A regulatory authority has to approve vaccines and medicines before these can be administered. The regulatory authority in India is the Central Drugs Standard Control Organization (CDSCO). Usually, the regulator grants approval after an assessment of their safety and effectiveness, based on data from trials. The regulator has to approve every stage of the trials. This long process is designed to ensure that the medicines or vaccine is safe and effective.

The Serum Institute of India which is conducting trials of a version of the AstraZeneca-Oxford vaccine, has confirmed that it will seek a EUA within the next two weeks. Both Pfizer and Moderna had applied for a EUA. The UK was the first country to grant such an approval to Pfizer to administer its vaccine.

In an emergency, like the current one, regulatory authorities around the world have developed mechanisms to grant interim approvals on the basis of sufficient evidence to suggest that a medicine or vaccine is safe and effective. A final approval follows after completion of the trials and analysis of full data. Until then, a Emergency use authorization allows the medicine or vaccine to be used. An application for EUA is considered only after sufficient efficacy data from Phase 3 trials has been generated.

<aside> ✅ The fastest approval was received for the mumps vaccine in the 1960s , four and a half years after it was developed.

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