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.
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