Just before 2020 ended, President Rodrigo Duterte granted the country's Food and Drug Administration the power to to authorize the emergency use of COVID-19 vaccines and drugs as the Philippines moves to end the pandemic.
Since then, the term "emergency use authorization" has frequently appeared in news reports as Filipinos wait for vaccine supplies. But what exactly does it mean, particularly, in the context of the ongoing pandemic?
According to the FDA, emergency use authorization or EUA is a process of reviewing vaccines that are still unlicensed or under development so that these can be used during public health emergencies of international concern.
This means that experts assess the vaccines based on an "essential set of available quality, safety, and efficacy performance data."
Why does it matter? It's because granting EUA to a vaccine would expedite its availability to the people who need it the most. In the case of the COVID-19 pandemic, the Philippine government is rushing to make vaccines available to the most vulnerable to the virus: medical frontliners, and the elderly.
Authorizing the emergency use of vaccines and drugs that are still under development is not unique to the Philippines with other countries, such as the United States, Australia, and China, practicing the same process.
In considering a vaccine or drug for emergency use, the FDA said the following factors are considered:
- The disease may cause an outbreak, epidemic or pandemic
- No products available capable of eradicating or preventing the disease
- Products are manufactured in compliance with Good Manufacturing Practices
- The applicant undertakes to complete the development of the product and apply for prequalification once it is licensed
For the COVID-19 vaccines, President Duterte said an EUA would only remain valid when the following circumstances are present:
- If it is reasonable to believe that the drug or vaccine may be effective to prevent, diagnose, or treat COVID-19 based on the available evidence including data from clinical trials.
- The known and potential benefits of the drug or vaccine when used to diagnose, prevent or treat COVID-19 outweigh the known and potential risks of the drug or vaccine if any
- There is no adequate, approved, and available alternative to the drug of vaccine for diagnosing, preventing or treating COVID-19.
Once vaccines that have been issued EUAs acquire full market authorization or a certificate of product registration, the country's FDA director-general would withdraw the EUA.
A post-authorization monitoring will follow, according to the FDA, to track any adverse event following immunization, product deployment and the status from the manufacturer concerning the product.
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