New Delhi: The Modi government’s expert panel has asked Pune-based vaccine maker, Serum Institute of India (SII), to revise protocol for conducting phase 3 trials on another leading Covid-19 vaccine candidate of an American firm.
In August, the SII had joined hands with American vaccine developer, Novavax, for the development and commercial collaboration of their vaccine in India.
Last week, the Serum Institute presented their proposal before the government’s subject expert committee (SEC) to seek permission for conducting the phase 3 trials of Novavax’s vaccine candidate.
The firm has asked for permission to conduct the “bridging trial to the ongoing Phase III clinical trial in the United Kingdom”. Bridging trial is a supplementary trial performed in a new region or country to get more clinical data on efficacy, safety and dose regimen.
Following the Serum Institute’s proposal, the SEC — which advises the Drug Control General of India on applications seeking approvals for new drugs, vaccines — recommended the company to revise the protocol based on its five recommendations.
“After a detailed deliberation, the committee recommended that the protocol should be revised,” the SEC told the Serum Institute, according to the minutes of the meeting that took place on 18 December. The minutes have been accessed by ThePrint.
The vaccine candidate — NVX-CoV2373 — is a protein-based platform engineered from the genetic sequence of SARS-CoV-2.
This week, Novavax has announced an agreement with the government of New Zealand for the purchase of 10.7 million doses of their vaccine.
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Revision of the protocol
The SEC has recommended revision of the protocol based on its five recommendations.
First, it said that the placebo arms should be included in the study. It means that a group of participants will be involved in the clinical trial who will not receive the vaccine shot, but just the dummy shot. It helps to compare the placebo group and non-placebo group Covid infection ratio, and decide the use and efficacy of the vaccine.
Further, the SEC asked the firm to submit the “interim safety data” from phase 2 clinical trials along with the recommendations of Data Safety Monitoring Board (DSMB) before proceeding to phase 3 clinical trials.
In the exclusion criteria, the panel has asked to specify the maximum dose of antiplatelet drugs permitted. Antiplatelet drugs prevent the formation of clots in the blood and some vaccine trials exclude people who are consuming such drugs, including immunosuppressing or immune-modifying drugs and anticoagulants.
The panel also said: “The firm should clarify the use of antiplatelet agents apart from Aspirin 325 mg and dual antiplatelet therapy to be used during the trial.”
The SEC has further asked the design of the clinical trial to be revised to adapt to Phase 2/3 clinical trials.
An adaptive design of the trial allows modifications to the trial and/or statistical procedures of the trial after its initiation without undermining its validity and integrity.
Submit more data, information, says panel
The panel has also asked the company to submit the safety data of M1 adjuvant — the patented technology of Novavax made to enhance the immune response — along with published literature.
They have also asked the company to “justify the non-inferiority margin proposed for statistical analysis”.
Non-inferiority margin is used to study “whether a new treatment is not worse than an active treatment it is being compared to”.
“Accordingly, the firm shall submit revised clinical trial protocol before the committee for further consideration,” the panel said.
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Seems that someone wants to get vaccine knowhow for free.
Is it? But there wd be protocols for confidentiality of data, no?