After UK MHRA nod, EMA asks for additional scientific information on issues related to quality, safety and efficacy of the Oxford University/AstraZeneca shot
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.
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 COVID-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 COVID-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. 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.
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