Duque urges Duterte to issue a COVID-19 vaccine emergency use EO

Health Secretary Francisco Duque III on Tuesday night urged President Rodrigo Duterte to issue an executive order for a Food and Drug Administration emergency use authorization on the COVID-19 vaccine.

In a briefing with Duterte, Duque said the issuance of the EO will cut processing time from six months to 21 days.

“We are respectfully requesting that you consider the issuance of the executive order for the FDA to grant an emergency use of authorization for the various vaccines that will enter the country and for which applications are to be filed para mabilis po ito,” Duque said.

“It will cut the processing time from 6 months to about 21 days so it will cut the red tape,” he added.

With an EUA, Duque said the country can use medicines, vaccines, and other health technologies through the process of reliance and recognition.

He said the EUA is a facilitated approval in the context of public health emergencies such as the COVID-19 pandemic.

“Ang reliance ay tumutukoy sa proseso ng pagtiwala ng ating FDA sa mga evaluations na ginawa sa national regular authority sa ibang bansa sa pagko-consider o pagdedesisyon nito ng mga application dito sa ating bayan,” Duque said.

“Ang recognition naman ay ang routine na acceptance ng FDA ng regulatory decision ng ibang national regulatory authorities or ibang mga trusted institutions,” he added.

Duque said the EUA may only be given if there is a medical health emergency, a serious or life-threatening disease, the product is proven effective to prevent, diagnose or treat the disease, there is a positive risk-benefit balance, and there is no adequate available alternative.

“Ang FDA ang mariin pong magsasagawa ng post-marketing surveillance activities at ang EUA ay maaaring i-revise o i-revoke ng FDA kung kinakailangan upang maprotektahan kalusugan,” he said. — DVM, GMA News