EMA Advises Spain To Adhere To The Correct Second Vaccine Dose Instructions Shown On The Packaging
After Spain had announced earlier today, Monday 19, its intentions of possibly lengthening the period in between the first and second doses of vaccine shots from 21 days, to 42 days, the European Medicines Agency (EMA) has warned Efe later on Monday that the authorized Covid-19 vaccines “must be used as described in the product leaflet”.
By this, the EMA means the administering of both doses with “three weeks” difference between the first and second in the case of Pfizer / BioNTech, and “28 days” for Moderna, as stated on the accompanying leaflet, in order to correctly achieve the same efficacy confirmed by clinical trials.
The inserted leaflet states that “the efficacy analyzes included participants who received their second vaccination within 19 to 42 days after their first vaccination”, but, it also states that “the majority (93.1 per cent) of vaccine recipients received the second dose 19 to 23 days after the first”, making the latter interval the one supported by Pfizer clinical trials.
In addition to this, the package inserts for the two vaccines emphasise that there is no data available on the interchangeability of these two different injections with other vaccines to complete the vaccination cycle, which means that the two doses the patient receives must be from the same pharmaceutical source, as reported by diariodesevilla.es.
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