Lift state of calamity, risk losing EUA validity—DOH

By Kathleen de Villa@kdevillaINQ

June 4, 2022 12:00:00

The country will risk losing the validity of the emergency use authorization (EUA) granted to vaccines and medications used to prevent and treat COVID-19 once the state of calamity status is lifted, according to a health official.

Health Undersecretary Maria Rosario Vergeire said the lifting of the state of calamity in the country was discussed by members of the the Inter-Agency Task Force for the Management of Emerging Infectious Diseases, but Department of Health (DOH) representatives raised the "operational implications" of such move.

"There is an implication when the state of calamity is lifted. The best example would be the emergency use authority of our vaccines. When the state of calamity is lifted, the EUA won't work already," Vergeire told reporters in an online briefing.

She pointed out that in a "nonemergency phase," people can only get COVID-19 jabs from vaccine manufacturers issued with certificate of product registration (CPR) by the local Food and Drug Authority. But for the companies to be eligible for CPR application, they would have to complete their Phase 4 clinical trials of their products.

All COVID-19 vaccines from the stockpile of the government and private sector are under emergency use because they underwent scrutiny only up to the third phase of clinical trials, Vergeire said.

"As of the moment, there has been no application from manufacturers for CPR [for COVID-19 vaccines] in the country," the health spokesperson said.

Presidential Adviser for Entrepreneurship Joey Concepcion had suggested lifting the public health emergency to resume more economic and social activities and promote productivity and confidence among the population. INQ