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Current Affairs

Emergency use authorisation

Date: 03 December 2020 Tags: Miscellaneous

Issue

US drug maker Moderna has said it is applying for emergency use authorization for its Covid-19 vaccine.

 

Background

Serum Institute of India was also planning to apply for emergency authorization for its AstraZeneca Oxford vaccine.

 

Details

  • Vaccines medicines and even diagnostic tests require approval from a regulatory authority before they can be administered. In India Central Drug Standard Control Organisation (CDSCO) is the main authority.

  • For vaccines and medicines, approval is granted after an assessment of their safety and effectiveness, based on data from trials.

  • In emergency situations, regulatory authorities along the world have developed mechanism to grant permission to use if there is sufficient evidence to suggest the medicinal product is safe and effective.

  • In US, the FDA grants permission for emergency use authorisation only if the potential benefits outweigh the risks from the medicine.

  • For that, the vaccine must show effectiveness for more than 50% during its final phase of trail to be eligible for emergency use.

  • In India drug regulations do not have provisions for emergency use authorisation and the process of receiving one is not clearly defined.

  • Any company planning to launch a vaccine tested elsewhere has to conduct trials on local Indian population to show its effectiveness.

  • Even after approval of vaccine, citizens cannot be forced to take the vaccine. They must be told the possible drawback before administering the vaccine.