a vaccine is administered

Bharat Biotech’s COVAXIN jab 81% effective in Phase III trial

pharmafile | March 4, 2021 | News story | |  Bharat Biotech, COVID-19, COVID-19 vaccine, Vaccine, bharat 

Bharat Biotech’s COVID-19 vaccine candidate has shown an interim efficacy of 81% in a Phase III trial, the company announced yesterday.

The study by the pharmaceutical company and the Indian Council of Medical Research used 25,800 participants, with half receiving the COVAXIN jab and the other half given a placebo.

The trial, which included 2,433 participants over the age of 60, and 4,500 with comorbidities, was based on the endpoint of mild, moderate and severe COVID-19 with onset at least 14 days after the second vaccination. The first analysis is based on 43 cases of COVID-19, of which 36 were observed in the placebo group, versus 7 in the COVAXIN group.

An additional interim analysis is planned for 87 cases, and the final analysis is planned for 130 cases, with results expected to be published in the near future.

Uniquely, COVAXIN has a 28-day open vial policy, which Bharat hopes will reduce wastage by 10-30%. The shot is stored at 2-8°C, meaning it can be shipped at refrigerated temperatures.

The positive results come after Bharat Biotech themselves advised certain groups not to take their vaccine in January, despite insisting it was safe and effective.

The vaccine was approved in India before Phase III trials were completed, which led to the company advising pregnant and breastfeeding women, those with allergies, and people suffering from any kind of medical disorder not to take the jab.

Despite this, Indian Prime Minister Narendra Modi himself received the vaccine earlier this week, in a bid to encourage more in the country to take the shot themselves.

Dr Krishna Ella, Chairman and Managing Director of Bharat Biotech, said: “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.”

Suchitra Ella, Joint Managing Director of Bharat Biotech, added: “I want to thank every one of the participants who volunteered to participate in this vital clinical trial, our partners, principal investigators across 25 study sites, and our team at Bharat Biotech who dedicated their time to this vaccine discovery.

“We could not have achieved this public-private partnership milestone without the relentless commitment of those involved.”

Jack Goddard

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