Bharat Biotech aims to launch India's first indigenous COVID-19 vaccine 'Covaxin' in Q2 of 2021, a top official of the company confirmed. Sai D Prasad, President, Quality Operations at Bharat Biotech, said the potential inoculation against coronavirus infection will have at least a 60 per cent efficacy rate but stopped short of revealing its price. Covaxin, a wholly-inactivated novel COVID-19 vaccine, is currently in its third-stage clinical trials. The inoculation is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
The Hyderabad-based biotech firm has started advanced phase testing of its potential COVID-19 vaccine, involving 26,000 volunteers this month across 25 centres in the country, including Hyderabad, Goa, Nagpur, Bhubaneswar, and Aligarh. Several other sites will commence phase 3 trials next week. According to Prasad, this is the largest clinical trial "conducted in our country", adding that India is holding talks with 10 nations that have expressed interest in its potential COVID-19 vaccine.
He said the result of the phase-3 trial will be available at the end of Q1 in 2021 after which the biotech firm will apply for regulatory approval for the release of the vaccine. Prasad added, "We will continue on to phase 4 which routinely follows up with participants for a few years."
When asked about the methodology used in the Covaxin trial, he informed that the phase 1 and 2 clinical trials were designed to study safety and immunogenicity of two doses of Covaxin.
He further stated that the World Health Organisation (WHO), the US FDA (Food and Drug Administration) and even India's Central Drugs Standard Control Organisation (CDSCO) would approve a respiratory vaccine if it achieves 50 per cent efficacy.
Bharat Biotech is aiming to achieve at least 60 per cent efficacy, which could also be more. "Chances of the vaccine being less than 50 per cent effective are remote, as suggested by our trial results so far," Prasad added.
However, other global drugmakers, such as Pfizer and Moderna Inc, have claimed to have achieved a 90-95 per cent efficacy rate. On this, Prasad struck a confident chord and defended the technology behind the development of indigenously developed Covaxin. Prasad said Covaxin is an inactivated vaccine derived from a strain of SARS-CoV-2 virus. He added that inactivated vaccine technology has delivered the safest form of vaccines for the past several decades, as opposed to other new and unproven technologies. Besides, Covaxin is required to be stored at 2-8 degrees Celsius, Prasad enunciated.
"The vero cell manufacturing platform used for Covaxin has delivered more than 300 million doses to date, with an excellent safety track record," Prasad told the channel.
Currently, Bharat Biotech has a 30 crore vaccine (300 million) vaccine production capacity, which will be increased to 50 crore by next year.
In the last 20 years, Bharat Biotech has conducted more than 80 clinical trials of other vaccines across 18 countries. "We take safety, quality, GxP's very seriously and conduct all product development and clinical development in full compliance with regulatory guidelines," Prasad said.
The search for a coronavirus vaccine is on globally and several companies in India are in different stages of clinical trials. The Oxford University-AstraZeneca vaccine that will be manufactured by the Serum Institute of India (SII), is hoping to bring the vaccine next year in January to vulnerable populations. While human trials of Russia's Sputnik V COVID-19 vaccine are likely to begin this week. Last week, Ahmedabad-based Zydus Cadila finished its phase-2 trial successfully.