© Reuters. FILE PHOTO: Pascal Soriot, CEO of pharmaceutical company AstraZeneca, attended an interview with travelers in Shanghai
(Reuters) – AstraZeneca (NASDAQ 🙂 is likely to run an additional global trial to assess the efficacy of its COVID-19 vaccine using low doses, with its chief executive on Thursday questioning its late results Was quoted in reply. Stage study.
Instead of adding the test to a continuing US process, AstraZeneca could launch a recent study to evaluate lower doses of its vaccines, which outperform full doses, Pascal Soriot told Bloomberg News.
“Now that we have found what looks like a better efficacy, we have to validate it, so we need to do an additional study,” he said, adding that new, potentially global, studies may be faster because it has less Subjects would be required since efficacy was already known to be high.
In response to questions about AstraZeneca’s success rate, the news came out that some experts say it could hamper the US and EU’s chances of getting regulatory approval.
Many scientists have expressed skepticism about the prevalence of the results released on Monday, which showed that the experimental vaccine trial was 90% effective in a subset of participants who initially mistakenly received one half after one full dose. Dose received.
Soriot said he did not expect additional testing to delay British and European regulatory approvals.
When asked about the Bloomberg report, a spokesperson for AstraZeneca said that the half-dose / full-dose diet had strong merit in continuing its investigation. Further insights from the data will be added from existing tests to those being prepared to present the regulator, he said.
Running an additional trial for a British drugmaker in the race to develop a vaccine to prevent the epidemic may not be too complicated, which has killed more than a million people and robbed the global economy.
Helen Fletcher, a professor of immunology at the London School of Hygiene and Tropical Medicine, said that another test does not necessarily delay achieving the green light because efficacy in the high-dose regime still meets the World Health Organization goal. He said that it was not uncommon to run new studies on approved vaccines.
The vaccine is one of three that may be approved before the end of the year. this month, Pfizer (NYSE:) and Moderna (NASDAQ 🙂 reported that their vaccines were about 95% effective in preventing the disease, setting up Bar Sky-High.
Nevertheless, the AstraZeneca shot developed with the University of Oxford is easier to make, deliver, and increasingly cheaper than its rivals.
The UK on Friday asked its drug regulator to assess whether the vaccine candidate meets the stringent safety standards for temporary supplies, a step towards starting the roll-out of the vaccine before the end of the year.
AstraZeneca expects 4 million doses to be available in the UK by the end of next month.
A peer-reviewed analysis of the data from the new trial will be published in a medical journal in the coming weeks.
The European Medicines Agency did not immediately respond to requests for comment.
AstraZeneca told Reuters earlier on Thursday that half the dose had been reviewed and approved by independent data security monitors and the British regulator, adding that the regulator had publicly confirmed “no worries”.
Soryote said approval from the US Food and Drug Administration (FDA) may take longer, as the agency is unlikely to approve the vaccine based on studies done elsewhere, especially given the questions on the results .
AstraZeneca’s research chief Mene Pangloss told Reuters on Monday that the firm would begin discussions with the FDA to change the design of its trial to add more effective dosing regimes.
In some countries, authorization is required even before the end of the year.
AstraZeneca (LON 🙂 has made deals to supply vaccines in several countries, including 120 million doses to Japan and 85 million to Australia.
Australian Prime Minister Scott Morrison, speaking to the media, expressed confidence about the vaccine, which is being manufactured by the country’s biomedical giant CSL (OTC 🙂 Ltd.
The Serum Institute of India is conducting a vaccine trial there.
“Even the lowest efficacy results are at 60–70%, making it a viable vaccine against the virus,” the institute said in a statement, adding that the tests were running smoothly.