Centre clears two new COVID vaccines, one antiviral drug; manufacturers welcome move

By Shalini Bhardwaj
New Delhi [India], December 28 : After the Union Health Ministry cleared two new COVID-19 vaccines and one anti-viral drug for emergency use on Tuesday, vaccine manufacturers welcomed the announcement and said that this would support the patients across India.
The government has given approvals to the CORBEVAX vaccine, COVOVAX vaccine, and anti-viral drug Molnupiravir for restricted use in an emergency situation.
The manufacturing company of CORBEVAX, Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company, said in a release that it is a "recombinant protein sub-unit" vaccine, developed from a component of the spike protein on the virus's surface, which helps the body build the immune response against the virus.
According to a press release by the company, the vaccine has the Receptor Binding Domain (RBD) protein as an antigen, and also an optimum adjuvant consisting of Dynavax (DVAX) CpG 1018 and alum.
"Biological E. Limited's CORBEVAX has completed two Phase III clinical trials involving more than 3000 subjects between the ages of 18 and 80 at 33 study sites across India. The vaccine was found to be safe, well-tolerated and immunogenic," said the release.
"CORBEVAX nAb GMT against the Delta strain indicates vaccine effectiveness of more than 80 per cent for the prevention of symptomatic infections based on published studies," it added.
Biological E. Limited plans to complete production at a rate of 75 million doses per month, anticipating 100+ million doses per month from February 2022. These capacities will enable the Hyderabad-based company to deliver 300 Million doses as promised to the Government of India. Soon, the company plans to deliver more than one billion additional doses globally.
Meanwhile, the union Health Ministry said in a press release, "Biological E has conducted animal studies in Rats, Mice, Rabbits and also conducted challenge studies in non-human primates (monkeys). Biological E has conducted Phase I/II, II/III clinical trials of the its Covid-19 vaccine in the country. Further, it has conducted Phase III active comparator clinical trial to evaluate superiority against the COVISHIELD vaccine."
Meanwhile, Cipla, one of the 13 manufacturing companies of the anti-viral drug Molnupiravir, on Tuesday said in a press release," Cipla plans to launch Molnupiravir under the brand name Cipmolnu.
"Cipla will soon make Cipmolnu 200mg capsules available at all leading pharmacies and Covid treatment centres across the country. The Company has adequate manufacturing capacities and a solid distribution mechanism in place to ensure speedy access to this effective treatment pan India," it said.
Molnupiravir is an oral antiviral that inhibits the replication of multiple RNA viruses including SARS-CoV-2. The drug is used for the treatment of non-hospitalized patients with confirmed COVID-19 globally.
Managing Director, MSD India Region, Rehan A Khan welcomed the decision by the government and said that the approval would support the patients across India.
"We welcome the decision of the Drug Controller General of India's approval for permission to manufacture and market anti-Covid pill Molnupiravir for restricted emergency use in India. The approval supports patient access to Molnupiravir in India and for more than 100 low-and middle-income countries," he said.
"Central Drugs Standard Control Organisation has received a total of 22 applications for the manufacture and market of the drug Molnupiravir in the country. Out of which, 8 including 5 applicants of a consortium (total 13)have submitted their clinical trial report interim or complete report. Based on the recommendation of the Subject Expert Committee (SEC) of the CDSCO, the drug is being approved for 13 companies who have submitted their clinical trial report interim or complete report.
According to the release by the ministry, the 13 companies include Dr Reddy's (Hyderabad), Natco (Hyderabad), MSN, (Hyderabad), Hetero, (Hyderabad), Optimus, (Hyderabad), Aurobindo, (Hyderabad), Mylan, (Hyderabad), Strides, (Bengaluru), Emcure, (Pune), Cipla, (Mumbai), Sun Pharma, (Mumbai), Torrent, (Ahmedabad) and BDR, (Ahmedabad).
"Serum Institute has conducted Phase II/III Immuno bridging clinical in the country for comparing safety and immunogenicity of COVOVAX of Serum and NOVAVAX vaccine. Novavax has conducted Phase III efficacy trials in USA and UK wherein the efficacy of the vaccine is reported to be 90.4 per cent and 86.9 per cent respectively. Novavax & COVOVAX has been granted emergency use listing by WHO," said the release by the Health Ministry.
The vaccines are to be used for people above 18 years of age.