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Overnight, the Centre’s arsenal against Covid-19 got strengthened with two vaccines and an anti-viral pill getting the drug regulator’s nod for restricted use in emergency situations.
The vaccines include Corbevax, an indigenously developed protein sub-unit vaccine from Hyderabad-based Biological E, and Covovax from Pune’s Serum Institute of India (SII), a recombinant nanoparticle protein-based vaccine licensed from American biotech company Novavax. Both vaccines were approved for those above 18 years.
The anti-viral pill Molnupiravir, from Merck and Ridgeback Biotherapeutics, is made in India by at least 13 companies. It works by interfering with the virus’ replication and the approval was to treat Covid-19 in adults with SpO2 > 93 per cent and those who had a risk of progression of the disease including hospitalisation or death. The regulatory approvals were announced by Health Minister Mansukh Mandaviya, in a tweet early Tuesday, after reports overnight indicated they had been cleared by the Subject Expert Committee.
While the vaccine- and drug-makers came out subsequently, announcing the roll-out of their individual products, much is still to be clear on the pricing and production details. Kedar Toraskar, member with the Maharashtra Covid-19 Task Force, told BusinessLine that the two vaccines belonged to a different group (compared to those presently available) and would make for good primary or booster doses.
30% efficacy not heartening
On the anti-viral pill though, he said, the scaled-back 30 per cent effectiveness was “not very heartening”. (Merck had revised its earlier statement and said that the pill was 30 per cent effective in preventing hospitalisation and death, down from 50 per cent mentioned earlier.) However, he added, more data was needed in real-world settings or from use in the community. The oral drug is given early in the infection, four 200 mg pills, twice a day, and it was important to not price it high, said Toraskar, Director, Critical Care at Mumbai’s Wockhardt Hospital. Reports suggest that globally the drug is pegged at about $700 per patient (over ₹52,000)
Anti-viral pill
Merck (or Merck Sharpe Dohme (MSD) outside the US and Canada) entered into voluntary licensing agreements with multiple companies in India on Molnupiravir. Some of the companies collaborated in a consortium led by Dr Reddy’s to undertake advanced clinical trials on the drug.
According to the Health Ministry, the drug regulatory authority had received 22 applications for the manufacture and marketing of Molnupiravir, of which, eight (including five applicants of a consortium) had submitted their clinical trial report interim or complete report.
With inputs from Delhi, Hyderabad, Ahmedabad, Mumbai bureaus
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