Biological E-manufactured J&J's single-dose COVID-19 vaccine in India by October

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Biological E-manufactured J&J
Biological E-manufactured J&J

09 Sep 2021: Biological E-manufactured J&J's single-dose COVID-19 vaccine in India by October

The one-dose COVID-19 vaccine developed by American pharma giant Johnson & Johnson and manufactured by the company's local partner, Hyderabad-based Biological E, is likely to be available in India by October, reported News18. The vaccine batches would reportedly undergo final testing next week at the country's premier laboratories, the state-run Central Drugs Laboratory (CDL), Kasauli, and the National Centre for Cell Science (NCCS), Pune.

Details: Vaccine likely to be available by next month: Government official

An official from the Union Health and Family Welfare Ministry, familiar with the development, told News18, "The inspection of batches [of the Biological E-manufactured J&J vaccine] and documents is on. Soon, they will be released for undergoing safety and quality testing." "The vaccine is likely to be available for immunization drive by next month, if everything goes smoothly," added the official.

Rollout 'very near': 'Awaiting the nod on some usual procedures from the DCGI'

Meanwhile, another source in the Union Health Ministry has also confirmed to News18 that the rollout of the J&J single-dose vaccine in India 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 official said.

Number of doses: Quantity of doses in initial rollout may not be high

However, it's still unclear how many doses of the J&J vaccine will be made available in India next month. Even the aforementioned Health Ministry officials couldn't provide details on this. "Quantity may not be much but...it's a single-shot vaccine. Their production is totally dependent on the APIs (active pharmaceutical ingredients)...from J&J. Biological E's role is to manufacture the final formulation," the second official said.

Approval in India: J&J vaccine received emergency approval in India last month

To recall, J&J's single-shot vaccine, called Janssen, was granted Emergency Use Authorization (EUA) by the country's top drug regulator, the Drug Controller General of India (DCGI), back on August 7. Earlier in May, it was announced that Johnson & Johnson has partnered with the Hyderabad-based biotechnology and biopharmaceutical firm, Biological E, for the production of its coronavirus vaccine in India.

Vaccines: Six vaccines approved for use in India so far

J&J's shot became the fifth vaccine against the deadly COVID-19 to receive the EUA in India. Later, on August 20, Zydus Cadila's three-dose ZyCoV-D vaccine also got the EUA from the DCGI, taking the number of approved vaccines for use in the country's COVID-19 immunization drive to six. These include Covishield (the Indian version of Oxford-AstraZeneca vaccine), COVAXIN, Sputnik V, Moderna, Janssen, and ZyCoV-D.

Fact: J&J shot has 85% efficacy in preventing severe infection

According to Johnson & Johnson, its one-shot vaccine has an efficacy rate of 66% in preventing symptomatic COVID-19 cases. J&J also said its jab was "85% effective in preventing severe disease... and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination."

Rollout by 2021-end?: J&J vaccine rollout likely by year end, says another report

Separately, Mint Thursday reported J&J's vaccine would arrive by 2021-end, citing the drugmaker's Chief Scientific Officer Paul Stoffels. At a press conference, Stoffels said, "We are transferring our technology to Biological E...for substance manufacturing...the active vaccine material has started and fill-and-finish (bottling) has started... By the end of this year, we expect 50% of our vaccines will be available to low- and middle-income countries."

The news article, Biological E-manufactured J&J's single-dose COVID-19 vaccine in India by October appeared first on NewsBytes.

Also see: J&J partners with India's Biological E to produce COVID-19 vaccine
US looking to produce of J&J's COVID-19 vaccine in India
US faces pressure to decide J&J COVID-19 vaccine's fate
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