Coronavirus

This is what consent form for second AstraZeneca dose for under-60s will look like

Bioethics committee approves consent form for AstraZeneca recipients under-60 refusing a Pfizer booster, stating they are aware of the "infrequent risks".

A nurse preparing to vaccinate with AstraZeneca at the Faculty of Geography and History of the UB.
21/05/2021
2 min

MadridSome two million people under the age of 60 in the state have received the first dose of AstraZeneca's vaccine and are waiting to complete the schedule. The public health commission decided on Tuesday, with internal division, that as a general rule this group will receive a second dose of Pfizer, but left the door open to also use the Anglo-Swedish drug. This was requested by many of the autonomous communities, such as Catalonia and Madrid. This Friday the bioethics committee has endorsed that people who choose to repeat doses with AstraZeneca will have to sign a consent form in which they state in writing that they reject the Pfizer vaccine to complete the schedule and that they accept the "infrequent risk of developing a thrombosis syndrome with thrombocytopenia".

The Ministry of Health has thus modified the update number 7 of the vaccination strategy to add as an annex a proposal for consent. In the first paragraphs it is stated that the immunisation of society is making progress thanks to the vaccine and that the restrictive measures of the last year have failed to curb the pandemic. "Through vaccination, not only can hospitalisation and death from covid-19 be avoided in a high proportion of vaccinated people, but it also reduces infection and, therefore, the transmission of the virus," introduces the written consent.

The document goes on to explain that the adverse effects of AstraZeneca's vaccine are similar to those of other vaccines and that its benefits outweigh the risks. Even so, it warns of the cases of thrombosis that were detected a few months ago and that led to limiting its use in people over 60 as of April 8. "In recent weeks some adverse events have been reported consisting of thrombosis of large vessels, cerebral and abdominal level (thrombosis syndrome with thrombocytopenia) which, although very infrequent, are also considered serious. These events seem to increase inversely to age, more frequently under the age of 60 years, and there is still uncertainty around them. There are a number of studies underway to further analyse why they occur," says the written consent.

Madrid says that it should be the other way around

This Friday Madrid Health Minister, Enrique Ruiz Escudero, has expressed disagreement with this written consent and has considered that it should be the other way around. That is, the default option should be AstraZeneca and only those refusing it should be given the option of a Pfizer vaccine. Ruiz Escudero has recalled that the data sheet of the vaccine and the European Medicines Agency endorse the full guideline of the Anglo-Swedish drug. Ruiz Escudero joined criticism against the ministry for leaving the decision in the hands of the public.

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