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NEW YORK (BLOOMBERG) – AstraZeneca Plc stopped injecting its experimental coronavirus vaccine after a person participating in one of the company’s studies fell ill, a possible adverse reaction that could delay or derail efforts to speed up an immunization. against Covid-19.
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.
Shares of the pharmaceutical company fell as much as 3 percent in London on Wednesday morning (September 9).
The vaccine, which AstraZeneca is developing with researchers at the University of Oxford, has been considered one of the leading candidates.
The partners aim to enroll up to 50,000 participants for late-stage trials underway in the UK, US, Brazil and South Africa, with others planned for Japan and Russia.
The decision to hit the brakes shook investors at AstraZeneca, which has a market value of approximately $ 140 billion (S $ 191.82 billion) and has the highest weight of any company in the UK’s FTSE-100 index.
Shares of Moderna Inc and BioNTech SE, which are working on rival vaccines, rose in late trading hours in New York on Tuesday.
“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. .
He said it is too early to determine the specific diagnosis of the sick participant.
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.
Dr Moncef Slaoui, head of the Warp Speed initiative, said in a statement that the Data Security Monitoring Boards in the US and the UK are “conducting an in-depth review of the vaccine candidate for the company, which is the standard procedure when an adverse event occurs. ”
A volunteer in the UK trials was diagnosed with transverse myelitis, an inflammation of the spinal cord usually caused by infections, the New York Times said, citing a person close to the situation who did not mention.
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. Dr. 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.
Dr. 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,” Dr. 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 ASKED
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, the main candidates in the race for a Covid-19 vaccine have vowed to avoid shortcuts in science as they face pressure to jump into the market.
Dr. 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.
The news of the reversal of the AstraZeneca trial was first reported by STAT.
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