In a major setback to COVID-19 vaccine hopes in India, the Serum Institute of India (SII), the frontrunner in trials in partnership with Oxford University, has halted clinical trials of the Oxford-AstraZeneca vaccine in the country.
SII had collaborated with the university and pharmaceutical firm AstraZeneca for the trial, manufacturing, and sale of the vaccine in India.
“We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials. We are following Drug Controller General of India (DCGI) instructions and will not be able to further comment on the trials,” the SII has stated.
The vaccine trials have been paused until further instructions from the Indian regulator and licensing authority, the Drug Controller General of India (DCGI) against the backdrop of continued trials by the institute, despite adverse effects reported by AstraZeneca during trials in other countries.
DCGI claims that SII has not reported the matter to the regulator and issued a notice to the company.
On 8 September, AstraZeneca announced the suspension of human clinical trials of the COVID-19 vaccine as a participant had developed an unexplained illness.
“We voluntarily paused vaccination to allow review of safety data by an independent committee. 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,” the company said.
However, until Wednesday, SII CEO Adar Poonawala maintained that reaction reported in the UK is not directly linked to the vaccine and the person having complications had an existing neurological condition.
Meanwhile, an Indian pharmaceutical firm, Bharat Biotech, has almost completed phase-II clinical trials of its COVID-19 vaccine, named Covaxin. For the purpose of the development of the vaccine, virus strains separated by the National Institute of Virology under the Indian Council of Medical Research (ICMR) were handed over to the company in June of this year. Another Indian pharmaceutical company in the race for a vaccine, Zydus Cadila is also in the process of phase II trials of its vaccine ZyCov-D.