77.8% efficacy, robust antibody response: 5 points from Lancet’s new study on Covaxin

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The Lancet peer-review has now corroborated Hyderabad-based Bharat Biotech’s efficacy analysis regarding Covaxin, its coronavirus disease (Covid-19) vaccine, and confirmed that the shot demonstrates 77.8 per cent efficacy against patients symptomatic with the infectious disease.

1 . In its new study, The Lancet noted that the Covid-19 vaccine made by Bharat Biotech is ‘highly efficacious’ and presents no safety concern, also inducing a “robust antibody response” two weeks after two doses of the shot are administered.

2. The Lancet journal, although it corroborated Bharat Biotech’s efficacy analysis for Covaxin, also noted that more research is needed to understand more about Covaxin’s long-term safety and effectiveness, as well as protection against hospitalisation.

3. Further research is also needed to effectively study Covaxin’s effect on deterring Covid-19 deaths, and also its ability to fend off the Delta variant and other variants of concern of the coronavirus.

4. Only 684 suspected Covid-19 cases were identified at least 14 days after the second dose, among the total 24,419 participants who received both doses of the vaccine.

5. Of the confirmed cases, nine did not meet the case definition, being either seropositive for SARS-CoV-2 at baseline or only having one symptom, and thus 130 cases were included in the efficacy analysis. 24 (0.3 per cent) cases occurred among 8471 participants in the vaccine group and 106 (1.2 per cent) among 8502 participants in the placebo group, resulting in an estimated vaccine efficacy of 77.8 per cent.

Notably, Covaxin was recently granted the much-coveted emergency use authorisation (EUA) by the World Health Organisation (WHO) and the shot has already been cleared for use in as many as 17 nations. With the recent green signal from the global health body, Covaxin has now joined a shortlist of anti-Covid vaccines approved by WHO – which include the shots manufactured by AstraZeneca/Oxford, Johnson&Johnson, Moderna, Pfizer/BioNTech, Sinopharm, and Sinovac.

While approving Covaxin, WHO noted that this vaccine is “extremely suitable for low- and middle-income countries due to easy storage requirements”.

Bharat Biotech had informed back in July that the safety and efficacy analysis data from the Phase-III clinical trials of Covaxin had shown an efficacy rate of 77.8 per cent against mild, moderate, and severe instances of Covid-19. Against severe symptomatic cases of Covid-19, on the other hand, Covaxin was found to be 93.4 per cent effective, the Hyderabad-based pharmaceutical firm had said.

The Phase III trials for Covaxin were conducted on 25,798 subjects – aged between 18 to 98 years – across 25 sites in India.

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