Tolerable safety outcomes in Covaxin Phase II trials
Updated:
Updated:
Vaccine candidate produced ‘high levels of neutralising antibodies’ in Phase 1 trial
Share Article
Vaccine candidate produced ‘high levels of neutralising antibodies’ in Phase 1 trial
COVID-19 vaccine candidate Covaxin, being developed by Bharat Biotech and Indian Council of Medical Research (ICMR), showed tolerable safety outcomes and enhanced humoral and cell-mediated immune responses, according to interim findings of Phase II trials shared in a pre-print paper.
In Phase 1 trial, the vaccine candidate produced “high levels of neutralising antibodies that remained elevated in all participants three months after the second vaccination.”
Titled ‘Safety and immunogenicity clinical trial of an inactivated SARS-CoV-2 vaccine, BBV152 (a phase 2, double-blind, randomised controlled trial) and the persistence of immune responses from a phase 1 follow-up’, the paper was shared on medRxiv, a fre
Coast guards rescue drowning fisherman, his boat off Bhatkal coast | Watch
It s been a few weeks since the Pfizer Vs Serum debate has received immense interest and raised eyebrows at the same time. Who will hit the Indian market first and more importantly, who will be more efficacious.
coronavirus vaccine. representational.
After Pfizer, Serum Institute of India became the second company to approach India s drug regulator DGCI (Drugs Controller General of India), with Hyderabad-based Bharat Biotech coming a close third. Now the Pune-based SII has approached DGCI once again with updated data seeking authorisation to market its potential Covid-19 vaccine.
Bharat Biotech Has Again Applied for Emergency Authorisation of Covid-19 Vaccine, Say Sources
FOLLOW US ON:
Hyderabad-based Bharat Biotech has applied for Emergency Use Authorisation of its Covid-19 vaccine COVAXIN again with the Drug Controller General of India (DCGI), sources told News18 on Wednesday.
COVAXIN, an inactivated vaccine candidate, is currently undergoing Phase III human clinical trials on 26,000 volunteers at 25 centres across India, after having undergone Phase I and II trials involving 1,000 volunteers.
Bharat Biotech had applied for the emergency use authorisation of its vaccine on December 7 and presented its proposal for the grant, along with the interim safety and immunogenicity data of Phase I and II clinical trials.
Bharat Biotech to submit additional data for vaccine s emergency approval(IANS Special)
By
Aakanksha Khajuria ( IANS) |
Published on
Wed, Dec 23 2020 18:33 IST |
0 Views
Bharat Biotech recruits 13,000 volunteers for Phase III trials of Covaxin. Image Source: IANS News
New Delhi, Dec 23 : Hyderabad-based Bharat Biotech, which is developing the country s indigenous coronavirus vaccine in collaboration with the Indian Council of Medical Research (ICMR), will submit the additional data sought by the Drug Controller General of India (DCGI) for grant of emergency use authorisation to its vaccine in a week or two .
COVAXIN, an inactivated vaccine candidate, is currently undergoing Phase III human clinical trials on 26,000 volunteers at 25 centres across India, after having undergone Phase I and II trials involving 1,000 volunteers.
Bharat Biotech, Ocugen to co-develop Covaxin for United States market ANI | Updated: Dec 22, 2020 21:42 IST
Hyderabad (Telangana) [India], December 22 (ANI): Hyderabad-based Bharat Biotech and US-based biopharmaceutical firm Ocugen Inc on Tuesday announced that they have signed a binding letter of intent (LOI) to co-develop the Indian firm s COVID-19 vaccine candidate Covaxin for the United States market.
As per the letter of intent (LOI), Ocugen will have US rights to the vaccine candidate and, in collaboration with Bharat Biotech, will be responsible for clinical development, registration, and commercialisation for the US market.
In a joint statement, the companies said that they have begun collaborating and will finalise details of the definitive agreement in the next few weeks. This collaboration leverages Ocugen s vaccine expertise, and its R&D and regulatory capabilities in the US.