[ad_1]
Maybe not such a “happy” accident after all.
AstraZeneca’s coronavirus vaccine is coming under scrutiny after its British scientists made a major “mistake” in testing – a mistake that could even prevent it from being approved, according to reports.
The British drug maker and its partner, the University of Oxford, admitted – after reporting that its vaccine had been tested to be 90% effective – that promising results came after a batch of volunteers received accidentally taking half doses. The vaccine’s efficacy was significantly lower at 62 percent for those who received the two full doses properly administered.
Lead researcher Mene Pangalos insisted it was a “fluke,” but the error, which was not reported in the initial results, put the vaccine under close scrutiny. from scientists and industry experts.
The half-dose group had only 2,741 volunteers – and all were under 55, which raised the question of whether the relative youth of the participants created the positive results, and not the size of the dose.
“It pains me to say this, but… I think the claims made for the Oxford / AstraZeneca Covid-19 vaccine are on * very * fragile ground. We should wait for a big solid trial ”, scientist Hilda Bastian tweeted after the confessions of the testers.
Chemist Derek Lowe says the revelations putting British vaccine makers ‘at a standstill’.
“They have strong data for a relatively weak vaccine and weaker data for a relatively strong vaccine,” he warned of low numbers accidentally given at the half dose.
“It’s really not handled well at all… it’s a good thing it’s not the first vaccine to read,” he added, referring to previous vaccine testing announcements from Pfizer and Moderna. .
The former head of research and development at one of those rivals, Pfizer, questioned whether this would derail the approval of the AstraZeneca vaccine.
“It’s hard to believe that the [US Food and Drug Administration] will issue [emergency use] for a vaccine for which the optimal dose has only been administered to 2,300 people ‘, Dr John LaMattina tweeted. “More data will be needed for this dosing regimen.”
Natalie Dean, biostatistician and vaccine trial design expert at the University of Florida, gave the British team “A bad mark for transparency and thoroughness.”
“It’s terribly confusing for experts and non-experts alike,” she writes.
The error and confusion over the results caused the company’s shares to fall 6.2%, with industry experts also losing confidence, according to Bloomberg News.
“Anytime you get confused in the essays it’s not a good thing because it effectively takes away any credibility you had,” Ketan Patel, a fund manager at EdenTree Investment Management, told Bloomberg.
“I think there will be much closer scrutiny of Astra’s product due to the manufacturing issue.”
Geoffrey Porges, an SVB Leerink analyst, was another predictor that this might be enough to prevent the FDA from approving the vaccine for use.
“I don’t believe the FDA will look positively on a trial where the dose, or age cohorts, or any other variable were changed midway through, either inadvertently or deliberately,” Porges told Bloomberg News. “I think they’ve really damaged confidence in their entire development agenda,” he told The Times.
Other experts are also concerned about the suggestion that the low-dose group increased overall effectiveness to 70 percent.
“You took two studies where different doses were used and you found a composite that does not represent any of the doses,” said David Salisbury, associate member of the Global Health Program in the Chatham House Think Tank. “I think a lot of people have problems with that.”
A spokesperson for Astra told Bloomberg that the trials had been conducted “to the highest standards” and that more analysis was underway to refine the reading of the efficacy.
With pole wires
[ad_2]
Source link