Serum Institute submits more data for emergency use licence
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 licence, officials aware of the process said on Tuesday, adding that a meeting will now be called this week to assess the information.
The meeting will also review data for the vaccine candidate by Pfizer, which too applied for emergency approval but sought more time when the last meeting was held on December 9. The applications are being assessed by the Central Drugs Standard Control Organisation (CDSCO)’s Subject Expert Committee (SEC), which had sought more data from SII in its last meeting on December 9, and gave Pfizer time till it was ready.
“The company (SII) yesterday (Monday) submitted the additional data that was asked by the subject experts. They have submitted both preliminary data from the trials in India, and the updated UK immunogenicity data. Pfizer is also ready with its data and has sought for a fresh date,” said a senior government official in the know of things, who did not wish to be named.
Earlier in the day, Dr VK Paul, member (health), Niti Aayog, confirmed that one of the companies got back with the additional data but did not name SII.
Experts at CDSCO are currently reviewing the data before they convene the meeting of SEC. A similar review is also underway at the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. It is the trial in the UK and Brazil from where Oxford-AstraZeneca determined the vaccine may be 62%-90% effective. During the last meeting, SEC indicated it may wait till MHRA’s assessment was complete and it had decided on whether to clear the vaccine in UK before the data presented by SII was reviewed. The official quoted above said that may not necessarily need to be. “Since both the regulators have the data, it is now a matter of who will review it first. There is always a possibility that India regulator may grant the necessary approvals if it is satisfied with the data that has been submitted,” the official said. While SII did not comment, a source close to the company confirmed they had submitted all the relevant data. In addition, Bharat Biotech also sought an approval. The SEC asked the company to present efficacy data, which is likely to take longer to derive since its late stage trials began in mid-November. Bharat Biotech is yet to reply, the person quoted above added.