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Health & Fit AstraZeneca will likely retest its COVID-19 vaccine, CEO says after admitting an error in the first trial that may have skewed results

22:55  26 november  2020
22:55  26 november  2020 Source:   businessinsider.com

Internal AstraZeneca safety report sheds light on neurological condition suffered by vaccine trial participant

  Internal AstraZeneca safety report sheds light on neurological condition suffered by vaccine trial participant CNN has obtained an internal safety report by pharmaceutical giant AstraZeneca that sheds light on the neurological condition suffered by one of the participants in its coronavirus vaccine clinical trial. © Jason Alden/Bloomberg/Getty Images A sign featuring the AstraZeneca Plc logo stands at the company's DaVinci building at the Melbourn Science Park in Cambridge, U.K., on Monday, June 8, 2020. AstraZeneca Plc has made a preliminary approach to rival drugmaker Gilead Sciences Inc. about a potential merger, according to people familiar with the matter, in what would be the biggest health-care deal on record.

a man standing in front of a sign: A man walking past an AstraZeneca sign in Macclesfield, England. Phil Noble/Reuters © Reuters A man walking past an AstraZeneca sign in Macclesfield, England. Phil Noble/Reuters
  • The UK pharmaceutical company AstraZeneca is likely to run a second global trial to assess its COVID-19 vaccine's efficacy, its CEO told Bloomberg News on Thursday.
  • AstraZeneca and the University of Oxford announced Monday that preliminary results indicated their two-dose vaccine could be up to 90% effective at preventing COVID-19.
  • But the team later said an error in the trial left some participants with half-doses instead of full doses.
  • Experts said that error cast doubt on the validity of the efficacy rate and warranted further study.
  • Visit Business Insider's homepage for more stories.

Experts' trust in the validity of AstraZeneca's reported COVID-19 vaccine data has quickly eroded.

Second coronavirus vaccine is 94.5% effective in clinical trial

  Second coronavirus vaccine is 94.5% effective in clinical trial US-based Moderna has got a deal to supply 100million doses to the US and potentially 160million to the European Union but the jab is not one of the six pre-ordered by British officials.Early results from the company's final stage of clinical trials bring another landmark success in the global race to end the pandemic after Pfizer's vaccine, which works the same way, was found to be 90 per cent effective. But there won't be any Moderna doses available in Europe until spring 2021, while the US will get it this year.

AstraZeneca and the University of Oxford said on Monday that their coronavirus vaccine was found to be up to 90% effective based on preliminary results from studies of 23,000 volunteers in Brazil and the UK.

But reports of an error during its initial trial prompted a barrage of questions.

On Thursday, the pharmaceutical company's CEO, Pascal Soriot, acknowledged the concerns and said it would likely conduct a second trial of the two-dose vaccine, Bloomberg News first reported Thursday.

"Now that we've found what looks like a better efficacy we have to validate this, so we need to do an additional study," Soriot told Bloomberg News.

The error meant about 2,700 participants got 1 1/2 vaccine doses instead of the intended two. That actually resulted in a higher efficacy rate in that group than among those who got the prescribed amount.

AstraZeneca and Oxford Say Vaccine Is Up to 90 Percent Effective

  AstraZeneca and Oxford Say Vaccine Is Up to 90 Percent Effective AstraZeneca and the University of Oxford announced on Monday that their inexpensive, easy-to-produce coronavirus vaccine appears effective, the latest in a string of encouraging results this month from leading vaccine developers. An early analysis of data from late-stage clinical trials found that AstraZeneca’s vaccine was either 62 percent or 90 percent effective, depending on the manner in which the doses were given. While the overall efficacyAn early analysis of data from late-stage clinical trials found that AstraZeneca’s vaccine was either 62 percent or 90 percent effective, depending on the manner in which the doses were given.

Soriot said that to clarify this discrepancy and meet the public-health community's demand for more data, AstraZeneca would likely run another "international study" to examine the strength of the half-dose/full-dose regimen among more participants.

