In a significant move, the Subject Expert Committee under India’s drug regulator recommended granting Emergency Use Authorisation to Serum Institute of India’s Covovax, Biological E’s Corbevax and antiviral Covid-19 pill molnupiravir, at a meeting held on Monday.
The recommendations have been sent to the Drug Controller General of India, which will soon decide on their approval. The new vaccines could possibly be used as booster shots in the days to come.
Commenting on the SEC nod to SII’s Covovax a person in the know said, “the experts were satisfied with the data presented to them.” Covovax is the Indian version of US drug manufacturer Novavax’s recombinant nanoparticle protein-based Covid-19 vaccine.
Novavax and SII have already received EUA for this vaccine in the Philippines. The World Health Organisation too recently granted Emergency Use Listing to Covovax, which brightened its chances of approval in India.
The other vaccine which was taken up for discussion was protein-based Corbevax, produced by Biological E Ltd. The company had been submitting rolling data from the clinical trial to the drug regulator. The Centre has already made an advance payment of Rs 1,500 crore to reserve 300 million doses of Corbevax.
The experts also evaluated granting EUA to antiviral Covid-19 pill molnupiravir.
Developed by MSD and Ridgeback Biotherapeutics, the drug works by introducing errors into the SARS-CoV-2 virus’ genetic code, which prevents the virus from further replicating. Ridgeback is collaborating with Merck on developing molnupiravir. It is administered as four 200 milligram capsules taken orally every 12 hours for five days, for a total of 40 capsules. Molnupiravir is not authorised for use for longer than five consecutive days.
Last week, the USFDA issued EUA to molnupiravir for the treatment of mild-to-moderate coronavirus disease in adults who are at high risk for progression to severe Covid-19, including hospitalisation or death.
In India, Merck & Co. has signed voluntary licensing agreements with Cipla Ltd, Dr Reddy’s Laboratories, Emcure Pharmaceuticals Ltd, Hetero Labs Ltd and Sun Pharmaceutical Industries Ltd, for allowing the drug to be manufactured and marketed in India.
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