When India started its vaccination drive in January 2021, a WhatsApp forward that started doing the rounds summed up the issues surrounding the vaccination drive with the observation: “Covid times have been crazy – politicians and bureaucrats are assuring doctors of vaccine safety!”
As part of the vaccination drive, which is purely voluntary, persons receiving the vaccine are deemed to be part of the larger clinical trial of the vaccines, which had received an accelerated approval under the New Drugs and Clinical Trial Rules, 2009 (the “Rules”). Both the Serum Institute and Bharat Biotech released fact sheets specifying those persons who should not be taking the vaccine. Interestingly, the fact sheet in relation to Covaxin notes that persons suffering from any other serious health-related issues, as determined by the Vaccinator/Officer supervising the vacation, should not be given the vaccine.
Please click here to read the full article by Arjun Krishnamoorthy, published in Express Healthcare.
Arjun is part of the Life Sciences, Healthcare and Pharma practice, with a focus on commercial contract advising (including service agreements, franchising agreements, and employment and consultancy contracts), M&A, regulatory compliances, data protection, and real estate matters.