SII Application For Oxford AstraZeneca COVID-19 Vaccine’s Emergency Use To Be Considered Today

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On the 30th of December, the Serum Institute India (SII) requested for emergency use of the Oxford vaccine for the Novel Coronavirus or COVID-19. 

According to sources, the emergency request would be considered today by the Central Government.

The SII’s emergency approval meeting came after the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (U.K.,) granted emergency use approval to the Oxford AstraZeneca vaccine.

The subject expert committee (SEC) of the national drugs regulator called for a meeting today regarding the same.

During the meeting, a decision on Serum Institute of India’s (SII) emergency use authorisation (EUA) application would be taken. usage.

SII partnered with the company to conduct clinical trials and manufacture the vaccine in India. On the 28th of December, the SII said they have manufactured 40 to 50 millions of the vaccine doses and would be able to manufacture 300 million doses by July 2021.

Meanwhile, on the 24th of December, the SII had submitted the additional clinical trials data to the Central Drugs Standard Control Organisation (CDSCO)’s SEC. With the same, the SII asked for emergency approval for the usage.

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 Pfizer, SII and Bharat Biotech, have applied for EUA for their COVID-19 vaccine candidates to the national drugs regulator.

SEC had recommended for the company to submit additional data. Bharat Biotech is yet to reply to the regulator for the emergency approval.

Meanwhile, the decision on the SII which resubmitted their data is yet to be made today.

Stay tuned for further updates.

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