With Phase 3 trials for the anti-COVID-19 vaccines entering the last lap in several parts of the world, the ball is now in the court of national regulators to fast-track approval procedures that used to take years in the past. The UK’s Medicines and Healthcare Regulatory Authority (MHRA) last week was the first to take the emergency use approval (EUA) route to sanction use of the vaccine developed by the pharma giant Pfizer and German firm BioNTech. Pfizer has now approached the Drugs Controller General of India (DCGI) for a similar approval to use its vaccine candidate in the country. The Pune-based Serum Institute, the Indian collaborator of the vaccine developed by Oxford University and AstraZeneca, has also sought an EUA from the country’s drug regulator. However, unlike “Section 174” of the UK’s Human Medicines Regulations or the US’s EUA guidelines, India’s drug regulations do not have clearly defined provisions for emergency approvals. The onus is, therefore, on the DCGI to ensure that the compressed procedure doesn’t compromise on safety thresholds and is scrupulously transparent at every stage.
During the pandemic, the DCGI has given emergency approvals to drugs such as remdesivir. However, these medicines were not new introductions to the pharmacopeia — remedesivir, for instance, has been used as a broad spectrum antiviral for about five years. They were repurposed for treating COVID-19 patients. Unlike drugs which are only administered to patients, vaccines are meant for mass use by healthy people. The safety bar must, necessarily, be set higher for the latter. That’s why regulatory procedures for vaccines are long-drawn out affairs. However, the pandemic has forced regulatory bodies to crunch timelines and grant interim approvals if they are satisfied that “the vaccine is safe and effective”.
Globally, the EUA is a very recent addition to the regulatory arsenal — in the US, it dates to 2009 and in the UK to 2012. They have been granted primarily for drugs, diagnostics, and equipment like ventilators or PPEs. When the search for a shield against COVID-19 began, the US Food and Drugs Administration (FDA) underlined that it will use the emergency provision only when it is evident “the potential benefits of a vaccine candidate outweigh its risks”. In October, the US regulator made a number of additions to this approval procedure to make it “more transparent”. People will have to be informed about the major risks associated with a vaccine candidate and “how that threat would be addressed by the product under the proposed use”. The DGCI would do well to draw lessons from its US counterpart, keep all channels of information open.