President Rodrigo Duterte has signed Executive Order (EO) No. 121 authorizing the Food and Drug Administration (FDA) to issue emergency use authorization (EUA) to coronavirus disease 2019 (Covid-19) vaccines that will be used in the Philippines.
“For this purpose, the FDA director-general may accept the regulatory decision of the WHO (World Health Organization), US-CDC (United States-Centers for Disease Control and Prevention), or other internationally recognized regulatory authorities,” Duterte said in the EO.
This means that any Covid-19 vaccine to be used in the Philippines can be approved in one month or less compared to the usual six months by the FDA and other concerned regulatory bodies.
Earlier, Vaccine czar Carlito Galvez Jr. said the government was seeking a faster process for the local approval of candidate Covid-19 vaccines, from the current six months to 21 to 30 days.
“Based on our report and recommendation to the President (Rodrigo Duterte), we can use the emergency utilization authority which will be given by the President, authorization by the President through an EO (executive order),” Galvez said in a virtual forum.Galvez said, however, that the process in the approval of the candidate vaccine will not be changed even if bureaucratic delays will be removed. SOVEREIGNPH