NEW DELHI: The Serum Institute of India (SII) has applied for emergency use authorization of the first Made in India COVID-19 vaccine, Covishield.
"As promised, before the end of 2020, SII 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 Narendra Modiji for their invaluable support," said SII CEO Adar Poonawalla in a tweet.
Covishield is a vaccine developed by AstraZeneca and Oxford and will be manufactured by SII. Earlier, Pfizer had become the first company to apply for EUA in India and sought permission to import the vaccines here. The UK and US are readying for vaccination programmes with the Pfizer vaccine.
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 that the SII is in the process of submitting the data for the clinical trials to the DCGI and will seek emergency use authorization.
He also said that 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 — where SII has a tie up— Poonawalla said that it is two months behind Astrazeneca; and the same process will be followed in terms of trials and approvals.
The third one — Codagenics is way behind and will take at least a year to get into licence stage. It is only starting stage-1 trials in the UK in December so that will take a year, Poonawalla said.
He further said that both these vaccines can be stored at temperatures of 2 to 8 degrees Celsius for which India has a lot of capacity. He added that for vaccines which require much lower temperatures India's capacity for storage is negligible.
The SII is currently producing 50-60 million (five to six crore) doses a month, which by January-February will be scaled up to 100 million (10 crore) doses a month. (IANS)