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By Sudarshan Varadhan and Krishna N. Das
CHENNAI/NEW DELHI, Jan 2 (Reuters) - India's drugs regulator
on Saturday recommended for emergency use a locally developed
coronavirus vaccine called COVAXIN, which is expected to be a
backup to the AstraZeneca/Oxford shot.
COVAXIN has been developed by Bharat Biotech, a company
based in Hyderabad, with backing from the state-run Indian
Council of Medical Research (ICMR).
Not much is known about the safety and efficacy of COVAXIN.
The company says it has submitted all data to the drugs
regulator.
The head of India's drugs regulator is expected to share
details about it at a news conference on Sunday, when its formal
approval is likely to be announced.
Here are some major developments related to COVAXIN:
June 30, 2020 - The Drugs Controller General of India (DGCI)
approves COVAXIN for human trials, making it the country's first
domestic vaccine candidate. (https://reut.rs/3hJ1j40)
July 3 - An official at ICMR, India's top clinical research
agency, says in a leaked letter it envisages launching a
coronavirus vaccine by Aug. 15, India's independence day,
leading to questions from some health experts about the short
timeline.
The same day, Bharat Biotech shares its target of producing
up to 300 million doses of the vaccine if its trials succeed.
July 4 - ICMR says its decision to fast-track development of
a potential coronavirus vaccine is in line with international
standards.
Oct 23 - Bharat Biotech says it is in discussions with more
than 10 countries that have shown an interest in its vaccine
candidate. It says Phase 1 and 2 trials have found the vaccine
to be safe.
Nov 01 - Bharat Biotech says it is planning to launch the
vaccine in the second quarter of 2021.
Nov 16 - Bharat Biotech says it is starting phase III
trials.
Nov 20 - Bharat Biotech offers Brazil the vaccine and a
possible technology-transfer partnership.
Dec 07 - Bharat Biotech seeks emergency use approval for
COVAXIN.
Dec 22 - U.S.-based drug developer Ocugen Inc says
it has partnered with Bharat Biotech to co-develop the vaccine
candidate for the U.S. market.
Jan 2 - Experts at India's drug regulator approve the
vaccine "for restricted use in emergency situation in public
interest as an abundant precaution, in clinical trial mode,
specially in the context of infection by mutant strains".
Bharat Biotech says it has recruited 23,000 volunteers out
of its target of 26,000 for an ongoing Phase-3 trial of COVAXIN
in India that began in mid-November. It is the largest Phase III
efficacy trial conducted for any vaccine in India.
(Reporting by Sudarshan Varadhan in CHENNAI and Krishna N. Das
in NEW DELHI; Editing by Christina Fincher)
