In a key development, the Government of India on Tuesday gave the nod to the export of country's indigenous vaccine Covaxin. This is done keeping in mind the increasing interest in Covaxin worldwide after the World Health Organisation's (WHO) Emergency Use Listing for Covaxin, which was approved on November 3.
The WHO's EUL process commenced on July 6, 2021, with rolling data submission. The WHO had conducted a meeting regarding the decision on granting EUL to Covaxin on October 26 and asked Bharat Biotech for some additional data for the same. The company had provided the data required, following which the health organization held its final meeting on November 3, and granted Covaxin the EUL status.
The Emergency Use Listing by WHO has expedited global access and availability of Covaxin. It has also facilitated countries to expedite their regulatory approval processes to introduce and administer India’s indigenous COVID-19 vaccine developed and manufactured by Bharat Biotech. It has also allowed procurement by UNICEF, PAHO, and the GAVI COVAX facility for distribution to countries in need.
Covaxin is a Whole Virion Inactivated Coronavirus Vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). 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. It showed overall 77.8% efficacy and 93.4% efficacy against severe COVID-19 disease as per the final results.
Efficacy data demonstrates 63.6% protection against asymptomatic COVID-19 cases. Most importantly, it has proven to neutralize variants such as B.1.1.7 (Alpha), B.1.617 (Kappa), B.1.351 (Beta), and B.1.617.2 (Delta).