it is the process and informed consent to use vaccines


Posted: Saturday May 22, 2021 8:13 AM

A key movement in the vaccination campaign in Spain soon after the results of the clinical trial of the Carlos III Institute became known. Health has already obtained informed consent for all people under the age of 60 who have received a first dose of AstraZeneca (also known as Vaxzevria) and who wish to supplement the regimen with the same formula. The bioethics committee approved this option on Friday, although the recommendation from the ministry, as well as communities, is that this group receive a second dose of Pfizer, the solution developed by BioNTech.

For now, Andalusia has already announced that it will begin next week to vaccinate people under the age of 60 who belong to essential groups and who have already received the first injection of AstraZeneca. However, they made it clear to the Board of Directors that they would also seek informed consent for those who are vaccinated with Pfizer. The same will be true for Galicia, Castile and León, Madrid or Murcia, which will begin to meet in the coming days to relaunch the chain of vaccination intended for those who have been using a single dose of Vaxzevria for weeks. In total, almost two million people in Spain took the first dose of this formula.

Is there a difference in this new protocol of action? Those groups awaiting the full schedule will, as has been done so far, receive a call or text message to inform them of when and where they need to go to complete the immunization process. Once in the determined center, depending on the territory, things change somewhat. In principle, patients will not have a choice between one solution and another, as it may seem so far. In other words, BioNTech will be offered directly. However, the person to be vaccinated may reject it.

In this case, AstraZeneca will be offered to you as an alternative. To do this, you must complete a form in which data such as name, surname, place and date of vaccination must be included. And also, of course, the signature. Because with this document – and with the relevant section – two points are certified: that it is refused to receive a dose other than the first and that it is explicitly claimed to complete the vaccination schedule with AstraZeneca. This is, in short, the solution the government has found to all the problems that have accompanied this vaccine almost from the start.

We recommend that all essential staff who were vaccinated on the first day with AstraZeneca follow the same formula. “

Not everyone is convincing. Although Pfizer is the vaccine health and the Autonomous Communities have agreed upon, there are groups that are distancing themselves from this decision. The Spanish Society of Clinical Pharmacy has asked the ministry – and recommends – that “all essential staff members who were vaccinated on day one with AstraZeneca receive the same formula. This is our request to the ministry ”. The same goes for firefighters or police unions. Most of these staff members prefer the directive to be supplemented with AstraZeneca. A path that can also be followed by many teachers.

AstraZeneca and the many obstacles

After approval by health authorities – including the European Medicines Agency, which insists on its use – and the subsequent distribution of AstraZeneca, a series of thrombus cases were observed which generated a wide wave of fear and fear. concern about the effects. had been observed in this remedy. But although statistics indicate that these possible thrombotic events can only occur in one in 100,000 people vaccinated with AstraZeneca, knowledge of this information has led many countries to question its use in the population.

Among them, Spain, which to make this decision relied on the data it collected in two different ways: the first, from the results that have been produced by clinical trials such as the one prepared by researchers belonging mainly to University of Oxford (the same one that develops Vaxzevria), or that of the Carlos III Institute in the study on the mixture of vaccines.

In the first study, conducted among 448 people – a sample insufficient to obtain real information on the impact of this vaccine – it was determined that the combination of AstraZeneca and Pfizer may increase the risk of adverse reactions, but they are light and short. -lived .; among them, headaches, fatigue or fever. In the second survey, the Spaniard deduced that “people who have received a first dose of AstraZeneca can safely and effectively receive a second dose of Comirnaty (Pfizer)”. 676 patients participated in this trial, also a small number.

The second way in which our country has taken into account to agree on the vaccine mix comes directly from Europe. More precisely, among the countries which already use this procedure to vaccinate their population. Although in territories like Norway or Denmark the use of Vaxzevria is suspended, in others like France, Sweden or Finland they have been combining the two formulas for more than a month. So far, none of those countries have reported any strange or rare adverse cases, which has given healthcare wings to endorse this same path.

Mixing up vaccines, an inevitable end

Spain has also set its sights on what happened in the UK, which is currently the country that has put the most doses of AstraZeneca. In total, nearly seven million who have helped them become one of the world leaders in immunization without recording serious consequences. However, as in other states, the British have also placed limits on its use, not being recommended for citizens under the age of 40. In any case, it should be pointed out that, although this had not been done so far, the vaccines were going to end up being mixed, yes or yes. All over the world, and of course in the European Union.

The EU has already announced that it will not renew its contracts with AstraZeneca. In other words, none of the Member States were going to receive more injections of the Oxford formula for a possible third dose, or to vaccinate annually if necessary. The reason, apart from the thrombus episodes recorded with this remedy which upset the foundations of the vaccination campaign, were the problems that the pharmaceutical company itself raised as a supplier of its product, distinguished by its delivery delays or guarantee them. In contrast, Europe has grown and signed new contracts with Pfizer as the main alternative to end the pandemic once and for all.

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