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Government explores modalities of emergency authorization of the Covid-19 vaccine | India News


NEW DELHI: The government is exploring emergency authorization modalities and the use of coronavirus vaccines until the phase three clinical trial and regular licensing is completed.
The issue of vaccine advance purchase commitment, including price, was also discussed at a recent meeting attended by NITI member Aayog (health) Vinod Paul, government chief scientific advisor K VijayRaghavan, and health secretary of the Union, Rajesh Bhushan.
“It was decided that the Vaccine Working Group (VTF) constituted by the PMO will establish the principles for the authorization of emergency use, while the National Group of Experts on Administration of Vaccines for COVID-19 (NEGVAC) should take the initiative in establishing the principles for the advanced market commitment, including the price of vaccines, “said a source.
These developments take on significance in the context of Pfizer seeking authorization for the emergency use of its COVID-19 vaccine from US regulators.Another US-based biotech giant, Moderna, said it also intends to apply for an Emergency Use Authorization (US) with the United States Food and Drug Administration (USFDA) in the coming weeks.
Meanwhile, five vaccines are in 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 have already started the phase three journey of the indigenously developed COVAXIN jab.
A locally developed vaccine by Zydus Cadila has completed the phase two clinical trial in the country. Dr Reddy’s Laboratories will soon begin phase two and three combined trials of the Russian COVID-19 Sputnik V vaccine in India.
According to the source, an urgent meeting of the Vaccine Working Group (VTF) with experts will be convened to review the scientific status of vaccines globally and if, if so, how and when the decision on the authorization of vaccines should be made. vaccine emergency.
Terms of reference will be established for two main bodies dealing with vaccine introduction: the National Technical Advisory Group on Immunization (NTAGI) and the Central Drug Standards and Control Organization (CDSCO), and their roles will be clearly defined for authorization and emergency authorization. .
It was also agreed at the meeting that a point of contact will be responsible for examining and responding to authorizations granted (or pending), globally, the source said.
To advance market engagement, NEGVAC should establish principles for procurement and pricing negotiations. Using these principles, negotiations should start quickly.
It was also decided at the meeting that a NEGVAC group should proactively communicate with each company as the results of phase three are announced, a source said.
Pfizer and its German partner BioNTech have announced that their vaccine appears to be 95 percent effective in preventing mild to severe COVID-19 disease in a large ongoing study. Moderna has also announced that its COVID-19 vaccine has been shown to be 94.5% effective in preventing the deadly disease.

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