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What is the emergency use authorisation drug makers are seeking for the Covid-19 vaccine?

Topics Covered: Issues related to health.

What is the emergency use authorisation drug makers are seeking for the Covid-19 vaccine?


Context:

  • US drugmaker Moderna is applying for emergency use authorisation for its Covid-19 vaccine.
  • A few days earlier, Pfizer applied for emergency use authorisation for the vaccine it has developed in collaboration with BioNTech.
  • 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.

 Regular procedure for drug approval:

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).
  • For vaccines and medicines, approval is granted after an assessment of their safety and effectiveness, based on data from trials.

When can emergency use authorisation (EUA) be granted?

In the US, the Food and Drug Administration (FDA) grants EUA only after it has been determined that the “known and potential benefits outweigh the known and potential risks of the vaccine” (or medicine).

  • This means that a EUA application can be considered only after sufficient efficacy data from phase 3 trials had been generated.
  • A EUA cannot be granted solely on the basis of data from phase 1 or phase 2 trials.

What is the process of getting an emergency use authorisation in India?

  • Experts and activists say India’s drug regulations do not have provisions for a EUA, and the process for receiving one is not clearly defined or consistent.
  • Despite this, CDSCO has been granting emergency or restricted emergency approvals to Covid-19 drugs during this pandemic for remdesivir and favipiravir.

Is there a risk in using a product that has only been granted an EUA?

According to the US FDA, the public has to be informed that a product has only been granted an EUA and not full approval.

  • In the case of a Covid-19 vaccine, for example, people have to be informed about the known and potential benefits and risks, and the “extent to which such benefits or risks are unknown”, and that they have a right to refuse the vaccine.

Sources: Indian Express.