Through a tweet, the Health Minister of India, Mansukh Mandaviya informed that India on Tuesday has approved two more vaccines under emergency use authorization along with an antiviral drug, Molnupiravir.
Currently, India uses Covishield, Covaxin and Sputnik V in its vaccination programme.
Corbevax to be made by Hyderabad-based Biological-E is a protein subunit vaccine and Covovax, to be manufactured by Serum Institute of India, Pune, is a nanoparticle-based vaccine.
Corbevax has been co-developed by Biological E, Baylor College of Medicine in Houston, United States, and American company Dynavax Technologies.
Covovax is produced by the Serum Institute of India under license from Novavax which is a U.S.-based biotechnology company. Covovax received prior approval from the World Health Organization (WHO) under its Emergency Use.
On the other hand, the Molnupiravir was approved this month by the U.S. Food and Drugs Administration (U.S. FDA). Thirteen companies in India have geared up to manufacture this drug. It has been approved under emergency use authorization for treating adults with COVID-19 "who have a high risk of progression to disease".
The U.S. FDA in a recent statement said that because Molnupiravir works by introducing genetic errors into the virus, it ought to be prescribed with caution and was not recommended as a preventive and only in "certain adults" in whom alternative COVID-19 treatment options authorised by the FDA were not accessible or clinically appropriate. Paxlovid is yet to be approved in India.
India's Prime Minister Narendra Modi recently announced that from January 3, those aged 15-17 would be eligible for Covaxin in the country.Cipla, one of the licensees, said in a statement that it planned to launch Molnupiravir under the brand name Cipmolnu.
There were no details available on when these vaccines would be included in India's vaccination programme.
India's Prime Minister Narendra Modi recently announced that from January 3, those aged 15-17 would be eligible for Covaxin in the country. Healthcare workers, frontline workers and those above 60 with comorbidities who have already got two shots will be eligible for a third dose from January 10.
In June the Centre declared that it had "reserved" 30 crore doses of Corbevax. Though early trials had shown the vaccine to be safe and capable of eliciting an immune reaction, no results are yet available on its efficacy. In June, results from a Phase 3 clinical trial of Novavax enrolling 29,960 adult volunteers in the U.S. and Mexico showed that the vaccine demonstrated 90.4% efficacy in preventing symptomatic COVID-19 disease. It also showed 100% protection against moderate and severe disease.
Official sources say that Dr Reddy's Laboratories in consortium with Cipla, Mylan, Torrent, Emcure and the Sun pharma had presented their proposal for approval of Molnupiravir 200mg capsules for approval in an emergency situation.
The SEC on COVID-19 of the CDSCO, which reviewed the EUA applications of the SII for the second time on Monday, noted that the vaccine is manufactured by technology transfer from Novavax and is approved by the European Medicines Agency for conditional marketing authorization and also granted emergency use listing by WHO.
The World Health Organization (WHO) had on December 17 issued an emergency use listing for Covovax, expanding the basket of jabs validated by the global health body against the viral disease.