The National Medicines Regulator’s Committee of Subject Matters (SEC) will meet again on Friday to make a decision on the Serum Institute of India (SII) Oxford-AstraZeneca’s Emergency Use Authorization Application (EUA) and Candidate Bharat Biotech vaccines against coronavirus disease. (COVID-19).
The SEC had met for a second time on Wednesday to review its US application, after the UK Medicines and Healthcare Products Regulatory Agency (MHRA) granted emergency use approval to the Oxford-AstraZeneca IBS vaccine on Wednesday.
SII has partnered with the company to conduct clinical trials and manufacture the vaccine in India.
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On December 24, the SII had submitted the additional data from the clinical trial that the SEC of the Central Drug Standards Control Organization (CDSCO) had requested at 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 from the local regulator, although it was not mandatory.
Three companies have applied for the USA 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 looked for more time, the expert panel reviewed the data from the other two companies and asked for more details.
The SEC had recommended that both companies submit additional data.
At Wednesday’s meeting it was also found that some documents were missing and the SII needed to update them and some additional data was requested from Bharat Biotech.
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