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Posted On: 12/03/2020 10:54:56 PM
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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.
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.
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