EMA Advises Spain To Adhere To The Correct Second Vaccine Dose Instructions

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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.

At the end of January, the Committee for Medicinal Products for Human Use (CHMP) updated Pfizer’s vaccine information, to clarify its position on the interval between the first and second doses, insisting that the administration of the second injection should be exactly “three weeks” after the first, modifying the previous prescription, which indicated “at least 21 days” after the first dose.
The EMA warned that with Moderna, “Currently, there is no clinical data on the efficacy of the vaccine when administered beyond the intervals used in the clinical trial, and according to the information on the product, it is recommended that the second dose be administered 28 days after the first”.

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.

The Euro Weekly News is running a campaign to help reunite Brits in Spain with their family and friends by capping the costs of PCR tests for travel. Please help us urge the government cap costs at http://www.euroweeklynews.com/2021/04/16/ewn-champions-the-rights-of-brits-in-spain-to-see-loved-ones-again/

Chris was born in a small village in Wales, where he ran his own successful construction company for many years, before deciding in 1990, to swap the grey skies and rain for the sunshine and lifestyle of the Costa del Sol. Late last year he made the move to Southern Portugal, and is now residing on the Algarve. Having sung and played in a rock band back in Wales, he still likes to go out and entertain in his spare time, singing in restaurants and golf clubs. Interests are of course music, especially from the 60s and 70s, movies, nice restaurants, and he has a passion for graphic design and online marketing.


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