August 15 deadline for COVID-19 vaccine: How efforts to fast track turned into controversy

KEY HIGHLIGHTS:

• Plans to fast track vaccine development was in place as early as March
• Department of Biotechnology guidelines recommended India must consider global research collaborations and prioritise approval process for clinical trials
• August 15 deadline triggered a controversy after experts claimed it was impossible to develop a ready-to-use vaccine that early
• Most experts globally are of the opinion that coronavirus vaccine will not be ready till next year

Indian Council of Medical Research (ICMR) chief Dr Balram Bhargava might have been criticised recently for giving a deadline - August 15 - for the development of indigenous COVID-19 vaccine, but the plans to fast track vaccine development was in place as early as March within the government machinery.

The Department of Biotechnology (DBT) on March 20 made public its decision to have a rapid response regulatory framework for COVID-19 to deal with applications for the development of vaccines, diagnostics, prophylactics and therapeutics. An interim set of instructions, prepared in consultation with the Drugs Controller General of India (DCGI) was also readied to reduce red-tapeism or procedural delays, something which Dr Bhargava wanted to cut down when he gave a deadline to Indian researchers.

On May 26, DBT came out with the rapid response regulatory framework specifically for COVID-19 vaccine development. The crux of the guideline was that India should consider the research collaborations that are taking place with Indian enterprises and foreign research organisations and prioritise the approval process for various phases of clinical trials on the basis of data generated elsewhere too. It wanted the preclinical studies already done outside India to be considered in regulatory submission and individual applications to be examined based on quality of data generated. "Conduct of limited preclinical study may be asked for after examination, if required", the guideline states.

The guidelines propose that the applicant may be allowed to submit parallel application for conducting appropriate phase of clinical trial to CDSCO for consideration at the time of conducting studies based on proof of concept. However, the guidelines stipulate that the application for clinical trial will be approved subject to clearance from DBT's Review Committee on Genetic Manipulation (RCGM) after examination of data of pre-clinical studies.

The DBT guideline also states that the data generated outside India will be considered and examined and an abbreviated pathway may be considered for COVID-19 vaccine based on scientific rationale and level of completeness of data in human trials in addition to satisfactory preclinical data. "Phase I/II or phase III multicentric study on statistically significant sample size may be considered based on, initial safety studies, proof of concept and dose finding data", the guideline states. However, it has also clarified that the guideline for COVID-19 vaccine rapid regulatory pathways is dynamic and recommendatory in nature.

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