The pharmaceutical company Bharat Biotech today, on July 3, released the data of the Covaxin phase-3 trial and stated that the indigenously developed COVID19 vaccine has an overall efficacy rate of 77.8 per cent and there aren’t any safety concerns in its use.

The Covaxin COVID19 vaccine has been produced by the Hyderabad-based Bharat Biotech in a partnership with the Pune-based National Institute of Virology (NIV) and the Indian Council of Medical Research (ICMR).

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The phase 3 trials of Covaxin were conducted on 130 symptomatic COVID19 cases that were reported at least two weeks after the second dose at 25 sites across the country.

“Covaxin was well tolerated and the Data Safety Monitoring Board has not reported any safety concerns related to the vaccine. The overall rate of adverse events observed in Covaxin was lower than that seen in other Covid-19 vaccines,” a statement released by Bharat Biotech stated.

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Covaxin vaccine was granted emergency use authorisation in India in January although the data of phase 3 trials were not available at that time. Also, on June 23, the vaccine’s manufacturer held a pre-submission meeting with the World Health Organization (WHO), which is the first step of seeking its approval for the vaccine for the emergency use listing (EUL).

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The statement issued by the Bharat Biotech stated that no licensed SARS-CoV-2 vaccine has reported efficacy against asymptomatic infection in a randomised controlled trial, based on qPCR (quantitative polymerase chain reaction) testing. Covaxin is the first to report promising efficacy against asymptomatic infections based on qPCR testing that will help in reducing disease transmission, it stated.

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The firm has been reported as saying that the Covaxin vaccine has been specifically designed to meet the needs of global distribution chains, the requirements for which are higher in low- and middle-income countries.

It has been formulated to enable shipping and long-term storage at 2-8 degree celsius. It is also manufactured in line with the multi-dose vial policy, in order to reduce open vial wastage which is supposed to save cost of procurement.