DOH: COVID-19 vaccine manufacturers encouraged to apply for product registration

Metro Manila (CNN Philippines, May 9) — The Department of Health (DOH) clarified on Tuesday that COVID-19 vaccination efforts in the country will continue despite the World Health Organization's lifting of the Public Health Emergency of International Concern (PHEIC) status on the disease.

Health officer-in-charge Maria Rosario Vergeire said the country's own declaration of a Public Health Emergency, signed by former President Rodrigo Duterte in March 2020, is still in place.

However, if this will also be lifted soon, manufacturers of COVID-19 vaccines, including bivalent vaccines, are encouraged to start applying for their Certificate of Product Registration (CPR) with the Food and Drug Administration (FDA).

"(If the PHE is lifted in the country) mawawala na po 'yong authority ng FDA to issue out this EUA (Emergency Use Authorization). Kahit po 'yong mga donasyon na darating sa ating bansa kailangan with CPR na," Vergeire said.

[Translation: If the PHE is lifted in the country, the authority of the FDA to issue this EUA will be dismissed. Even vaccines that will be donated will need to have a CPR.]

"Ito lang ay kailangang pag-aralang maigi at siyempre ma-facilitate at magtulung-tulungan tayo so that we can do this once the public health emergency has been lifted in our country."

[Translation: This will need to be studied carefully and of course, be facilitated and we need to work together so we can do this once the public health emergency has been lifted in our country.]

Currently, the use of COVID-19 vaccines is under an EUA from the FDA, in line with the public health emergency as stated in Executive Order No. 121.

With a CPR from the FDA, vaccines may be available for purchase in the private market. Despite this, the national government may still subsidize a portion of the cost of vaccines if needed by the vulnerable sectors, according to Vergeire.

In response to the call of Sen. Chiz Escudero to lift the secrecy on funds spent on vaccine procurement, Vergeire explained that confidentiality was part of the deals with vaccine manufacturers when the vaccines were procured.

"These confidentiality agreements are part of the conditions of manufacturers once we enter into agreements with them," she said.

"Though syempre, kapag CPR na ito mababago ang landscape. Mababago na 'yong mga conditionalities dapat ng mga manufacturers since it is already registered and we can already pursue negotiation even without the confidentiality agreement," Vergeire added.

[Translation: Once they have a CPR, the landscape will change. Conditionalities with manufacturers will be different since it is already registered and we can already pursue negotiation even without the confidentiality agreement.]