Duterte allows emergency use authorization for COVID-19 vaccines

President Rodrigo Duterte has signed an executive order allowing the country's Food and Drug Administration (FDA) to fast-track its approval of a COVID-19 vaccine, from the usual 6 months to as fast as 21 days.

Malacanang on Wednesday, December 2, released Executive Order No. 121 giving the FDA director-general the power to issue Emergency Use Authorization (EUA) for vaccines or treatments that experts will deem as safe and effective against the coronavirus.

The FDA must make sure these 3 conditions are met before issuing an EUA:

  • It is reasonable to believe that the drug or vaccine may be effective to prevent, diagnose, or treat COVID-19, based on the totality of evidence available
  • 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
  • There is no adequate, approved, and available alternative to the drug or vaccine for diagnosing, preventing, or treating COVID-19
What does this mean for Filipinos?

Now that the FDA has the power to grant EUAs for COVID-19 vaccines and drugs, it will be much quicker for them to give the go-signal for a vaccine to be distributed locally.

Only a vaccine with FDA approval can be purchased in the Philippines, or administered through a government vaccination program. The EUA means this approval can be issued as fast as 21 days after a government agency or company asks the FDA to evaluate a particular vaccine.

Faster approval means vaccination programs can begin at a sooner time. For those who want to purchase their vaccine and not wait for the government, it also means the vaccine will be commercially available sooner than without an EUA.

What's the process like?

To catalyze the process of issuing an EUA for a vaccine or drug, the concerned industry or government agency must submit an application to the FDA.

According to the EO, the government agency can pertain to the "national procurer or public health program implementer."

A panel of experts to be convened by the FDA will evaluate the vaccine or drug for its efficacy and safety. The experts panel is supposed to submit its recommendations to the FDA director general.

The EUA issued by the FDA will only be valid "within the duration of the declared public emergency due to COVID-19." The FDA director general, however, may "revisit or revoke" the EUA "to protect the general public health and safety."

The EO also gives the EUA holder the responsibility of tracking the effects of the drug or vaccine on the public after it is administered to portions of the population.

The FDA and the Department of Health are mandated to monitor these effects as well. – Rappler.com

Pia Ranada

Pia Ranada is a senior reporter for Rappler covering Philippine politics and environmental issues. For tips and story suggestions, email her at pia.ranada@rappler.com.

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