A central government panel from the Central Medicines Authority has recommended granting emergency use authorization (EUA) for the Serum Institute of India’s Covovax COVID-19 vaccine and the E Corbevax biologic vaccine, reported the PTI news agency. The Central Drugs Standard Control Organization (CDSCO) COVID-19 Subject Matter Expert Committee (SEC) also recommended on Monday that approval be granted to manufacture and market the anti-COVID pill Molnupiravir for use in Emergency restricted for the treatment of adult patients with 93 percent SpO2 who are at high risk of disease progression, including hospitalization or death, under certain conditions. All recommendations have been sent to the Drugs Controller General of India (DCGI) for final approval.
Covovax is a vaccine subunit developed by Novavax and the Coalition for Epidemic Preparedness Innovations (CEPI). It requires two doses and is stable at refrigerated temperatures of 2-8 ° C. The vaccine uses a new platform and is produced by creating a modified baculovirus containing a gene for a modified SARS-CoV-2 spike protein. The vaccine is already approved in Indonesia and the Philippines. The NOVOVAX vaccine on which COVOVAX is based was shown to be 89.7% effective after two doses and had “high efficacy” against variant B.1.1.7.
Biological E’s coronavirus vaccine, Corbevax, is an RBD protein subunit vaccine and is currently in Phase 2/3 clinical trials in adults. The Phase 3 trials are going to be a study compared to already licensed vaccines, although the study in children is not a comparative study. Biological E Ltd previously said it had reached an agreement with Janssen Pharmaceutica NV, part of pharmaceutical major Johnson & Johnson, for the creation and improvement of production capacities to manufacture the latter’s COVID-19 vaccine.
Molnupiravir works by blocking the ability of the virus to copy its genetic code and to replicate itself. If approved, it would be the first oral antiviral drug for COVID-19. All other available treatment options require an infusion or injection given in hospitals or clinics. A pill that can be taken at home could be a game-changer in the fight against the pandemic.
– Agency contributions