In a key development, a top official at the WHO estimated that a decision on COVID-19 vaccine Covaxin's inclusion in the Emergency Use List will be taken next month. Earlier on July 9, Bharat Biotech had submitted the data required for the WHO's approval for its COVID-19 vaccine. Dr. Mariangela Simao, the WHO Assistant Director General for Access to Medicines, Vaccines and Pharmaceuticals told the media that the UN health agency's assessment of Covaxin was at an advanced stage. Moreover, she opined that a decision regarding the same can be expected by mid-September.
The emergency use approval can be a gamechanger amid the COVID-19 crisis as it is likely to encourage countries to import the vaccine, facilitate its manufacturing abroad and ease global travel for those vaccinated with it. Apart from Covishield and Covaxin, the Drugs Controller General of India (DCGI) has also approved Sputnik V, Moderna, and the Johnson & Johnson vaccine. A total of 40,72,15,900 persons have been inoculated whereas 11,54,65,625 of them have received the second dose of the vaccine too.
COVAXIN is a Whole Virion Inactivated Coronavirus Vaccine developed by Bharat Biotech in collaboration with Indian Council of Medical Research (ICMR) and 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 has shown overall 77.8% efficacy and 93.4% efficacy against severe COVID-19 disease as per the final results.
On the other hand, efficacy data demonstrates 63.6% protection against asymptomatic COVID-19 disease. Most importantly, it has proven to neutralise variants such as B.1.1.7 (Alpha), B.1.617 (Kappa), B.1.351 (Beta) and B.1.617.2 (Delta). Under the aegis of the ‘Mission COVID Suraksha- the Indian COVID-19 Vaccine Development Mission’, the Haffkine Biopharmaceutical Corporation Ltd, Mumbai; Indian Immunologicals Limited in Hyderabad and Ankleshwar and Bharat Immunologicals Biologicals Limited in Bulandshahr have also been permitted to produce Covaxin.
A day earlier, the DCGI approved a study on mixing Covishield and Covaxin. This came after the ICMR observed in a preprint study that a combination of these COVID-19 vaccines elicited better safety and immunogenicity results than two doses of the same vaccine. In this case, the Christian Medical College, Vellore will conduct the clinical trials on 300 healthy volunteers. The aim of this study will be to ascertain whether two different vaccine doses can be administered to a person instead of the current practice of administering two shots of the same vaccine.