What is Emergency Use Authorization (EUA) for vaccines and why it has been in controversy in India recently? Also show how different countries handle EUAs.

Introduction

 (Give context)

The world Nations race for vaccination, the need for urgent use of vaccine has raised the controversy of emergency use authorisation. Emergency use authorisation is an interim mechanism by which the vaccine is applied to the public to tackle the pandemic situation without complete trial and approval procedure.

Need for emergency use authorisation

• State provides the legal authority for the use of vaccine in India CSDO approves vaccines.
• In emergency situations regulatory authorities around the world have developed mechanism to grant interim approvals
• The time taken for final approval
• The Corona pandemic spread has been increasing
• To reduce the death rate ( 8 cr around the world ) and to protect the front running health warriors the emergency approval is needed
• State is the welfare state which needs to care for the health of the public
• Vaccine gives confidence and boost the economy to overcome the slowdown 

The controversy of emergency use authorisation in India 

• Efficacy of the vaccine can be proved only at the phase III of the research has raised questions approval in other Western Nations like UK US and Russia have let the Indian vaccine corporates to propel their interest to be a part of the competition of vaccine business
• Immunogenicity and clinical efficacy are to be tested, immunogenicity translate into clinical efficacy until then clinical efficacy cannot be shown
• The new drugs and clinical trials rules 2019 where accelerated approval is based on clinical trial data
• (Clinical trial data of covaxin is yet it to be accepted)
• Quote, The controversy of 2 biotech corporate giants (India),rushing to govt for approval and critizing each other’s efficacY
• The proponents of wax in approval clean the urgent situation and the vaccination authorisation in other countries as basis for authorisation in India

 Approval across countries

• New Drugs and Clinical Trials Rules, 2019, term this ‘accelerated approval’ Accelerated approval will be based on data from clinical trials where a surrogate endpoint(s) shall be considered rather than using standard outcome measures such as survival or disease progression, which are reasonably likely to predict clinical benefit, or a clinical endpoint.
• US FDA only gave approval to AstraZeneca to restart its trial in October. As the FDA requires the company to enrol 30,000 participants, it shall only consider their data once that threshold has been passed
• UK, while the Medicines and Healthcare products Regulatory Agency has been conducting a rolling review of vaccines—observing them from the development stage—it only considered Pfizer for approval to Pfizer BioNTech vaccine after submission of primary efficacy data 

Conclusion

Suggest

• Need for scientific approval not a bureaucratic procedure in approval of vaccine
• To avoid citizens from being vaccine hesitant