One of the frontrunners for a vaccine to wipe out COVID-19 – AstraZeneca and the University of Oxford’s vaccine which has been ordered by dozens of countries – has been put on hold.
The final Phase 3 study testing of the COVID-19 vaccine by AstraZeneca and the University of Oxford at dozens of sites across the US, the UK and South America has been put on hold due to a suspected serious adverse reaction in a participant in the UK.
A spokesperson for AstraZeneca said in a statement that the company’s “standard review process triggered a pause to vaccination to allow review of safety data.”
It was not immediately clear who placed the hold on the trial, though it is possible it was placed voluntarily by AstraZeneca and not ordered by any regulatory agency. The nature of the adverse reaction and when it happened were also not immediately known, though the participant is expected to recover, according to an individual familiar with the matter, Stat reported.
The spokesperson described the pause as “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”. The spokesperson also said that the company is “working to expedite the review of the single event to minimise any potential impact on the trial timeline”.
An individual familiar with the development said researchers had been told the hold was placed on the trial out of “an abundance of caution”. A second individual familiar with the matter, who also spoke on condition of anonymity, said the finding is having an impact on other AstraZeneca vaccine trials underway — as well as on the clinical trials being conducted by other vaccine manufacturers.
The news broke after the CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi vowed to not seek approvals or emergency use authorisations for their COVID-19 vaccine candidates without conclusive positive data as unsubstantiated concerns that the release of a vaccine may be politicised grow.
The drugmakers will “only submit for approval or emergency use authorization (sic) after demonstrating safety and efficacy through a phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA,” they said.
AstraZeneca announced on September 3 that trial centres across the US were recruiting up to 30,000 adults aged 18 years or over from diverse racial, ethnic and geographic groups who are healthy or have stable underlying medical conditions, including those living with HIV, and who are at increased risk of infection from COVID-19. Centres outside the US also were included based on predicted transmission rates of the virus and the company said sites in Peru and Chile are planned to initiate recruitment shortly.
AstraZeneca and Oxford University’s vaccine is a frontrunner among more than 130 in development across the industry.
AstraZeneca CEO Pascal Soriot said in June that “if all goes well, we will have the results of the clinical trials in August/September”.
“We are manufacturing in parallel,” he added. “We will be ready to deliver from October if all goes well.”