New Delhi, Dec 7: After Pfizer and Serum Institute, Hyderabad-based pharmaceutical firm Bharat Biotech on Monday applied to the central drug regulator seeking emergency use authorisation for its COVID-19 vaccine Covaxin, official sources said.
Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
The Hyderabad-based firm is conducting phase-3 clinical trial of its vaccine in around 25 places, including Delhi, Mumbai, Patna and Lucknow.
The firm, while applying for the phase-3 trial, had stated that the vaccine was well-tolerated in all dose groups and no serious adverse events have been reported. The most common adverse event was transient pain at the injection site, a source said.
The Drugs Controller General of India (DCGI) had on October 23 granted permission to the firm for conducting phase-3 clinical trial of Covaxin after assessing the safety and immunogenicity data of phase 1 and 2 trials.
An expert committee of the Central Drugs Standard Control Organisation (CDSCO) will meet on Wednesday to review applications of Pfizer, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their COVID-19 vaccine candidates.
At an all-party meeting on December 4, Prime Minister Narendra Modi had expressed hope that a COVID-19 vaccine may be ready in a few weeks.
That evening, the Indian arm of US pharmaceutical giant Pfizer had sought approval for its vaccine from the central drug regulator, after the firm secured such clearance in the UK and Bahrain.
The Serum Institute sought the nod for the Oxford COVID-19 vaccine, Covishield, on December 6.
"DCGI has already started processing the applications. The subject expert committee on COVID-19 at CDSCO will deliberate on the applications by Pfizer, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their COVID-19 vaccines on December 9," a source said.
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Maharajganj (UP) (PTI): A 29-year-old married woman was found hanging at her in-laws' home here, with her in-laws claiming it was suicide while her mother alleging murder over dowry, police said on Sunday.
According to police, Anukriti (29) had married Manoj Gond six years ago and lived with her in-laws in Mahadeva village.
Her in-laws claimed that she died by suicide after allegedly hanging herself inside a room of the house on Saturday evening, police said.
After receiving information about the incident, a police team reached the spot and sent the body for a post-mortem.
Paniyara police station in-charge Sanjay Kumar Singh said that based on a complaint filed by the woman’s mother, a case was registered on Sunday against her husband Manoj Gond, mother-in-law Punam, father-in-law Sumer Gond, and brother-in-law Munna Gond.
The complainant alleged that Anukriti was being harassed for dowry by in-laws and was murdered over dowry-related demands, Singh said.
(Assistance for overcoming suicidal thoughts is available on the state’s health helpline 104, Tele-MANAS 14416.)
