15 Sep 2021: 35 lakh doses of J&J COVID-19 vaccine reach Kasauli lab
Around 35 lakh doses of the COVID-19 vaccine developed by United States pharma giant Johnson & Johnson have reportedly reached the apex vaccine testing laboratory in Kasauli, Himachal Pradesh. The single-shot vaccine, called Janssen, has been found to be 85.4% against severe disease. India had approved the vaccine in August and it is being manufactured in collaboration with Hyderabad-based Biological E.
Details: Vaccine to be tested on 100 participants
An official of the Union Health Ministry told CNN-News18 that 35 lakh doses have been sent to the Kasauli lab in the first batch for testing. "It will take around two to three weeks for testing at CDL (Central Drugs Laboratory)," added the official. Thereafter, the COVID-19 vaccine will be tested on 100 participants for seven days in a fast-tracked model.
Fact: 'After testing on 100 people, national rollout will be approved'
The official said, "After completing the testing, the vaccine will be administered to 100 participants first, as mentioned in the rules for foreign vaccines. After analyzing those 100 participants for seven days, the regulator will approve the vaccine for national rollout."
Background: Vaccine granted EUA in August; 6 shots approved so far
Earlier, it was reported that Janssen will be rolled out by October. The vaccine had been granted Emergency Use Approval (EUA) by the Drug Controller General of India (DCGI) on August 7, making it the fifth COVID-19 vaccine approved in India. Overall, six vaccines have been approved for use in India so far: Covishield, COVAXIN, Sputnik V, Moderna, Janssen, and Zydus Cadila's ZyCoV-D.
Rules: India had fast-tracked approvals for certain foreign vaccines
The Union Health Ministry had revised its rules on April 13, allowing fast-tracked approval for foreign COVID-19 vaccines that have been granted emergency approval for restricted use by the US-FDA, the EMA, the UK-MHRA, the PMDA-Japan, or the World Health Organization. These vaccines will be granted approval after bridging trials on 100 beneficiaries for seven days instead of full-fledged local clinical trials.
Vaccine: What is the J&J vaccine?
J&J's vaccine uses a single shot, which has a clear advantage in mass vaccinations among hard-to-reach populations, such as homeless people. Janssen—which can be stored at 2-8°C—is 85.4% effective in preventing severe disease and 93.1% effective in preventing hospitalization. Earlier, there had been concerns about a blood clot risk, which had prompted the European Medicines Agency to suggest listing it as a rare side-effect.
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