Test Large Sample Size Before Vaccine Cleared For Emergency Use: Panel


Any vaccine against COVID-19 should be granted emergency use authorisation only after proper consideration and conducting its trials on a sufficient sample size, a parliamentary panel chaired by senior Congress leader Anand Sharma has recommended to the government.

In a report submitted Monday to Rajya Sabha chairman and Vice President M Venkaiah Naidu, the Parliamentary Standing Committee on Home Affairs also said there was a need for a comprehensive public health law to keep a tab on private hospitals and check black marketing of medicines.

The report comes even as the government considers applications of at least three firms seeking emergency approval to roll out their vaccines against the coronavirus in India.

The centre last Tuesday said the applications — by Bharat Biotech, Serum Institute of India and Pfizer — filed with the Drugs Controller General of India are being examined by the COVID-19 subject expert committee of Central Drugs Standard Control Organization (CDSCO).

The parliamentary committee report noted that the CDSCO has given no emergency use authorisation in the past, and suggested that all necessary and mandatory requirements must be duly fulfilled and all trial phases completed.

“Trials on small animals, human trials should be mandatorily undertaken on a sufficient sample size population — if at all emergency authorisation would be given, it should be given by Government with proper consideration and caution and this provision should be used in rarest of the rare cases,” the report reads.

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