Covid-19 has been pushing the limits of science and regulatory processes. Pharmaceutical companies are at phase 3 trials around the world, while the UK green-lighted emergency-use authorisation (EUA) of the Pfizer vaccine in early December.
On November 17, the US Food and Drug Administration (FDA) said that reviews of all data and information regarding EUAs granted to Covid-19 drugs and vaccines would be made public. “Today’s transparency action is just one of the number of steps we are taking to ensure public confidence in our EUA review process for drugs and biological products, especially any potential Covid-19 vaccines,” said USFDA Commissioner Stephen Hahn in a statement published by Reuters.
Around the same time in November, two of India’s largest clinical trials—being conducted by Pune-based Serum Institute of India (SII) and Hyderabad-based Bharat Biotech—came under scrutiny when one volunteer each from both trials were hospitalised after being administered a vaccination dosage. Although Union Secretary of Health and Family Welfare Rajesh Bhushan assured that these developments would not affect vaccine timelines in India, experts think pharma companies and the Drugs Controller General of India (DCGI) should be more transparent and accountable about explaining how evidence is being examined and decisions are being taken with respect to these procedures.
“The [investigation] process does not have to be put out in the public domain, but more details have to be shared. We have an unprecedented situation where a trial participant has gone public decrying the clinical trials process,” says Anant Bhan, a bioethics and global health policy researcher. “Confrontational or hyper-aggressive responses by companies and authorities, without offering more clarity, will lead to a trust breakdown in the vaccination process.”
Bhan is referring to the adverse event during the clinical trials of SII’s Covishield. A Chennaibased, 40-year-old volunteer sent a legal notice to SII, demanding ₹5 crore in compensation for a severe neurological reaction he alleged he developed after receiving a dose of Covishield, being developed by University of Oxford and British pharma giant AstraZeneca, which SII is manufacturing.
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