The University of Oxford partnered with pharmaceutical giant AstraZeneca to trial its COVID-19 vaccine in April of this year. Phase III trials were paused this week, however, to investigate a “potentially unexplained illness” in one of the trial participants. Pascal Soriot, AstraZeneca’s CEO, wouldn’t confirm speculation on what the illness is. “We don’t know if it’s transverse myelitis… We don’t know what the final diagnosis is,” Soriot was reported as saying in The Guardian. He added that he believes the vaccine trial is still on track “for having a set of data that we would submit before the end of the year.”
Astra Zeneca believes slowing down the trial to look into the illness was the right thing to do. “Our standard review process triggered a pause to vaccination, to allow the review of safety data,” AstraZeneca said in a statement this week. “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.”
UCI Health has joined the list of public health organizations concerned about the potential impact and side effects of expedited COVID-19 clinical trials. Chad Lefteris, the CEO of UCI Health said today that the response to halt the Astra Zeneca trial was appropriate and that high standards must be upheld in the development and trials of pharmaceuticals. “Vaccines must be vetted and conducted through transparent clinical research to understand their safety, dose-response effects, adverse reactions, and effectiveness,” Lefteris wrote in an email. “Rushing to approve and distribute a vaccine before it is proven safe and effective upends the rigorous process developed over decades to test vaccines.”
Lefteris also noted that accuracy is paramount in the current circumstances. “Speed cannot compromise the required processes for quality and safety, even in a pandemic,” Lefteris said. He issued a warning about the trust that citizens put in the trial process and the need for it to be upheld. “A poorly vetted COVID-19 vaccine could end up causing greater harm to the public’s willingness to accept other well-vetted and effective vaccines. Several vaccine trials are now underway that are expected to provide the necessary evidence needed to make an informed choice.”
Thomas LaVeist, the Dean of the School of Public Health at Tulane University is also concerned about the fast-tracking a COVID-19 vaccine, calling it dangerous. “Vaccine development requires painstaking work,” Dr LaVeist told Healthline. “Typically, a vaccine will take more than a decade to be developed and deployed. So, putting an artificial deadline on the production of a vaccine is extremely dangerous.”
Phases I and II of the trial were undertaken between April 23 and May 21, 2020, according to the medical journal the Lancet. AstraZeneca noted in a statement on September 3, that it is committed to the highest standards in conducting a COVID-19 vaccine clinical trial that has so far enrolled 30,000 adults. “We are moving quickly but without cutting corners, and regulators have clear and stringent efficacy and safety standards for the approval of any new medicine, and that includes this potential COVID-19 vaccine,” said Soriot, AstraZeneca’s CEO. “We will remain true to our values as we continue our efforts to bring this vaccine broadly and equitably to billions of people around the world.”
The chief adviser for the White House vaccine program, Moncef Slaoui, said in an interview with NPR this week that the CDC has started preparing for the distribution of a COVID-19 vaccine by the end of the year. Slaoui says it is appropriate to be prepared, however, there is a “very, very low chance” that vaccine trials will have data available by the end of October. Soriot says AstraZeneca “could still have a vaccine by the end of this year, early next year,” despite the current pause in the trial. “It’s very common, actually, and many experts will tell you this,” Soriot adds. “The difference with other vaccine trials is the whole world is not watching them. They stop, they study and they restart.”