New Delhi: The Serum Institute of India (SII) will seek emergency use authorisation for the AstraZeneca Covid 19 vaccine in about two weeks.
Adar Poonawalla, Founder and CEO, SII said on Saturday that SII is in the process of submitting the data for the clinical trials to the DCGI and will seek emergency use authorisation.
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.
Speaking after Prime Minister Narendra Modi’s visit to the SII facility in Pune, Poonawalla said PM Modi discussed in detail the vaccination scenario and reviewed the vaccine production status.
“Had a good interaction with the team at Serum Institute of India. They shared details about their progress so far on how they plan to further ramp up vaccine manufacturing. Also took a look at their manufacturing facility,” PM Modi said in a tweet.
He said 50-60 per cent of the world’s vaccines are made in India and with Atmanirbhar Bharat in mind, SII today showcased the largest pandemic facility at their facility in in Pune.
He added that the implementation plan for the AstraZeneca and Oxford vaccine, Covishield will be clear only after emergency use authorisation is received. SII is in the process of submitting to DCGI. There are plans to roll out hundreds of millions of doses in the second quarter but only after all regulatory approvals are received.
He said so many different vaccines were discussed with PM Modi and their logistical and pricing issues. As of now, there is nothing in writing from the Indian government but Health Ministry has announced a target of 300-400 million doses by July 2021, which SII is scaling up for, he added.
SII is in the process of applying of emergency use licence in two weeks. It will be distributed in India initially and then the Covax countries of Africa.
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 UK in December so that will take a year, Poonawalla said.
He said both these vaccines can be stored at temperatures of 2-8 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 doses a month which by January-February will be scaled up to 100 million doses a month.
Issues about how to distribute and where to distribute the vaccine will become clear after the vaccine gets emergency use authorisation which will take a few weeks to happen, Poonawalla added.
He added that a delayed approval in UK does not have much impact as stock piling and manufacturing is going on and a delay of a couple of weeks will not make much impact.
The AstraZeneca vaccine has shown zero hospitalization and reduced the virus by 60 per cent. So those who got infected were not passing it on and there was no severe attack of coronavirus requiring hospitalisation.