DUTERTE ALLOWS FDA TO ISSUE EMERGENCY USE OF COVID-19 VACCINE
The Food and Drug Administration (FDA) has allowed by President Rodrigo Duterte to grant emergency use authorization (EUA) to expected COVID-19 vaccines that will be made available in the Philippines.
In an EO no. 121 signed Dec. 1 and made public Wednesday, Duterte authorized the FDA director-general to issue a EUA to COVID-19 drugs or vaccines.
The FDA director-general was also authorized by the President to “accept the regulatory decision of the [World Health Organization], [US Centers for Disease Control and Prevention], or other internationally recognized regulatory authorities.
With the FDA allowed to issue EUAs, the process of approving COVID-19 vaccines will be shortened from six months to 21 days.
The EO states, conditions for the issuance of EUA to COVID-19 drug or vaccine are the following:
Based on the totality of evidence available, including data from adequate and well-known controlled trials, 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
Health Secretary Francisco Duque III earlier said, asked the President to grant the FDA with EUA to “cut the red tape.”
Among the pharmaceutical firms who already applied for an EUA of their COVID-19 vaccines before U.S. health regulators are Pfizer and Moderna.
Meanwhile, COVID-19 vaccines of China’s Sinovac and Russia’s Gamaleya Research Institute have already secured EUA from their respective governments.