Famous biopharma company based in UK, AstraZeneca has said that phase 3 testing of its COVID-19 vaccine which was being developed along with Oxford University has been put on a halt because a volunteer fell ill. As per AstraZeneca its "standard review process triggered a pause to vaccination to allow the review of safety data.” According to a source, when the development took place the nature of the adverse reaction was not initially clear. However, it is being said that the participant is expected to recover.
Company's spokesperson termed 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." He said the company is "working to expedite the review of the single event to minimise any potential impact on the trial timeline."
Another person familiar with the matter said that the incident has impacted other AstraZeneca vaccine trials and other clinical trials which were under process. There is still no confirmation regarding when the trial will resume, however, the progress of the company's trial and other COVID-19 vaccines in development are being closely watched.
AstraZeneca is the first Phase 3 COVID-19 vaccine trial known to have been put on a halt. It began its Phase 3 trials in US during August. According to clinicaltrials.gov, a government registry the trial across the country is currently underway at 62 sites. Phase 2 and 3 trials of the vaccine previously started in the UK, South Africa and Brazil.
As per a study of Phase 1 and Phase 2 published in July, around 60 per cent of 1,000 participants experienced side effects due to the vaccine. The side effects included fever, headaches, muscle pain and injection site reactions.