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AstraZeneca may have to conduct an additional global trial to assess the efficacy of its COVID-19 vaccine, after concerns were raised about the effectiveness of its vaccine.
The British company’s chief executive, Pascal Soriot, said in a Bloomberg News report Thursday that an additional study would be conducted to evaluate a lower dose that worked better than a full amount in the AstraZeneca studies.
“Now that we’ve found what looks like better efficacy, we have to validate this, 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 fewer patients.”
The news comes as AstraZeneca and its partner, the University of Oxford, have faced questions about its success rate that some experts say could hamper their chances of gaining speedy approval from US and EU regulators. European.
Several scientists have raised questions about the robustness of results published Monday that show the experimental vaccine was 90 percent effective in a subset of trial participants who mistakenly initially received a half dose followed by a full dose.
Soriot said he did not expect the additional trial to delay regulatory approvals from the UK and Europe.
However, approval by the U.S. Food and Drug Administration (FDA) may take longer because the agency is unlikely to approve the vaccine based on studies done elsewhere, especially given questions about the results, he said. .
Authorization is still awaited in some countries before the end of the year, he added.
AstraZeneca’s head of research, Mene Pangalos, told Reuters on Monday that researchers had stumbled upon the half-dose regimen by accident, saying that a subset of the trial was given a smaller starting dose by mistake.
It had previously said that the company would initiate discussions with the FDA to change the design of its experimental COVID-19 vaccine 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 work in AstraZeneca’s favor.
“What they found … was that they had one group of people who had a response rate of more than 90 percent to their vaccine, and another group that responded slightly less well, 60 or 70 percent less,” he said. Smith to Al Jazeera.
“Then, looking at the data, they found that people who got a smaller amount first and then a higher dose later actually responded better than people who got two higher doses,” he said.
“If that’s the case, then the 100 million doses of the vaccine that the UK has already purchased from AstraZeneca, rather than treating half the population, will provide sufficient coverage for the entire population,” Smith added.
Meanwhile, on the same day, the British government’s chief scientific adviser, Patrick Vallance, said that the main point of the AstraZeneca vaccine against COVID-19 was that it worked, when asked about questions that had been raised about the vaccine.
“The main result is that the vaccine works and that is very exciting,” Vallance said during a news conference with Prime Minister Boris Johnson.
Chief Medical Advisor Chris Whitty, answering the same question, said there was always a scientific debate about just about everything.
“The key from our point of view is to leave this up to the regulator … They will do an evaluation with a lot of data that is not currently in the public domain on efficacy and safety,” said Whitty.
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