India may get a coronavirus vaccine early, ICMR says they might consider emergency authorisation

With the pandemic far from over and cities reporting a resurgence of COVID cases, having a vaccine ready to fight the battle could be our only ray of hope and India, with the 3rd biggest COVID count could be on its way to get priority access to vaccines.

According to a recent briefing held by Indian Council of Medical Research (ICMR), the government might consider availing the option of granting emergency use authorisation to some of the vaccines under contention right now.

The news comes after India witnessed one of the biggest single day spikes, with almost 70k new infection cases.

Balram Bhargava, head of the ICMR talked about the move in a discussion held with MPs during a parliamentary session. The authorisation, at first could be granted to locally produced and manufactured vaccines.

India's homegrown vaccines, in the middle of trials were a late-entrant in the vaccine race.

ZyCOV-D and Covaxin, which are currently, in the middle of phase II of trials have shown promising results in early studies. A third vaccine, which was talked about in the past week is also in critical stages of development, although no other detail has been revealed as of yet.

Locally produced vaccines, Bharat BioTech's Covaxin and Zydus Cadila's ZyCOV-D, which started clinical trials in the month of July were fast-tracked and are now in the middle of mid-scale trials. Private vaccine maker, Serum Institute of India is also overseeing simultaneous phase II/III trials of the Oxford-AstraZeneca vaccine, which started this week.

Bhargava, while admitting that under normal circumstances, vaccine trials could take anywhere between 6-9 months to complete said that if the authorities allow for it, vaccines could be used for emergency use.

This is not the first time emergency authorisation (EUA) would be considered for use. Considering the timeline, emergency use authorisation allows the ‘restricted’ use of unapproved drugs for the treatment of illness in public health emergencies. EUA does not mean a formal approval for the use or marketing of the drug.

While this will be the first time a vaccine could be issued emergency authorisation, treatment drugs and methodologies have been given fast approvals. Life-saving drug, Remdesivir was given fast track authorisation to be used in severe infection cases, to be administrated under hospital settings.

Vaccine trials take a long time to develop and test before they are approved for use. Any vaccine which reaches us at this point would carry a certain level of ambiguity and a risk of danger. Much like the controversies that Russian vaccine, Sputnik V finds itself in right now, an expedited vaccine approval would mean that there may be many side-effects which can be experienced if an experimental vaccine is deployed for public consumption.

Fast trials and administration won't really mean that it would be safe to use by all sections. Unless and until a vaccine is found to be safe for all age groups and provides protection for a longer time, it is not considered ideal for use. The same applies for Covaxin and ZyCoV-D. A lot of extensive studies and researches are needed before we pin our hopes on the indigenous vaccines.

In a past briefing, Zydus Cadila CEO talked about ramping up production to have vaccine doses ready if emergent needs arise.

Interestingly, ICMR has only talked about issuing emergency authorisation for homegrown vaccines and not the other global vaccines in consideration. Out of all the vaccines under testing, Indian authorities have pegged hopes on vaccines produced by Oxford University and Moderna Therapeutics Inc., both of which are in phase III of testing.

Serum Institute of India CEO, Adar Poonawalla also spoke about the country getting priority access to the Oxford vaccine, which will be marketed as 'Covishield' in India. According to Poonawala, first batch of doses could be ready for deployment as early as December 2020. SII has ramped up production facilities and revised its testing protocols so that a vaccine could be made ready for the masses as early as possible. Leading pharma companies, which are in contention for producing a vaccine in India also held high-level talks over the week to present a roadmap of production possibilities, marketing and pricing.