Bharat Biotech's Covaxin shows 81% efficacy in Phase 3 trials conducted on 25k subjects

Two months after being granted permission for restricted use in India, Hyderab-based pharmaceutical firm Bharat Biotech has said that its COVID-19 vaccine - Covaxin - has shown an interim clinical efficacy of 81% in its Phase 3 trials. phase 3 trials involved 25,800 subjects and is largest ever trial conducted in India, Bharat Biotech said on Tuesday. vaccine has been in use since India began its first phase of COVID-19 immunization drive back in January this year. 

Elaborating on details of Phase 3 study, pharma firm said that participants enrolled were between of 18-98 years old including 2,433 over of 60 and 4,500 with comorbidities. " primary endpoint of Phase 3 clinical trial is based on first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) COVID-19 with onset at least 14 days after second study vaccination in serologically negative (to SARS-CoV-2) ult participants at baseline," Bharat Biotech ded. 

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"Today is an important milestone in vaccine discovery, for science and our fight against coronavirus. With today's results from our Phase 3 clinical trials, we have w reported data on our COVID-19 vaccine from Phase 1, 2, and 3 trials involving around 27,000 participants," Bharat Biotech Chairman and Managing Director Krishna Ella said.

Bharat Biotech's Covaxin has been indigeusly developed in collaboration with Indian Council of Medical Research (ICMR). It is one of two COVID vaccines cleared by DCGI for emergency use in India. or vaccine - Covishield, manufactured by Serum Institute - has reported 70% efficacy after ministration of second dose. d given to Covaxin by government even before results of phase 3 trials h invited sharp criticism. Meanwhile, Me in India vaccine has also begun exporting doses to several countries under India's 'Vaccine Maitri' initiative. 

interim results of clinical trials h earlier indicated that Indian COVID-19 vaccines would be effective against mutated virus strains reported from United Kingdom, South Africa, and Brazil said Indian Council of Medical Research (ICMR). 

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PM Modi takes Covaxin jab

As India began its second phase of iculation from Monday, Prime Minister Narendra Modi received his first dose of Covaxin at AIIMS hospital in national capital. PM Modi tweeted a picture of himself receiving COVID vaccine and lauded doctors and scientists for spearheing global fight against COVID-19. Furrmore, he also appealed eligible people to take vaccine, when me available. 

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As Prime Minister received Covaxin jab, Bharat Biotech said that it will give a ‘huge boost’ to nation’s immunization campaign and furr reduce hesitancy among citizens. Dr. Krishna Ella, Chairman & Managing Director, Bharat Biotech International Limited also expressed gratitude to Prime Minister for setting a “powerful example”. Ella said, “We thank Hon’ble Prime Minister Sh., Narendra Modi, for taking first dose of COVID-19 vaccine himself and are deeply appreciative of gesture.”

second phase of COVID-19 vaccination program started at over 10,000 designated government facilities and 20,000 private hospitals and vaccination centres on Monday. While first phase of Coronavirus vaccination drive focused on healthcare and frontline workers, second phase is dedicated to those above 60 years of and those above 45 years with co-morbidities. 

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