Bharat Biotech claims Covaxin shows 81% interim efficacy; says it is effective against UK variant

The interim projections now are based on Covaxin's Phase-3 trials, conducted with 25,800 participants across the country

Vaccine maker Bharat Biotech has announced that its indigenously developed vaccine has demonstrated an efficacy of 81 per cent in preventing Covid-19 infection.

The interim projections are based on Phase-3 trials of Covaxin.

Bharat Biotech also claimed that Covaxin is showing significant immunogenicity against the rapidly emerging SARS-CoV-2 variants like the UK strain.

The vaccine was made part of the ongoing Covid-19 immunisation programme in January despite doubts raised by a section of experts and politicians over its efficacy.

Covaxin was administered to Prime Minister Narendra Modi on Monday.

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Covishield, the other vaccine included in the national drive, reportedly shows around 70 per cent efficacy.

“Covaxin demonstrated 81 per cent interim efficacy in preventing Covid-19 in those without prior infection, after the second dose,” Bharat Biotech stated on Wednesday.

Beginning in November, Covaxin's Phase-3 trials were conducted with 25,800 participants from across the country between 18-98 years age, including 2,433 volunteers over 60 years age and 4,500 with comorbidities.

The first interim analysis now is based on 43 cases, of which 36 cases of Covid-19 were observed in the group given a placebo and seven cases which received COVAXIN, resulting in a point estimate of vaccine efficacy of 80.6 %, the biotech firm said.

The analysis showed that severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups.

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An additional interim analysis is planned for 87 cases, and a final one for 130 cases.

The Hyderabad based company termed Covaxin's efficacy outcome as “an important milestone in vaccine discovery, for science and our fight against the coronavirus.”

“With today’s results from our Phase 3 clinical trials, we have reported data on our COVID-19 vaccine from Phase 1 to 3 involving around 27,000 participants. Covaxin not only demonstrates high clinical efficacy trend against Covid-19 but also a significant immunogenicity against the rapidly emerging variants,” said Dr Krishna Ella, Chairman & Managing Director, Bharat Biotech.

Bharat Biotech said that the National Institute of Virology's analysis indicated that the vaccine-induced antibodies can neutralise the UK variant strains and other heterologous strains.

Bharat Biotech developed BBV152 or Covaxin in collaboration with the Indian Council of Medical Research-National Institute of Virology.

Covaxin was given the emergency use authorization by the central drug authorities on 3 January even as it was in the Phase-3 trials, and amid an uncertainty over its efficacy.

Covishield, developed by Oxford University-AstraZeneca, and manufactured by the Serum Institute of India, Pune is also part of the ongoing vaccination drive.

However, PM Modi chose to take the first dose of the home grown vaccine on Monday at AIIMS, New Delhi, to mark the inauguration of Phase-2 Covid-19 immunisation programme.

Covaxin contains a whole virion inactivated SARS-CoV-2 vaccine. It is stable at 2 to 8°C and is shipped in a ready-to-use liquid formulation that permits distribution using existing vaccine supply chain channels.

Bharat Biotech said that more than 40 countries globally have expressed their interest in Covaxin.