India probably will wait till UK authorities clear the coronavirus vaccine developed by University of Oxford and AstraZeneca as experts from India's drug regulators sought their data before assessing the vaccine candidate on their own. Being manufactured and tested in India by the Serum Institute of India (SII), the vaccine candidate is among three that have applied for an emergency approval. The others include Pfizer-BioNTech's mRNA vaccine, and a domestic vaccine called Covaxin being developed by Bharat Biotech.
The Central Drugs Standard Control Organisation's Subject Expert Committee (SEC) reportedly said, “After detailed deliberation, the committee recommended that the firm should submit the following data/information for further review: 1. Updated safety data of the Phase II/III clinical trial in the country; 2. Immunogenicity data from the clinical trial in UK and India; (and) 3. The outcome of the assessment of UK-MHRA for grant of EUA (emergency use authorisation).” The assessments will be sent as recommendations to the CDSCO, which will take the final call.
The committee reportedly also asked Bharat Biotech, which presented Phase I/2 data, to present data from its Phase 3 trials. The meeting, conducted last week, marks the formal beginnings of Covid-19 vaccine candidate testings that may have derived enough data to judge its safety and efficacy. Pfizer, meanwhile, sought more time to appear before the committee.
Media reports quoted a source as saying Pfizer has been told they can approach whenever they are ready. The next SEC meeting is expected to undertake once the two manufacturers submit their data. Pfizer's vaccine is the furthest along, showing 95 per cent efficacy. However, there has been no trial in India for the vaccine.
The Oxford-AstraZeneca, to be manufactured and marketed by the Serum Institute of India, is currently conducting a phase III trial in India with 1,600 participants across 15 sites.
