The British newspaper “Daily Mail” confirmed that the trials of the third stage of the Corona virus vaccine, which was developed by the University of Oxford and AstraZeneca, have been suspended after “serious harm” was reported to a participant in the United Kingdom, and serious adverse events in human trials are suspected reactions to vaccines or drugs. It requires hospitalization and may be life threatening or fatal.
It is not clear what the exact nature of the reaction was, but someone familiar with the matter told a newspaper. Stat News“It is expected that the person who experienced this serious event will recover.
Postponing the vaccine is a blow to global hopes that the vaccine will be ready in the coming months, as many – including the World Health Organization – considered that a vaccine AstraZeneca It is the leading candidate worldwide.
For his part, British Health Minister Matt Hancock said earlier this week that he hoped it would be launched in the first few months of 2021.
Australia, for example, has spent $ 1.7 billion ($ 1.24 billion) securing access to supplies of 84 million vaccines. COVID-19 If the clinical trial is successful.
Vaccine development is being monitored AstraZeneca And eight others are in Phase III trials closely in the hope that they can wipe out the coronavirus pandemic that has killed more than 894,000 people worldwide, including nearly 190,000 Americans, and cost tens of millions their jobs.
It comes after vaccine developers have pledged – including AstraZeneca – Not to be interrupted by safety and efficacy tests, despite the urgent pressure from President Trump to the Food and Drug Administration (FDA) To grant emergency approval for a vaccine before the November 3 elections.
A spokesman said AstraZeneca “As part of the ongoing global randomized controlled trials of the Oxford Coronavirus vaccine, our standard review process has been run and we have voluntarily stopped vaccination to allow for an independent review of safety data by an independent panel,” told the Daily Mail.
“This is a routine procedure that should happen when there is a potentially unexplained disease in an experiment, while investigating it, which ensures that the integrity of the trials is preserved,” he added.
In large trials, diseases occur by chance but must be independently reviewed to check this carefully..We are working to speed up individual event review to minimize any potential impact on the experimental schedule. We are committed to participant safety and the highest standards of behavior in our experiments. ”
Fertilization AstraZeneca The candidate, known as AZD1222 , In the third phase of trials – the last stage before safety and efficacy data are submitted to regulators for approval – at dozens of locations across the United States and around the world.
Besides a company Pfizer And Modern , she was AstraZeneca And her partner, University of Oxford, are hoping to know if the vaccine works and is safe by the end of the year.
Hancock said Monday that the “best-case scenario” in the UK is to get the vaccine for the most vulnerable patients within months, a time frame that now appears less likely to be met.
He said on a British radio station LBCWe’ve already had the 30 million doses that we’ve contracted with AstraZeneca“.
“In fact, they have already started manufacturing these doses, before approval, so approval has to come – and it is still not confirmed but looking – if that approval is obtained, we are ready to issue it.”
“The best-case scenario is for it to happen this year. I think it’s likely the first part of next year – in the first few months of next year is more likely..but we also bought a vaccine before getting approval for a whole different series of international vaccines as well,” he said. . “
More than 50,000 people around the world have participated in “ Phase 3 ” studies to see if the Oxford injection can actually prevent people from getting infected with: Covid-19.
In these tests, tens of thousands of people in real-world environments are given the vaccine to see if it prevents them from contracting HIV Covid-19 In the community.
While the trial to review safety data is not necessarily harmful, pausing is in an experiment AstraZeneca It could significantly delay the prospective results and completion of one of the fastest vaccine development lines in human history.