Made-in-India Covid-19 vaccine Covaxin has 81% efficacy. The results of phase-3 trials of the indigenously developed vaccine are out. Hyderabad-based Bharat Biotech International Limited (BBIL) along with the Indian Council of Medical Research (ICMR) conducted phase-3 trials on a total of 25,800 individuals across 21 sites in India in mid-November 2020 and Covaxin was found 81% effective in preventing Covid-19. The interim efficacy trend of 81%, analyzed as per the protocol approved by the DCGI, is at par with global front-runner vaccines.
“The bench-to-bedside journey of completely indigenous COVID-19 vaccine in less than 8 months’ time showcases the immense strength of Atmanirbhar Bharat [self-reliant India] to fight the odds and stand tall in the global public health community. It is also a testament to India’s emergence as a global vaccine superpower,” said Dr. Balram Bhargava, Director General, ICMR.
The Covaxin is the first COVID-19 vaccine that has been developed completely in India. In March 2020, following the successful isolation of the SARS CoV-2 virus at ICMR-National Institute of Virology (NIV), ICMR entered into a public-private partnership with BBIL to develop the virus isolate into an effective vaccine candidate. ICMR-NIV characterized the vaccine developed by BBIL through in-vitro experiments and electron microscopy studies.
Pre-clinical studies in small animals and hamsters showed promising results in terms of safety and immunogenicity. Further studies conducted in rhesus macaques also established remarkable safety and protective efficacy of Covaxin. Phase-1 and Phase-2 clinical trials conducted in 755 participants demonstrated a high safety profile of the candidate vaccine with seroconversion rates of 98.3% and 81.1% on days 56 and 104 respectively.
Covaxin works against UK variant of Covid-19
Covaxin has been developed on the WHO prequalified Vero cell platform, which is globally recognized with a well-established track record of safety. Covaxin’s ability to neutralize the UK variant strain of SARS-CoV-2 has also recently been established.
“The development and deployment of Covaxin ensure that India has a powerful weapon in its arsenal in a continually evolving pandemic situation and will go a long way in helping us win the war against COVID-19. The need of the hour is to ensure that people in India continue to receive the vaccine and break the chain of virus transmission,” said Dr. Samiran Panda, Head, Epidemiology and Communicable Disease, ICMR and Director, National AIDS Research Institute.
The Covaxin journey:
March 11, 2020: When COVID-19 was declared a pandemic by the World Health Organization (WHO), India joined the global race of developing safe and effective vaccines to protect its citizens as well as the global community from this dreaded disease.
March 13, 2020: ICMR-National Institute of Virology (ICMR-NIV) successfully isolates the SARS-CoV-2 virus. India becomes the 5th country in the world to achieve this feat.
April 2020: ICMR enters into a public-private partnership with Bharat Biotech International Ltd (BBIL) for developing an effective vaccine candidate for SARS-CoV-2.
May 2020: ICMR-NIV transfers the virus strain to BBIL and characterizes the vaccine developed by BBIL through in-vitro experiments and electron microscopy studies.
June-August 2020: Experiments in small animals (mouse, rats and rabbits) and hamsters established promising safety and immunogenicity of Covaxin. Data has been published by the highly reputed journal of the Cell Press.
July-August 2020: Studies conducted in rhesus macaques established the safety and protective efficacy of Covaxin. The results established the remarkable ability of the vaccine candidate to clear the virus from infected organs along with its capacity to mount B and T cell immune response.
July-October 2020: Phase-1 and 2 clinical trials conducted in 755 participants demonstrated a high safety profile of the candidate vaccine along with seroconversion rates of 98.3% and 81.1% respectively on days 56 and 104 respectively. The results are published in Lancet journal.
November 2020: The largest ever clinical trial for COVID-19 in India, launched for the third phase with over 25,800 participants.
January 3, 2021: Drugs Controller General of India (DCGI) provides approval for Restricted Use in Emergency Situations for Covaxin.
January 16, 2021: India rolls-out phase-wise COVID-19 vaccine administration starting with healthcare and frontline workers.
January 27, 2021: Covaxin’s ability to neutralize UK variant strain of SARS-CoV-2 established and published in Journal of Travel Medicine.
March 3, 2021: Interim results of Phase 3 efficacy trials of Covaxin show 81% efficacy against SARS-CoV-2virus. The follow-up of participants in the trial is still ongoing.