New Delhi: Drugs Controller General of India (DCGI) has given permission to Serum Institute of India to resume clinical trial of the Oxford Covid-19 vaccine candidate in the country. The earlier order of suspending any new recruitment for phase two and three trial has been revoked by DCGI Dr V G Somani.
The DCGI, however, put certain conditions like taking extra care during screening, providing additional information in informed consent and close monitoring for adverse events during follow-up of the study which have to be “scrupulously” followed by Serum Institute of India (SII).
SII has also been asked to submit to the DCGI’s office details of medication used in accordance with the protocol for management of adverse events.
On 11 September, the DCGI had directed SII to suspend any new recruitment in the phase two and three clinical trial of the Oxford COVID-19 vaccine candidate till further orders in the backdrop of pharma giant AstraZeneca pausing the clinical trials in other countries because of ‘an unexplained illness’ in a participant in the study.
Meanwhile, at a time when the whole country is waiting with bated breath for Covid-19 vaccine, Adar Poonawalla, the CEO of Serum Institute, the world’s largest vaccine manufacturer, came up with a shocker recently.
While a vaccine for Covid-19 could be first made publicly available anywhere from this month to the end of September depending on which vaccine you want and where you live, the odds of everyone on the planet being able to access one are low until at least 2024, he said.
Speaking to Financial Times, Adar Poonawalla said that it would take four to five years until everyone gets the vaccine on the planet.
He added that distribution in India would be difficult given the lack of a sophisticated cold chain system.
“I still don’t see a proper plan on paper to do that (in India) beyond 400 million doses…you don’t want a situation with the vaccine where you have capacity for your country but you can’t consume it,” he was quoted as saying.