The Coronavirus Vaccine Trial, the flagship of AstraZeneca and the University of Oxford, is currently being tested at dozens of sites across the US due to an “unexplained disease” in someone receiving the vaccine.
The state was given a first-day break on Tuesday due to suspected serious adverse reactions in a man who participated in a trial in Britain. It is unknown what health problems a person experiences.
A spokesperson for AstraZeneca said the test was stopped as a precautionary measure so that scientists could investigate whether the disease was actually linked to the vaccine.
“This is a routine action that occurs in any test with a potentially unexplained disease while it is examined, ensuring that we maintain the integrity of the test,” the spokesperson said.
“In large trials, the disease will be coincidental, but should be reviewed independently,” the spokesperson said. “We are working to expedite single incident review to minimize any potential impact on the trial timeline. We are committed to the safety of our participants and the highest standards of conduct in our trials.”
Other scientists cautioned that the stagnation is indeed there to investigate how clinical trials should work.
“It’s not common, but it does happen,” Paul Efitt, a vaccine specialist at the Hospital of Children’s Philadelphia, who sits on the FDA Vaccine Advisory Committee, told Buzzfeed News. “This vaccine is meant to stop SARS-CoV-2. It is not designed to stop everything that happens in life. You want to make sure that it was related to the vaccine, especially if it was after the vaccine started. Happened after some time. ”
Last week, the National Institutes of Health announced that the trial of Phase 3 of AstraZeneca began in the US, aiming to recruit 30,000 participants across 80 sites across the country to see if the vaccine COVID-19 Whether or not it is safe and effective in preventing symptoms. AstraZeneca received $ 1.2 billion in US funding for 300 million doses, part of the Operation Tana Speed effort to fast-track the coronovirus vaccine. Large trials are underway at sites in Britain, South Africa and Brazil.
The vaccine relies on a harmless chimpanzee virus that contains the gene for the SARS-CoV-2 spike protein to trigger an immune response. This is a new approach that has yet to lead to an approved vaccine, but has been tested in experimental vaccines against other viruses, including influenza and Ebola.
Phase I and 2 trials of the vaccine tested in 1,077 patients, promising “neutral” antibodies in approximately 90% of participants. About 60% of patients reported mild or moderate side effects, including fever, headaches, and muscle aches, which were resolved during all tests. No serious adverse events were recorded during the initial tests.
The stagnation comes as scientists and the public have expressed increasing concern about the possibility that President Donald Trump may try to run a coronovirus vaccine before the US election.
On Tuesday, nine pharmaceutical executives, including the CEO of AstraZeneca, issued a statement that they would follow “high ethical standards and sound scientific principles” and “demonstrate safety and efficacy through Phase 3 after approval or emergency use of the authority.” Will present. Clinical studies. ” The office called such a statement on behalf of drug officials “unprecedented”.
“The Trump administration strengthens science-based federal agencies,” Offit said. “People are worried that the FDA is not looking out for their interests. So the pharmaceutical companies stepped in and said that we are looking out for our interests.”
Others criticized the fact that the American public had to rely on pharmaceutical companies for information about the vaccine, rather than receiving clear information from the federal government.
“I am concerned that Operation War Speed is like any other product, leading the industry,” Peter Howitz, a vaccine researcher at Baylor College of Medicine in Houston, told Buzzfeed News. “Their silence reflects a tone of deafness to the fact that the COVID-19 vaccine is not the same as a new product for acne.”