines Agency is critical of these considerations. Therefore, a longer interval would have an impact on approval.
In the discussion about postponing the second vaccination dose in favor of more possible first vaccinations, the European approval authority Ema is lowering expectations. Although an upper limit for the time interval between doses was not explicitly defined, the evidence of effectiveness was based on a study in which the doses were administered at intervals of 19 to 42 days, Ema announced.
Administration roughly every six months is out of compliance with regulations and therefore should be considered off-label use, he said. Specifically, this means that such a change would require a change in approval, as well as more clinical data to support such a change, “as there is currently no data showing protection after the first dose beyond two to three weeks.”
For a few days it has been debated whether the second necessary vaccination dose could be administered later in order to vaccinate as many people as possible with scarce supplies. “Since the interval between the two vaccinations can most likely vary within wide limits and the protection is already very good even after a vaccine, it is definitely worth considering giving the first vaccine first,” said Thomas Mertens, president of the Said the standing committee on vaccination of the Robert Koch Institute.
Bonn virologist Hendrik Streeck had made a similar statement. The president of the Paul Ehrlich Institute, Klaus Cichutek, said Wednesday that from his point of view the above approach was very sensible and correct. Because the corresponding efficacy and safety data are available.
