India’s first indigenous COVID-19 vaccine Covaxin, co-developed by Bharat Biotech along with the Indian Council of Medical Research (ICMR)–National Institute of Virology (NIV), is going to be shipped globally, according to the Indian vaccinemaker. While the vaccine was given emergency use approval by the Drugs Controller General of India in early January, it is still currently in Phase III clinical trials with around 26,000 volunteers around the country and Phase I and II data have shown that is effective against the novel coronavirus.
According to a report in Mint, Chairman and Managing Director of Bharat Biotech Dr Krishna Ella said that the first interim reading of efficacy data from Phase III will be out in March. Recent data from the company indicates the COVAXIN shot is effective against the new SARS-CoV-2 variant that emerged from the UK. However, three other variants are also circulating in the global population currently, originating in South Africa, Brazil and Japan.
Bharat Biotech signed a contract with US biopharmaceutical company Ocugen to co-develop, supply, and sell its COVID-19 vaccine COVAXIN in the USA. While Ocugen prepares to production the vaccine en masse, Bharat Biotech will still supply the initial doses, the exact number of which has yet to be announced.
Ocugen has already begun discussions with Food & Drug Administration (FDA) and the Biomedical Advanced Research and Development Authority (BARDA) in order to get the necessary approvals to introduce the vaccine in the US and make it a part of the country’s national inoculation drive. So far, the country has also granted emergency use approval to COVID-19 vaccines from Pfizer-BioNTech and Moderna.
Bharat Biotech has sold the exclusive right to COVAXIN and Ocugen will enjoy the 45 percent of the profits.
A team from Brazil’s Precisa Medicamentos visited the Bharat Biotech facility in India on 7 and 8 January. The pharma company signed a deal to export the vaccine to Brazil. The Ambassador of Brazil André Aranha Corrêa do Lago has also expressed an interest in getting the vaccine to the South American country.
The government will buy the vaccine for public use while the private market will get the vaccine once approved by ANVISA, the Brazilian regulatory authority.