The subject expert committee (SEC) of the national drugs regulator will meet in a short while to take a decision on Serum Institute of India’s (SII) emergency-use authorisation (EUA) application for the Oxford-AstraZeneca vaccine candidate against Coronavirus disease (Covid-19).
The move comes after UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted emergency-use approval to the vaccine on Wednesday
SII has partnered with the company to conduct clinical trials and manufacture the vaccine in India.
On December 24, SII had submitted the additional clinical trials data that the Central Drugs Standard Control Organisation (CDSCO)’s SEC had asked for in its meeting held on December 9 to review its application.
The UK regulator (UK-MHRA) was also reviewing the necessary data, and according to experts it would have been advantageous if there was already an approval in place from the local regulator, even though it was not mandatory.
Three companies have applied for EUA for their Covid-19 vaccine candidates to the national drugs regulator. The companies are Pfizer, SII and Bharat Biotech. While Pfizer did not show up for the presentation on the earlier date, the expert panel had reviewed the data of the other two companies and asked for more details.
SEC had recommended for the company to submit additional data. Bharat Biotech is yet to reply to the regulator.