Emergency use authorisation drugmakers seeking for the Covid-19 vaccine

US drugmaker Moderna was applying for emergency use authorisation for its Covid-19 vaccine. A few days earlier, Pfizer applied for emergency use authorisation for the vaccine it has developed in collaboration with BioNTech.

Daily Current Affairs Quiz 2020

Key-Points

Vaccines and medicines, and even diagnostic tests and medical devices, require the approval of a regulatory authority before they can be administered. In India, the regulatory authority is the Central Drugs Standard Control Organisation (CDSCO).

For vaccines and medicines, approval is granted after an assessment of their safety and effectiveness, based on data from trials. This is a long process, designed to ensure that a medicine or vaccine is absolutely safe and effective.

In emergency situations, like the current one, regulatory authorities around the world have developed mechanisms to grant interim approvals if there is sufficient evidence to suggest a medical product is safe and effective.

Final approval is granted only after completion of the trials and analysis of full data; until then, emergency use authorisation (EUA) allows the medicine or the vaccine to be used on the public.