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Pune SII: Will apply for emergency licence for vaccine use within two weeks

PUNE: Serum Institute of India (SII) CEO Adar Poonawalla on Saturday said they were in the process of applying for an emergency use licence (for AstraZeneca-Oxford’s Covid vaccine in India) in the “next two weeks”.

Poonawalla said he discussed the implementation plan with PM Narendra Modi during his visit to the facility. SII has partnered with the University of Oxford and AstraZeneca for the manufacture and distribution of the vaccine.

Modi on Saturday visited SII’s new plant at Manjari and interacted with its team about the manufacturing, logistics and distribution of its Covid-19 vaccine — Covishield. In a tweet, the PM said, “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.”

SII: Will apply for emergency licence within two weeks

Modi reached the plant of SII at 4.30pm and spent an hour there. Poonawalla shared with the Prime Minister the details of how they plan to scale up the vaccine manufacturing by producing 100 million doses every month from January.

Currently, it is producing 60 million doses every month. The company has so far stockpiled around four crore doses and would have around 10 crore doses ready by January.

During an online interaction with the reporters in the evening, Poonawalla confirmed that SII would be applying for emergency regulatory approval in two weeks.

The phase III clinical trials of Covishield on 1,600 participants across India are expected to be completed soon. A total of 17 trial sites are studying the safety and immunogenicity of the Oxford University vaccine candidate in India. “The interim data of our trials so far has been promising. The Indian trials are running smoothly with strict adherence to all the necessary processes and protocols,” Poonawalla said.

On Saturday, Modi visited the units of three vaccine manufacturers in India. First, he went to the Zydus Biotech Park in Ahmedabad, followed by Bharat Biotech in Hyderabad, and then SII in Pune.

The PMO had tweeted that as India entered a decisive phase of the fight against Covid-19, Modi’s visit to these facilities and discussions with scientists would help him get a first-hand perspective of the preparations, challenges and roadmap in India’s endeavour to vaccinate its citizens.

Modi had earlier visited SII in November 2016 for its “Clean City” initiative.

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