FDA eyes use of home test kit for COVID-19

MANILA, Philippines — The test kit for coronavirus disease 2019 that can be used at home may 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-testing kit for COVID-19 when its manufacturer applies for the required registration.

The first self-test kit for COVID is available in the US.

The US-FDA issued an emergency use authorization (EUA) for the Lucira COVID-19 all-in-one test kit.

It has been authorized by the US-FDA for home use with self-collected nasal swab samples for people aged 14 years old and above who are suspected to be infected with the novel coronavirus.

Domingo said it won’t take long to register the self-testing kit since this is neither drug nor vaccine.

He said products given EUA are still required to register or apply in the Philippines.

At this time, the FDA has no power to grant EUA, but Domingo expressed optimism that President Duterte will ask the Department of Health to grant the agency such authority.

If given the power, the FDA can issue EUA for the use of COVID vaccines thatstill “under development” or undergoing Phase 3 clinical trial.

There are five COVID vaccine manufacturers that applied for the conduct of clinical trials in the country, Domingo said.

He said all anti-COVID drugs and vaccines worldwide are considered “investigational” at this time.

Vaccine manufacturers must be able to prove its safety and efficacy before the FDA can grant EUA or approve its use in the country.

Many pharmaceutical companies are expected to apply for EAU once it becomes available to be able to distribute vaccines against coronavirus disease in the country.

Domingo said vaccine manufacturers given EAU in other countries are likely to secure similar authorization from the Philippines.

“Once we are given the authority to issue EAU, vaccine manufacturers will likely apply, particularly those that got EUA in other countries,” Domingo said.

But Domingo said FDA will first evaluate the safety and efficacy of the products before issuing EUA.

Domingo said the FDA would rather look at different vaccines because pharmaceutical companies are unlikely to be able to produce sufficient global supply.

“To be able to provide vaccine to all Filipinos, we should look at different vaccines,” he said.