Panel Recommends Nod To Serum Institute For Covid Jab Trials On Children
Official sources claim that today’s expert panel of the Central Drugs Standard Control Organisation recommended that the Serum Institute of India (SII), be granted permission to conduct phase 2/3 trials of Covovax in children between 2 and 17 years old with certain conditions.
The trials would include 920 children and 460 in each age group (12-17, 2-11 years old) across 10 sites.
Sources said that the Subject Expert Committee (SEC), on COVID-19, of the Central Drugs Standard Control Organization(CDSCO), deliberated on Tuesday on the revised study protocol application submitted by SII and recommended that the firm be granted permission to conduct phase 2/3 trials of Covovax in children between 2 and 17 years.”
The Pune-based pharmaceutical company submitted a revised protocol to include a pediatric cohort in ongoing Covovax Phase 2 and 3 observers-blind randomized controlled studies in Indian adults over 18 years. This was done to establish safety and immunogenicity.
Prakash Kumar Singh, director of SII (government and regulatory affairs), and Dr. Prasad Kulkarni, director, stated in the revised application that all adults over 18 years are being vaccinated. After this population is protected from COVID-l9 the children will be the most vulnerable.
“There have been numerous reports of severe diseases, including the deaths of vulnerable children. The country’s third pandemic wave is also predicted.
“Moreover, vaccination is available for all ages, even children, up to the age of 20. They stated that the SARS-CoV-2 virus could still be in circulation, putting everyone at risk for severe diseases.
The SII stated that several companies have begun to evaluate the safety and immunogenicity of COVID-19 vaccines in children.
According to the SII, they informed Novavax, Inc., the USA that their collaborator had already generated large amounts of data in adults across different countries. The safety, efficacy, and immunogenicity data for the Novavax COVID–I9 vaccine are extremely robust. This includes data from Australia, South Africa, the USA, and preliminary safety data in 2248 kids.
The application stated that more than 1400 people have been vaccinated in India’s ongoing Phase 2/3 study. There are no safety concerns.
“This will ensure that the emergency use authorization is granted immediately for the pediatric population, as well as the adult population so that the life-saving vaccine can be delivered quickly to our children.”
Mr. Singh stated in the application that “This approval will assure an early availability COVID-19 vaccination for children in our country by our prime minister’s clarion call Atmanirbhar Bharat and will aid in faster elimination COVID-19 pandemic.”
On June 30, the SEC had recommended against SII’s permission to conduct phase 2 and 3 Covovax trials on children between 2 and 17 years. The company had submitted a revised protocol last week.
Novavax, Inc, a US-based vaccine manufacturer, announced a license agreement with SII in August 2020 for the development and commercialization of NVXCoV2373, their COVID-19 vaccine candidate, to low- and middle-income countries.