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MANILA – The Health Department said Wednesday that an executive order granting emergency use powers to the Food and Drug Administration (FDA) is necessary to expedite the approval of COVID-19 vaccines entering the country.
The Undersecretary of Health Maria Rosario Vergeire during a virtual forum pointed out that the Republic Law 9711 or the FDA Law does not oblige the regulatory body to grant authority for the emergency use of products, even during a pandemic.
“So we are asking the president to give FDA authority to have it because of our laws, we can no longer provide it,” he said.
(This is why we asked the president to give the FDA authority because in our laws, we cannot provide for this.)
Vergeire said this a day after the Secretary of Health, Francisco Duque III, asked President Rodrigo Duterte for an executive order on the matter.
“We are respectfully requesting that you consider issuing an executive order for the FDA to grant an Emergency Use Authorization (EUA) for the various vaccines that will enter the country and for which applications will be submitted,” Duque told Duterte during a meeting. . On tuesday night.
Duque said the USA would “cut red tape” and processing time from 6 months to about 21 days.
He also explained that an EUA would allow the FDA to use the assessment of other national regulatory authorities when considering the application of vaccine developers.
Vergeire noted that the FDA needs a political basis for issuing an EUA, although the Bayanihan Act 2 already allows vaccines in development to enter the country.
While vaccines must regularly pass 4 phases of clinical trials, countries around the world now allow public use after Phase 3 due to the emergency situation brought on by the COVID-19 pandemic.
Vergeire also noted that Phase 4 trials, which look at the side effects of a vaccine in larger populations, will still be conducted, although acquisition is already allowed after Phase 3.
He noted that prior to the pandemic, the FDA regulatory process can last anywhere from 270 days to a year.
He said that even if the process is sped up to just 21 days, they have safeguards, such as pre-screening by a panel of experts.
The secretary of the vaccine czar, Carlito Gálvez, supported the DOH’s request for an EO. He said that of the 17 potential vaccines from other countries, 9 are already in Phase 3. Three of them could undergo clinical trials in December and January, he said.
Gálvez said that the private sector has already raised money to help purchase vaccines.
He asked Duterte to submit to an “Advance Market Pledge” for the purchase of vaccines through the World Bank and the Asian Development Bank as financial managers.
“At the same time, we also have to have various modes of financing, including the Public-Private Tripartite Agreement without the cost with the government. Then the private sector will finance it by buying directly from the vaccine company but with one year — with the regulation that it will be the DOH who will know, who will decide where the vaccine will be administered, ”said Gálvez.
– With a report by Joyce Balancio, ABS-CBN News
COVID-19, coronavirus, COVID-19 vaccine, Food and Drug Administration, Department of Health
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