(Reuters) – AstraZeneca is likely to conduct a further global study to assess the effectiveness of the COVID-19 vaccine using a lower dose, the CEO was quoted as saying in a late-stage study on Thursday.
Instead of adding the study to an ongoing U.S. process, AstraZeneca could launch a new study to evaluate a lower dose of the vaccine that performs better than the full dose, quoted Pascal Soriot in a Bloomberg News report.
“Now that we’ve found better efficiency, we need to prove that, so we need to do more research,” he said.
Soriot says there will probably be another “international study, but it could be faster because we know the efficiency is high, so we need fewer patients”.
The news comes when AstraZeneca faces issues of failure that some experts say could hinder the chances of obtaining official approval from the US and the EU as soon as possible.
Several scientists have expressed doubts about the reliability of the results published on Monday that the experimental vaccine was 90% effective in a subset of experimental participants who initially received half a dose by mistake and then a full dose.
Soriot said he did not expect further negotiations to delay UK and European official approvals.
Asked about the Bloomberg report, an AstraZeneca spokesman said there were “serious merits in further investigating half-dose / full-dose dosing.”
“We will continue to evaluate the data and work with regulators on the best approach to further evaluation,” he said.
“This would complement existing experiments that are currently being prepared for regulatory submission.”
AstraZeneca told Reuters on Thursday that the administration of the half-dose had been reviewed and approved by independent data security observers and the UK regulator, adding that the regulator had publicly confirmed “no concern”.
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 elsewhere, especially considering issues over the results, Soriot said.
In some countries, licensing is expected before the end of the year, he added.
AstraZeneca research manager Mene Pangalos told Reuters on Monday that researchers accidentally came across the half-dose regime, saying one subgroup of the study had mistakenly given a lower starting dose.
Earlier, he said the company is starting talks with the FDA to change the design of the COVID-19 vaccine trial to add a more effective dosing system.
Running another trial shouldn’t be too much of a complication for the British pharmaceutical company in the race to develop a successful vaccine to curb the pandemic that is killing more than a million people and upsetting the global economy.
Helen Fletcher, a professor of immunology at the London School of Hygiene and Tropical Medicine, said another study did not necessarily delay the green light because the effectiveness of the higher-dose system remained in line with WHO targets and it was not uncommon to run new tests on approved vaccines. .
“It’s entirely possible that AZ and Oxford could allow the high dose and then quickly request an adjustment to apply the low dose if they have enough data,” he said.
The vaccine is one of three that can be approved before the end of the year. Earlier this month, Pfizer and Moderna reported that their vaccines were about 95% effective in preventing disease and setting the bar high.
Nevertheless, the AstraZeneca shot developed at the University of Oxford is cheaper, easier to distribute and scalable faster than its rivals.
An expert evaluation of the test data will be published in a medical journal in the coming weeks.
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) is continuing its review of the vaccine, June Raine, chief executive of the regulator, said in an email on Thursday.
“Any vaccine must undergo rigorous clinical trials in accordance with international standards, under the supervision of the Medicines and Health Products Regulatory Agency (MHRA), and no vaccine may be authorized for transport in the UK unless the expected safety, quality and efficacy standards they are satisfied, he said.
The European Medicines Agency did not respond immediately to the comments on the possibility of another study.
Report by entrepreneur Sabahatjahan in Bengaluru and Alistair Smout in London; By Josephine Mason; Edited by Alexander Smith, Pravin Char, Elaine Hardcastle and Tom Brown
