Clinical trials testing a potential COVID-19 vaccine developed by AstraZeneca and the University of Oxford are set to resume after a six-day pause due to “potentially unexplained illness” in the United Kingdom.
An independent safety review was conducted Sept. 6 during what was referred to as a “routine action” to maintain the “integrity of the trials.” It concluded on Saturday.
In a release sent to Global News, Oxford University said the study vaccines had been administered to some 18,000 patients as part of the trial.
“In large trials such as this, it is expected that some participants will become unwell and every case must be carefully evaluated to ensure careful assessment of safety,” the release said, adding they were unable to disclose the patient’s medical information due to “participant confidentiality.”
On Thursday, a spokesperson for AstraZeneca said the brief pause was triggered after one woman developed “severe neurological symptoms” after taking the experimental COVID-19 vaccine.
AstraZeneca said the company’s “standard review process triggered a study pause to vaccination across all of our global trials to allow the review of safety data by an independent safety review committee, and the national regulators.”
“All routine follow-up appointments continued as normal during this period,” they said.
“We are committed to the safety of our participants and the highest standards of conduct in our studies and will continue to monitor safety closely.”
On Thursday, Dr. Soumya Swaminathan, the World Health Organization’s chief scientist, urged against becoming “overly discouraged” by the halt in the Oxford and AstraZeneca vaccine trial.
Instead, she said the pause should serve as a “wake-up call” to the global community to recognize the inevitable “ups and downs in clinical development.”
“This is normal procedure, this is good clinical practice because safety is the highest priority in any clinical trial,” she said.
AstraZeneca is considered one of several pharmaceutical companies most likely to help produce the world’s first viable COVID-19 vaccine.
On Tuesday, executives from those companies made what they called an “historic pledge” to “uphold the integrity of the scientific process” amid rising concerns that drugmakers would skirt safety procedures in the face of political pressure from United States President Donald Trump to rush the vaccine.
“We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved,” the pledge read.
AstraZeneca, a British-Swedish multinational pharmaceutical and biopharmaceutical company, is collaborating with Oxford University to manufacture 2 billion doses of the COVID-19 vaccine.
Dr. Adrian Hill, director of the Jenner Institute at Oxford University said during a previous interview that high-risk groups could be vaccinated by December, but “certainly there’ll be a million doses around in September,” due to a manufacturing “scale-up.”
In July, a study on the immunization’s Phase I/II trial published in The Lancet found that a single dose of the vaccine being developed by Oxford University neutralized the effects of the virus in 91 per cent of participants over the course of a month, and in 100 per cent of participants who received a second dose.
The Phase I/II trial included 1,077 participants.
“In all participants, a T-cell response was induced, peaking by day 14, and maintained two months after injection,” AstraZeneca said in a release.
Andrew Pollard, co-author of the trial and chief investigator of the Oxford Vaccine Trial at Oxford University, said researchers found the best results in respondents who received two doses of the vaccine, “indicating that this might be a good strategy for vaccination.”
“The immune responses observed following vaccination are in line with what we expect will be associated with protection against the SARS-CoV-2 virus, although we must continue with our rigorous clinical trial programme to confirm this,” he said.View link »