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.
