New Delhi, Sep 20: Union health minister Dr Harsh Vardhan has said that India could consider granting “emergency use” authorisation for a COVID-19 vaccine. This, Vardhan said, would be done to ensure that the vaccine can be made available for the elderly and frontline workers.
“Normally, the third trial [Phase 3] takes about six to nine months. But if the government decides, this period can be cut short by giving an emergency authorisation,” Vardhan said. “Any emergency authorisation is always done by adopting reinforced safeguard[s] so that people don’t worry about the safety. A high-level group has been formed to monitor the pace of the vaccine development under the direct guidance of Prime Minister Narendra Modi. There will be no shortcut on safety. Emergency authorisation will be given only if it meets the standards,” he said.
India, however, doesn’t have a regulatory framework for granting emergency use authorisation for vaccines, though a system to do so is in place for drugs, top experts have said in an article published in the Indian Journal of Medical Research, the peer-reviewed in-house publication of the ICMR. “India’s New Drugs and Clinical Trial Rules, 2019, accommodates “special situations for a new drug where relaxation, abbreviations, omission or deferment of data may be considered”, but this does not explicitly include public health emergencies such as novel epidemics and pandemics, nor does it have the provision for granting emergency use authorisation (EUA), reads the article ‘Revisiting regulatory framework in India for accelerated vaccine development in pandemics with an evidence-based fast-tracking strategy’.
Authors of the piece, Dr Amit Kumar Dinda, department of pathology, AIIMS, Dr Santanu Kumar Tripathi, Calcutta school of Tropical Medicine and public health expert Dr Bobby John of Aequitas Consulting explain that while the US FDA can accelerate the availability of pharmaceutical products and vaccines by using the mechanism of emergency use authorization (EUA), the Indian regulator lacks a similar mechanism.
“Under an EUA, it is possible for US FDA to authorize the marketing of an unapproved product or the unapproved use of an approved product when a justifiable health emergency or a potential emergency exists,” they say.
In India, though, the drug regulator has responded by allowing ‘restricted emergency use’ permission for a few drugs, and put out a formal notification allowing for manufacture of novel vaccines for COVID-19, they point out.
Regardless, questions around how exactly vaccine trials need to be ‘shortened’, and a safe vaccine be made available to the vulnerable population—and eventually, to all—albeit without compromising safety, remain, not just in India, but across the world. Vaccines take long—trials proceed sequentially in Phase 1, 2, 3 and 4—and typically take years before a safe and effective product.