MANILA, Sept 9 (Mabuhay) — The Philippine Food and Drug Administration on Thursday said it expects COVID-19 vaccine manufacturers to start applying for certificates of product registration next year.
Vaccine makers developing inoculants for common diseases such as COVID-19 need to have at least a year’s worth of data on the efficacy of their jabs before they can apply for a certificate of product registration, FDA Director General Eric Domingo said in a virtual press conference.
“I think, by end of the year or early next year, marami sa mga vaccines na ginagamit ngayon (most of the vaccines we use now) would have enough data to apply for a certificate of product registration,” he said.
“Kapag marketing authorization… kailangan mas longer term yung mga clinical trial mo. Hindi na interim results,” he said.
“One year [worth of] data for the vaccine would be enough,” he added.
COVID-19 vaccines with approved product registrations from the FDA may begin selling their products to pharmacies and hospitals, while those with emergency use authorization may only transact with the government.
“More responsibility is also given to the manufacturer kasi siya na mismo nagga-guarantee sa product niya,” Domingo said.
Price of Pfizer COVID-19 shots may go up after US FDA ‘full approval’— official
So far, the FDA has granted emergency use authorization for 7 vaccine brands currently being used in the government’s COVID-19 inoculation program.
Last month, the US FDA granted full approval for Pfizer’s COVID-19 vaccine in a bid to encourage residents to get their jabs following increasing cases due to the highly transmissible Delta variant.
Domingo said Pfizer has yet to apply for a CPR in the Philippines.
“Mag-aapply muna sa sila sa European Union bago sa atin… ‘Yung complete approval [ng Pfizer sa Philippines], probably next year pa,” he said. (MNS)