DCGI denies permission to SII for COVOVAX trials on children- All you need to know!

The Serum Institute of India had applied to the Drugs Controller General of India on June 28, 2021, seeking permission to conduct a trial of COVAVAX on 920 children, 460 each in 12-17 and 2-11 age groups, at sites.

Created On: Jul 1, 2021 12:07 IST
COVAVAX vaccine
COVAVAX vaccine

An expert panel of India’s Central Drug Authority on June 30, 2021, recommended against granting permission to the Serum Institute of India (SII) to conduct the phase 2/3 trials of COVAVAX Covid-19 vaccine on children aged 2-17 years.

The Serum Institute of India had applied to the Drugs Controller General of India on June 28, 2021, seeking permission to conduct a trial of COVAVAX on 920 children, 460 each in 12-17 and 2-11 age groups, at sites.

However, the subject expert on COVID-19 of the Central Drugs Standard Control Organisation- CDSCO, which deliberated on the application of SII, stated that the trials cannot be conducted on children as the vaccine has not been approved in any country.

SII must submit safety data of COVAVAX: CDSCO

The Central Drugs Standard Control Organisation has recommended that the Pune-based Serum Institute of India must submit the safety and immunogenicity data of COVAVAX from ongoing trials in adults to consider the possibility of clinical trials in children. The recommendations have also been approved by DCGI.

India to allow COVAVAX entry after US approval

As the Government of India expects 200 million doses of COVAVAX to be available between August and September 2021.

However, reportedly, India will allow the entry of this vaccine once it gets approval from the United States FDA.

NOVAVAX agreement with India:

•  The United States-based vaccine-maker NOVAVAX Inc., in November 2020, had announced a license agreement with the Serum Institute of India for the development and commercialization of NVX-CoV2373, its Coronavirus vaccine candidate, in low and middle-income countries and India.

•  The clinical trials of COVAVAX started in India in March 2021 and the Serum Institute hopes to launch it by September for adults.

COVAVAX vaccine: Key details

The NOVAVAX Covid-19 vaccine, codenamed NVX-CoV2373, is a Coronavirus vaccine candidate developed by NOVAVAX, a US-based biotechnology company, and the Coalition for Epidemic Preparedness Innovations (CEPI).

NVX-CoV2373 is described as both a protein subunit vaccine and a virus-like particle vaccine. It is produced by creating an engineered baculovirus containing a gene for modified SARS-CoV-2 spike protein.

The two-dose vaccine has been undergoing trials in India under the brand name COVAVAX and is expected to be available in September 2021.

 

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