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FDA Observes Use of COVID-19 Home Test Kit
Mayen Jaymalin (The Philippine Star) – November 20, 2020 – 12:00 am
MANILA, Philippines – The 2019 coronavirus disease test kit that can be used at home will soon be available in the country, the Food and Drug Administration (FDA) said yesterday.
FDA Director General Eric Domingo said the agency could easily process and approve the use of a self-assessment kit for COVID-19 when its manufacturer requests the required registration.
The first self-assessment kit for COVID is available in the US.
The US FDA has issued an Emergency Use Authorization (EUA) for the Lucira COVID-19 All-in-One Test Kit.
It has been cleared by the US FDA for home use with nasal swab samples collected by themselves for persons 14 years of age and older who are suspected of being infected with the novel coronavirus.
Domingo said it won’t take long to register the self-assessment kit, as it is not a drug or a vaccine.
He said products receiving the US have yet to register or order in the Philippines.
At this time, the FDA does not have the power to grant the US, but Domingo expressed optimism that President Duterte will ask the Department of Health to grant the agency such authority.
If empowered, the FDA can issue USA for the use of COVID vaccines that are still “in development” or in clinical trial phase 3.
There are five COVID vaccine manufacturers that have requested clinical trials in the country, Domingo said.
He said that all COVID drugs and vaccines around the world are considered “investigational” at this time.
Vaccine manufacturers must be able to demonstrate their safety and efficacy before the FDA can grant USA or approve their use in the country.
Many pharmaceutical companies are expected to apply for UAE once it becomes available so that they can distribute coronavirus disease vaccines in the country.
Domingo said vaccine manufacturers receiving UAE in other countries are likely to get similar clearance from the Philippines.
“Once we are granted the authority to issue UAE, it is likely that vaccine manufacturers will ask for it, particularly those that obtained USA in other countries,” Domingo said.
But Domingo said the FDA will first evaluate the safety and efficacy of the products before issuing the US.
Domingo said the FDA would prefer to consider different vaccines because pharmaceutical companies are unlikely to be able to produce enough global supply.
“In order to provide vaccines to all Filipinos, we have to consider different vaccines,” he said.
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