'Covaxin demonstrates high clinical efficacy trend against COVID-19 but also significant immunogenicity against the rapidly emerging variants,' said Chairman and Managing Director Krishna Ella
The clinical trial will continue through to final analysis at 130 confirmed cases in order to gather further data and to evaluate the efficacy of Covaxin in additional secondary study endpoints
Hyderabad-based vaccine manufacturing company Bharat Biotech on Wednesday announced phase 3 clinical results of its indigenously-made Covid-19 vaccine candidate, Covaxin. In the trial results, the company says that Covaxin demonstrates an interim clinical efficacy of 81% against novel coronavirus.
The data come from 25,800 participants who received a vaccine or placebo in a 1:1 ratio and showed that the vaccine candidate was well tolerated, the company stated. The trials were conducted in partnership with the Indian government's medical research body ICMR.
"The clinical trial will continue through to final analysis at 130 confirmed cases in order to gather further data and to evaluate the efficacy of COVAXIN in additional secondary study endpoints," the company further stated.
"Today is an important milestone in vaccine discovery, for science and our fight against coronavirus. With today's results from our Phase 3 clinical trials, we have now reported data on our COVID-19 vaccine from Phase 1, 2, and 3 trials involving around 27,000 participants," Bharat Biotech Chairman and Managing Director Krishna Ella said.
Covaxin demonstrates high clinical efficacy trend against COVID-19 but also significant immunogenicity against the rapidly emerging variants, he added.
Thirty-six of the 43 cases were recorded in participants who received a placebo, compared with seven cases in people who were given the Bharat Biotech vaccine, pointing to an efficacy rate of 80.6%, the company said.
Bharat Biotech said the interim analysis of its vaccine included a preliminary review of the safety database, which showed that severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups, the company said.
The trial's conduct and monitoring are as per good clinical practice guidelines and have been outsourced to IQVIA, it added.
"Analysis from the National Institute of Virology indicates that vaccine-induced antibodies can neutralize the UK variant strains and other heterologous strains," Bharat Biotech said.
"The bench-to-bedside journey of completely indigenous COVID-19 vaccine (COVAXIN) in less than 8 months’ time showcases the immense strength of Atmanirbhar Bharat to fight the odds & stand tall in the global public health community," said ICMR DG Dr Balram Bhargava later in the day.
Bharat Biotech's data comes a few days after India's drug regulator committee had asked the vaccine manufacturer to submit efficacy data of the ongoing phase 3 trials of its Covid-19 vaccine candidate 'Covaxin.'
The Central Drugs Standard Control Organization (CDSO)'s Subject Expert Committee said in a statement, "Firm should submit Efficacy and Safety data of the ongoing Phase III clinical trial in adults along with the age subgroup analysis."
The findings cement Bharat Biotech’s claims of the vaccine being safe and may help overcome vaccine hesitancy as India gears up to ramp Covid-19 vaccination drive.
Covaxin is one of the two Covid-19 vaccines approved for emergency use in India for its mega vaccination drive, which started on 16 January, 2021 and is now in the next phase. The other one is Serum Institute of India's locally-made Oxford-AstraZeneca’s COVID 19 vaccine, Covishield.
Covaxin has been administered to hundreds of Indian citizens already including to Prime Minister Narendra Modi, who took the first shot on Monday marking the beginning of the second phase of vacciantions in the country for elderly citizens above 60 years of age and those above 45 years of age with comorbidities.
More than 1.48 crores doses of the COVID-19 vaccine have been administered till Tuesday. Out of this, 2.08 lakh doses have been given to people who are 45 years to 59 years of age with comorbidities & people with above 60 years of age.
Bharat Biotech's efficacy data comes at a time when India has been witnessing a surge in coronavirus cases, especially in states like Maharashtra, Kerala. The Union Health Ministry informed that Maharashtra, Kerala, Punjab, Tamil Nadu, Gujarat and Karnataka continue to report a surge in fresh COVID-19 cases and they account for 85.95 per cent of the cases reported in a span of 24 hours.
The ministry said that 14,989 new cases were registered in a span of 24 hours.
Maharashtra has reported the highest daily new cases at 7,863. It is followed by Kerala with 2,938, while Punjab reported 729 new cases.
India's total active caseload has reached 1,70,126 today. India's present active caseload now stands at 1.53 per cent of the total positive cases.
Meanwhile, Bharat Biotech has been supplying its vaccine doses to other countries apart from India. Recently, the vaccine maker confirmed that the company has signed an agreement with Brazil for the supply of 20 million doses of Covaxin vaccine.