AstraZeneca CEO expects to conduct a brand new international research on the COVID-19 vaccine: Bloomberg
© Reuters. FILE PHOTO: Pascal Soriot, Managing Director of pharmaceutical company AstraZeneca, attends an interview with Reuters in Shanghai
(Reuters) – AstraZeneca (NASDAQ 🙂 is likely to conduct an additional global study to assess the effectiveness of its COVID-19 vaccine at a lower dose, its board chairman said Thursday amid questions about the results of its late stage study.
Instead of adding the study to an ongoing U.S. lawsuit, AstraZeneca could start a new study to evaluate a lower dosage of its vaccine that is better than a full dosage, Pascal Soriot told Bloomberg News.
“Now that we’ve found better effectiveness, we need to validate this. So we need to do an additional study,” he said, adding that the new, likely global study could be faster as fewer subjects would be needed as the effectiveness already exists was known as high.
The news comes as AstraZeneca is faced with questions about its success rate, which some experts believe could affect its chances of rapid US and EU approval.
Several scientists have expressed doubts about the robustness of the results released Monday, showing that the experimental vaccine was 90% effective in a subset of study participants who were initially mistakenly given half a dose followed by a full dose.
Soriot said he didn’t expect the additional process to delay UK and European approvals.
When asked about the Bloomberg report, an AstraZeneca spokesperson said it made very good sense to investigate the half-dose / full-dose regimen further. Any further insights from the data would be added to insights from existing studies that are being prepared for regulatory filing, he said.
Conducting an additional study may not be too much of a complication for the UK drug maker in the race to develop a vaccine to contain the pandemic that has killed more than a million people and upset the global economy.
Helen Fletcher, a professor of immunology at the London School of Hygiene & Tropical Medicine, said another study wouldn’t necessarily delay getting the green light, as the effectiveness of the regimen with higher doses still meets the World Health Organization’s goal. It is not uncommon to do new studies on approved vaccines, she said.
The vaccine is one of three vaccines that could be approved before the end of the year. This month, Pfizer (NYSE 🙂 and Modern (NASDAQ 🙂 reported that their vaccines were about 95% effective against disease and raised the bar.
Even so, the AstraZeneca shot developed with Oxford University is cheaper to manufacture, easier to distribute, and faster to scale than its competitors.
The UK on Friday asked its Medicines Agency to review whether the vaccine candidate meets strict safety standards for temporary care. This is a step towards introducing the vaccine before the end of the year.
AstraZeneca expects 4 million cans to be available in the UK by the end of next month.
An expert-reviewed analysis of the data from the new study will be published in a medical journal in the coming weeks.
The European Medicines Agency did not immediately respond to requests for comments.
AstraZeneca told Reuters earlier Thursday that the half-dose administration had been reviewed and approved by independent data security monitors and the UK regulator, adding that the regulator had publicly confirmed that there were “no concerns”.
However, clearance 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 said Soriot.
AstraZeneca’s chief research officer Mene Pangalos told Reuters on Monday that the company would start talks with the FDA to change the design of its study and add the more effective dosing system.
In some countries, approval is expected before the end of the year.
Astrazeneca (LON 🙂 has agreements to deliver the vaccines in several countries, including 120 million doses to Japan and 85 million doses to Australia.
Speaking to the media, Australian Prime Minister Scott Morrison said he was confident about the vaccine, made by biomedical giant CSL (OTC 🙂 Ltd. of the country is made.
The Serum Institute of India is conducting tests with the vaccine there.
“Even the lowest efficacy results come in at 60-70%, making it a viable vaccine for the virus,” the institute said in a statement, adding that the studies went smoothly.