India adds two new vaccines and anti-viral drug to its armoury

Thirteen Indian companies have received approval from the CDSCO for domestic production

A man receives a dose of the Covid-19 vaccine at a market in New Delhi on Tuesday.: PTI Photo

G.S. Mudur   |   TT  |  New Delhi   |   29.12.21  : India has added two new vaccines and an early-use anti-viral drug to its armoury to fight Covid-19, all three products based on core technologies developed in the US but produced in India.

The Central Drugs Standard Control Organisation (CDSCO), the country’s apex regulatory authority, has approved the Corbevax vaccine produced by the Hyderabad-based Biological-E and Covovax that will be manufactured by the Pune-based Serum Institute, the Union health ministry said on Tuesday.

The ministry said the CDSCO had also approved molnupiravir, an anti-viral drug developed by the US-based Ridgeback Biotherapeutics and Merck and shown to reduce Covid-19 hospitalisation and deaths when used during early stages of the infection.

Thirteen Indian companies, including Cipla, Dr Reddy’s Laboratories and Sun Pharmaceuticals, producing molnupiravir under licensing pacts, have received approval from the CDSCO for domestic production.

The recommended dose of molnupiravir is 800mg twice daily for five days for the treatment of adults with Covid-19 with an oxygen level of 93 per cent or higher and who have a high risk of progression of disease, including hospitalisation or death.

The health ministry and health minister Mansukh Mandaviya on Tuesday described Corbevax as an indigenously developed protein subunit vaccine against Covid-19.

“It is now the third vaccine developed in India,” the ministry quoted the minister as saying.

Biological-E also described Corbevax as India’s first indigenously developed protein subunit vaccine. Covaxin from the Hyderabad-based Bharat Biotech and a DNA-based vaccine from the Ahmedabad-based Zydus Cadila are the two homegrown Covid-19 vaccines hitherto approved by the CDSCO.

But Biological-E has developed the vaccine through technology procured from BCM Ventures, the Baylor College of Medicines’ commercialisation arm, and Dynavax, a biopharmaceuticals corporation, the company itself said in a media release on Tuesday.

A Biological-E official, when asked by this newspaper why it was described as indigenously developed when its core technologies were procured from the US, said the company had acquired the technology and “further developed and produced the vaccine”.

The company said it planned to complete production at 75 million doses per month and anticipated to produce over 100 million doses per month from February 2022. The Centre had in June announced an advanced purchase pact of Rs 1,500 crore for 300 million doses of the vaccine.

Corbevax has shown an efficacy of over 90 per cent for prevention of symptomatic infection against the original Wuhan strain of the coronavirus and over 80 per cent against the delta variant — which had fuelled India’s second wave while spreading worldwide.

Covavax, produced in India by the Serum Institute under a technology transfer agreement with the US-based Novavax, has an efficacy of 90.4 per cent, the ministry said. The World Health Organisation has granted emergency use listing — a stamp of quality and efficacy — to Covavax.

India’s vaccination campaign currently uses Covaxin from Bharat Biotech and Covishield from Serum Institute.