COVAXIN 77.8% effective; government panel reviews Phase III trial data
COVAXIN, the COVID-19 vaccine developed by Bharat Biotech, has been found 77.8% effective against the viral disease, Phase III trial data reportedly revealed. The Subject Expert Committee (SEC) under the Drugs Controller General of India (DCGI) met earlier in the day to analyze the data submitted by the Hyderabad-based firm. It was submitted over the weekend and was cleared by the SEC on Tuesday.
Data yet to be published in internationally recognized, peer-reviewed journal
The Phase III trial data is yet to be published in an internationally recognized, peer-reviewed journal. Earlier this month, Bharat Biotech had announced a timeline of approximately three months for the publication of trial data. As per the "first interim analysis" of Phase III trials released in March, COVAXIN was 81% effective in offering protection against COVID-19 and 100% effective against hospitalizations.
COVAXIN an inactivated vaccine for SARS-CoV-2
COVAXIN has been developed indigenously by Bharat Biotech in collaboration with the Indian Council of Medical Research's National Institute of Virology (ICMR-NIV). The ICMR is India's apex medical research body at the forefront of the fight against COVID-19. It is an inactivated vaccine, i.e., it uses an inactivated or killed pathogen (SARS-CoV-2) to trigger an immune response.
Phase III data clearance to make WHO listing easier
Clearance to the vaccine's Phase III data will also likely facilitate the EUL (emergency use listing) for Bharat Biotech from the World Health Organization. This would allow the company to export COVAXIN. It would also make international travel easier for those vaccinated with the shot. Notably, several foreign governments have not recognized COVAXIN yet, citing the incomplete trial data.
Bharat Biotech meeting with WHO authorities tomorrow
Further, Bharat Biotech has scheduled a pre-submission meeting with WHO authorities on Wednesday. The final submission of required data and documents will be discussed at the meeting. Reportedly, the firm has already submitted 90% of the required paperwork. Last month, the firm had said that it is expecting approval by the global health body for COVAXIN by September.
Under clinical trials, COVAXIN was granted emergency approval in January
COVAXIN was controversially cleared for emergency use in India this year in January while still under clinical trials. Several experts had raised questions about the permission for "restricted use in an emergency situation in public interest" in the "clinical trial-phase."