NEW DELHI: Bharat Biotech, the Hyderabad based vaccine-maker, which is carrying out phase 3 clinical trials of its COVID-19 vaccine Covaxin in the country, has promised priority vaccination to trial volunteers -- even those under 60 years -- who end up getting the placebo and not the actual vaccine.
Covaxin, India’s first homegrown vaccine, which is derived from the inactivated SARS CoV 2 isolated in the country, is planned to be tested in collaboration with the ICMR on about 26,000 volunteers across 25 sites as part of the late-stage trial, which can establish its efficacy.
As the trial plans to involve 26,000 volunteers, about 13,000 of whom have already been recruited, nearly half of them will receive a placebo as this is a double blind, placebo-controlled trial.
The development comes amidst reports that at some of the trial sites, there are not enough volunteers showing interest in participation.
The vaccine-maker, meanwhile, along with two other companies has already applied for emergency use authorisation of Covaxin to the Drug Controller General of India, based on the results of phase 1 and 2 data but has been asked to furnish additional data.
In a document issued to the principal investigators of the trial, the company has said that those who receive a placebo will be contacted and given the vaccine, thus getting priority access to the vaccine—even those below 60 years.
A two-page document containing frequently asked questions was shared with the PIs earlier this week, in response to demands that some of the queries trial participants have are not covered in the trial consent form.
“Since there is also an equal chance of getting a placebo for every participant, 50% of the participants will get the placebo and they may get SARS-CoV-2 infection or COVID-19 anytime after vaccination,” says the document.
“Currently no vaccine has been approved in India. Whenever a vaccine gets approval, healthcare workers and frontline workers will receive it first,” it adds. “It will take at least 6 months for the elderly and a minimum of 6-12 months for a person under the age of 60 to receive a vaccine, due to limited supply.”
The document adds, “If you participate in this trial, this vaccine will most likely get licenced within a few months and if you received a placebo, we will contact you and give you the vaccine, thus giving you priority access to the vaccine (even if you are below 60 years).”