CDSCO experts to meet again on Jan 1 on EUA for vaccine

CDSCO experts to meet again on Jan 1 on EUA for vaccine

84
Meeting Committee FDA
Picture: Pixabay

Last Updated on January 1, 2021 by The Health Master

The Subject Expert Committee (SEC) in the Central Drugs Standard Control Organisation (CDSCO) has decided to reconvene tomorrow, January 1 (Friday) after its meeting on December 30 to consider the Emergency Use Authorisation (EUA) request of Pfizer, Serum Institute of India (SII) and Bharat Biotech.

While Pfizer asked for more time, the SEC is perusing and analysing the additional data and information presented by SII and Bharat Biotech.

CDSCO FDA

On December 30, the UK government had accepted the recommendation from the Medicines and Healthcare products Regulatory Agency (MHRA) and granted a temporary authorisation of supply of Oxford University/AstraZeneca’s C-19 vaccine in an emergency use setting.

The EMA is analysing data submitted by AstraZeneca and Oxford University the as part of a rolling review process towards conditional marketing authorisation of C-19 vaccine.

As per an EMA release, so far, some evidence has been assessed on safety and efficacy coming from a pooled analysis of interim clinical data from four ongoing clinical trials in the UK, Brazil and South Africa.


Also read | Centralization of KYC registrations for Pharma exporters


The agency is currenlty assessing data from the latest clinical package received on December 21. CHMP has already assessed data from laboratory studies (non-clinical data) and is currently assessing data on the vaccine’s quality (on its ingredients and the way it is manufactured).

Additional scientific information on issues related to quality, safety and efficacy of the vaccine is necessary to support the rigour required for a conditional marketing authorisation and this has been requested from the company.


The Health Master is now on Telegram. For latest update on health and Pharmaceuticals, subscribe to The Health Master on Telegram.

Follow and connect with us on Facebook and Linkedin

Go to main website, click here