Senator Bong Go lauded President Rodrigo Duterte for issuing Executive Order 121 granting authority to the Director General of the Food and Drug Administration to issue Emergency Use Authorization (EUA) for the coronavirus disease (COVID-19) drugs and vaccines once they are available.
“Maraming salamat sa ating Pangulo sa pag-issue ng EO na naglalayong mapapabilis ang proseso ng authorization para sa COVID-19 vaccine at mga kaakibat na mga medisinang kailangan,” Go said.
The EO will help the government continue managing and addressing the impact of the pandemic by ensuring the accessibility and immediate availability of COVID-19 drugs and vaccines in the market.
“Napaka-importante po na mabilisan ang proseso upang makabangon muli ang bansa at makabalik na sa normal na pamumuhay ang ating mga kababayan,” the legislator added.
“The necessary studies must be conducted to ensure the safety and efficacy of COVID-19 vaccines prior to use and distribution.”
The lawmaker, however, emphasized that the necessary studies must be conducted to ensure the safety and efficacy of COVID-19 vaccines prior to use and distribution. Once available, the senator reiterated President Duterte’s desire to prioritize poor and vulnerable sectors.
“Dapat siguraduhin ang safety at efficacy ng mga COVID-19 vaccines at dapat gawin itong accessible at available sa lahat matapos dumaan sa masusing proseso,” he said.
“No Filipino must be left behind.”
“Tulad ng sabi ng Pangulo, no Filipino must be left behind. Huwag natin pabayaan ang mga Pilipinong pinaka-nangangailangan. Dapat maibigay ito ng libre sa mga mahihirap at vulnerable sectors at gawing prayoridad sila kasama na ang mga frontliners, tulad ng medical workers, uniformed personnel at pati mga guro,” Go added.
With the COVID-19 situation and the recent reports that the vaccines for the disease are in the latter stages of development, the Sub Technical Working Group for Vaccine Development and the National Task Force against COVID-19, led by Chief Implementer and Vaccine Czar, Secretary Carlito Galvez, Jr., have recommended that an EO must be issued for such authorization.
“Dahil sa EUA na ito, mapapabilis ang proseso. Habang sinisiguro natin na ligtas at epektibo ang vaccine, dapat lang na kumilos tayo agad at pasimplehin ang mga hakbang dahil bawat oras ay buhay ng kapwa nating Pilipino ang nakasalalay dito,” he explained.
According to the Department of Health, the EUA will allow market activities for any drug or vaccine that are still ineligible for product registration as they are still under clinical trials.
Additionally, the EUA is useful in emergency situations where no registered product for prevention, diagnosis and treatment of a novel disease or condition exists.
It is also noted that no unregistered COVID-19 drug and vaccine may be manufactured or marketed without an EUA.
The conditions set for the issuance of EUA are based on three guidelines. First, it is reasonable to believe that the drugs or vaccine may be effective to prevent, diagnose or treat COVID-19. Second, the potential benefits of the drugs or vaccine must outweigh the risks of the product. Lastly, there is no adequate, approved and available alternative to the subject drug or vaccine.
Moreover, the EUA is only valid within the duration of the declared public health emergency due to COVID-19.
An industry or government agency concerned, such as the national procurer or the public health program implementer, may submit an application for the issuance of an EUA. The application must show compliance with the present Good Manufacturing Practices, with an undertaking by the manufacturer to complete the development of the drug and vaccine.
A panel of experts on drug and vaccine development shall be convened by the FDA. The panel shall conduct a thorough review of available data on the safety and effectiveness of the drug and vaccine. Its findings shall be the basis of the issuance of the EUA by the FDA head.
The EO is also in line with the COVID-19 National Vaccine Program that Go has been pushing to facilitate the vaccine supply chain and ensure the equitable and systematic provision of the vaccine once it is available.
“When the time comes that there is a vaccine and medicine against COVID-19, we must be ready to provide these to all Filipinos who are in need whether they are rich or not. Dapat magkaroon tayo ng plano kung saan pantay-pantay at hindi lang ang mga may kaya sa buhay ang makakuha,” Go emphasized.
“Huwag nating pabayaan ang mga ordinaryong Pilipino na kailangan na makabalik sa normal na pamumuhay upang maibangon mula sa kahirapan ang kanilang pamilya,” he concluded.