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Posted On: 12/03/2020 11:36:20 PM
Whole thing . Last helpful post for you *****
Metro Manila (CNN Philippines, December 2) — President Rodrigo Duterte on Wednesday signed an order granting the country's Food and Drug Administration the power to allow emergency use of COVID-19 vaccines and treatments.
Executive Order No. 121 allows FDA Director General Eric Domingo to issue Emergency Use Authorization (EUA) to drug and vaccine makers.
With the newly-signed order, a vaccine can be approved for use within one month instead of undergoing the usual six-month review period.
Dr. Jaime Montoya, executive director of the Philippine Council for Health Research and Development, explained that when submitting an application for EUA, a vaccine company may present data analysis on only at least half of the vaccine recipients included in its Phase 3 clinical trials, granted that there are at least two months of safety follow-up evaluation.
Clinical trials for a COVID-19 vaccine are done in three phases, with the last one involving larger populations in different countries to confirm its efficacy and safety.
“This can already be submitted to their FDA in their home country,” Montoya told CNN Philippines' News Night, referring to the interim results of the Phase 3 trials. “After which, if they are given approval on EUA, then it can now be submitted for EUA also in other countries that have this mechanism in place, like the Philippines.”
According to EO 121, an EUA for a COVID-19 drug or vaccine shall only be issued when all three circumstances are present:
• It is reasonable to believe that the drug or vaccine may be effective to prevent, diagnose or treat COVID-19;
• The known and potential benefits of the drug or vaccine when used to diagnose, prevent or treat COVID-19 outweigh the known and potential risks of the drug or vaccine if any; and
• There is no adequate, approved and available alternative to the drug or vaccine for diagnosing, preventing or treating COVID-19.
The filing of application for EUA issuance shall be done by the industry or government concerned, “such as the national procurer or the public health program implementer,” the EO read.
The safety and effectiveness of a COVID-19 drug or vaccine will then be reviewed by a panel of experts convened by the FDA, which shall also submit its report to Domingo.
An issued EUA will only be valid within the duration of the declared public health emergency due to COVID-19 and may be revoked or revisited by the FDA Director General.
Domingo previously assured the public that safety will not be compromised with the sped-up process. He said the FDA and Department of Health are already working on strengthening the government's vaccine monitoring efforts to easily spot possible adverse effects after inoculation.
The country's COVID-19 task force is looking to administer vaccines from different manufacturers to at least 70 million Filipinos. The vaccination program will be carried out for three to five years with 25-30 million Filipinos vaccinated each year.
Metro Manila (CNN Philippines, December 2) — President Rodrigo Duterte on Wednesday signed an order granting the country's Food and Drug Administration the power to allow emergency use of COVID-19 vaccines and treatments.
Executive Order No. 121 allows FDA Director General Eric Domingo to issue Emergency Use Authorization (EUA) to drug and vaccine makers.
With the newly-signed order, a vaccine can be approved for use within one month instead of undergoing the usual six-month review period.
Dr. Jaime Montoya, executive director of the Philippine Council for Health Research and Development, explained that when submitting an application for EUA, a vaccine company may present data analysis on only at least half of the vaccine recipients included in its Phase 3 clinical trials, granted that there are at least two months of safety follow-up evaluation.
Clinical trials for a COVID-19 vaccine are done in three phases, with the last one involving larger populations in different countries to confirm its efficacy and safety.
“This can already be submitted to their FDA in their home country,” Montoya told CNN Philippines' News Night, referring to the interim results of the Phase 3 trials. “After which, if they are given approval on EUA, then it can now be submitted for EUA also in other countries that have this mechanism in place, like the Philippines.”
According to EO 121, an EUA for a COVID-19 drug or vaccine shall only be issued when all three circumstances are present:
• It is reasonable to believe that the drug or vaccine may be effective to prevent, diagnose or treat COVID-19;
• The known and potential benefits of the drug or vaccine when used to diagnose, prevent or treat COVID-19 outweigh the known and potential risks of the drug or vaccine if any; and
• There is no adequate, approved and available alternative to the drug or vaccine for diagnosing, preventing or treating COVID-19.
The filing of application for EUA issuance shall be done by the industry or government concerned, “such as the national procurer or the public health program implementer,” the EO read.
The safety and effectiveness of a COVID-19 drug or vaccine will then be reviewed by a panel of experts convened by the FDA, which shall also submit its report to Domingo.
An issued EUA will only be valid within the duration of the declared public health emergency due to COVID-19 and may be revoked or revisited by the FDA Director General.
Domingo previously assured the public that safety will not be compromised with the sped-up process. He said the FDA and Department of Health are already working on strengthening the government's vaccine monitoring efforts to easily spot possible adverse effects after inoculation.
The country's COVID-19 task force is looking to administer vaccines from different manufacturers to at least 70 million Filipinos. The vaccination program will be carried out for three to five years with 25-30 million Filipinos vaccinated each year.
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