Indian companies looking to import or test potential COVID-19 vaccines, that have been developed internationally, could get leeway in the number of India-specific tests and trials they would need conduct, says a guidance document from the Department of Biotechnology (DBT).
Normally, a vaccine that has been licensed in another country, would still need to repeat all human safety tests in India.
Use of earlier data
“Data generated outside India will be considered and examined and an abbreviated pathway may be considered for COVID-19 vaccine based on scientific rational and level of completeness of data in human trials in addition to satisfactory pre-clinical data. Phase I/II or phase III multi-centric study on statistically significant sample size may be considered based on, initial safety studies, proof of concept and dose finding data,” says the document that was published on May 23, but has only now been made public.
The Pune-based Serum Insitute of India (SII), which has a partnership with AstraZeneca to manufacture a potential vaccine being developed at Oxford University, has announced plans to conduct phase II/III clinical trials , meaning it will test the potential vaccine in Indians to determine if the vaccine is capable of stimulating an immune response and if it is capable of protecting people from the infection.
However the SII’s application to the Drug Controller General of India is partly premised on promising data on the vaccine candidate generated in the United Kingdom.
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Hyderabad-based Bharat Biotech has also begun testing its product Covaxin — based on a SARS-CoV2 strain sourced from ICMR-National Institute of Virology, Pune — at different sites on volunteers, but these are early phase-I and phase-II trials.
The same company has also been funded by the DBT to test a vaccine candidate utilising the inactivated rabies vector platform, developed with the Jefferson Vaccine Centre (JVC) in Pennsylvania in the U.S.
Parallel tests
In an earlier interview to The Hindu , Secretary, DBT Renu Swarup had said regulatory approvals would be accelerated but no important stages would be skipped. This would include different stages of vaccine tests being conducted in “'parallel.”
The clause also finds mention in the guidelines. “The applicant may submit parallel application for conducting appropriate phase of clinical trial to CDSCO (the drug regulator) for consideration... However, the application for clinical trial will be approved subject to ‘No objection certificate' from RCGM after examination of data of pre-clinical studies.”
The RCGM is the Review Committee on Genetic Manipulation, a DBT body that approves trial procedures on biological products that involves genetic manipulation. These can include DNA or modified vaccine candidates.