"But this one could be faster because we know the efficacy is high so we need a smaller number of patients," he added.

Experts question AstraZeneca's data

Vials of AstraZeneca's experimental vaccine. VINCENZO PINTO/AFP via Getty Images © VINCENZO PINTO/AFP via Getty Images Vials of AstraZeneca's experimental vaccine. VINCENZO PINTO/AFP via Getty Images

AstraZeneca is the third company to report positive initial results from late-stage studies. Moderna and Pfizer said earlier this month that their vaccines were found to be 94.5% and 95% effective.


Video: AstraZeneca announces its vaccine efficacy rate, CDC group meets to discuss distribution (CNBC)

AstraZeneca's efficacy rate, however, was more complicated.

AstraZeneca, Oxford say their vaccine is up to 90% effective

  AstraZeneca, Oxford say their vaccine is up to 90% effective AstraZeneca and the University of Oxford announced Monday that late-stage trials show their COVID-19 vaccine was up to 90% effective in preventing the disease. © Siphiwe Sibeko/Pool via AP A volunteer receives an injection at the Chris Hani Baragwanath Hospital in Johannesburg, South Africa, on June 24, 2020, as part of Africa's first participation in the AstraZeneca/Oxford COVID-19 vaccine trial. The results are based on interim analysis of phase 3 trials in the United Kingdom and Brazil, which looked at two different dosing regimens.

A dosing error during its trial resulted in about 2,700 participants receiving a half-strength dose followed by a full-strength dose. In that subgroup, the vaccine was 90% effective at preventing COVID-19, AstraZeneca said.

But in a group of about 9,000 participants who received two full-strength doses, that efficacy rate dropped to 62%.

Confused experts tried to interpret this broad range in efficacy, but that turned sour when AstraZeneca announced that the most effective regimen was an accident.

Sheila Bird, a biostatistician from the University of Cambridge's Medical Research Council, told Politico on Thursday that "this is a considerable complication" because the half-dose/full-dose regimen "occurred in error" and was not by design.

Moncef Slaoui, the head of the US's Operation Warp Speed vaccine-development program, also pointed out that the small group didn't include any participants over the age of 55, which could explain why the vaccine was more effective at preventing COVID-19.

Others accused the company of "cherry-picking" data to make it seem as if the vaccine had a higher efficacy rate and of not being transparent about how it arrived at its 70% average efficacy figure, Wired reported on Wednesday.

AstraZeneca and Oxford University's vaccine is effective at preventing COVID-19, trial results suggest. Here's everything we know so far.

  AstraZeneca and Oxford University's vaccine is effective at preventing COVID-19, trial results suggest. Here's everything we know so far. AstraZeneca and The University of Oxford's covid-19 vaccine is 70% effective, the groups say. Here's everything we know about the vaccine so far.The results follow months of trials of more than 20,000 volunteers in the UK, Brazil, and South Africa, and showed that the vaccine stopped people from developing any COVID-19 symptoms in 70% of the cases on average.

A volunteer in South Africa receiving an injection in a clinical trial of an experimental coronavirus vaccine. REUTERS/Siphiwe Sibeko © REUTERS/Siphiwe Sibeko A volunteer in South Africa receiving an injection in a clinical trial of an experimental coronavirus vaccine. REUTERS/Siphiwe Sibeko

All three vaccine frontrunners are still experimental. None of the companies has published results in a medical journal, and US regulators have not authorized any of the shots for emergency use, let alone given them full approval.

Andrew Dunn contributed reporting to this story.

Read the original article on Business Insider

FDA advisory committee to consider second COVID-19 vaccine, this one from Moderna, during all-day meeting .
An FDA advisory panel is expected Thursday to recommend authorization of the COVID-19 vaccine developed by Moderna. It could be in states by Monday.This time, the committee is reviewing a vaccine made by Cambridge, Massachusetts, biotech Moderna, with similar technology and results as the one it supported last week by Pfizer and its German collaborator, BioNTech.

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