Friday, January 15

The EMA advises against delaying the second dose of the Pfizer vaccine more than 42 days


A Pfizer vaccine.

A Pfizer vaccine.
EFE

The European Medicines Agency (EMA) advises against delaying the second dose by more than 42 days of the Pfizer-BioNTech vaccine against Covid-19, while countries such as Germany or Belgium are studying giving the first injection to more people at the beginning and delaying the second beyond the prescribed 21 days.

That agency, in charge of the technical evaluation of vaccines in the European Union (EU), points out that “those vaccinated cannot be fully protected until 7 days later of its second dose, “as Pfizer has indicated after its clinical trials, EMA spokeswoman Sophie Abbe told EFE.

However, the EMA does not prohibit extending the administration of the second dose to 42 days. While the product information “does not explicitly define the upper limit for the time between doses, the dosage recommendations make an explicit reference (…) where it is specified, respectively, that the efficacy evidence is based on a study in which the administration of 2 doses was carried out with 19 to 42 days apart“he added.

“Any change” in that mode of use “would require a variation of marketing authorizationas well as more clinical data to support this change; otherwise, it would be considered ‘off-label use’, “added the EMA spokeswoman.

Ante la initial vaccine shortages while increasing production capacityAt the expense of other vaccines such as the American laboratory Moderna or the British prototype from AstraZeneca and the University of Oxford being authorized in the EU, there are countries that are considering modifying their vaccination strategies.

The European Comissionwhich ultimately approves the distribution of vaccines in the EU if the European Medicines Agency considers the prototypes to be effective and safe, had avoided entering the clinical debate on dosages and had referred that medical decision to the EMA.

Belgium was the first EU member state to publicly state that it would ask its experts to analyze this possibility, an initiative that has also been joined by Germany, which is studying postponing the second dose until that theoretical maximum of 42 days.

Immunize the greatest number of people

Given the increased transmissibility of the British variant of the coronavirus, the Belgian virologist Pierre Van Damme, who is part of the Belgian working group on the coronavirus, even proposed that only the first dose be administered to immunize as many people as possible, or leave the second for six months later, when there is sufficient production, although that idea has been discarded.

Also, the UK, which is no longer a Member State of the EU and is not subject to the decisions of the EMA Instead of the regulation of the British Regulatory Agency for Health Products and Medical (Mara, in English), it studies concentrating vaccination on the first doses and postponing the second injection.

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