India’s Covaxin® 81 percent effective against COVID-19

An interim analysis reveals the Covaxin® (BBV152) vaccine was relatively safe and 81 percent effective in preventing symptomatic COVID-19.

Doctor drawing liquid into a syring from a vial labelled 'COVID-19 VACCINE', in front of an Indian flag (Horizontal stripes orange, white and green) - idea of COVID-19 vaccines being developed/authorised in India

Bharat Biotech has announced that Covaxin® (BBV152), its COVID-19 vaccine developed and authorised for emergency use in India, was shown to be approximately 81 percent effective at preventing COVID-19 in an interim analysis.

The analysis assessed data from a trial involving 25,800 subjects between 18-98 years of age, the largest ever conducted in India. The Phase III trial includes 2,433 people over the age of 60 and 4,500 who have comorbidities.

The primary endpoint of trial is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 14 days after the second study vaccination in serologically negative adult participants at baseline.

The first interim analysis includes 43 cases, of which 36 cases were observed in the placebo group versus seven cases in the Covaxin group. This results in a point estimate of vaccine efficacy of 80.6 percent.

The interim analysis also included a preliminary review of the safety database, which indicates that severe, serious and medically attended adverse events occurred at low levels and were balanced between Covaxin and placebo groups.

Aside from the clinical data, a preclinical study by the National Institute of Virology (NIV) indicates that Covaxin-induced antibodies can neutralise the UK variant strains and other heterologous strains, which has been published in preprint on bioRxiv.

“Today is an important milestone in vaccine discovery, for science and our fight against coronavirus. With today’s results from our Phase III clinical trials, we have now reported data on our COVID-19 vaccine from Phase I, II and III trials involving around 27,000 participants. Covaxin® demonstrates high clinical efficacy trend against COVID-19 but also significant immunogenicity against the rapidly emerging variants,” said Dr Krishna Ella, Chairman & Managing Director, Bharat Biotech.

Covaxin contains a whole virion inactivated SARS-CoV-2 vaccine, which is produced in Vero cells. It is stable at refrigerated temperatures and is shipped in a ready-to-use liquid formulation that permits distribution using existing vaccine supply chain channels. Covaxin has a 28-day open vial policy as a unique product characteristic, thus reducing vaccine wastage by approximately 10-30 percent.

Bharat Biotech expects to share further details of the trial results as additional data become available. An additional interim analysis is planned for 87 cases and the final analysis is planned for 130 cases. All data from the second interim and final analyses will be shared via prepublication servers, as well as submitted to a peer-reviewed journal for publication.

Prashant Khadayate, Pharma Analyst at GlobalData, stated in response to the news: “Interim efficacy data will improve the market penetration of Covaxin both in India and other countries.” According to Khadayate, so far, Covaxin has accounted for just 12 percent of the >15 million COVID-19 vaccine doses delivered in India, with the other 88 percent “belong to Covishield from Serum Institute of India/ AstraZeneca”, which was shown to be 62 percent effective in interim analyses.

4 responses to “India’s Covaxin® 81 percent effective against COVID-19”

  1. SUSHIL JAIN says:

    Indian Scientists have again proved their mettle. Covaxin will be the best vaccine for China Virus (Covid 19), because we Indian knows very well how to contain and eliminate China Virus 🙂

  2. Mumbo Jumbo says:

    I think about the poor countries that do not have the capacity to develop their own vaccines and dependent on countries that have been able to develop vaccines. I think we Indians are very fortunate to have developed the capabalities to produce vaccines and can afford to dilly dally.

  3. Corona virus not only changed our lives forever but also changed the way we see this world. We learnt to live secluded life, turn to online milieu, realized the importance of hygiene in our life, not to mention the boredom and panic it brought. The life after corona is not going to be the same as before.

  4. Krrao says:

    Good achievement of our great Scientists sir. We are proud of them.

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