COVAXIN is likely to get approval from the WHO by the end of the third or fourth quarter of 2021, Bharat Biotech's Business Development and International Advocacy Head Dr. Raches Ella revealed. At present, those on the WHO's Emergency Use Listing include vaccines from Moderna, Pfizer, AstraZeneca, Johnson and Johnson, and Sinopharm. The emergency use approval can be a gamechanger amid the COVID-19 crisis as it is likely to encourage countries to import COVAXIN, facilitate its manufacturing abroad and ease global travel for those vaccinated with it.
Even as the WHO approval is pending, Foreign Secretary Harsh Shringla will reportedly hold a meeting with Bharat Biotech on Monday to expedite the process.
Speaking with members of the FICCI Ladies Organisation in Hyderabad, Dr. Raches Ella stated that the company is looking to ramp up its capacity to 700 million doses by the end of 2021. Mentioning that the pediatric trials of COVAXIN may begin in June, he asserted that the vaccine for children may get approval in the third quarter of this year.
COVAXIN is a Whole Virion Inactivated Coronavirus Vaccine developed by Bharat Biotech in collaboration with ICMR and NIV. It has shown overall 78% efficacy and 100% efficacy against severe COVID-19 disease as per interim results from Phase 3 trials. 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%.
In a statement on April 21, Bharat Biotech stated, "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% against mild, moderate, and severe COVID-19 disease. The efficacy against severe COVID-19 disease was 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. A total of 15,01,82,739 persons have been inoculated in India whereas 4,16,97,326 of them have received the second dose of the vaccine too.