Coronavirus vaccine: Govt seeks more data from Serum Institute, Bharat Biotech for emergency use authorisation

The government has sought more data from vaccine makers on the safety and efficacy of their shots, thereby deferring recommending them for emergency use.

The Subject Expert Committee (SEC), a government panel tasked with vetting coronavirus vaccines, has asked Bharat Biotech International (BBIL) and Serum Institute of India (SII) to submit updated country-specific trial data of their vaccine candidates Covaxin and Covishield.

The panel has asked Bharat Biotech to provide data from its phase-3 clinical trial, along with phase-1 and 2 trial information, according to minutes of the meeting published on Wednesday on the Central Drugs Standard Control Organisation's website.

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"After detailed deliberation, the committee recommended that the firm should present the safety and efficacy data from the ongoing Phase 3 clinical trial in the country for further consideration," according to the minutes of the SEC meeting.

The SEC asked Serum Institute to present updated safety data of its phase-2/3 human clinical trials in the country along with immunogenicity data from the trial in the UK and India. Immunogenicity data refers to a vaccine prompting an immune response or producing antibodies in the study participant's body.

Pune-based SII is presently conducting bridge phase-3 trials of its experimental vaccine Covishield on 1600 study participants in India.

The expert committee (SEC), which is advising the DCGI (Drug Controller General of India) on the matter, also raised several concerns such as why the AstraZeneca vaccine, with which Serum Institute has a tie-up, has not yet been granted approval in the UK, its home country.

The panel added that since Oxford-AstraZeneca's proposal for emergency use authorisation (EUA) grant is presently under evaluation with the UK drug regulator MHRA, the SII must also furnish details regarding the outcome of the assessment by the UK-MHRA for the grant of EUA.

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"As per the condition of the permission to conduct phase II/III clinical trial in the country, the clinical data generated in the trial shall be considered along with the data from the Oxford clinical trial outcome," the minutes of the meeting said.

The committee, constituting specialists in varied medical fields, also sought information regarding the casual relationship analysis of the adverse drug reaction of the Chennai-based participant in the Serum Institute's trial.

Meanwhile, Pfizer, which along with Serum Institute and Bharat Biotech, has applied for an emergency use nod for its vaccine candidate, did not come for the review meeting on Wednesday.

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