EMERGENCY USE APPROVAL

EMERGENCY USE APPROVAL

Subject : Governance

Context : An expert body under India’s apex drug regulator has recommended against granting approval to Pfizer’s Covid vaccine under emergency circumstances, prompting the American drug giant to withdraw its request.

Concept :

Emergency Use Approval

• There is nothing such as emergency use approval in Indian rules, however the 2019 rules provide for “Accelerated Approval Process” in several situations that would include the one like the current pandemic.
• In such situations, there is a provision for granting approval to a drug that is still in clinical trials provided the product is of meaningful therapeutic benefit.
• Accelerated approval may also be granted to a new drug if it is intended for the treatment of a serious, or life-threatening condition, or disease of special relevance to the country, and addresses unmet medical needs.
• A new drug, or a vaccine, can be considered for approval if remarkable effectiveness is reported even from phase-II trials.
• In such cases, additional post licensure studies may be required.
• The approval granted to drugs or vaccines that are still in clinical trials is temporary, and valid only for one year.

Pfizer Vaccine :

• BNT162b2 is a COVID-19 vaccine candidate developed by BioNTech and Pfizer and given by intramuscular injection.
• It is an RNA vaccine composed of nucleoside-modified mRNA encoding a mutated form of the spike protein of SARS-CoV-2, and is encapsulated in lipid nanoparticles.