Biological E gets approval to manufacture J&J Covid-19 vaccine in India

Johnson & Johnson’s (J&J’s) arm Janssen’s Covid-19 vaccine has received permission for imports, while its local partner Biological E has got approval to start manufacturing the vaccine at its facility in Telangana. How­ever, there is no clarity yet on when the vaccine would be available in India or whether the matter on indemnity has been amicably settled.

 

According to sources, discussions are on between J&J and the Centre on the matter of indemnity against any serious adverse effect after vaccination. The J&J single-dose vaccine is ex­pected to be imported for ‘fill and finish’. This means that a local partner would put the vaccine into vials and make it ready for distribution. The J&J vaccine can remain stable at 2-8 degree Celsius for up to three months and the company will ship the vaccine using cold-chain technologies, the pharma firm said.

 

According to the Central Drugs Standard Control Organisation’s (CDSCO’s) list, Janssen Pharmaceu­ticals’ recombinant Covid-19 vaccine Ad26.COV2-S got the permission for imports on August 6, around the same time when the vaccine was approved for rest­ricted emergency use in India. Meanwhile, on Aug­ust 18, Biological E got the nod from the CDSCO to ma­n­ufacture the Ad26. COV2-S vaccine at its Kolt­hur plant situated within a SEZ in Telangana.

 

“Our teams are working round the clock to develop and broadly activate our manufacturing capabilities to supply vaccine. We beli­eve Biological E will be an important part of our global Covid vaccine supply chain network,” a J&J India spokes­person said.