EMERGENCY USE AUTHORIZATION

EMERGENCY USE AUTHORIZATION

Subject : Governance

Context : The government-appointed expert panel on Friday emergency use approval for the Oxford University-AstraZeneca Vaccine made and distribute by the Serum Institute of India.

Concept :

• After Drugs Controller General of India (DCGI) gives its approval India too will likely begin the mass immunisation programme with a dosing regimen that had shown an efficacy rate of 62 Percent.
• AstraZeneca had said its vaccine had shown 90% efficacy in a small subset of volunteers — none older than 55 administered with a half dose followed by a full dose a month.

Emergency Use Authorisation (EUA)

• 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).
• The approval is granted after an assessment of their safety and effectiveness, based on data from trials. In fact, approval from the regulator is required at every stage of these trials.
• This is a long process, designed to ensure that medicine or vaccine is absolutely safe and effective.
• The fastest approval for any vaccine until now — the mumps vaccine in the 1960s — took about four-and-a-half years after it was developed.

Accelerated Approval Process in India

• Under this process, a new drug is approved based on data generated in clinical trials. The Rules provide a relaxation for skipping Phase III clinical trials, which crucially test for a vaccine or drug’s efficacy in preventing disease in the local population.
• Phase III trial is allowed to be skipped if ‘remarkable efficacy’ is observed with a defined dose in the Phase II clinical trial of the new drug.
• The regulator can then also grant market approval for the new drug or vaccine based on Phase II data to meet what the Rules call ‘unmet medical needs of serious and life threatening diseases in the country’.
• The Rules also state that in such cases, additional studies ‘may’ be required after approval to generate data on a larger population to verify its benefits.
• Unmet medical needs essentially means a situation where treatment or diagnosis of disease is not addressed adequately with the available therapy.
• Further, the Rules provide for relaxations for unapproved or imported drugs or vaccines. The regulator relies on clinical trial data generated abroad to approve the vaccines in such scenarios and additional non-clinical or clinical data may be required to back the claims.

Exceptions for emergency

• In emergency situations, like the current one, regulatory authorities around the world have developed mechanisms to grant interim approvals.
• However, there should 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, EUA allows the medicine or the vaccine to be used on the public.
• India’s drug regulations do not have provisions for a EUA, and the process for receiving one is not clearly defined or consistent.