US drugmaker Moderna applies for Emergency Use Authorisation (EUA)

US drugmaker Moderna applies for Emergency Use Authorisation (EUA)

Part of: GS Prelims and GS-III – Sci & Tech

In news

• US drugmaker Moderna said it was applying for emergency use authorisation for its Covid-19 vaccine. 
• In India, Serum Institute of India, which is trialling a version of the AstraZeneca-Oxford vaccine, has said it expects to seek emergency use authorisation within the next two weeks.

Key takeaways

• Vaccines, medicines, 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 COVID-19, 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.