Go welcomes Duterte order that will speed up access to COVID-19 vaccines
MANILA, Philippines — Sen. Christopher “Bong” Go welcomed Executive Order 121, which President Rodrigo Duterte issued last Tuesday, Dec. 1, allowing the chief of the Food and Drug Administration (FDA) to issue an emergency use authorization (EUA) for COVID-19 vaccines once they become available.
“It’s very important to have a quick process so that the country can rise up again and we can return to normal the lives of our countrymen,” Go said in Filipino in a statement issued on Wednesday.
Go stressed, howeer, that studies should be done to ensure the safety and efficacy of COVID-19 vaccines before distribution and use.
According to Go, the president issued the order on the recommendation of Secretary Carlito Galvez Jr., chief implementor of the National Plan vs COVID-19, and the Sub Technical Working Group for Vaccine Development.
“Because of this EUA, the process [of making the vaccine available] will be speeded up. While we are making sure that the vaccine is safe and effective, it’s only right that we should act immediately and simply the steps because with every hour that passes it’s our countrymen’s lives that are at stake,” Go said.
Citing the Department of Health, Go said the EUA would allow market activities for any drug or vaccine that are still ineligible for product registration, subject to three condions:
• It’s reasonable to believe that the drugs or vaccine may be effective to prevent, diagnose or treat COVID-19.
• The potential benefits of the drugs or vaccine must outweigh the risks of the product.
• There’s no adequate, approved and available alternative to the drug or vaccine.
Moreover, G0 pointed out, the EUA would only be valid within the duration of the declared public health emergency due to COVID-19.
Go said any company or government agency may apply for a EUA. The application must show compliance with good manufacturing practices, with an undertaking by the manufacturer to complete the development of the drug and vaccine.
The FDA will then convene a panel of experts on drug and vaccine development to conduct a thorough review of available data on the safety and effectiveness of the drug or vaccine. Its findings will be the basis of the issuance of the EUA by the FDA head.
Go said the president’s order was in line with the COVID-19 National Vaccine Program that he had been pushing for 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,” he said. “We should have a plan under which everyone is treated equally — not only those who can afford it.”
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