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Emergency Use Authorisation (EUA)

Emergency Use Authorisation (EUA)

Context:

The US drug-maker Moderna mentioned that it was applying for emergency use authorization for its Covid-19 vaccine. The decision was taken after Pfizer applied for emergency use authorization for the vaccine it has developed in collaboration with BioNTech.

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. 
  • The approval for vaccines and medicines is granted after an assessment of their safety and effectiveness, based on data from trials.
  • In emergency situations, 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. 
  • The final approval is granted only after completion of the trials and analysis of full data and until then, emergency use authorization (EUA) allows the medicine or the vaccine to be used on the public.

Granting of Emergency Use Authorisation (EUA):

  • In the US, the Food and Drug Administration (FDA) grants a EUA only after it has been determined that the “known and potential benefits outweigh the known and potential risks of the vaccine”.
  • It implies that a EUA application can be considered only after sufficient efficacy data from phase 3 trials had been generated.
  • The EUA cannot be granted solely on the basis of data from phase 1 or phase 2 trials, although these too need to show the product is safe.
  • The FDA, for COVID vaccines, has specified that it would consider an application for EUA only if phase 3 data showed it was at least 50 % effective in preventing the disease.

Emergency Use Authorisation (EUA) in India:

  • In India, the regulatory authority is the Central Drugs Standard Control Organisation (CDSCO).
  • India’s drug regulations do not have provisions for a EUA, and the process for receiving one is not clearly defined or consistent.
  • The CDSCO has been granting emergency or restricted emergency approvals to Covid-19 drugs such as remdesivir, favipiravir, and tocilizumab.

Source: Indian Express