Serum Institute India Seeks Emergency Use Nod For Covishield
New Delhi: 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, @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 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, Serum Institute of India (SII) had announced it will seek emergency use authorization for the AstraZeneca Covid 19 vaccine in about two weeks.
Poonawalla had said SII is in the process of submitting the data for the clinical trials to the 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, where 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 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 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.
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.