India has approved two more vaccines under emergency use authorisation and an antiviral drug, Molnupiravir, Health Minister Mansukh Mandaviya tweeted on Tuesday. Currently, India uses Covishield, Covaxin and Sputnik V in its vaccination programme.
Corbevax to be made by Hyderabad-based Biological-E is a protein sub-unit vaccine and Covovax, to be manufactured by Serum Institute of India, Pune, is a nanoparticle-based vaccine.
Corbevax is 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 licence from Novavax, a U.S.-based biotechnology company. Covovax has been approved by the World Health Organisation (WHO) under its Emergency Use Listing and, therefore, will also be available globally as part of the COVAX initiative to ensure that at least 40% of world is vaccinated on priority.
Molnupiravir, that was approved this month by the U.S. Food and Drugs Administration (U.S. FDA), on the heels of Paxlovid by Pfizer Inc, is said to be a promising drug for those with mild and moderate disease and also easily administered as a pill. Thirteen companies in India are set to manufacture this drug. It has been approved under emergency use authorisation for treating adults with COVID-19 “who have 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.
Cipla, one of the licensee, 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.
Prime Minister Narendra Modi announced on Saturday that from January 3 those aged 15-17 would be eligible for Covaxin. 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. There are no studies so far to show how effective the new vaccines will be in giving protection against symptomatic infection when employed as a third dose though the WHO's general observation is that same or mixed vaccine regimens “improve immunological response” are better protective against disease and death.
In June the Centre had said 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.
