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Biological E may launch vaccine by August
- Biological E is also contract manufacturing the single-dose vaccine developed by Johnson & Johnson, and the latter has sought an approval from the Drugs Controller General of India for conducting a bridging study for the jabs
Biological E Ltd is about to complete phase 1 and 2 trials of its covid-19 vaccine and is expected to launch the jab by August after completing its phase 3 trial and securing authorisation from the Indian regulator, NITI Aayog member-health V.K. Paul said.
“Biological E has almost completed its phase 1, phase 2 trial. They will submit their data in a few days and after that they will go into phase 3,” Paul said, adding that the development is significant because the company can produce around 70 million doses per month.
The capacity for Biological E, as mentioned by Paul, is similar to that of Serum Institute of India currently for manufacturing Covishield.
Biological E is currently conducting the trial of a protein-subunit vaccine it is co-developing with US-based Baylor College of Medicine, the agreement for which it had signed in August last year.
A protein subunit vaccine against coronavirus contains only its spike protein, which is the part of the virus that attaches itself to human cells before replication of the RNA begins. The vaccine is generally considered by experts as being one of the safest platforms of vaccine.
Another protein subunit vaccine, developed by US-based Novavax, will be contract manufactured by Serum Institute of India under the brand Covovax. The Pune-based firm is currently conducting a phase 2 and 3 bridging study to prove that the jabs manufactured in India are the same as those produced by Novavax.
Biological E is also contract manufacturing the single-dose vaccine developed by Johnson & Johnson, and the latter has sought an approval from the Drugs Controller General of India for conducting a bridging study for the jabs.
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First Published:21 Apr 2021, 09:58 PM IST
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