For about a week now, India has been administering COVID-19 vaccines to frontline workers. Two vaccine candidates have been approved for emergency usage even as controversy continues to rage over the fact that trials are still underway for one of the vaccines - Bharat Biotech and ICMR's indigenous Covaxin.
Currently the Indian government does not give people a choice between the two vaccines when being inoculated. At the same time, those receiving a dose of Covaxin are being asked to sign a separate consent form, acknowledging that the jab is being administered without the phase-3 trial. The form also assured compensation if any adverse effect was found linked to the vaccine. Needless to say, this has caused quite a bit of hesitation among those getting vaccinated, with allegations continuing to fly.
Now, medical journal The Lancet might offer those being vaccinated some reassurance as newly published data from Phase 1 trial for BBV152 (Covaxin) is published online.
According to the report published on The Lancet, a "double-blind, multi-centre, randomised, controlled phase 1 trial" was conducted at 11 hospitals across India to assess the safety and immunogenicity of the vaccine candidate. As the paper explains, BBV152 is a whole-virion inactivated SARS-CoV-2 vaccine formulated with a toll-like receptor 7/8 agonist molecule adsorbed to alum (Algel-IMDG) or alum (Algel).
"BBV152 led to tolerable safety outcomes and enhanced immune responses. Both Algel-IMDG formulations were selected for phase 2 immunogenicity trials. Further efficacy trials are warranted," the researchers add.