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AstraZeneca may need to conduct an additional global trial to assess the effectiveness of its COVID-19 vaccine, after concerns were raised about the effectiveness of its vaccine.
The UK company’s chief executive, Pascal Soriot, reportedly said in a Bloomberg News report Thursday that additional study would be conducted to assess a lower dosage that worked better than a full amount in AstraZeneca studies.
“Now that we’ve found what appears to be better efficacy, we need to validate that, so we need to do an additional study,” Soriot said.
Soriot said it would probably be another “international study, but this one could be faster because we know the efficacy is high, so we need a smaller number of patients.”
The news comes as AstraZeneca and its partner the University of Oxford have faced questions over its pass rate that some experts believe could hamper its chances of getting early approval from US regulators. and the European Union.
Several scientists have questioned the robustness of results released Monday showing the experimental vaccine to be 90% effective in a subset of trial participants who initially mistakenly received a half dose followed by a full dose.
Soriot said he did not expect the additional testing to delay regulatory approvals in the UK and Europe.
US Food and Drug Administration (FDA) approval may take longer, as the agency is unlikely to approve the vaccine based on studies conducted elsewhere, especially given questions about the results, he said.
Authorization in some countries is still expected before the end of the year, he added.
AstraZeneca chief research officer Mene Pangalos told Reuters on Monday that researchers stumbled upon the half-dose regimen by accident, saying a subgroup of the trial received an initial dose smaller by mistake.
Previously, he said the company would enter into discussions with the FDA to change the design of its COVID-19 vaccine investigational trial to add the most effective dosing regimen.
‘The vaccine works’
While this could be a setback for the UK company, Chris Smith, a consultant virologist at the University of Cambridge, said the mistake could actually turn out in AstraZeneca’s favor.
“What they found… was that they had a group of individuals who had a response rate of over 90% to their vaccine, and another group who responded a little less well, down. 60 or 70%, ”Smith told Al Jazeera.
“Then, analyzing the data, they found that people who received a smaller amount first, and then a larger dose afterwards, actually responded better than people who received two larger doses,” said he declared.
“If this turns out to be the case, then the 100 million doses of vaccine that the UK has already purchased from AstraZeneca, instead of treating half the population, will provide enough coverage to cover the entire population. population, ”Smith added.
Meanwhile, on the same day, UK government chief scientific adviser Patrick Vallance said the main point about the AstraZeneca COVID-19 vaccine was that it worked, when asked about the doubts that have been raised about the vaccine.
“The main result is that the vaccine works and it’s very exciting,” Vallance said at a press conference with Prime Minister Boris Johnson.
Chief Medical Advisor Chris Whitty, answering the same question, said there was still a scientific debate about virtually everything.
“The gist of our point of view is to leave that in the hands of the regulator … They will do an assessment with a lot of data that is not currently in the public domain on efficacy and safety,” said Whitty.
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