"Therefore, for BLA, data from an additional clinical trial will be required to support the marketing application submission for COVAXIN This process will extend our timelines," it added.
In February, Ocugen and Bharat Biotech had entered into a definitive agreement to co-develop, supply, and commercialise Covacin for the US market.
FDA has asked Ocugen, the US partner of Bharat Bio, to launch an additional trial so that it can file for for a full approval
The study found that vaccination with Covaxin produced neutralising titres against all key emerging variants tested including B1617 and B117, first identified in India and the UK, respectively.
May 22, 2021
Hyderabad, May 13 : Bharat Biotech‘s Joint Managing Director Suchitra Ella‘s tweet saying 50 of their employees tested…
May 13, 2021
Earlier the proposal was deliberated in the SEC meeting dated February 24 and the firm was asked to submit a revised clinical trial protocol.
May 12, 2021
The district health department said on Tuesday that it was holding back Covishield doses for people in the 18-44 age group due to limited allocation of the vaccine by the state
May 12, 2021
Aam Aadmi Party leader Atishi on Tuesday claimed that Delhi’s stock of Covaxin for people in the 18-44…
May 11, 2021
Mumbai: Maharashtra urgently needs Covaxin doses as four to five lakh people in the state are waiting for…
May 9, 2021
The ‘Indian strain’ has been found prevalent largely in Maharashtra and Delhi that have been severely hit by a devastating second wave of the pandemic.
April 28, 2021
Bharat Biotech further announced that it will also export Covaxin and the export price of the vaccine would be between $15-$20, i.e., between Rs 1,100 to Rs 1,500 per dose, approximately.
April 25, 2021
More than 21,000 people tested positive for COVID-19 after taking the first dose of either Covishield or Covaxin, while over 5,500 contracted the infection after taking the second dose, the Centre said on Wednesday.
April 22, 2021
Haffkine Biopharma Corporation, Mumbai, has received permission from the Union government to manufacture Covaxin, an anti-coronavirus vaccine of…
April 16, 2021
The vaccine maker said in phase 1 and phase 2 clinical trials, Covaxin has demonstrated the ability to produce antidotes against COVID- 19
January 17, 2021
Doctors of Delhi’s premier RML Hospital have shot a letter to the hospital superintendent saying they do not want to take the Bharat Biotech vaccine – Covaxin – and would instead prefer the Covishield vaccine of Serum Institute of India.
January 16, 2021
The Centre has asked the Bharat Biotech to supply around 55 lakh doses to 12 centres before 14 January.
January 12, 2021
Mumbai, Jan 4 : Actress Deepti Naval is apprehensive about the possible side effects of the forthcoming Covid…
January 4, 2021
The company has already built capacities to manufacture 200 million doses of vaccine and plan to further enhance to 500 million doses.
January 3, 2021
The DCGI gave approval for the emergency use of two Covid-19 vaccines, one developed by AstraZeneca and Oxford University and the other by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV).
January 3, 2021
Their approval by DCGI will bring major relief for India which has the second highest number of infections in the world, after the United States.
January 3, 2021
The leading vaccine maker is also developing a single-dose nasal vaccine for Covid-19.
December 30, 2020
India has eight Covid-19 vaccine candidates, including three indigenous vaccines, under different stages of clinical trials which could be ready for authorization in near future.
December 19, 2020
Was told antibodies build up 14 days after 2nd shot, clarifies Anil Vij after testing COVID positive despite taking ‘Covaxin’
New Delhi: A day after testing positive for coronavirus despite being a volunteer for Covaxin’s human phase trial,…
December 6, 2020
The SII has almost completed its phase 3 trials in India and a follow-up of the data is likely to start soon.
November 23, 2020
He further informed that the Vice-Chancellor Prof Tariq Mansoor had volunteered himself for Phase-3 trial of the Covaxin.
November 15, 2020
Guwahati, Aug 18 : The Gauhati Medical College and Hospital (GMCH) has been selected for the second phase…
August 18, 2020
According to a senior official, recently the ethics committee has given a go-ahead for human trials for the vaccine, and AIIMS will begin registering volunteers as per the procedure.
July 19, 2020
Bharat Biotech got the country's drug regulator's approval to start clinical trials of its anti-Corona vaccine Covaxin recently
July 17, 2020