President Rodrigo Duterte talks on the phone with PDEA Director-General Wilkins Villanueva following his meeting with the Inter-Agency Task Force (IATF) on Emerging Infectious Diseases core members at the Malacañang Golf (Malago) Clubhouse in Malacañang Park, Manila on Oct. 14, 2020. Beside the President is Sen. Christopher “Bong” Go. ROBINSON NIÑAL/ PRESIDENTIAL PHOTO

President Rodrigo Duterte has authorized the Food and Drug Administration (FDA) to issue emergency use authorization (EUA) for Covid-19 drugs and vaccines to be used in the Philippines.

In Executive Order (EO) No. 121 signed on Dec. 1, Duterte directed FDA director general Rolando Enrique Domingo to issue an EUA for the upcoming vaccines.

Giving emergency use authorization would allow vaccines to be approved for use in the Philippines within 21 days instead of the six-month frame without the authorization.

Duterte said Domingo could only issue EUAs if the following conditions are met:

  • 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.

Duterte also ordered the FDA to form an expert panel on drug and vaccine development.

The panel will conduct a review of available data on the safety and effectiveness of Covid-19 vaccines applying for an EUA. It will then submit a report and recommendations on the application to the FDA director general.

In evaluating EUA applications, Duterte said the FDA may accept the regulatory decision of the World Health Organization, US Centers for Disease Control and Prevention or other internationally recognized and established regulatory authorities.

The president also ordered the FDA to submit a monthly report on the implementation of EO 121.

The Philippines aims to launch its national vaccination program in the first quarter of 2021. John Ezekiel J. Hirro