AstraZeneca repeats coronavirus vaccine tests, according to its CEO, after admitting a mistake in trials that could have skewed the results: Expert confidence in the validity of Covid-19 vaccine data released by AstraZeneca has eroded rapidly in just a few days.

The company reported Monday that its coronavirus vaccine had an efficacy of up to 90%, according to preliminary results of a study with 23, 000 volunteers in Brazil and the United Kingdom.

But it was later discovered that an error occurred during the clinical trial, which triggered a flood of doubts.

This Thursday, the CEO of the pharmaceutical company, Pascal Soriot, has admitted the concerns, and has said that they will probably conduct a second trial of the two-dose vaccine candidate, as Bloomberg has advanced this Thursday.

"Now that we have found what appears to be greater efficacy we have to validate it, so we need to do an additional study," Soriot acknowledged to Bloomberg.

The error, which meant that about 3,000 participants received one and a half doses of the vaccine instead of the planned two, actually produced a higher efficacy rate than those who received the planned amount.

To clarify this divergence and meet the demands of the public health community for more data, AstraZeneca is likely to conduct another "international study," Soriot said.

AstraZeneca repeats coronavirus vaccine tests

The objective will be to examine the solidity of this fortuitous half-dose regimen among more participants, he explained, adding that the study "could be faster because we know that the effectiveness is high, so we need a smaller number of patients".

AstraZeneca is the third company to report positive results during late-stage studies, following announcements by Moderna and Pfizer that their vaccines had an efficacy of 94.5% and 95%, respectively, earlier this month.

AstraZeneca's effectiveness rate, however, turned out to be a much more complex issue.

In a small group of participants (about 2, 700) a dose error occurred during the trial, so they received first half a dose, and then a second full dose. In that subgroup, the vaccine was 90% effective in preventing COVID-19, according to AstraZeneca.

But in a larger trial group, with 9,000 people, who received two full doses in succession, the efficacy was reduced to 62%.

Hours of bewilderment among experts trying to interpret this wide range of efficacy turned gloomy when AstraZeneca announced that the most effective regimen was the result of an accident.

"This is a considerable complication because [the half-dose/full-dose protocol] was produced by mistake, not [by] design," Sheila Bird, a biostatistician at the University of Cambridge's Medical Research Council, explained to Politico by email this Thursday.

Moncef Slaoui, head of us operation Warp Speed, also noted that the small group did not include any participants over the age of 55, which could explain why the vaccine was more effective in preventing COVID-19.

Others accused the company of "picking" the data to make it appear that the vaccine had a higher efficacy rate, and of not being transparent about how AstraZeneca reached its 70% efficacy figure, Wired reported Wednesday.

AstraZeneca repeats coronavirus vaccine tests


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