Bharat Biotech's Covaxin 77.8% Effective in Phase Three Trial

On Tuesday, India's drug regulator's Subject Expert Committee (SEC) approved Bharat Biotech's Covaxin as it found 77.8% effective in phase-3 trial data against the Covid-19 pandemic.

According to data from Phase III trial, it involves 25,800 participants across India.

According to sources, the DCGI's Subject Expert Committee reviewed trial data and results on Tuesday and recommended approval. Over the weekend, the information was submitted to the DCGI.

The meeting was held prior to Bharat Biotech's 'pre-submission' meeting with the World Health Organization (WHO) on Wednesday to seek approval for their COVID vaccine 'Covaxin.'

As per government sources, the Hyderabad-based COVID vaccine manufacturing company Bharat Biotech submitted data from the Phase III clinical trials of Covaxin to the Drugs Controller General of India (DCGI) over the weekend.

Covaxin from Bharat Biotech is one of three vaccines presently in use in India. The phase III data of its vaccine have been questioned several times, which makes the data critical in determining the efficacy of the vaccine.

The vaccine was created in collaboration with the Indian Council of Medical Research (ICMR).

Meanwhile, Covaxin got a nod in the last year for emergency use while it was in the clinical phase. It raised concern and was seen as a major reason for the hesitancy for the public to get vaccinated. It was given "restricted use in emergency situations in public interest.

Whereas now the approved Phase III data will help to erase doubts from the minds of several people and therefore the government will seek to accelerate vaccination in preparation for a possible third wave and to protect against the country's mutated versions of the virus.