Mamaland is the first-ever Virtual Mommy and Baby..
FDA Director General Eric Domingo announced that a home test kit for COVID-19 may soon be available in the country.
The Food and Drug Administration (FDA) said on Thursday, November 20, that test kits for coronavirus disease 2019 (COVID-19) which can be used at home for self-testing may soon be made available in the Philippines.
According to FDA Director General Eric Domingo, FDA could process and approve the use of COVID-19 home test kits when the manufacturer applies for the mandated registration.
The first self-test kit was first made available in the U.S. It was used after the US-FDA issued an emergency use authorization (EUA) for the Lucira COVID-19 all-in-one test kit, which was used at home for people aged 14 years old above who might be infected with COVID-19.
Domingo said that the products authorized with EUA are still mandated to register or apply in the country. It won’t also take long for the self-testing kit to be registered as it is neither vaccine nor drug.
As for the COVID-19 vaccine, Domingo said that all anti-COVID vaccines and drugs are considered “investigational” at the moment.
He adds that the FDA doesn’t have the power to grant EUA, but he mentioned that President Rodrigo Duterte will ask the Department of Health to give the agency the authority to issue the EUA.
Several pharmaceutical firms are expected to apply for EAU once it is available in order to distribute COVID-19 vaccines in the country.
Domingo said that many vaccine manufacturers may apply in the country once FDA is granted the authority to issue an EAU, but he stated that the FDA will make sure to evaluate the efficacy and safety of the vaccines or drugs before issuing EUA.