COVID-19 Vaccine Update: In a rather unfortunate turn on the COVID-19 vaccine front, pharmaceutical major AstraZeneca has said that it “voluntarily paused” the clinical human trials of its vaccine candidate ‘Covishield’ with University of Oxford after one of the volunteers developed an unexpected illness.
“As part of the ongoing randomized, controlled global trials of the Oxford coronavirus vaccine, our standard review process was triggered and we voluntarily paused vaccination to allow a review of safety data by an independent committee,” the pharma said in a statement.
According to the company, a volunteer developed an adverse reaction to the vaccine trial for reasons not yet known. However, they said that the participant is expected to recover.
Further explaining why it had to stop the trials immediately, AstraZeneca said it was 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.”
“We are working to expedite the review of the single event to minimize any potential impact on the trial timeline,” the statement added.
Notably, the Oxford-AstraZeneca vaccine for coronavirus entered phase three clinical trials in the US last month, joining the group of vaccines in their final stage.
Meanwhile, the Serum Institute of India in Pune, which is handling the Phase 3 trials in India, is preparing a list of volunteers who will be inoculated free under the National Immunization Programme (NIP).
A total of 1,600 eligible participants of more than or equal to 18 years of age will be enrolled in the study, which will be conducted on 17 sites in India.
The remaining 1,200 participants from safety cohort will be randomly assigned in a 3:1 ratio to receive either Covishield or Placebo, respectively