BackBharat Biotech’s Covaxin is 81% effective in trials
Covaxin becomes the first locally developed vaccine to hit the key milestoneAs part of a plan to bolster people’s confidence, PM Modi was given the first shot of Covaxin on 1 March at an event
_1594052644844_1594052732451_1614778493800.jpg "Covaxin showed interim clinical efficacy of 81% in Phase 3 trial: Bharat Biotech")
PremiumBharat Biotech Ltd’s Covaxin showed to be 81% effective in protecting people from covid-19 in an early analysis of phase 3 trial data, becoming the first locally developed vaccine to hit the key milestone and giving a shot in the arm to India’s efforts to contain the pandemic.
The first interim analysis of the vaccine, co-developed by the Indian Council of Medical Research, is based on 43 covid-19 cases, of which 36 were in the placebo group and seven among those that received the vaccine, Bharat Biotech said in a statement on Wednesday. The phase 3 trial involved 25,800 people between 18 and 98 years of age.
To be sure, the data is yet to be peer reviewed.
The better-than-expected test data—Bharat Biotech expected Covaxin to be 60% effective—will help the company put behind the controversy surrounding the government’s hurried decision to give the indigenous vaccine approval for emergency use. It could also boost the export prospects of the shot, which is already being sought by several nations, including Brazil.
“More than 40 countries globally have expressed their interest in Covaxin. These countries are highly satisfied with the safe, inactivated vaccine technology and robust data package for safety and immunogenicity," Bharat Biotech said.
Crucially, the vaccine is effective against some of the new and more dangerous variants of the coronavirus, said Dr Krishna Ella, chairman and managing director of Bharat Biotech.
An analysis from the National Institute of Virology (NIV), ICMR indicated that the vaccine can neutralize the UK variant and some other strains, ICMR said in a separate statement.
India has reported more than 210 cases of the UK variant, four cases of the South African variant and one case of the Brazil strain.
“Covaxin demonstrates high clinical efficacy trend against covid-19 but also significant immunogenicity against the rapidly emerging variants," Ella said.
Bharat Biotech said it will share details of the trial results as more data become available.
Additional interim analysis is planned for 87 cases, and the final analysis is planned for 130 cases.
All the data from the second interim and final analyses will be submitted to a peer-reviewed journal for publication, the company said.
Despite the government vigorously defending the use of Covaxin in its mass vaccination programme, many frontline workers have been reluctant to get the shot, given the lack of data regarding its effectiveness.
The hesitancy resulted in the government getting only about half the 30 million frontline workers it wanted to be vaccinated in the first phase of the programme.
Earlier this week, the government expanded access to vaccines to people aged over 60 and those above 45 with comorbidities.
The government plans to vaccinate 27 million people in the second phase.
The results of the Phase 3 trials could encourage more people to take the shot, which would help stem the spread of infections.
A successful vaccination programme, in turn, will make people more confident about resuming travel and returning to offices, boosting economic growth.
As part of a plan to bolster people’s confidence in the vaccine, Prime Minister Narendra Modi was given the first shot of Covaxin on 1 March in a publicized event.
Many other government ministers, including Union home minister Amit Shah, also received shots of the homegrown vaccine.
The experimental vaccine, scientifically known as BBV152, contains inactivated whole SARS-CoV-2 virion.
The shot has been developed on the World Health Organization’s (WHO’s) prequalified vero cell platform, with a well-established track record of safety.
Vero cells are derived from the kidney of the African green monkey and are commonly used for developing vaccines.
Covaxin is stable at 2 to 8°C and is shipped in a ready-to-use liquid formulation that permits vaccine distribution using existing channels.
Covaxin also has a 28-day open vial policy, reducing wastage by approximately 10-30%, the indigenous vaccine maker said.
India started the first phase of the nationwide covid-19 vaccine drive on 16 January with Covaxin and Covishield—the vaccine developed by AstraZeneca Plc and Oxford University and manufactured by Serum Institute of India.
The AstraZeneca vaccine was found to be about 70% effective, but the efficacy rate increases if the gap between the first and the second dose is longer than a month.
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