Government exploring modalities of emergency authorisation of COVID-19 vaccine

The government is exploring the modalities of emergency authorisation and usage of anti-coronavirus vaccines pending completion of phase-three clinical trial and regular licensure.

The issue of advance purchase commitment for vaccines, including pricing, was also discussed in a recent meeting attended by NITI Aayog Member (Health) Vinod Paul, Principal Scientific Advisor to the government K VijayRaghavan and Union Health Secretary Rajesh Bhushan.

"It was decided that the PMO-constituted Vaccine Task Force (VTF) will lay down the principles for emergency use authorisation while the National Expert Group On Vaccine Administration for COVID-19 (NEGVAC) should take the lead in setting the principles for advance market commitment, including vaccine pricing," a source said.

These developments assume significance against the backdrop of Pfizer seeking emergency use authorisation of its COVID-19 vaccine from the US regulators. Another US-based biotechnology giant, Moderna, said it also intends to apply for an emergency use authorisation (EUA) with the US Food and Drug Administration (USFDA) in the coming weeks.

Meanwhile, five vaccines are under different phases of clinical trials in India. The Serum Institute of India is conducting the phase-three trial of the Oxford-AstraZeneca COVID-19 vaccine, while Bharat Biotech and ICMR has already started the phase-three trail of the indigenously developed COVAXIN jab.

An indigenously developed vaccine by Zydus Cadila has completed phase-two clinical trial in the country. Dr Reddy's Laboratories will soon start combined phase two and three trials of the Russian COVID-19 vaccine Sputnik V in India.

According to the source, an urgent meeting of the vaccine task force (VTF) with experts will be convened to review the scientific status of vaccines globally and whether, if so how and when should the decision on emergency authorisation of vaccines be taken.

The terms of references for two major bodies dealing with vaccine introduction -- the National Technical Advisory Group on Immunisation (NTAGI) and the Central Drug Standards and Control Organisation (CDSCO) -- will be set and their roles clearly defined for authorisation and emergency authorisation.

It was also agreed at the meeting that one point of contact will be responsible for examining and responding to authorisations given (or in the pipeline), globally, the source said.

Towards advance market commitment, NEGVAC should lay down principles for procurement and price negotiations. Using these principles, negotiations should be speedily initiated.

It was also decided at the meeting that a NEGVAC group should be proactively reaching out to each company as their results from phase three are announced, a source said.

Pfizer and its German partner BioNTech have announced that its vaccine appears 95 per cent effective at preventing mild to severe COVID-19 disease in a large, ongoing study. Moderna has also announced that its COVID-19 vaccine has shown to be 94.5 per cent effective in preventing the deadly disease.