New Delhi, Dec 27: An expert panel of the country’s Central Pharmaceutical Authority has recommended immediate approval of Serum Institute of India’s COVID-19 vaccine Kovavax and Biological E-vaccine Corvavax, subject to certain conditions, official sources said on Monday. The COVID-19 subject matter expert committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) on Monday also recommended that SpO2 allow the manufacture and marketing of anti-covid pills malnupiravi for limited emergency use in the treatment of 93 percent of adult patients. And those with certain conditions have a higher risk of progressing the disease, including hospitalization or death.
All recommendations have been forwarded to the Drug Controller General of India (DCGI) for final approval. The SEC of CDSCO’s Covid-19, which reviewed the Serum Institute of India’s (SII) Emergency Use Approval (EUA) applications for the second time on Monday, recommended that Covovax be granted EUA after detailed discussions.
The committee noted that the vaccine was developed through technology transfer from NovaVax and was approved by the European Medicines Agency for conditional marketing approval and a list of emergency uses by the WHO, an official source said. Prakash Kumar Singh, director, government and regulator of SII affairs, submitted an application to DCGI in October for market approval for Covovax for limited use in emergency situations.
The DCGI office May 17 granted SII permission to manufacture and stock Covovax. Based on DCGI approval, to date, Pune-based firms have developed and stockpiled doses of the vaccine.
In August 2020, US-based vaccine maker Novavax Inc announced a licensing agreement with SII for the development and commercialization of its COVID-19 vaccine candidate NVX-CoV2373 in low- and middle-income countries and India. The World Health Organization (WHO) on December 17 issued an emergency use list for Kovavax, expanding the basket of legalized jabs by the World Health Organization against viral diseases.
In the case of Biological E’s Corvevax, in light of the recommendations of the SEC meeting held on December 10, the firm proposed marketing approval of the vaccine for limited emergency use among adults, as well as updated Phase 2 intermediate safety and immunogenicity data. / 3 Interim safety and immunogenicity data of clinical trials and phase 3 active comparative trials have been updated. The committee noted that the firm submitted a 6-month safety follow-up post-second dose from Phase-1 clinical trials, 90-day safety from Phase-2 part and 60-day safety data from Phase 2/3 and Phase 3 active comparative studies.
The firm submitted interim immunogenicity data from a phase-3 active comparative trial that showed superiority over the comparator in the case of viral neutralization antibody titers, official sources said. “After detailed deliberations, the committee has recommended approval of the marketing of SARS-CoV-2 containing RBD antigen of SARS-CoV-2 (Covid-19) vaccine for limited use in emergencies subject to various regulatory provisions,” the source said.
The vaccine should be administered intramuscularly in two doses of 0.5 ml each at 28-day intervals (0 and 28 days) and stored between 2 সেল C and 8 সেল C, the source added. The SEC on Monday also recommended that SpO2 93 percent of adult COVID-19 patients under special conditions and those with a high risk of disease progression be allowed to manufacture and market anti-covid pills malnupiravi for limited emergency use.
Dr. Reddy’s laboratories at Cipla, Mylan, Torrent, MQ and Sun Pharma Association submitted their proposals for the approval of 200mg capsules of Malnupiravi for emergency use with various supporting documents. With the country’s clinical data, official sources said. Under the condition, the drug should be retailed only on the prescription of medical specialists.
Under the terms, the drug is not approved for use in patients under 18 years of age and for immediate treatment in hospitalized patients due to COVID-19 at that stage. However, if it is started before hospitalization due to COVID 19, it can be continued, the source said.
It is not approved for use in pregnant women for more than five consecutive days for COVID-19 prevention and for pre-exposure or post-exposure prophylaxis. The US Food and Drug Administration recently approved Marx’s Malnupiravir in mild to moderate covid-19 cases in adults at risk of serious disease.
Earlier in November, the UK gave conditional approval to Mark’s coronavirus antiviral, the first pill being successfully shown for the treatment of Covid-19. The purpose of taking the pill twice a day for five days at home in people with mild to moderate covid-19.
In a clinical trial of high-risk individuals during the illness, he found Mark’s drug reduced hospital admissions and deaths by about 30 percent.
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