New Delhi/Hyderabad: The drug regulator on Tuesday approved two new COVID vaccines – Serum Institute of India’s Kovovax and Biologicals E’s Corbevax – for restricted use in emergency situations.
The regulator has also granted Emergency Use Authorization (EUA) to Molnupiravir, which has shown promise in early use in the treatment of mild to moderate COVID-19 in adults, slashing the risk of hospitalization and death by almost half.
Mahima Datla, Managing Director of Biologicals E, told TOI that Corbevax will be one of the cheapest and safest COVID-19 vaccines. “We have already produced 200 million doses that are stored in our cold rooms. We expect to meet the government’s order of 300 million doses by February 2022,” said Datla. Vials may be administered via intramuscular injection at 28-day intervals in two doses of 0.5 ml stored between 2-8°C.
Approvals by Drugs Controller General of India (DCGI) assumes significance as they will expand the basket of jabs providing people with more options. The approval of Molnupiravir, developed by Merck and its partner Ridgeback, is also touted as a game-changer for high-risk individuals and those with weakened immunity as it is the world’s first drug to treat symptomatic COVID-19. About 13 major local pharmaceutical companies have got permission to manufacture the drug.
“Congratulations India. Further strengthening the fight against Covid-19, CDSCO, @MoHFW_INDIA has given 3 approvals in a single day: – CORBEVAX Vaccine – COVOVAX Vaccine – Anti-viral drug Molnupiravir for restricted use in emergency situations ,” Health Minister Mansukh Mandaviya tweeted.
India still has at least two more promising candidates in the vaccine pipeline that could get approval next year. Genoa Biopharmaceuticals has developed India’s first mRNA vaccine named HGC019, which is currently under Phase 2/3 trials. The company is expected to complete the process by the end of January.
Bharat Biotech is also developing a nasal vaccine, which the company says cuts transmittance by attacking the points of entry – the nose and upper respiratory tract. The vaccine has completed Phase 2 testing and is also likely to seek approval early in 2022.
The regulator has also granted Emergency Use Authorization (EUA) to Molnupiravir, which has shown promise in early use in the treatment of mild to moderate COVID-19 in adults, slashing the risk of hospitalization and death by almost half.
Mahima Datla, Managing Director of Biologicals E, told TOI that Corbevax will be one of the cheapest and safest COVID-19 vaccines. “We have already produced 200 million doses that are stored in our cold rooms. We expect to meet the government’s order of 300 million doses by February 2022,” said Datla. Vials may be administered via intramuscular injection at 28-day intervals in two doses of 0.5 ml stored between 2-8°C.
Approvals by Drugs Controller General of India (DCGI) assumes significance as they will expand the basket of jabs providing people with more options. The approval of Molnupiravir, developed by Merck and its partner Ridgeback, is also touted as a game-changer for high-risk individuals and those with weakened immunity as it is the world’s first drug to treat symptomatic COVID-19. About 13 major local pharmaceutical companies have got permission to manufacture the drug.
“Congratulations India. Further strengthening the fight against Covid-19, CDSCO, @MoHFW_INDIA has given 3 approvals in a single day: – CORBEVAX Vaccine – COVOVAX Vaccine – Anti-viral drug Molnupiravir for restricted use in emergency situations ,” Health Minister Mansukh Mandaviya tweeted.
India still has at least two more promising candidates in the vaccine pipeline that could get approval next year. Genoa Biopharmaceuticals has developed India’s first mRNA vaccine named HGC019, which is currently under Phase 2/3 trials. The company is expected to complete the process by the end of January.
Bharat Biotech is also developing a nasal vaccine, which the company says cuts transmittance by attacking the points of entry – the nose and upper respiratory tract. The vaccine has completed Phase 2 testing and is also likely to seek approval early in 2022.
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