The Indian drug regulator on Tuesday approved emergency use of two new vaccines against Covid-19 besides allowing local manufacturing of a brand new Covid medicine by 13 drug companies in an effort to provide more weapons to doctors fighting the pandemic.
Both the vaccines and the medicine were designed in the USA, but would be produced in India in collaboration with domestic vaccine and pharmaceutical companies that tied up with the original developers for further research and carried out necessary regulatory trials in India.
The Central Drug Standards Control Organisation granted the emergency use authorisation (EUA) for a recombinant protein-based Covid-19 vaccine called Covovax. manufactured by the Serum Institute of India in partnership with the US firm Novavax.
Similar approval was given to Corbevax, a protein subunit vaccine for which Biological E partnered with the Baylor College of Medicine, Houstan and Dynavax Technologies, for industrial development of a vaccine candidate developed at the US institute and to manufacture it following trials.
Both are double dose vaccines that are stable at 2-8 degrees Celsius. Corbevax is more than 90% effective against the Wuhan strain and more than 80% effective against the Delta variant. The Covovax, on the other hand, has been found to be 90% effective. The first one is to be administered on zero and 28th day whereas Covovax is to be given on zero and 21st day.
The Union Health Ministry in June signed a Rs 1,500 crore agreement with Biological E, pre-booking 30 crore doses of the vaccine as and when it would be ready.
The DCGI also approved Merck's anti-viral drug Molnupiravir that inhibits replication of the novel coronavirus inside the body and is considered an early initiation therapy for Covid-19.
The drug has been approved for manufacturing by 13 companies who have submitted their clinical trial reports to the Indian regulator. The companies are Dr Reddy's Lab, Natco Pharma, MSN, Hetero, Optimus, Aurobindo, Mylan, Strides, Emcure, Cipla, Sun Pharma, Torrent, and BDR.
Earlier this month, the UK and USA regulatory agencies approved the medicine for treatment of mild to moderate Covid-19 in adults.
The CDSCO permitted manufacture and marketing of Molnupiravir 200 mg capsule with a recommended dose of 800 mg twice daily for 5 days for restricted use under emergency situation for adult Covid-19 patients with blood oxygen level more than 93% and who have high risk of progression of the disease including hospitalisation or death. It would be sold as a prescription drug.
Biological E Limited plans to complete production at a rate of 75 million doses per month, anticipating 100 million plus doses per month from February 2022, whereas SII is yet to come out with its production and roll out plans.
Zydus-Cadila's Covid-19 vaccine ZyCoV-D, which received the regulator's nod in August, is yet to be used in the vaccination programme with the Union government ordering one crore doses – one fifth of what it intended to procure in 2021 – in November.
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