Duterte grants FDA authority to issue emergency use of COVID-19 vaccines

MANILA, Philippines — President Rodrigo Duterte has allowed the Food and Drug Administration (FDA) to grant emergency use authorization (EUA) to expected COVID-19 vaccines that will be made available in the Philippines.

In Executive Order No. 121 signed Dec. 1 and made public Wednesday, Duterte authorized the FDA director-general to issue a EUA to COVID-19 drugs or vaccines.

The President also authorized the FDA director-general to “accept the regulatory decision of the [World Health Organization], [US Centers for Disease Control and Prevention], or other internationally recognized regulatory authorities.

With the FDA allowed to issue EUAs, the process of approving COVID-19 vaccines will be shortened from six months to 21 days.

According to the EO, conditions for the issuance of EUA to COVID-19 drug or vaccine are the following:

• Based on the totality of evidence available, including data from adequate and well-known controlled trials, it is reasonable to believe that the drug or vaccine may be effective to prevent, diagnose or treat COVID-19;
• 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; and
• There is no adequate, approved and available alternative to the drug or vaccine for diagnosing, preventing or treating COVID-19

Earlier, Health Secretary Francisco Duque III asked the President to grant the FDA with EUA to “cut the red tape.”

Pfizer and Moderna are among the pharmaceutical firms who already applied for an EUA of their COVID-19 vaccines before U.S. health regulators.

Meanwhile, COVID-19 vaccines of China’s Sinovac and Russia’s Gamaleya Research Institute have already secured EUA from their respective governments.

JE