The Serum Institute of India (SII) will seek emergency use authorization for the AstraZeneca Covid-19 vaccine in about two weeks.
Adar Poonawalla, founder and CEO of SII said on Saturday that the company will submit the data for the clinical trials to the Drugs Controller General of India (DCGI) and seek emergency use authorization.
There will be no delays in the rollout of the AstraZeneca vaccine as the trials are sufficient for establishing its efficacy.
It will not affect emergency use authorization of the vaccine in Europe and 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 the way all vaccines go. You first have to establish safety for adults and then go for studies on the impact on children,” a report quoted Poonawalla.
He added that the implementation plan for the AstraZeneca and Oxford vaccine, Covishield will be clear only after emergency use authorization is received.
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SII is currently producing 50-60 million doses of the vaccine a month and its production will be scaled up to 100 million doses a month by January-February next year.
The Union health ministry has announced a target of 300-400 million doses by July next year and accordingly SII is increasing its production.
The vaccine will be distributed in India initially and then in the Covax countries of Africa.
Novava, another vaccine with which SII has a tie-up, is two months behind Astrazeneca and the same process will be followed in terms of trials and approvals.
The third vaccine, Codagenics is way behind and will take at least a year to reach the licence stage. Stage 1 trial on the vaccine will begin in UK in December and will take a year.
He said both these vaccines can be stored at temperatures ranging between 2-8 degree celsius and the country has a lot of capacity.
However, the country does not have the capacity to store vaccines with much lower storage temperatures.
He added that a delayed approval in the UK does not have much impact as stockpiling and manufacturing are going on and a delay of a couple of weeks will not make much impact.