Asia-Pacific Roundup: India seeks more data on AstraZeneca COVID vaccine

 By Nick Paul Taylor 

India’s Subject Expert Committee (SEC) has asked to see additional data on AstraZeneca’s COVID-19 vaccine before deciding whether to grant emergency use authorization (EUA). The Central Drugs Standard Control Organization (CDSCO) wants to see immunogenicity data from patients in the UK and India and safety data beyond the 14 November cut-off shared with it to date.

Serum Institute of India, which is partnered with AstraZeneca on ADZ1222, a viral vector vaccine, put an EUA proposal to SEC at a meeting last week. The proposal was supported by interim safety data from an Indian Phase 2/3 clinical trial, plus interim safety and efficacy from the global late-phase program.

SEC has agreed to consider data from multiple countries but found gaps in the evidence presented at the meeting. The CDSCO committee wants Serum to submit updated safety data, as well as immunogenicity data from clinical trial sites in the UK and India.

Serum, working with its partners at AstraZeneca and the University of Oxford, can handle those data requests itself. However, the third request to come out of the meeting is out of Serum’s hands. SEC wants to see the outcome of the UK Medicines and Healthcare products Regulatory Agency’s assessment of the application before making its own decision on the EUA. 

The request for more data by SEC follows a period of public scrutiny of results on the COVID-19 vaccine developed by AstraZeneca and Oxford. While Moderna and Pfizer ran single pivotal trials of at least 30,000 people, Oxford sponsored smaller national trials that featured two different vaccine regimens and a wide range of times between the first and second doses.

SEC’s request for additional data provides an early glimpse of how regulators may approach Oxford’s pooled analysis. The vaccine has begun the rolling review process in territories including the UK and European Union, setting the stage for conclusive regulatory verdicts on the vaccine in the coming weeks.

Pfizer was due to present data on its COVID-19 vaccine, which has emergency authorization in countries including the UK and US, at the SEC meeting. However, SEC said Pfizer has asked for more time before making its presentation.

SEC was able to review results on Bharat Biotech’s coronavirus vaccine. Bharat Biotech presented a proposal for EUA alongside interim safety and immunogenicity data from a Phase 1/2 clinical trial. SEC has asked to see safety and efficacy data from an ongoing Phase 3 clinical trial.