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The Swedish-British pharmaceutical AstraZeneca admitted on Thursday that its project for a vaccine against covid-19, which had an efficacy of close to 70 percent, as initially revealed from preliminary reports, needs an “additional study”.
Specifically, the executive director of the laboratory considered that it is necessary to carry out further research on its vaccine against covid-19, following questions about the protection it can offer against the coronavirus.
“Now that we have found what appears to be greater efficacy we have to validate it, so we need an additional study.”Pascal Soriot said in an interview with Bloomberg.
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This Thursday, precisely, the University of Oxford, which is also participating in this project, admitted that, by mistake, there were “differences” in the way of administering the doses of its vaccine against covid-19 to the volunteers in the trials, but he clarified that the methods to measure the concentration of the antidote have already been “established”.
In a statement, the British university wanted to clear up the growing doubts that have arisen in recent days about the effectiveness of up to 90 percent that was observed in the subgroup that received first half a dose and then a full dose of the product.
After announcing on the 23rd the preliminary results of the third phase of the tests, the university implicitly acknowledges that the administration of the doses to the trial participants was based on an error. The group of experts, led by Andrew Pollard and Sarah Gilbert, initially reported that the vaccine, offered in two doses – preparatory and booster – is effective by an average of 70.4 percent, although the variation in the amount of each dose affects the result.
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When half a dose is given followed by a full dose, the level of efficacy rises to 90 percent – and reduces transmission. and it drops to 62 percent when volunteers receive two full doses of the antidote.
After the announcement, it was learned that the differences in the quantity of the doses administered between the different groups were based on a mistake and that the dose that obtained an efficacy of 90 percent was assigned to a group with much fewer participants, which for some implies questioning the results.
In its note, the university explains that in its study “two dose levels were used, based on the same measure of concentration used in phase I, but, as a result of a difference in the manufacturing process for the last study, This method was later shown to overestimate the dose in the new batches, which resulted in the administration of half a dose as the first dose. ”
He adds that “when it became clear that a lower dose had been used” the question was referred to the regulator and a plan was agreed to test that combination, allowing the research team “to include both approaches in phase III of the trial.”
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“The methods for measuring concentration have been established and we can ensure that all batches of the vaccine are now equivalent,” the note concludes.
For its part, a spokesperson for AstraZeneca argued that the trial was conducted adhering to “the highest standards” and anticipated that more analyzes will be carried out to establish the duration of protection offered by the vaccine.
According to the “Financial Times” newspaper, the head of the financing program for the development of vaccines in the US, Moncef Slaoui, revealed on the 24th that the subgroup – of just 2,300 people – that received the most effective dose was limited to individuals under 55 years of age, with a lower risk of developing severe symptoms of covid, a data that neither the university nor AstraZeneca disclosed when presenting their data. Therefore, Slaoui considers the possibility that the difference in the effectiveness of the
vaccine was “fortuitous”.
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