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AstraZeneca has halted all clinical trials of the Covid-19 vaccine it is developing with the University of Oxford after a participant in the UK section of the study suffered a suspected serious adverse reaction.
The UK-based drug manufacturer voluntarily suspended the trial after the discovery of the ill participant. AstraZeneca said it was working to review the event to make sure it would not cause a significant delay in the study.
Shares of the UK pharmaceutical company fell just over 2 percent in early trading in London on Wednesday. The group’s New York-listed shares fell in after-hours trading Tuesday after the trade publication STAT first reported that the test had to stop.
AstraZeneca was on track to become one of the first drug manufacturers to deliver the results of a large trial of a Covid-19 vaccine in a race in which many pharmaceutical companies are moving at breakneck speed. The White House has considered speeding up the company’s vaccination ahead of the U.S. presidential election, according to people familiar with the matter.
“As part of the ongoing global randomized controlled trials of the Oxford coronavirus vaccine, our standard review process caused a pause in vaccination to allow review of safety data,” said a spokesperson.
“This is a routine action that has to happen whenever there is a potentially unexplained illness in one of the trials, while it is being investigated, ensuring that we maintain the integrity of the trials,” he added. “In large trials, illnesses will happen by chance, but they need to be independently reviewed to check this carefully.”
It is not uncommon for clinical trials to stop. But in the most scrutinized vaccine development process in history, any sign of potentially negative side effects could be seen as a dashed hope for quick relief from the pandemic.
“The test was expected to be read in November (as a maximum estimate) and potentially in the coming weeks,” analysts at Shore Capital said. “However, any suspension of the trial is likely to cause delays in these deadlines.”
Even if the AstraZeneca vaccine is eventually approved, concerns about side effects may deter people from getting vaccinated.
Experts have expressed concern that approval of a vaccine could be rushed as the process becomes politicized, although drug companies and the US Food and Drug Administration have insisted that inoculation would only be authorized on the basis of in solid science.
Joe Biden, the Democratic presidential candidate, and Kamala Harris, his running mate for vice presidency, called on the Trump administration on Tuesday to ensure that “politics play no role in the approval and distribution of a Covid-19 vaccine. safe and effective “. .
AstraZeneca is marketing the vaccine created by researchers at the University of Oxford under an agreement signed in April. To speed up the process, the drugmaker has started manufacturing the jab before trials are completed or the vaccine is approved.
The association, which has received more than $ 1 billion in funding from the US Agency for Advanced Biomedical Research and Development, has agreed to deliver more than 300 million doses to the US government.
The UK has ordered 30 million of the possible AstraZeneca vaccine. Matt Hancock, UK health secretary, said this week that it would “probably” be available in early 2021.
The data from the first trial of the vaccine looked promising, producing strong immune responses and only mild side effects, such as those that can be treated with over-the-counter pain relievers.
The initial phase two / three study did not include sites within the US, but late last month the phase three trial, which will have 30,000 participants, began enrolling in the US.
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The trial was voluntarily stopped by the drug manufacturer. These decisions are normally made by an independent monitoring committee.
Paul Offit, an infectious disease expert on the FDA’s vaccine advisory committee, said AstraZeneca would need to examine whether the side effect could have been caused by an immune reaction to the vaccine, or was likely related to the participant’s medical history.
“It all depends on what the problem was,” he said.
In the initial study, he said that more than half of the people had a fever. “When you give it to hundreds of people, that may be all you see. But if you start giving it to thousands or tens of thousands, there may be people with a stronger immune response, “he added.
