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LONDON (REUTERS) – AstraZeneca is likely to conduct an additional global trial to assess the efficacy of its Covid-19 vaccine, its chief executive, Pascal Soriot, said on Thursday (Nov. 26) after questions about the results of its latest stage. . study.
Rather than adding the trial arm to an ongoing process in the US, a new study would be conducted to evaluate a lower dose that worked better than a full amount in the AstraZeneca studies, Soriot said in a Bloomberg report. News.
“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 is faced with questions about its success rate that some experts say could hamper its chances of gaining speedy regulatory approval from the US and the EU.
Several scientists have raised questions about the robustness of results published Monday that show the experimental vaccine was 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 trial to delay regulatory approvals from the UK and Europe.
When asked about the Bloomberg report, an AstraZeneca spokesperson said there was “great merit in continuing to investigate the half-dose / full-dose regimen.”
“We are evaluating the data further and will work with regulators on the best approach for further evaluation,” he said.
“This would be in addition to data from existing trials that are currently being prepared for regulatory submission.”
AstraZeneca told Reuters early Thursday that the administration of half the dose had been reviewed and approved by independent data safety monitors and the UK regulator, adding that the regulator publicly confirmed that “there were no concerns.”
However, approval by the US Food and Drug Administration (FDA) may take longer because the agency is unlikely to approve the vaccine based on studies done elsewhere, especially given the questions about the results, said.
Authorization is still expected in some countries before year-end, 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 received 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.
Conducting an additional test might not be a huge complication for the British drugmaker in the race to develop a successful vaccine to help control the pandemic, which has killed more than a million people and affected the global economy.
Helen Fletcher, a professor of immunology at the London School of Hygiene and Tropical Medicine, said another trial would not necessarily delay getting the green light, as efficacy at the highest dose regimen still met the World Organization’s target for Health, and it was not unusual to do so. new studies on approved vaccines.
“It is very possible that AZ and Oxford could authorize the high dose and then quickly seek an amendment to use the low dose when they have sufficient data,” he said.
The vaccine is one of three that could be approved before the end of the year. Earlier this month, Pfizer and Moderna reported that their vaccines were approximately 95% effective at preventing disease, setting the bar very high.
Still, the AstraZeneca outlet developed with the University of Oxford is cheaper to make, easier to distribute, and faster to scale than its rivals.
A peer-reviewed analysis of the trial data will be published in a medical journal in the coming weeks.
The UK’s Medicines and Health Products Regulatory Agency (MHRA) continues its ongoing review of the vaccine, the regulator’s chief executive June Raine said in an email on Thursday.
“Any vaccine must undergo robust clinical trials according to international standards, with oversight provided by the Medicines and Healthcare Products Regulatory Agency (MHRA), and no vaccine would be authorized to supply in the UK unless meet the expected standards of safety, quality and efficacy are met, “he said.
Meanwhile, the developers of the Sputnik V Covid-19 vaccine said Thursday that AstraZeneca should try to combine its experimental injection with the Russian one to increase efficacy.
Russia said its Sputnik V vaccine is 92 percent effective in protecting people from Covid-19, based on interim trial results, while AstraZeneca said its Covid-19 vaccine was 70 percent effective in pivotal trials and could be up to 90 percent effective. .
“If they opt for a new clinical trial, we suggest trying a combination regimen of the AZ injection with the injection of the human adenoviral vector #SputnikV to increase efficacy,” said the developers of the Russian vaccine on their Twitter account.
“The combination of vaccines may be important for revaccinations.”
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