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Senator Christopher Go with President Rodrigo Duterte
MANILA, Philippines – Senator Christopher “Bong” Go welcomed Executive Order 121, which President Rodrigo Duterte issued on Tuesday, December 1, allowing the head of the Food and Drug Administration (FDA) to issue an authorization for use. (USA) for COVID-19 Vaccines once they are available.
“It is very important to have a speedy process so that the country can get back up again and we can return the lives of our compatriots to normal,” Go said in Filipino in a statement issued Wednesday.
However, emphasize that studies must be conducted to ensure the safety and efficacy of COVID-19 vaccines prior to distribution and use.
According to Go, the president issued the order on the recommendation of Secretary Carlito Gálvez Jr., main executor of the National Plan against COVID-19, and of the Technical Working Subgroup for Vaccine Development.
“Because of this USA, the process [of making the vaccine available] it will accelerate. While we make sure that the vaccine is safe and effective, it is right that we act immediately and simply take the steps because with every hour that passes it is the lives of our compatriots that are at stake, ”said Go.
Citing the Health Department, Go said that the USA would allow market activities for any drug or vaccine that is not yet eligible for product registration, subject to three conditions:
• It is reasonable to believe that the medications or the vaccine can be effective in preventing, diagnosing, or treating COVID-19.
• The potential benefits of the drugs or vaccine must outweigh the risks of the product.
• There is no suitable, approved, and available alternative to the drug or vaccine.
Furthermore, G0 noted, the EUA would only be valid within the duration of the public health emergency declared by COVID-19.
Go said that any company or government agency can apply for an EUA. The application must demonstrate compliance with good manufacturing practices, with the manufacturer’s commitment to complete drug and vaccine development.
The FDA will then convene a panel of drug and vaccine development experts to conduct a comprehensive review of the available data on the safety and efficacy of the drug or vaccine. Their findings will be the basis for the US FDA’s issuance of the EUA.
Go said the president’s order was in line with the National COVID-19 Vaccine Program that he had been lobbying for to ease the vaccine supply chain and ensure the equitable and consistent provision of the vaccine once it becomes available.
“When the time comes when there is a COVID-19 vaccine and drug, we must be prepared to provide them to all Filipinos who need them, rich or not,” he said. “We should have a plan where everyone is treated equally, not just those who can afford it.”
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