New Delhi: Hyderabad-based Bharat Biotech, the maker of India’s only home-made vaccine against Covid-19, has finally submitted its phase 3 trial data to the Drug Controller General of India (DCGI), ThePrint learnt.
“We have received the phase 3 trial data,” said a senior government official privy to the development.
Bharat Biotech — which developed and manufactures Covaxin, one of the three vaccines being used in India currently — has been facing tough questions over the delay in announcing its phase 3 trial data of the vaccine.
Phase 3 trial data is crucial for it will clearly state the efficacy of the vaccine developed by Bharat Biotech in association with the Indian Council of Medical Research.
The DCGI in January granted permission for emergency use of Covaxin based on its phase 1 and 2 clinical trials that comprised about 680 participants. The move, though, was questioned by public health experts, bringing greater attention to the phase 3 data. More eyebrows were raised when the company, which first promised a June announcement, pushed it to July.
ThePrint reached Bharat Biotech for comments via text message, but did not receive a response till the time of publishing this report.
In a press conference on 12 June, Dr V.K. Paul, who heads the country’s Covid task force, said the publication of Covaxin’s phase 3 trial data would happen in the next “7-8 days”.
Also read: Covaxin effective against Delta, Beta variants of coronavirus, ICMR study says
Why results of phase 3 trials are important
Under the phase 3 trial, investigators keep track of participants for at least six months after the last vaccine dose. If and when a participant falls sick, the data of those falling sick among the vaccinated and unvaccinated cohorts helps calculate the efficacy of the vaccine.
The trial also helps highlight the possible adverse events of a vaccine.
Favourable phase 3 results that confirm the efficacy and side-effects leads to the vaccines being approved for general human use.
(Edited by Manasa Mohan)
Also read: Complex manufacturing, R&D, risks, losses — Bharat Biotech explains why Covaxin is expensive