The Food and Drug Administration (FDA) – Philippines has approved Pfizer-BioNTech’s coronavirus vaccine and this is the first vaccine that was given Emergency Use Authorization (EUA) in the country.
“Today, the Food and Drug Administration (FDA) grants its first Emergency Use Authorization (EUA) to Pfizer-BioNTech COVID19 Vaccine (BNT162b2) Suspension for IM Injection (Puurs, Belgium Site).”
Here’s a statement of Director-General Eric Domingo stated on the FDA website”:
“After a thorough review of the currently available data by medical and regulatory experts, the FDA is granting Emergency Use Authorization to Pfizer-BioNTech COVID-19 vaccine.
Furthermore, Domingo mentioned that “the interim data from the ongoing phase 3 trial shows that the vaccine has an efficacy of 95% in the study population and at least 92% among all racial groups.”
As more than 5 million people worldwide who used the vaccine has identified severe allergic reaction in a few individuals”Vaccinations must be done by health professionals trained to recognize and manage adverse reactions and they should have resources at hand to adequately respond” as the rollout of the vaccine and use in according to Domingo.
Severe allergic reaction in a few individuals who used the vaccine has been identified according to Domingo “vaccinations must be done by health professionals trained to recognize and manage adverse reactions and they should have resources at hand to adequately respond.”
Also, it was reported on the FDA website that the patient’s response to the vaccine will be reported through the pharmacovigilance system.
The said system will be activated once the vaccination program is implemented.
Executive Order No. 121, Series of 2020
In EO No. 121, as stated by FDA, vaccines under development can be granted a EUA where there is no adequate, approved, and available alternative to a vaccine for preventing coronavirus during this present public health emergency.
Note: The granting of the EUA is not a marketing authorization or a Certificate of Product Registration, hence this cannot be used to market the vaccine commercially.
Read the full statement of FDA, HERE.
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