Reuters. File photo: Chief Executive Officer of the pharmaceutical company AstraZeneca, Pascal Soriot, attends an interview with Reuters in Shanghai
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(Reuters) – AstraZeneca (Nasdaq 🙂 is likely to run an additional global trial to evaluate the low-dose effectiveness of its COVID-19 vaccine, its chief executive said on Thursday amid questions about its end results. Stage study.
Ongoing U.S. Instead of adding trial to the process, AstraZeneca could launch a new study to evaluate the low dose of its vaccine that performed better than the full dose, Pascal Soriot told Bloomberg News.
“Now that we’ve discovered that this belief seems like we have a better effectiveness, we need to do an additional study,” he said, adding that a new, potentially global, study could be accelerated. It will require fewer subjects. Because the effectiveness was already considered to be high.
As the news spreads, AstraZeneca is facing questions about its success rate, which some experts say could lead to a U.S. recession. And its chances of obtaining EU regulatory approval may be hampered.
Some scientists questioned the strength of the results released Monday, saying the experimental vaccine was 90% effective when used in a subgroup of trial participants who initially mistakenly received half the dose after the full dose.
Soriot said he did not expect the additional trial to delay British and European regulatory approvals.
Asked about the Bloomberg report, a spokesperson for Ast Strazeneca said there was a lot of merit in continuing to investigate the half-dose / full-dose method. Any further insights from the data will be added to the trial tests being prepared for regulatory presentation, he said.
Running additional trials may not complicate the race to develop a vaccine to help the British drugmaker control the epidemic, which has claimed more than a million lives and plunged the global economy.
Helen Fletcher, a professor of immunology at the London School of Hygiene and Tropical Medicine, said there would be no delay in getting Lilizandi in the second trial because the effectiveness of the high-dose regime still meets the World Health Organization’s goal. He said it was not uncommon to run new studies on approved vaccines.
The vaccine is one of three 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 in preventing illness, raising the bar to the skies.
Still, Ox developed with Oxford University is cheaper to make AstraZeneca shots, easier to distribute and scale faster than its competitors.
Britan asked its medicine regulator to assess on Friday that if the vaccine candidate adheres to strict safety standards from the point of view of temporary supply, it is 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 Britain by the end of next month.
Tpism
A peer-reviewed analysis of the data from the new trial will be published in a medical journal next week.
The European Medical Agency did not immediately respond to a request for comment.
AstraZeneca told Reuters early Thursday that the half-dose administration had been reviewed and approved by independent data safety monitors and British regulators, adding that the regulator had publicly confirmed there were no concerns.
U.S. Approval from the Food and Drug Administration (FDA) may take longer, although the agency is unlikely to approve the vaccine based on studies conducted elsewhere, especially given the results in question.
AstraZeneca’s head of research, Maine Pangalos, told Reuters on Monday that Pay-P would begin discussions with the FDA to change the design of its trial to add a more effective dose regime.
Authorization is expected in some countries before the end of the year.
Astrageneca (LON 🙂 has made deals to supply vaccines to many countries, including 120 million doses to Japan and 85 million doses to Australia.
Speaking to the media, Australian Prime Minister Scott Morris expressed confidence in the vaccine, which is being developed by the country’s biomedical giant CSL (OTC 🙂 Limited.
The Serum Institute of India is conducting vaccine tests there.
“Even the lowest efficacy results are -0-at0%, making it a suitable vaccine against the virus,” the organization said in a statement.
