US Pharma giant Johnson & Johnson’s single shot vaccine manufactured by Hyderabad-based Biological E is likely to be rolled out by October, News18.com has learnt.
On August 7, the vaccine was approved for use in India by the apex drug regulator, Drug Controller General of India (DCGI), making it the fifth vaccine to get Emergency Use Approval (EUA).
While Covishield, Covaxin, Sputnik V and Moderna were approved earlier, Zydus Cadila’s ZyCoVD was approved after J&J.
The vaccine batches are expected to go for the final testing at the apex laboratories — Central Drugs Laboratory (CDL), Kasauli and National Centre for Cell Science (NCCS), Pune — by next week.
“The inspection of batches and documents is on. Soon, they will be released for undergoing safety and quality testing,” said a government official privy to the development.
“The vaccine is likely to be available for immunisation drive by next month, if everything goes smoothly,” he said.
Another source in the Ministry of Health and Family Welfare confirmed that the roll out of the vaccine is “very near”. “We are awaiting the nod on some usual procedures from the DCGI. Once he gives the go ahead, it will take less than a month for the vaccine to hit the market,” the second official from the ministry said.
A Johnson & Johnson India spokesperson said: “Our teams are working around the clock to develop and broadly activate our manufacturing capabilities to supply our Covid-19 vaccine. We believe Biological E. will be an important part of our global COVID-19 vaccine supply network. While we look forward to meeting our delivery commitments, it is premature for us to speculate on the timing of our vaccine deliveries.”
Number of doses in first rollout may not be high
Both officials News18.com spoke to were unable to divulge details on the number of doses likely to be rolled out.
“We are not sure about the number of vials that Biological E will be able to roll out immediately. Quantity may not be much but we must remember, it’s a single shot vaccine,’ the second official said.
“Their production is totally dependent on the APIs they have been receiving from J&J. Biological E’s role is to manufacture the final formulation,” he added.
APIs — the active pharmaceutical ingredients — are the raw materials for the production of medicine or vaccine which is responsible for releasing the therapeutic effect. For instance: Paracetamol is an API in Crocin.
The vaccine has demonstrated 85 percent efficacy in preventing severe disease across regions, according to the statement released by J&J earlier. “It protects against covid-related hospitalization and death 28 days after vaccination,” J&J had claimed.