Covaxin Bharat Biotech Vaccine Update

COVAXIN, India's indigenous COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) high containment facility

8 January 2020 

According to the statement released from Biotech , the team from Precisa Medicamentos met Bharat Biotech CMD Dr Krishna Ella in Hyderabad. The meeting discussed potential export possibilities of Covaxin. 

11 January 2020 

Bharat Biotech signed a purchase agreement with government of India to provide 55 lakh doses of Covaxin at Rs 295 per dose. 

Sources have reported that dispatches will start from January 12. 

17 January 2021 

After being approved in India for emergency use in phase III clinical trials , the company will be approaching WHO for pre qualification of Covaxin as informed by the company spokesperson. 

19 January 2021

Bharat Biotech has issued a fact sheet about the process of vaccination and who should not take Covaxin.

The sheet was displayed on their official website and adviced people with severe allergies, fever, bleeding disorders, weaker immunity or those taking any immunity related medicines to not take Covaxin.

The doses are to be provided in two stages.

22 January 2021 

The phase I trial of Covaxin was published in the Lancet . It showed that Covaxin induced binding and neutralizing antibody responses against the novel Coronavirus and was safe to use. 

7 January 2021

Bharat Biotech completes it’s volunteer enrollment for phase 3 clinical trials constituting 25,800 volunteers as told by ICMR chief Dr Balram Bhargava 

Covaxin: Covaxin shows promising efficacy in phase 1 trials, caused no serious adverse effects

Covaxin, India's home-grown COVID-19 vaccine has shown promising efficacy, and proven safe in the phase 1 trials, interim trial results suggest. 

The phase 1 interim trial results of Covaxin have shown that the vaccine is well-tolerated, and no adverse events were reported among the participants. 

After the first dose of vaccine was administered to participants in phase 1 trials, the side effects were reported to be mild or moderate. 

The adverse effects experienced were also resolved rapidly, and did not require any prescribed medication.

The most common side effect of vaccination was pain at the injection site, which has been reported by many vaccines in the past as well. 

Country of origin: India

Previous phase trial results: 

The trial size for phase-1 and -2 trials was set at 1,125 candidates. Of this, 375 volunteers were vaccinated in phase-1. So, 750 were to be a part of the phase-2 studies. 

The company confirmed the phase-2 will test only 380 volunteers but refused to share details.

Phase 3:

Trials are in progress with 26,000 volunteers under ICMR supervision

Bharat Biotech has guaranteed at least 60% effectiveness

Side effects

The firm said volunteers did not complain of any major side effects apart from fever and body aches.

The vaccine earned DCGI clearance for Phase I & II Human Clinical Trials, and studies began in July 2020 across India. Following the successful completion of the interim review of the COVAXIN Phase 1 & 2 clinical trials, Bharat Biotech obtained DCGI approval for Phase 3 clinical trials from 26,000 participants in more than 25 centres across India.

Latest Update (8th December): Bharat Biotech Seeks Emergency Use Authorisation From DCGI For Its Covid-19 Vaccine Covaxin

After Pfizer And Serum Institute, Hyderabad-Based Pharmaceutical Firm Bharat Biotech On Monday Applied To The Central Drug Regulator Seeking Emergency Use Authorization 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).

Prime Minister Narendra Modi On Monday Said That The Country Will Not Have To Wait Too Long For The Coronavirus Vaccine Even As He Cautioned People That There Should Be No Laxity As Far As Prevention Of The Infection Is Concerned.

Chief Minister Amarinder Singh Has Urged Prime Minister Narendra Modi To Ensure Priority Allocation Of COVID-19 Vaccine To Punjab On Account Of Its Higher Mortality Rate And High Levels Of Co-Morbidities In The State.

Latest Update (26th November): Covaxin Phase 3 trials to start in Gujarat civil hospital.

The phase-3 clinical trials of Bharat Biotech's Covid-19 vaccine candidate will begin at Sola civil hospital in Ahmedabad, Gujarat.

The hospital received 500 doses of the Covaxin for the trial, which have been kept in cold storage at the hospital.

The vaccine (candidate) will be tested on volunteering citizens living in urban and rural areas, healthy and elderly volunteers and health workers.

Latest Update (1st December): Covaxin Phase 3 trials are underway at AIIMS, Delhi.

Phase-three of the human clinical trial of Covaxin is currently underway at AIIMS in Delhi with Dr. MV Padma Srivastava, the chief of Neurosciences Centre at the premier institute, and three other volunteers receiving the first dose.

Srivastava was the first one to receive the shot, which would be given to around 15,000 volunteers at the AIIMS over the next few days.

The first dose of 0.5 ml intramuscular injection was given to four volunteers. They were under observation for two hours and will be monitored for the next few days.