DOH to accept donated COVID-19 vaccines only if with EUA approval from FDA | ABS-CBN
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DOH to accept donated COVID-19 vaccines only if with EUA approval from FDA
DOH to accept donated COVID-19 vaccines only if with EUA approval from FDA
Kristine Sabillo,
ABS-CBN News
Published Jan 20, 2021 01:04 PM PHT
MANILA — The Department of Health (DOH) on Wednesday said it can only accept COVID-19 vaccine donations that successfully went through the Food and Drug Administration’s approval process.
MANILA — The Department of Health (DOH) on Wednesday said it can only accept COVID-19 vaccine donations that successfully went through the Food and Drug Administration’s approval process.
“Basta may EUA (Emergency Use Authorization), papayag kami,” Health Undersecretary Maria Rosario Vergeire said during a virtual briefing when asked what the DOH would do if legislators pressure them to accept vaccine donations.
“Basta may EUA (Emergency Use Authorization), papayag kami,” Health Undersecretary Maria Rosario Vergeire said during a virtual briefing when asked what the DOH would do if legislators pressure them to accept vaccine donations.
(As long as there is an EUA, we will accept.)
(As long as there is an EUA, we will accept.)
“It has to be registered. At iyan ay kasama sa kahit anong batas dito…na nangingibabaw pa rin yung batas natin na hindi natin ipagamit sa ating mga kababayan kung hindi rehistrado. O, di kaya, with this public health emergency, dapat may emergency use authority bago tayo tumanggap ng donasyon,” she added.
“It has to be registered. At iyan ay kasama sa kahit anong batas dito…na nangingibabaw pa rin yung batas natin na hindi natin ipagamit sa ating mga kababayan kung hindi rehistrado. O, di kaya, with this public health emergency, dapat may emergency use authority bago tayo tumanggap ng donasyon,” she added.
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(It has to be registered. And that’s in our law… that says Filipinos cannot be given unregistered vaccine. Or with this public health emergency, there should be emergency use authority before we accept a donation.)
(It has to be registered. And that’s in our law… that says Filipinos cannot be given unregistered vaccine. Or with this public health emergency, there should be emergency use authority before we accept a donation.)
Vergeire explained that both donations and procurement would require an EUA.
Vergeire explained that both donations and procurement would require an EUA.
Currently, only Pfizer, which has also been approved for emergency use by the World Health Organization, has secured an EUA in the Philippines.
Currently, only Pfizer, which has also been approved for emergency use by the World Health Organization, has secured an EUA in the Philippines.
China recently said it plans to donate 500,000 vaccine doses to the Philippines.
China recently said it plans to donate 500,000 vaccine doses to the Philippines.
The FDA has so far not granted an EUA to any of the China-made vaccine candidates, particularly those from Sinovac and Sinopharm.
The FDA has so far not granted an EUA to any of the China-made vaccine candidates, particularly those from Sinovac and Sinopharm.
Sinovac, which already has a 25 million supply deal with the Philippines, is still undergoing FDA evaluation.
Sinovac, which already has a 25 million supply deal with the Philippines, is still undergoing FDA evaluation.
The FDA previously said that they are still waiting for Sinovac’s Phase III interim results, which is the most important among the documents required since it would show the safety and efficacy rate of the vaccine on a larger trial group.
The FDA previously said that they are still waiting for Sinovac’s Phase III interim results, which is the most important among the documents required since it would show the safety and efficacy rate of the vaccine on a larger trial group.
The FDA also said that it won’t be pressured into approving the EUA application of Sinovac even with China's pledged donation.
The FDA also said that it won’t be pressured into approving the EUA application of Sinovac even with China's pledged donation.
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Read More:
COVID-19 vaccine
COVID-19 vaccine in the Philippines
Sinovac
vaccine donation
China donation
China vaccine
Department of Health
Food and Drug Administration
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