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The symptomatic covid-19 vaccine developed by the English University of Oxford with the pharmaceutical company AstraZeneca it has acceptable levels of safety and is effective, according to preliminary results from Phase 3 of clinical trials published this Tuesday in the journal ‘The Lancet’ (read the article here).
The Oxford experts published on Tuesday, for the first time, the conclusions of their clinical tests, which showed an absence of hospitalizations or “severe illness” in the individuals of the vaccinated group.
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These results on the clinical efficacy of the drug (AZD1222) -reviewed by other independent experts- come from the analysis of a pre-specific group of Phase 3 carried out in the United Kingdom and Brazil with 11,636 subjects, to which is added “safety data” from a total of 23,745 individuals tested in four tests carried out in the UK, Brazil and South Africa.
The Oxford team, led by Andrew Pollard and Sarah Gilbert, found that their vaccine, administered in two doses (preparatory and booster), is effective in an average of 70 percent, although the variation in the amount of each dose affects in the result. Thus, when half a dose is administered followed by a full dose, the efficacy level of the vaccine rises to 90 percent and drops to 62 percent when volunteers receive two full doses of the preparation.
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Among the 23,745 immunized people, only three in a median period of 3.4 months experienced “serious adverse effects” that could be attributed to the vaccine, although all have recovered or are recovering and continue to participate in clinical trials, the Oxford experts explained in a statement.
“In future analyzes, with the inclusion of more data as it becomes available, we will investigate differences in key sub-groups -such as older adults-, various ethnicities, doses, times of administration of booster vaccines, and thus we will determine which responses immune systems offer protection against infection or disease, “said Merryn Voysey, one of the study’s authors.
Pollard, for his part, stressed that “the efficacy of our vaccine” has exceeded the thresholds set by the health authorities, including those of the European Union (EU), which has yet to give its approval to this drug.
We will only achieve control of the pandemic if the licensing, manufacturing and distribution of these vaccines can be carried out on an unprecedented scale …
“We will only be able to control the pandemic if the licensing, manufacturing and distribution of these vaccines can be carried out on an unprecedented scale, and the vaccination process reaches the most vulnerable,” said the Oxford scientist.
But nevertheless, The efficacy of the vaccine could not be assessed in older age groups because there were not enough infections, according to the data. Because older adults were recruited into the studies later than younger ones, “they have had less time for cases to accumulate in those age groups and for us to measure a signal of efficacy,” Pollard said.
“The evidence we have so far on the immune response suggests that there are likely similar levels of protection at all ages,” he added.
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How does the vaccine work?
AZD1222 has been made from the genetic modification of a common cold virus that affects chimpanzees, But it does not cause disease in humans and is capable of expressing the S protein of SARS-CoV-2, the coronavirus that causes covid-19.
In essence, this vaccine is based on the viral-vector platform that uses a designer virus to carry coronavirus genes and produce defense reactions in the body. In this case, a chimpanzee adenovirus called ChAvOx1 has been taken, which when tested in humans has been effective in terms of protection in people over 18 years of age.
This project has the great advantage of using a more traditional technology than its competitors, which makes it less expensive and easier to store and transport, since it does not need to be kept at a very low temperature: it can be stored for at least six months refrigerated between 2ºC and 8ºC, specified the British team.
The United States gave the project $ 1.2 billion, which separated 300 million doses, if approved. In the same sense, the European Union made agreements for 14 million doses and some countries, through collective strategies, have also negotiated.
EFE AND HEALTH UNIT
