Putting end to all speculation, Bharat Biotech (BBL) has finally published Covaxin's phase-3 trial data late on Friday night. Clocking an overall efficacy of 77.8%, Covaxin is 93.4% efficacious against severe symptomatic cases, 78% effective against mild and moderate cases and 63% effective on asymptomatic cases. The vaccine has also shown 65.2% efficacy against the Delta variant of COVID-19 with the vaccine being well tolerated with no clinically or statistically significant differences in serious adverse events. Covaxin has been tested on 25,800 volunteers across 25 trial sites on subjects ages 18-98 years - India's largest efficacy trial.
Reacting to Covaxin's success, ICMR Director Dr Balram Bhargava said, “I am delighted to note that COVAXIN has demonstrated an overall efficacy of 77.8% in India’s largest COVID phase 3 clinical trial thus far. COVAXIN will not only benefit the Indian citizens but would also immensely contribute to protect the global community against the deadly SARS-CoV-2 virus". COVAXIN is currently undergoing additional clinical trials to establish safety and efficacy in children between 2-18 years of age.
BBL Joint MD Suchitra Ella said, “It is a momentous day for everyone, at Bharat Biotech, as we announce the Final Phase-3 Results of COVAXIN and its efficacy of 77.8%. We wish to thank ICMR, NIV-Pune, Virovax, DSMB and Adjudication Committee. We earnestly thank our clinical trial sites, Principle Investigators, IQVIA, and every participant who has reposed their faith in COVAXIN. COVAXIN has been evaluated through neutralizing antibody responses against several variants of concern, namely B.1.617.2 (Delta), B.1.617.1 (Kappa), B.1.1.7 (Alpha), B.1.351 (Beta), P2- B.1.1.28 (Gamma)."
In March, Bharat Biotech said that its COVID-19 vaccine - Covaxin - a Whole Virion Inactivated Corona Virus Vaccine - has shown an interim clinical efficacy of 81% in its Phase 3 trials. The phase 3 trials involved 25,800 subjects and is the largest ever trial conducted in India. COVAXIN has been granted permission for restricted use in an emergency situation by the DGCI in January 3. Union Health Minister Dr. Harsh Vardhan explained that COVAXIN is more likely to work against newer variants like N501Y Variant (UK variant) and the recent double mutation (Indian variant). The participants enrolled were between the age of 18-98 years old including 2,433 over the age of 60 and 4,500 with comorbidities. Amid heavy politicisation, Centre roped in several PSUs to produce Covaxin and approved an advance payment of Rs 1500 crores to BBL to ramp up COVID-19 vaccine production.
BBL has informed that Covaxin will even undergo phase-4 trials to check the real-world effectiveness of the vaccines to meet every rigorous scientific standard for safety, effectiveness, and manufacturing quality needed to support emergency use authorization. Centre has capped vaccine prices at Covishield Rs 780 per dose, Covaxin Rs 1,410 and Sputnik V Rs 1,145, while vaccines are provided free of cost at govt centres from June 21 as Covaxin is supplied to Centre at Rs 150. India has ordered an additional 19 crore Covaxin doses till September 2021, while Covaxin awaits WHO's approval.