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AstraZeneca vaccine: Peruvian volunteers will be followed for two years

In the race to find an alternative to curb the pandemic of COVID-19Thousands of volunteers around the world were enrolled in various clinical trials of vaccines. In Peru, one of the countries most hit Due to the health crisis, many people made their time and health available to test the vaccines in development.

One of the trials conducted in the country is that of the Oxford / AstraZeneca vaccine, which counts. In total, the investigation, which was also carried out in Chile and the United States, enrolled 32,451 people.

One group received the vaccine and the other a placebo, with the aim of determining the efficacy of the AZD1222 viral vector immunizer (ChAdOx1 nCoV-19) for 15 days after the second dose in adults and older adults. The phase III clinical trial was double blind and randomized; that is, neither the participants nor the researchers knew which group they belonged to.

Now, a recent study published in The New England Journal of Medicine, one of the most important medical publications in the world, reports the results of these tests:

According to the article, the trial was not designed to determine efficacy by country, but overall efficacy was. This is due, among other factors, to the difference in the number of participants per region.

“There are two factors to take into account: one, effectively, is the number of participants and two is the it was much shorter […] There is no precise efficacy by country, but I believe that the laboratory has been as transparent as possible in exposing the data of each country ”, says the Peruvian doctor Alfredo Guerreros, one of the signatories of the study.

The trial included healthy people over 18 years of age with comorbidities (cancer, diabetes, HIV, etc.); 60% had more than one of them. In addition, people with a high degree of exposure to contagion and older adults were included.

“At the time that we have carried out the recruitment of patients, and we had no prevention alternatives [para el COVID-19]″, clarifies the researcher.

, in order to monitor their health status after the application of the vaccine, which is currently the third most used in the immunization campaign against COVID-19.

Viral vector vaccines are used against COVID-19.  This is the technology used by Oxford / AstraZeneca.  (Image: CDC-USA)

Vaccine safety

Overall, the vaccine was safe for the participants. Among the most common adverse effects, the. All of them short-lived.

The incidence of serious adverse effects was low: 0.5% of the total, both in the placebo group and the vaccine group.

As it is known, the AstraZeneca vaccine was questioned by some [coágulo sanguíneo que puede llegar a ser mortal] after the injection, which has not yet been directly related to the vaccine.

The authors clarify that within the framework of this study “There were no cases in any of the groups (placebo and vaccine) of tcerebral venous sinus rhombosis or venous thrombosis in unusual locations ”.

The effects of interest recorded, which were treated medically, were significantly rare and presented in a similar proportion in both groups. They were registered from neurological, vascular and hematological problems, but they only affected

A health worker prepares a dose of the AstraZeneca / Oxford vaccine at a coronavirus vaccination center at the Wanda Metropolitano stadium in Madrid, Spain.  (GABRIEL BOUYS / AFP).

It is important to clarify that in a clinical trial an adverse event is any incident that is detrimental to the health of the volunteer, which has not necessarily been caused by the product under investigation. This means that every health problem in a volunteer will be recorded, but

“From our experience in the research center [de la Clínica Internacional] that we direct -which was the one that recruited the most in Peru, 580 patients-, . Some patient had local allergic reactions, such as redness and even some cellulitis, which I would consider to be the most serious, but vaccine-associated thrombocytopenia, which is the most serious event related to this vaccine, there was none “, the researcher details. Three research centers were included in the country.

During the investigation period, seven deaths were recorded in participants in the AZD1222 group and seven in the placebo group. “The researchers considered that no deaths were related to the vaccine or the placebo. (vaccine), and there were two COVID-19 related deaths in the placebo group “, the authors note.

The variants of SARS-CoV-2, the virus that causes COVID-19, detected in the study were Alpha, Beta, Epsilon and Iota. Delta was not yet predominant.

Most used COVID-19 vaccines in the country.  (Minsa / Reunis)

In Peru, about 13 million people have been administered and have the complete scheme, which represents 47% of the target population. As for the AstraZeneca vaccine, more than 1.2 million doses have been applied; It is the third most used in the country.

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