Bharat Biotech's Covaxin booster trial shows 'long-term safety, no serious side-effects'

In a key development, vaccine manufacturer Bharat Biotech on Saturday said that its trial of COVID vaccine Covaxin has demonstrated 'long-term safety with no serious adverse events', as a booster dose. The Hyderabad-based company has conducted a phase 2, double-blind, randomised controlled trial. 

The trial showed, six months after a two-dose BBV152 vaccination series cell-mediated immunity and neutralising antibodies to both homologous (D614G) and heterologous strains (Alpha, Beta, Delta, and Delta plus) persisted above baseline, although the magnitude of the responses had declined. 

Neutralising antibodies against homologous and heterologous SARS-CoV-2 variants increased 19- to 265- fold after a third vaccination. Booster BBV152 vaccination is safe and may be necessary to ensure persistent immunity to prevent breakthrough infections.

Further, reactogenicity after vaccine and placebo was minimal and comparable, and no serious adverse events were reported.
While protection against the severe disease remains high across the full 6 months, a decline in efficacy against symptomatic disease over time and the continued emergence of variants are expected. Based on emerging data, Bharat Biotech believes that a third dose may be beneficial to maintain the highest levels of protection.

Dr Krishna Ella, Chairman and Managing Director of Bharat Biotech, said, “These trial results provide a strong foundation towards our goal to provide Covaxin as a booster dose. Our goals of developing a global vaccine against COVID-19 have been achieved with Covaxin indicated for adults, children, 2 dose primary and booster doses. This enables the use of Covaxin as a universal vaccine.”

'Eligible, fully vaccinated people need not register for booster shot'

On December 25, the Central government under Prime Minister Narendra Modi announced that the administration of booster dose for healthcare and frontline workers and those 60 years and above with comorbidities will start on January 10, Monday.

During a briefing thereafter, NITI Aayog's Dr VK Paul remarked, "The precautionary vaccine dose that will be given to healthcare workers, frontline workers and individuals 60 years and above with comorbidities will be the same vaccine that has been given to them previously. Those who have received Covaxin will receive Covaxin, those who have received the primary doses of Covishield will receive Covishield."

It is pertinent to mention here that there is no need for new registration for administrating booster doses. Those who have taken two doses of the COVID-19 vaccine, be it Covaxin or Covishield can directly take an appointment or walk-in to any vaccination centre. Schedules will be published on 8th January.