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/

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Written by

Chris King

Originally from Wales, Chris spent years on the Costa del Sol before moving to the Algarve where he is a web reporter for The Euro Weekly News covering international and Spanish national news. Got a news story you want to share? Then get in touch at [email protected]

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