J&J’s single-dose COVID-19 vaccine manufactured by Biological E in India by October | Web News Observer

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

According to sources, the one-dose COVID-19 vaccine developed by American pharma giant Johnson & Johnson and produced by the company’s local partner, Hyderabad-based Biological E, would be accessible in India by October.

The vaccination batches are expected to go through final testing next week at the country’s top facilities, the state-run Central Drugs Laboratory (CDL) in Kasauli and the National Centre for Cell Science (NCCS) in Pune.

The vaccine is expected to be ready by the end of next month: Government

An official from the Union Health and Family Welfare Ministry, who is aware of the situation, told the source, “The inspection of batches and papers [of the Biological E-manufactured J&J vaccine] is now underway. They will be issued soon for safety and quality testing.”

“If everything goes as planned,” the source continued, “the vaccine should be available for the immunization drive by next month.”

‘Awaiting the DCGI’s approval on some routine operations’

Meanwhile, another source in the Union Health Ministry has verified that the J&J single-dose vaccination will be available in India “very near.”

“We are waiting for the DCGI’s approval on some routine operations. Once he provides his approval, the vaccine will be available in less than a month “added the official.

The number of dosages in the initial rollout may be insufficient

However, it is unknown how many doses of the J&J vaccine would be available in India next month. Even the aforementioned Health Ministry authorities were unable to give further information.

“The quantity may be little, but it is a one-time use vaccination. Their manufacturing is entirely reliant on APIs (active pharmaceutical ingredients) supplied by J&J. The final composition is manufactured by Biological E “explained the second official.

Last month, India granted J&J vaccine emergency approval

To remember, J&J’s Janssen single-dose vaccination was given Emergency Use Authorization (EUA) by the country’s top pharma regulator, the Drug Controller General of India (DCGI), on August 7.

Earlier this month, Johnson & Johnson announced a collaboration with the Hyderabad-based biotechnology and biopharmaceutical business Biological E to manufacture its coronavirus vaccine in India.

So far, six vaccinations have been authorized for use in India

J&J’s vaccine was the fifth to acquire the EUA in India against the deadly COVID-19.

Later, on August 20, the DCGI authorized Zydus Cadila’s three-dose ZyCoV-D vaccine, bringing the total number of licenced vaccinations for use in the country’s COVID-19 immunisation push to six.

Covishield (the Indian version of the Oxford-AstraZeneca vaccine), COVAXIN, Sputnik V, Moderna, Janssen, and ZyCoV-D are among them.

The J&J injection has an 85% success rate in avoiding serious illness

Johnson & Johnson claims that its one-shot vaccination has a 66 percent effectiveness rate in preventing symptomatic COVID-19 infections. J&J also claimed that its vaccine was “85% effective in preventing severe disease… and showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination.”

Another source claims that the J&J vaccine will be available by the end of the year

Separately, Mint reported Thursday that J&J’s vaccine will be available by the end of 2021, citing the drugmaker’s Chief Scientific Officer Paul Stoffels.

Stoffels stated at a news conference, “We are transferring our technology to Biological E…for substance manufacturing…production of active vaccine material has begun, as has fill-and-finish (bottling)… We anticipate that by the end of this year, half of our vaccinations will be available to low- and middle-income coworkers

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