Oxford COVID-19 vaccine trials not paused in India, clarifies Serum Institute
Sep 09, 2020
New Delhi [India], September 9 : After AstraZeneca suspended the trials of COVID-19 vaccine in the UK, Indian pharmaceutical giant Serum Institue of India (SII) on Wednesday clarified that testing of the possible vaccine candidate in India is ongoing and has not faced any issue so far.
"We can not comment much on the UK trials, but they have been paused for further review and they hope to restart soon. As far as Indian trials are concerned, it is continuing and we have faced no issues at all," SII said in a statement.
On Tuesday (local time), UK-based biopharma giant AstraZeneca has said that the phase 3 testing of its COVID-19 vaccine being developed with Oxford University has been put on hold, due to a suspected serious adverse reaction in a participant in the United Kingdom.
The SII had initiated the phase two, three clinical trials to evaluate the safety and immune response of the Oxford University coronavirus vaccine candidate on healthy Indian adults after the pharma company got approval from Drugs Controller General of India (DCGI) last month. In India, the vaccine would be manufactured by Serum Institue of India.
According to the Clinical Trial Registry India, the scientific title of the study says that phase 2/3 clinical trial will be observer-blind, randomised, controlled study to determine the safety and immunogenicity of Covishield (COVID-19 vaccine) in healthy Indian adults.
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.
AstraZeneca said its "standard review process triggered a pause to vaccination to allow the review of safety data," health news site Stat News reported on Tuesday (local time).
The nature of the adverse reaction and when the development took place were not initially clear, although the participant is expected to recover, said an individual familiar with the matter.
