iNDICA NEWS BUREAU & IANS
Serum Institute of India (SII) has applied for emergency use authorization of Covishield, the Covid-19 vaccine developed by pharmaceutical company AstraZeneca and Oxford University.
The development comes a day after Pfizer applied for emergency use authorization in India of its vaccine developed with BioNTech. While Covishield has undergone trials in India, the Pfizer-BioNTech vaccine has not.
“As promised, before the end of 2020, @SerumInstIndia has applied for emergency use authorisation for the first made-in-India vaccine, COVISHIELD. This will save countless lives, and I thank the Government of India and Sri @narendramodiji for their invaluable support,” Adar Poonawalla, CEO, SII said in a tweet.
Covishield is a vaccine developed by AstraZeneca and Oxford and will be manufactured by the SII.
In November end, the SII had announced it will seek emergency use authorization for the AstraZeneca Covid 19 vaccine in about two weeks.
Poonawalla had said the SII was in the process of submitting the data for the clinical trials to India’s drug regulator DCGI and will seek emergency use authorization.
He said there will be no delays in the AstraZeneca vaccine rollout as the trials are more than enough for establishing efficacy and it will not affect emergency use authorization in Europe and certainly not in India.
There was a recent error in dosage during trials which AstraZeneca is trying to correct, as per reports.
“What we might have to do is trials for under-18 candidates. That is way all vaccines go. You first have to establish safety for adults and then go for studies on the impact on children,” he added.
On the other vaccine, Novavax, for which the SII has a tie up, Poonawalla said it is two months behind AstraZeneca and the same process will be followed in terms of trials and approvals.
The third one, Codagenics, is will take at least a year to get into license stage. It is only starting stage 1 trials in the UK in December so that will take a year, Poonawalla said.
He said both these vaccines can be stored at temperatures of 2 to 8 degrees Celsius for which India has a lot of capacity. He said that for vaccines which much lower temperatures India’s capacity for storage is negligible.
The SII is currently producing 50-60 million doses a month which by January-February will be scaled up to 100 million (10 crore) doses a month.