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What must regulating bodies, such as the Food and Drug Administration (FDA), look out for when approving a vaccine for Emergency Use Authorization (EUA) vs. approving a vaccine for general use?

This article was published on
April 21, 2021

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Regulatory agencies in multiple countries began granting approvals for emergency use of COVID-19 vaccine candidates in late 2020. The standards can vary from place to place but are typically rigorous, with a focus on evidence for safety and efficacy from large-scale clinical trials. Notable exceptions include China and Russia, which provided early approvals of vaccine candidates before large-scale clinical trials were completed and began widespread vaccinations of people outside of trials months earlier than most other countries. The process for emergency use authorizations can vary widely. For example, some regulatory agencies need to consider not only their country’s policies, but also regional agreements between countries like in the European Union. A few regulatory agencies, such as the U.S. FDA, also do their own careful analysis of the raw data, as opposed to relying on the findings provided from the vaccine manufacturers like the U.K. regulatory agency.  Several health experts have now raised the importance of approving the COVID-19 vaccines for general use, not just emergency use. A major concern is that COVID-19 vaccines may still be needed after the emergency nature of the current pandemic has finally subsided, in order to continue to protect people against COVID-19 in the future. As regulatory licensing for general use can take time and require even higher standards of evidence (ex. often the completion of phase 3 clinical trials), experts are urging regulatory agencies to continue these processes in order to be prepared for health needs after the pandemic. Otherwise, there is a risk of a gap in being able to vaccinate people against COVID-19 once the immediate emergency is over, if only emergency use authorizations have been granted.

Regulatory agencies in multiple countries began granting approvals for emergency use of COVID-19 vaccine candidates in late 2020. The standards can vary from place to place but are typically rigorous, with a focus on evidence for safety and efficacy from large-scale clinical trials. Notable exceptions include China and Russia, which provided early approvals of vaccine candidates before large-scale clinical trials were completed and began widespread vaccinations of people outside of trials months earlier than most other countries. The process for emergency use authorizations can vary widely. For example, some regulatory agencies need to consider not only their country’s policies, but also regional agreements between countries like in the European Union. A few regulatory agencies, such as the U.S. FDA, also do their own careful analysis of the raw data, as opposed to relying on the findings provided from the vaccine manufacturers like the U.K. regulatory agency.  Several health experts have now raised the importance of approving the COVID-19 vaccines for general use, not just emergency use. A major concern is that COVID-19 vaccines may still be needed after the emergency nature of the current pandemic has finally subsided, in order to continue to protect people against COVID-19 in the future. As regulatory licensing for general use can take time and require even higher standards of evidence (ex. often the completion of phase 3 clinical trials), experts are urging regulatory agencies to continue these processes in order to be prepared for health needs after the pandemic. Otherwise, there is a risk of a gap in being able to vaccinate people against COVID-19 once the immediate emergency is over, if only emergency use authorizations have been granted.

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What our experts say

Regulatory agencies in multiple countries began granting approvals for emergency use of COVID-19 vaccine candidates in late 2020. The standards can vary from place to place but are typically rigorous, with a focus on evidence for safety and efficacy from large-scale clinical trials. Notable exceptions include China and Russia, which provided early approvals of vaccine candidates before large-scale clinical trials were completed and began widespread vaccinations of people outside of trials months earlier than most other countries.

The process for emergency use authorizations can vary widely. For example, some regulatory agencies need to consider not only their country’s policies, but also regional agreements between countries like in the European Union. A few regulatory agencies, such as the U.S. FDA, also do their own careful analysis of the raw data, as opposed to relying on the findings provided from the vaccine manufacturers like the U.K. regulatory agency. 

Several health experts have now raised the importance of approving the COVID-19 vaccines for general use, not just emergency use. A major concern is that COVID-19 vaccines may still be needed after the emergency nature of the current pandemic has finally subsided, in order to continue to protect people against COVID-19 in the future. As regulatory licensing for general use can take time and require even higher standards of evidence (ex. often the completion of phase 3 clinical trials), experts are urging regulatory agencies to continue these processes in order to be prepared for health needs after the pandemic. Otherwise, there is a risk of a gap in being able to vaccinate people against COVID-19 once the immediate emergency is over, if only emergency use authorizations have been granted.

Context and background

Vaccinations are a critical tool for addressing the current global COVID-19 pandemic, but vaccine development and testing is only a part of the picture. Vaccines also need to be approved, purchased, and distributed - and monitoring needs to continue while vaccines are being rolled out to better understand the safety and efficacy of the vaccines in the general population outside of clinical trials.

As of January 2021, COVID-19 vaccine candidates have mostly been granted emergency use authorizations, rather than general use authorizations. Some countries that have been able to authorize emergency use of the vaccines and have had the funding to purchase vaccines are now distributing and monitoring vaccines in their populations.

Unfortunately, there have been inequities in which countries have had the resources to begin vaccinating their populations. Global pledges, commitments and initiatives, including by vaccine manufacturers and members of the World Health Organization COVID-19 Technology Access Pool (C-TAP), have attempted to address some of these inequities but have not resolved them.

Resources

  1. FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine (U.S. FDA)
  2. Emergency Use Authorization for Vaccines Explained (U.S. FDA)
  3. What Is Emergency Use Authorization? (John Hopkins University)
  4. The granting of emergency use designation to COVID-19 candidate 4. vaccines: implications for COVID-19 vaccine trials (The Lancet)
  5. Drug-Company CEOs Sign Pledge on Covid-19 Vaccine (Wall Street Journal)
  6. COVID-19 technology access pool (WHO)

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