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In next step to bringing its Covid shot to India, J&J moves to validate manufacturing process

J&J says it is steadfast in its goal of supplying its single-shot Covid-19 vaccine to India, and has begun talks with relevant government agencies.

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New Delhi: To launch the single-shot Covid-19 vaccine in India, American pharma giant Johnson & Johnson (J&J) has started working with the Modi government to authenticate its manufacturing process.

Speaking to ThePrint, the company said it is in talks with government departments and remained “steadfast” in its goal.

“We have been steadfast in our goal to accelerate the supply of our Covid-19 vaccine to India,” the company’s spokesperson said.

The spokesperson added that the company is working with “the relevant government agencies to validate its manufacturing process and specifications”.

J&J had recently started discussions with the country’s apex vaccine testing laboratory in Kasauli, the Central Drugs Laboratory (CDL), through its Indian partner Biological E.

In April, J&J told ThePrint that it is in discussions with the Government of India with the objective of starting a bridging clinical study. However, now, according to new rules, it is not mandatory for a vaccine approved by the US drug regulator to conduct bridging trials in India.

The government is currently exploring all avenues to boost vaccine supply urgently to inoculate India’s population. According to Dr V.K. Paul, NITI Aayog member (health), the government hopes to receive the Covid-19 vaccine developed by global pharmaceutical giants Pfizer and Moderna this year.

Also read: India administers record 75 lakh vaccine doses as revised procurement policy kicks in

J&J in talks for testing its vaccine in India

In the second week of June, representatives from pharma company Biological E began discussions with the CDL.

“The officials from Biological E, last week, began their discussions with CDL. While they have explained to the laboratory officials the methods they use for quality testing, the CDL officers, in turn, have asked the company to supply the specific list of reagents used for testing,” a senior government official had told ThePrint.

In the meeting, representatives from Biological E wanted to know what type of tests and techniques will be conducted on their vaccines. This is because testing procedures used for other Covid-19 vaccines are different from that needed to test J&J’s vaccine, such as the potency testing procedure.

(Edited by Manasa Mohan)

Also read: India’s ZyCoV-D set to become world’s first DNA Covid vaccine as govt approval likely soon

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