Throughout the world there are185,354,379 confirmed cases of coronavirus and 4,008,610 deaths across nearly 200 countries recorded since China reported its first cases in December 2019. The US remains the worst-hit country with 34,618,968 cases, followed by India, Brazil, France and Russia. India on Wednesday recorded a spike of 43,733 new infections, taking the total caseload to 30,663,665, according to MoHFW. As per the new data death count increased to 404,211 with 930 new fatalities. The five most affected states by total cases are Maharashtra (6,113,335), Kerala (2,981,721), Karnataka (2,856,491), Tamil Nadu (2,500,002), and Andhra Pradesh (1,905,023). Meanwhile, Kerala reported 14,373 new infections, followed by Maharashtra (8,418), Tamil Nadu (3,479), Andhra Pradesh (3,042), Karnataka (3,104), Delhi (79) and West Bengal (962).
While, on this Saturday Bharat Biotech’s Covaxin concluded after the phase-3 clinical trial claiming to be 77.8 per cent effective against COVID-19. Also it added that Covaxin gives 65.2 per cent protection against the SARS-CoV-2, B.1.617.2 Delta variant. It was also found to be “93.4 per cent effective” against severe symptomatic COVID-19, the company said. Covaxin is a whole virus inactivated vaccine against SARS-CoV2, developed by Bharat Biotech in partnership with ICMR and NIV Pune.
The Phase 3 clinical trial was an event-driven analysis of 130 symptomatic COVID-19 cases, reported at least two weeks after the 2nd dose, conducted at 25 sites across India.
Dr. Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, “The successful safety and efficacy readouts of Covaxin as a result of conducting the largest ever Covid vaccines trials in India establishes the ability of India and developing world countries to focus towards innovation and novel product development. We are proud to state that Innovation from India will now be available to protect global population.”
“The successful development of Covaxin has consolidated the position of Indian academia and Industry in the global arena,” Prof. (Dr) Balram Bhargava, Secretary Department of Health Research & Director General Indian Council of Medical Research, said.
Bharat Biotech co-founder Suchitra Ella said in a late-night tweet, “We are proud to put India on the global map with scientific conviction, competence and commitment. Covaxin scores 10 world-class publications endorsing Innovation, clinical research, data, safety, efficacy. Thank collaborators & Positive BB teamwork enduring a pandemic.”
In a statement, the vaccine maker further said, “Efficacy analysis demonstrates Covaxin to be 77.8 per cent effective against symptomatic COVID-19, through evaluation of 130 confirmed cases, with 24 observed in the vaccine group versus 106 in the placebo group.”
Covaxin produced in India in collaboration with the Indian Council of Medical Research and National Institute of Virology was approved for emergency use in January 2021, even though its Phase III trials were ongoing. This decision was criticised by many experts as there was not enough evidence proving that the vaccine worked in neutralising the virus. The statement released by Bharat Biotech claims that Covaxin was not only effective against the original strain but also all the other variants 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).at varying efficacies. The vaccine produced neutralising antibodies against all the strains.
Bharat Biotech’s final results come at a time when it needs approval in other countries such as US that require complete efficacy data for authorising emergency use. Even the WHO required the company to send Phase III results to apply for Emergency Use Listing from the WHO. While Covaxin has received EUA from 16 countries, its purchase order was suspended in Brazil after reports of corruption in this deal were raised in the Brazilian parliament.
