MANILA (UPDATE) — The Philippines has allowed emergency use of vaccines and drugs against COVID-19, 8 months into the crisis that has seen over 430,000 people infected and the economy dragged into recession due to prolonged quarantine restrictions.
President Rodrigo Duterte, in an executive order, has allowed the Food and Drug Administration to issue emergency use authorization for COVID-19 vaccines and drugs.
This means that coronavirus vaccines approved by the countries where they were developed can be used locally after 21 days, down from the current required 6-month verification, Presidential Spokesperson Harry Roque earlier said.
The authorization will be issued and remain valid “only when all of the following circumstances are present,” according to Duterte’s Executive Order No. 121.
- - Based on the totality of evidence available, including data from adequate and well-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.
The emergency use authorization “shall be valid only within the duration of the declared public health emergency due to COVID-19,” said Duterte.
Applications for emergency use should “demonstrate compliance with Good Marketing Practices, and accompanied by an undertaking by the manufacturer to complete the development of the drug and vaccine.”
Duterte authorized the FDA to “accept the regulatory decision” of the World Health Organization, US Centers for Disease Control and Prevention, or other internationally recognized and established authorities.
On Wednesday, Britain approved BioNTech-Pfizer's COVID-19 vaccine. China and Russia earlier allowed the emergency use of their own vaccines.