COVAXIN shows overall 78% efficacy & 100% efficacy against severe COVID in Phase 3 trials

In a heartening development, COVAXIN has shown overall 78% efficacy and 100% efficacy against severe COVID-19 disease as per interim results from Phase 3 trials. COVAXIN is a Whole Virion Inactivated Coronavirus Vaccine developed by Bharat Biotech in collaboration with ICMR and NIV. On Wednesday, Bharat Biotech stated that the second interim analysis suggests a reduction in hospitalization cases and decreased transmission in recipients of this vaccine. Moreover, the efficacy against asymptomatic novel coronavirus infection was 70%. 

It noted, "The second interim analysis is based on accruing more than 87 symptomatic cases of covid-19. Due to the recent surge in cases, 127 symptomatic cases were recorded, resulting in a point estimate of vaccine efficacy of 78% (95%ci: 61-88) against mild, moderate, and severe COVID-19 disease. The efficacy against severe COVID-19 disease was 100% (95%ci: 60-100), with an impact on reduction in hospitalizations."

While the phase 3 trials entailed 25,800 participants between 18-98 years of age including 10% over the age of 60, the analysis was conducted 14 days after administering the second dose of the vaccine. The final efficacy results shall be available in June and will be published in a peer-reviewed publication. Speaking on this development, ICMR Director General Dr.Balram Bhargava expressed happiness over the fact that COVAXIN works well against most variants of COVID-19 including the double mutant strain. 

Bharat Biotech Joint Managing Director Suchitra Ella remarked, “COVAXIN's evidence-based development has proved its suitability for global access, with excellent efficacy results against symptomatic, asymptomatic, and severe disease. The interest from countries worldwide has quietly validated our efforts. We thank our volunteers, principal investigators, partners and Team Bharat Biotech for their contribution to this project towards improving global public health.”

India's vaccination policy

Apart from COVAXIN and COVISHIELD, the DCGI accepted the recommendations of the Subject Expert Committee of the Central Drugs Standard Control Organisation, paving way for the approval of Sputnik V on April 12. Moreover, the Union government declared that those vaccines that have been granted emergency approval for restricted use by USFDA, EMA, UK MHRA, PMDA Japan, or which are listed in WHO (Emergency Use Listing) will be granted emergency use approval in India. The Centre has also gradually evolved its vaccination policy.

While only healthcare and frontline workers were vaccinated at government facilities in the initial phase, the inoculation drive was expanded to include people above 60 years of age and those aged above 45 years having comorbidities in the second phase. From April 1 onwards, all persons above the age of 45 became eligible for inoculation. Amid increasing demands from states to remove the inoculation age cap, the Centre on Monday announced that all adults can now get themselves vaccinated. A total of 11,12,87,780 persons have been inoculated in India till now, 1,78,09,646 of them have received the second dose of the vaccine too.