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AstraZeneca has had to put its Covid-19 vaccine trial on hold, after a participant in one of the studies fell ill. The pharmaceutical company is developing the vaccine with researchers and experts from the University of Oxford. The trial has been seen as one of the leading candidates. While clinical holds on medical trials aren’t unusual, there is no way of knowing how long this delay will last. AstraZeneca and Oxford University are still aiming to gain 50,000 participants for “late-stage trials” that are currently taking place in the UK, US and even South Africa. A spokesperson for AstraZeneca has said that the company has voluntarily put the vaccine trial on hold. – Jarryd Neves
AstraZeneca vaccine tests face delay after patient gets ill
By Michelle Fay Cortez and Riley Griffin
(Bloomberg) – AstraZeneca Plc stopped giving shots of its experimental coronavirus vaccine after a person participating in one of the company’s studies got sick, a potential adverse reaction that could delay or derail efforts to speed an immunisation against Covid-19.
The pause stemmed from a standard review of the company’s vaccine trials after one person developed an unexplained illness, AstraZeneca said in a statement. The move was intended to give researchers time to examine safety data while maintaining the integrity of the trials, the company said. The drugmaker’s shares fell as much as 3% in London Wednesday morning. Later, they pared the decline to 1.1% as investors took it in stride as a fairly common event during testing.
The vaccine, which AstraZeneca is developing with researchers from the University of Oxford, has been viewed as one of the leading candidates. The partners are aiming to enrol as many as 50,000 participants for late-stage trials that are underway in the UK, the US, Brazil and South Africa, with others planned for Japan and Russia.
AstraZeneca has a market value of about U$140-billion and the largest weighting of all the companies in the UK’s FTSE-100 Index.
“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, ensuring we maintain the integrity of the trials,” AstraZeneca spokeswoman Michele Meixell said in a statement. She said that it’s too early to determine the sick participant’s specific diagnosis.
The development has the potential to disrupt one of the most closely watched scientific sprints in history. Companies have been working to find a vaccine in hopes of blunting a pandemic that has sickened more than 27 million people and killed over 894,000 worldwide. Health officials in the US and President Donald Trump have repeatedly said that it’s possible to have an immunisation before the end of the year, and potentially as early as next month.
The top US official in charge of Operation Warp Speed, the Trump administration’s program to support the rapid development of Covid-19 vaccines and therapeutics, said experts monitoring the trials in the UK paused the late-stage trial in coordination with their US counterparts.
Moncef Slaoui, the head of the Warp Speed initiative, said in a statement that Data Safety Monitoring Boards in the US and UK are “conducting an in-depth review of the company’s vaccine candidate which is standard procedure when an adverse event occurs.”
A volunteer in the UK trials was diagnosed with transverse myelitis, an inflammation of the spinal cord generally caused by infections, the New York Times said, citing a person close to the situation that it didn’t name.
A Data Safety Monitoring Board is a panel of outside experts that watches for potential harm from experimental drugs and vaccines during clinical trials. The bar to pause a vaccine trial is generally low since participants are healthy and may never need the immunization they have volunteered to receive.
The members of the monitoring board have unparalleled insight into clinical studies. Unlike doctors and researchers, they are told whether those participating received the vaccine or a placebo, and they are given regular updates on how each group is faring.
Oxford University said the pause was triggered by its standard review process.
“This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the studies, while it is investigated, ensuring we maintain the integrity of the trials,” the university said in an emailed statement. “In large trials, illnesses will happen by chance but must be independently reviewed to check this carefully.”
Some scientists downplayed the significance of the halt. Eric Topol, a cardiologist and clinical-trials expert at the Scripps Research Translational Institute in San Diego, said such pauses in large studies are “not uncommon at all.” There is a high likelihood the adverse event will turn out not to be related to the vaccine, he said in an email.
“It’s a safety precaution,” he said.
Paul Offit, a pediatrician and vaccine expert at the Children’s Hospital of Philadelphia, said the AstraZeneca shot involves giving large doses of a monkey adenovirus engineered so it can’t replicate. It is therefore important for researchers to investigate whether the adverse event wasn’t somehow being triggered by a reaction to that large viral dose, he said.
What Bloomberg Intelligence Says
“With much hope based on early trials, the halt to that of AstraZeneca’s Covid-19 vaccine shows the perils of rushing to market. The side effect may have nothing to do with the vaccine, but could slow recruitment into its trials if they are restarted, and those of others.”
– Sam Fazeli, pharma analyst
Astra Covid-19 vaccine halt a wake-up call to warp speeders
“When you have that kind of viral load, you can have side effects,” said Offit. The question is whether the adverse event could somehow be related to the large number of viral particles being given, or whether it is just a coincidence. If after investigating, the monitoring board is comfortable there are reasons unrelated to the vaccine to explain the adverse event, the trial will be able to continue, he said.
The US and other governments have invested billions of dollars to develop a shot at an accelerated pace, and more than two dozen vaccines are now being tested in volunteers less than a year after the virus was first discovered. Eleven candidates are in late-stage trials.
The setback comes as a group of international scientists raised questions over a fast-moving vaccine from Russia, saying some results of a study appeared improbable. The two incidents highlight the difficulty in getting an effective vaccine to the public quickly as the Covid-19 pandemic spreads unabated.
Politics have also complicated the pursuit of a vaccine. Amid concerns about the Trump administration politicizing the rollout of a vaccine before the elections, frontrunners in the race for a Covid-19 vaccine pledged to avoid shortcuts on science as they face pressure to rush a shot to market.
News of AstraZeneca’s trial setback was first reported by STAT.
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