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Serum Institute sends more data for emergency use license


The Serum Institute of India (SII), which is manufacturing and testing the Oxford-AstraZeneca coronavirus vaccine in India, has submitted new data to regulators for its application for an emergency use license, officials familiar with the said Tuesday. process, and they added that a meeting will now be convened this week to evaluate the information.

The meeting will also review data for the Pfizer vaccine candidate, which also requested emergency approval but sought more time when the last meeting was held on Dec. 9. Applications are being evaluated by the Central Drug Standards Control Organization (CDSCO). The Committee of Experts on the Subject (SEC), which had sought more data from the SII at its last meeting on December 9, and gave Pfizer time until it was ready.

“The company (SII) yesterday (Monday) presented the additional data that were requested by the experts in the field. They have presented both preliminary data from trials in India and updated immunogenicity data from the UK. Pfizer is also ready with their data and has looked for a new date, ”said a senior government official familiar with the matter, who did not want to be named.

Earlier in the day, Dr. VK Paul, member (health), Niti Aayog, confirmed that one of the companies responded with the additional data but did not name SII.

CDSCO experts are reviewing the data before calling the SEC meeting. A similar review is also taking place at the UK Medicines and Health Products Regulatory Agency (MHRA). It is the trial in the UK and Brazil from where Oxford-AstraZeneca determined that the vaccine can be 62% to 90% effective. During the last meeting, the SEC indicated that it could wait until the MHRA assessment was completed and decided whether to phase out the vaccine in the UK before the data submitted for IBS was reviewed. The official quoted above said it may not necessarily be necessary. “Since both regulators have the data, it is now a question of who will review it first. There is always the possibility that the Indian regulator will grant the necessary approvals if they are satisfied with the data that has been submitted, ”the official said. Although the SII did not comment, a source close to the company confirmed that they had presented all the relevant data. Furthermore, Bharat Biotech also requested an approval. The SEC asked the company to submit efficacy data, which will likely take longer to derive since its late-stage trials began in mid-November. Bharat Biotech has yet to respond, the person quoted above added.

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