Govt. Exploring Ways For Emergency Authorisation

New Delhi, 23 Nov 2020:

The Union government is exploring the modalities of emergency authorisation and usage of anti-coronavirus vaccines pending completion of Phase 3 clinical trial and regular licensure.

The issue of advance purchase commitment for vaccines, including pricing, was also discussed at 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.

Market commitment

“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 U.S.-based biotechnology giant, Moderna, said it also intended to apply for an emergency use authorisation (EUA) with the U.S. Food and Drug Administration (USFDA) in the coming weeks.

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 how and when should the decision on emergency authorisation of vaccines be taken.

Terms of references

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 would be responsible for examining and responding to authorisations given (or in the pipeline), globally, the source said.The Hindu