Department of Health (DOH) chief Francisco Duque III urged President Rodrigo Duterte to release an executive order for COVID-19 vaccine emergency use through the Food and Drug Administration.
Duque told Duterte that the EO would shorten the 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 (EAU) 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.
Duque said the EUA would allow the country to use medicines, vaccines, and other health technologies through the process of reliance and recognition.
The EUA is a facilitated approval for public health emergencies like 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.
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EO for COVID-19 vaccine emergency use urged
“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.
The EUA could 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, Duque added.
“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.
Last week, Malacañang said that there is a good chance that the Philippines will use the vaccine developed by Pfizer and BioNTech in the United States to prevent coronavirus disease.
According to Presidential Spokesperson Harry Roque, it is possible to approve it immediately for “emergency use in the Philippines.”