Covaxin booster dose trial shows 'long-term safety': Bharat Biotech

New Delhi, Jan 8: Hyderabad-based vaccine manufacturer Bharat Biotech said on Saturday that its trials for Covaxin booster dose have shown 'long-term safety with no serious adverse events'.

Bharat Biotech said that 90 per cent of the recipients of the booster dose had a "detectable neutralising antibody response" against the wild-type strain, six months after the second Covid dose.

"The analysis showed that 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," the vaccine manufacturer said in a statement.

It added that the 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," said the vaccine manufacturer.

Krishna Ella, Chairman and Managing Director at 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. Covaxin is now indicated for adults, children, 2-dose primary and booster doses. This enables the use of Covaxin as a universal vaccine."

Based on emerging data, Bharat Biotech believes that a third dose may be beneficial to maintain the highest levels of protection, he added.