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AstraZeneca CEO expects to run new global trial of COVID-19 vaccine: Bloomberg

Coronavirus Nov 26, 2020 10:45PM ET
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2/2 © Reuters. FILE PHOTO: Pascal Soriot, chief executive officer of pharmaceutical company AstraZeneca, attends an interview with Reuters in Shanghai 2/2

(Reuters) - AstraZeneca (NASDAQ:AZN) is likely to run an additional global trial to assess the efficacy of its COVID-19 vaccine using a lower dosage, its chief executive was quoted as saying on Thursday amid questions over the results of its late-stage study.

Instead of adding the trial to an ongoing U.S. process, AstraZeneca might launch a fresh study to evaluate a lower dosage of its vaccine that performed better than a full dosage, Pascal Soriot told Bloomberg News.

"Now that we've found what looks like a better efficacy we have to validate this, so we need to do an additional study," he said, adding that the new, likely global, study could be faster because it would need fewer subjects as the efficacy was already known to be high.

The news comes as AstraZeneca faces questions about its success rate that some experts say could hinder its chances of getting speedy U.S. and EU regulatory approval.

Several scientists have raised doubts about the robustness of results released on Monday showing the experimental vaccine was 90% effective in a sub-group of trial participants who, by error initially, received a half dose followed by a full dose.

Soriot said he did not expect the additional trial to delay British and European regulatory approvals.

Asked about the Bloomberg report, an AstraZeneca spokesman said there was strong merit in continuing to investigate the half-dose/full dose regimen. Any further insights from the data would be added to those from existing trials that are being prepared for regulatory submission, he said.

Running an additional trial might not be too much of a complication for the British drugmaker in the race to develop a vaccine to help tame the pandemic, which has killed more than a million people and roiled the global economy.

Helen Fletcher, professor of immunology at the London School of Hygiene & Tropical Medicine, said another trial would not necessarily delay getting a green light as efficacy in the higher dose regime still met the World Health Organization's target. It was not unusual to run new studies on approved vaccines, she said.

The vaccine is one of three that could get approved before the end the year. This month, Pfizer (NYSE:PFE) and Moderna (NASDAQ:MRNA) reported that their vaccines were about 95% effective in preventing illness, setting the bar sky-high.

Even so, the AstraZeneca shot developed with Oxford University is cheaper to make, easier to distribute and faster to scale up than its rivals.

Britain on Friday asked its medicine regulator to assess if the vaccine candidate met rigorous safety standards with a view for temporary supply, a step towards beginning a 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.

OPTIMISM

A peer-reviewed analysis of data from the new trial will be published in a medical journal in coming weeks.

The European Medicines Agency did not immediately respond to requests for comment.

AstraZeneca told Reuters earlier on Thursday that administering of the half dose had been reviewed and approved by independent data safety monitors and the British regulator, adding that the regulator publicly confirmed there was "no concern".

Clearance from the U.S. Food and Drug Administration (FDA) may take longer, though, because the agency is unlikely to approve the vaccine based on studies carried out elsewhere, especially given the questions over the results, Soriot said.

AstraZeneca research chief Mene Pangalos told Reuters on Monday the firm would start discussions with the FDA to change the design of its trial to add the more-effective dosage regime.

Authorisation in some countries is still expected before the end of the year.

Astrazeneca (LON:AZN) has struck deals to supply the vaccines in several countries, including 120 million doses to Japan and 85 million doses to Australia.

Australian Prime Minister Scott Morrison, talking to media, expressed confidence about the vaccine, which is being manufactured by the country's biomedical giant CSL (OTC:CSLLY) Ltd.

The Serum Institute of India is conducting trials of the vaccine 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 trials were running smoothly.

AstraZeneca CEO expects to run new global trial of COVID-19 vaccine: Bloomberg
 

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Comments (8)
Roger Miller
Roger Miller Nov 26, 2020 10:14PM ET
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In reality the initial half dosing regime may be promising, but discovering it was a fluke and probably had much fewer participants. The they also have to ask if they screwed up the dosing what else could have been messed up? My main problem is the article stating that the the global economy was roiled by the pandemic, when it was the response to it...which may or may not have been the correct one. Spinning it like that reduces the chance that we will analyze the response, and learn from our mistakes.
Vivek Purav
Vivek Purav Nov 26, 2020 9:34PM ET
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90%  - 95% efficiency sounds 5% - 10% chance to say good by ,
Jacob Steinschlag
Jacob Steinschlag Nov 26, 2020 9:34PM ET
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You obviously have zero idea how vaccines work and whaf they're supposed to do.
Harry Wilson
Harry Wilson Nov 26, 2020 8:32PM ET
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Ok so one of the 99 vaccines has a dosing problem, big deal. Moderna's vaccine is perfect.
Robert Cox
Robert Cox Nov 26, 2020 8:32PM ET
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As evidenced by all of the executives selling their shares and none of them actually purchasing any.
Jesse Mulliniks
Jesse Mulliniks Nov 26, 2020 7:24PM ET
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Reality is setting in. The vaccine pumps were the last chance before the wealthy elites jump ship and sell everything. We are about to witness a massive crash. SPY will go below $200 by end of 2021
Edmund Bloom
Edmund Bloom Nov 26, 2020 7:21PM ET
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They should've done this during their phase 3 trial . One group is placebo, another group for full dose and the last is the half dose . This company is a joke .
James Bell
James Bell Nov 26, 2020 7:08PM ET
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these companies stock will suffer horribly if their vaccines don't perform as advertised in the field.
New Jazenevd
New Jazenevd Nov 26, 2020 6:35PM ET
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Europe cannot do anything right. Big surprise.
Jurgen Daub
Jurgen Daub Nov 26, 2020 6:35PM ET
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the parent (country) fell not far from the child
Jacob Steinschlag
Jacob Steinschlag Nov 26, 2020 6:35PM ET
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Is that so? Biontechs/Pfizers vaccine has been developed 50/50 in Germany and America.
marv chin
marv chin Nov 26, 2020 5:22PM ET
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Long story short: the whole vaccine is a complete joke!
Amit Patel
Amit Patel Nov 26, 2020 5:22PM ET
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They wanted their stock to go up so the higher ups could cash out.
John Stanton
John Stanton Nov 26, 2020 5:22PM ET
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90-95% efficacy sounds good to me
Jesse Mulliniks
Jesse Mulliniks Nov 26, 2020 5:22PM ET
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Amit Patel its true.
 
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