The numbers are staggering. At least 5.7 billion doses of Covid-19 vaccines have been pre-ordered pre-ordered Hindustan Times Pre-orders of Covid-19 vaccine top five billion Read more  globally, without a guarantee that all or any of them would pass muster in Phase III trials. It’s akin to countries buying premium health insurance for their people, and kick-starting their economies.

If manufacturers and heads of state wait for adequate regulatory approvals, then the world, put on notice in January, would claim a victory against the virus. If countries jump the gun, the way Russia did Russia did Livemint Russia announces world's first Covid-19 vaccine, Putin's daughter gets vaccinated Read more , they’d fuel vaccine-denialism of a kind that would hurt society long after the scourge of the novel coronavirus has waned. 

Last week, India’s “Covid custodian” displayed a dangerous kind of vaccine evangelism. The Indian Council of Medical Research (ICMR) said India might consider emergency use authorisation emergency use authorisation Times of India India May Get A Coronavirus Vaccine Early, ICMR Says They Might Consider Emergency Authorisation Read more  (EUA) for locally developed and manufactured vaccines. Of the handful of vaccines that India, its Department of Biotechnology (DBT) specifically, has committed to supporting at the development stage, three are in mid-stage trials: 

  1.  Bharat Biotech, which is working with ICMR on a strain identified by the National Institute of Virology, is currently testing the vaccine under Phase II study.
  2. Zydus Cadila, which has developed its own DNA vaccine candidate, is in Phase II, 1000 people, placebo-controlled trial.
  3. Gennova Biopharmaceuticals, which, according to sources, has received the highest grant so far, will enter Phase 1 human trials in October. 

Pune-based Serum Institute, the world’s largest vaccine manufacturer, has no locally developed Covid vaccine in its five-candidate arsenal, but it is conducting a 1,500-person Phase III trial as part of its collaboration with the Oxford University-AstraZeneca vaccine programme. Globally, this vaccine is the furthest along furthest along Financial Express Coronavirus vaccine: Oxford University led AstraZeneca front-runner in covid19 vaccine race, says WHO chief scientist Read more  in clinical testing. 

With vaccine development being compressed from 10-12 years to 10-12 months for the first time ever, serious regulators around the world, including China’s National Medical Products Administration (NMPA) have made public made public Global Regulatory Partners China's NMPA introduces new guidance for Covid 19 trials Read more  their guidelines for approval.

AUTHOR

Seema Singh

Seema has over two decades of experience in journalism. Before starting The Ken, Seema wrote “Myth Breaker: Kiran Mazumdar-Shaw and the Story of Indian Biotech”, published by HarperCollins in May 2016. Prior to that, she was a senior editor and bureau chief for Bangalore with Forbes India, and before that she wrote for Mint. Seema has written for numerous international publications like IEEE-Spectrum, New Scientist, Cell and Newsweek. Seema is a Knight Science Journalism Fellow from the Massachusetts Institute of Technology and a MacArthur Foundation Research Grantee.

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