DOH, FDA welcome EO on emergency use authorization

 Press Release | 03 December 2020

 

The Department of Health (DOH) welcomed the issuance of Executive Order (EO) No. 121 signed yesterday by President Rodrigo Roa-Duterte which grants the Food and Drug Administration (FDA) the authority to issue Emergency Use Authorization (EUA) for COVID-19 treatment drugs and vaccines that are still under development. Health Secretary Francisco T. Duque III likewise lauded the Palace for the urgent issuance of the EO.

 

Ngayong unti-unti na nating binubuksan ang ekonomiya, kailangan natin ng agarang aksyon para ma-prevent ang pagkakaroon ng COVID-19 o tuluyan nang wakasan ito. At kailangan din na masiguro na ang ating ibibigay na gamot o bakuna sa sambayanang Pilipino ay safe at effective. The passage of EUA is critical in our fight against COVID-19,” Sec. Duque said. “So we thank the President for heeding our call to grant FDA the authority to issue EUA.”

 

In the special media forum held by DOH, FDA Director General Rolando Enrique Domingo provided an overview on how the EUA issuance will be implemented.

 

DG Domingo identified the industry and the national government through the national procurer or the public health program implementer as eligible applicants for the EUA. He further explained that EUA will only be granted if the evidence or data on controlled trials show that the benefits of the said vaccine or treatment outweigh the risks it poses.

 

Ang EUA ay isang risk-based na paraan ng pag-eevaluate kung ano ang mga bakuna na sa ngayon ay hindi pa lisensyando ang pwede nating gamitin sa panahon ng pandemya. Sinusuri natin yung mga posible na mga risk sa paggamit ng bakuna laban sa inaaasahan naman nating benefits upang masigurado natin ang kalidad nito at ang kaligtasan ng gagamit nito,” DG Domingo said.

 

The FDA also identified reliance or recognition pathways that aid in the granting of EUA—if the drug or the vaccine has an EUA from the country of origin, if an FDA counterpart in other countries with the same stringent measures have granted EUA, or if it has been pre-approved by the World Health Organization Prequalification Committee. The applicant must also guarantee the government that it will complete the vaccine or drug development process until they reach full application and licensing.

 

Furthermore, the FDA and the DOH Epidemiology Bureau are setting up a post-authorization monitoring mechanism that will monitor the roll-out of vaccines and escalate if there are reported incidences of adverse effects from the use of the treatment or vaccines.

 

When asked how the government will respond to those who are against the vaccination program, DG Domingo said that there will be a full disclosure of the risks and benefits of the vaccine to ensure that the potential recipient will have an informed-choice. Furthermore, the DOH will conduct information, education, and communications campaigns regarding the vaccines or drugs that will be granted EUAs.

 

DG Domingo said that FDA will issue the implementing guidelines for EUA next week.