Except, apparently not restarting in the US or elsewhere just yet. 18,000 people have been placed in the trials (they're aiming for 30,000 people in the UK and IIRC, 80,000 in the US). This is the second pause.
So, that means no late October vaccine available (unless the UK accepts a short trial period with a lesser number of people). Certainly, the US will want a larger trial before approving it.
AstraZeneca coronavirus vaccine clinical trials resume in U.K. after pause over safety concerns
Was it paused in the US or Brazil? I don't think I read that fact.
They didnt intend to pause it in India initially.
Oxford University Covid-19 vaccine trials in India to continue despite 'pause' in UK: Serum Institute
This article mentions pausing in Brazil South Africa and US.
A leading coronavirus vaccine trial is on hold: scientists react
On Tuesday, health-news website
STATreported that the
US phase III trial of the coronavirus-vaccine candidate had been paused. On Wednesday, the University of Oxford confirmed to
Nature that enrolment in trials of the vaccine in Brazil, South Africa and the United Kingdom will also be paused.
“As part of the ongoing randomized, controlled global trials of the Oxford coronavirus vaccine, our standard review process was triggered and we voluntarily paused vaccination to allow review of safety data by an independent committee,” AstraZeneca said in a statement.
“This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated. We are working to expedite the review of the single event to minimize any potential impact on the trial timeline. We are committed to the safety of our participants and the highest standards of conduct in our trials,” the statement notes.
The race for coronavirus vaccines: a graphical guide
“If the event is linked definitively, or even probably, to the vaccine, it could be a definitive blow to this particular vaccine candidate. If unrelated, the hold might be lifted in a matter of weeks,” says Kieny.
But without more details of the adverse event, including how serious it is and when it happened, it is difficult to assess the impact it will have on the trials and the timeline for the vaccine’s approval, say scientists.
It is the second time that administration of the vaccine has been paused in the UK, according to two people who took part in the study and to information sheets uploaded to a clinical trial registry. Previously, a participant developed symptoms of transverse myelitis, an inflammation of the spinal cord which is often sparked by viral infections, according to an
information sheet given to trial participants dated 12 July. After a safety review, the trial resumed. The individual was diagnosed with an
“unrelated neurological illness”.
Cross-country trial
AstraZeneca started the trial of its vaccine candidate AZD1222 in the United States last month, with plans to enrol 30,000 adults at about 80 sites across the country. Efficacy trials in the United Kingdom, Brazil and South Africa involving a total of around 17,000 people are also under way. In a double-blind trial, roughly 20,000 of the US trial participants were to be given two doses of the vaccine, while the other 10,000 would receive a placebo. Such large-scale testing in people is needed before regulators, such as the US Food and Drug Administration, will approve a vaccine for widespread use.
Many countries, including the United States, have pre-ordered millions of doses of the Oxford vaccine in the hope that it will be successful. By late last month,
countries had ordered at least 2.94 billion doses — more than any other coronavirus-vaccine candidate. More than a third of those doses have been bought by the United Kingdom and other European nations, Japan and the United States. The US Biomedical Advanced Research and Development Authority has given AstraZeneca more than US$1 billion to develop the Oxford vaccine.
Very large article with a lot more info continues at the above link.
