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(Sept. 9): AstraZeneca Plc stopped giving injections of its experimental coronavirus vaccine after a person participating in one of the company’s studies fell ill, a potential adverse reaction that could delay or derail efforts to accelerate an immunization against Covid-19 for the world.
The hiatus was due to a standard review of the company’s vaccine trials after a person developed an unexplained illness, AstraZeneca said in a statement. The move was intended to give investigators time to examine safety data while maintaining the integrity of the tests, the company said.
The vaccine, which AstraZeneca is developing with researchers at the University of Oxford, has been seen as one of the main candidates to reach the market. The decision to hit the brakes shook investors, causing AstraZeneca’s US-listed shares to plummet dramatically, while also boosting the shares of some rivals who developed different potential Covid-19 opportunities.
“This is a routine action that has to happen whenever there is potentially unexplained illness in one of the trials, while it is being investigated, ensuring that we maintain the integrity of the trials,” AstraZeneca spokesperson Michele Meixell said in a statement. . She said the company is working to expedite the review of the incident.
Scientific sprint
The development has the potential to disrupt one of the most closely followed scientific sprints in history. Companies have been working to find a vaccine in hopes of mitigating a pandemic that has sickened more than 27 million people and killed more than 894,000 worldwide. Health officials in the US and President Donald Trump have repeatedly said it is possible to get vaccinated before the end of the year and possibly starting 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 therapies, said experts monitoring the UK trials halted the latest stage of the trial in coordination. with their American counterparts.
Moncef Slaoui, head of the Warp Speed initiative, said in a statement that the Data Security Monitoring Boards in the US and UK are “conducting an in-depth review of the company’s candidate vaccine, which is the standard procedure when an adverse event occurs. “
A Data Safety Monitoring Board is a panel of outside experts that monitors the potential harm of experimental drugs and vaccines during clinical trials. The bar for pausing a vaccine trial is generally low, as participants are healthy and may never need the vaccine they have volunteered to receive.
The members of the monitoring board have unmatched knowledge of clinical studies. Unlike the doctors and researchers, they are informed whether the participants received the vaccine or a placebo, and are regularly informed about how each group is doing.
The Jenner Institute at the University of Oxford did not immediately respond to requests for comment.
‘Safety precautions’
Some scientists downplayed the importance of the disruption. Eric Topol, a cardiologist and clinical trial 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 probability that the adverse event will turn out to be unrelated to the vaccine, he said in an email.
“It is a security measure,” he said.
Paul Offit, a pediatrician and vaccine expert at Children’s Hospital of Philadelphia, said the AstraZeneca injection involves administering large doses of a monkey adenovirus engineered so that it cannot replicate. Therefore, it is important for researchers to investigate whether the adverse event was not somehow triggered by a reaction to that large viral dose, he said.
“When you have that kind of viral load, you can have side effects,” Offit said. The question is whether the adverse event could be somehow related to the large number of viral particles being delivered, or if it is just a coincidence. If after investigating, the monitoring board feels comfortable that there are reasons unrelated to the vaccine to explain the adverse event, the trial may continue, he said.
The United States and other governments have invested billions of dollars to develop a vaccine at an accelerating rate, and now more than two dozen vaccines are being tested in volunteers less than a year after the virus was first discovered. Eleven candidates are in advanced stage trials.
Questions raised
The setback comes when a group of international scientists raised questions about a fast-moving vaccine from Russia, saying some results from a study seemed unlikely. The two incidents highlight the difficulty of getting an effective vaccine to the public quickly, as the Covid-19 pandemic spreads unabated.
Politics has also complicated the search for a vaccine. Amid concerns that the Trump administration will politicize the launch of a vaccine before the election, pioneers in the race for a Covid-19 vaccine have vowed to avoid shortcuts in science as they face pressure to go to market. .
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Tuesday that it is “unlikely” that a Covid-19 vaccine will be available to the public on November 3.
In recent trading in New York, AstraZeneca shares fell as much as 8.3%, while Moderna Inc. and BioNTech SE saw their shares rise. All three companies are participating in Operation Warp Speed. The news of the reversal of the AstraZeneca trial was first reported by STAT.
Read also:
AstraZeneca vaccine trial pause is not necessarily a setback, says UK health minister
WHO says vaccine safety top priority as AstraZeneca halts study
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