The subject expert committee (SEC) of the national drugs regulator will meet again on Friday to take a decision on the emergency-use authorisation (EUA) application of Serum Institute of India’s (SII) Oxford-AstraZeneca and Bharat Biotech’s vaccine candidates against Coronavirus disease (Covid-19).
The SEC had met a second time on Wednesday to review their EUA application, after UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted emergency-use approval to the SII Oxford-AstraZeneca 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 trial 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. The companies are Pfizer, SII and Bharat Biotech. While Pfizer did not show up for the presentation on the earlier dates and sought more time, the expert panel reviewed the data of the other two companies and asked for more details.
SEC had recommended that both the companies submit additional data.
In Wednesday’s meeting also some documents were found lacking and needed to be updated by SII and some additional data was sought from Bharat Biotech.