The Central Drugs Standard Control Organisation on Tuesday approved two more coronavirus vaccines and one anti-viral drug for emergency use in India amid the spread of the Omicron variant of the coronavirus, Health Minister Mansukh Mandaviya announced on Twitter.
Serum Institute of India’s Covovax, Biological E’s vaccine Corbevax and United States-based pharmaceutical company Merck’s anti-viral pill molnupiravir were cleared by the Centre.
The approval came a day after the Subject Expert Committee on Covid-19 of the Central Drugs Standard Control Organisation recommended emergency use authorisation for Covovax, Corbevax and molnupiravir. The recommendations by the subject expert committee were sent to the Drug Controller General of India.
Covovax is the Indian version of US drug manufacturer Novavax’s recombinant nanoparticle protein-based Covid-19 vaccine.
Chief Executive Officer of Serum Institute of India Adar Poonawalla said that Covovax’s approval was a significant development in India’s immunisation programme.
The vaccine is being evaluated in two Phase 3 trials. In the United Kingdom, Covovax showed 96.4% efficacy against the original virus strain, 86.3% against the Alpha variant and 89.7% overall. The vaccine in the United States and Mexico trials demonstrated 100% protection against moderate and severe disease and 90.4% overall efficacy.
Hyderabad-based firm Biological E’s Corbevax is India’s first homegrown “RBD [receptor binding domain] protein sub-unit vaccine”, Mandaviya said in a series of tweets. He added, “It’s a hat-trick! It’s now 3rd vaccine developed in India!”
A senior government official, who did not want to be identified, had earlier told Scroll.in that the Centre has placed an advance order for 300 million doses of Corbevax with Biological E.
Corbevax is a recombinant protein sub-unit vaccine, which is developed from a component of the spike protein on the virus’ surface that helps the body build an immune response to a disease. The vaccine has been developed by Biological E Limited with Texas Children’s Hospital Center for Vaccine Development in the United States and the Baylor College of Medicine (Baylor) in Houston, Texas.
A spokesperson for Biological E said that the company had completed two Phase 3 trials involving over 3,000 persons of 18 to 30 years of age from India. It added that the vaccine has over 90% efficacy in preventing symptomatic infections.
“The vaccine was found to be safe, well-tolerated and immunogenic,” the spokesperson for Biological E said. The company plans to produce 75 million doses of Corbevax per month.
Vikram Paradkar, vice-president of Biological E, told Scroll.in that the company has committed 300 million doses to the Government of India. “The timeline has not yet been finalised,” he said.
Paradkar said that the company is waiting for government guidelines to be able to determine if Corbevax will be launched on January 10. On that day, India will start administering booster doses for healthcare, frontline workers and senior citizens with co-morbidities.
13 companies to manufacture molnupiravir
Meanwhile, molnupiravir will be manufactured in India by 13 companies for restricted use under emergency situation for treatment of adult patients with Covid-19, Mandaviya said.
The pill, developed with biotechnology company Ridgeback Biotherapeutics, showed a 30% reduction in hospitalisations and deaths in a clinical trial of high-risk individuals.
Pharmaceutical company Cipla plans to launch the pill under the brand name Cipmolnu. It noted that the pill inhibits the replication of multiple RNA (ribonucleic acid) viruses including SARS-CoV-2, which causes Covid-19.
Last week, the US Food and Drug Administration authorised molnupiravir for the treatment of mild-to-moderate coronavirus disease in adults.
On November 4, the United Kingdom had became the first country in the world to approve the pill to treat mild to moderate Covid-19.
Before this, six coronavirus vaccines – Serum Institute’s Covishield, Bharat Biotech’s Covaxin, Zydus Cadila’s ZyCoV-D, Russia’s Sputnik V and the United States-made Moderna and Johnson and Johnson –have received emergency use authorisation from the Indian drug regulator.
As the country grapples with the prospect of another Covid wave, fuelled by the Omicron variant this time, Prime Minister Narendra Modi on Saturday announced that India’s vaccination programme will be opened to children over the age of 15 from January 3. He also said that a “precautionary dose” would be administered to healthcare workers and those over 60 years old with co-morbidities, from January 10.
The newly-approved vaccines could be used as booster shots in the coming days, reports said.