SII in process to seek emergency use licensure for Covid-19 vaccine in two weeks: Adar Poonawalla

The Serum Institute of India is conducting clinical trials of AstraZeneca-Oxford's Covid-19 vaccine candidate in India

Vaccine major Serum Institute of India (SII) on Saturday said it is in the process of applying for an emergency use licensure for the AstraZeneca-Oxford's Covid-19 vaccine candidate in India in the next two weeks.

Addressing a virtual press conference on the visit of Prime Minister Narendra Modi to the company's Pune facility, Serum Institute of India CEO Adar Poonawalla said: "We discussed the plan, the implementation plan which will happen only after the emergency use licensure, that is granted based on the data that will have to be submitted. We are in the process of submitting that officially to the drug controller of India...".

When asked if the company has applied for the emergency authorisation, Poonawalla said: "We are in the process of applying in next two weeks for an emergency use licensure."

The vaccine will be distributed initially in India and then the company will look at Covax countries, which are mainly in Africa, he added.

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Serum Institute of India (SII) is conducting clinical trials of AstraZeneca-Oxford's Covid-19 vaccine candidate in India.

Poonawalla also said it was a special day for the company with the Prime Minister visiting them to go into details on the manufacturing status not only its plants in Pune but on various partnerships and the impact the vaccine industry is going to have to India and the globe.

In a tweet, the prime minister 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."

Poonawalla said, "Worldwide everybody is now dependent and is looking forward to the vaccines coming out in large volumes and at affordable price from India as everybody already knows that more than 50 to 60 per cent of all vaccines are made in India."

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With the Aatmanirbhar Bharat vision in mind, Serum Institute has built the largest pandemic level facility in Pune in its sister campus at Manjri and that was showcased also to the Prime Minister, he added.

Earlier in a tweet, Adar Poonawalla said: "Thank you @narendramodi for visiting @SerumInstIndia. We share your vision and continue to work towards ensuring a safe and secure India".

In another tweet, he said: "Sri @narendramodi Ji, it was a great honour for you to have spared the time, to visit us here at @SerumInstIndia to discuss in detail, the complex challenges yet to come and review the vaccine production status. @PMOIndia".

Earlier in the day, Modi visited Zydus Biotech Park in Ahmedabad, and Bharat Biotech in Hyderabad to review the development and manufacturing process of Covid-19 vaccines.

Emphasising the importance of the visit, Bharat Biotech said Prime Minister Narendra Modi's visit to the company's manufacturing facility in Genome Valley in Hyderabad further reinforces its commitment towards scientific discovery and solving public health issues.

Modi visited Bharat Biotech's facility located at Genome Valley and reviewed the progress of Covaxin, a vaccine candidate for Covid-19 being developed by the company.

"The prime minister's visit serves as a great inspiration to our team, and further reinforces our commitment towards scientific discovery, solving public health issues, and the nation's fight against Covid-19," Bharat Biotech said in a statement.

Currently, the phase-3 clinical trial of Covaxin is being conducted across India involving 26,000 participants. The vaccine will be produced in the Biosafety Level 3 production facility of the company, it added.

"We take this opportunity to thank the Government of India, regulators, our vaccine development partners, medical fraternity, medical investigators including hospitals for their relentless assistance and cooperation in the development of vaccines, also phase-3 clinical trials for Covaxin," Bharat Biotech said.

Expressing similar sentiments, Zydus Cadila said the presence of Prime Minister Narendra Modi at its Zydus Biotech Park will motivate the company to scale greater heights in its pursuit to bridge unmet healthcare needs.

Modi visited Zydus Cadila's manufacturing facility near Ahmedabad, as he began his three-city visit to review ongoing coronavirus vaccine development work.

"His inspiring presence will motivate us to scale greater heights in our quest to bridge unmet healthcare needs," Zydus Cadila said in a regulatory filing.

The Zydus family comprising 25,000 Zydans stands committed to the ''Atmanirbhar Bharat'' mission and offering the nation safe and efficacious vaccines, therapeutics and diagnostics to fight Covid-19, it added.

Zydus Cadila had earlier announced that the phase-I clinical trial of its vaccine candidate ZyCoV-D is over and it commenced phase-II clinical trials from August.