MANILA — China-backed pharmaceutical company Sinovac’s COVID-19 vaccine cannot be used for inoculation in the Philippines without an emergency use authority (EUA), even if it arrives next month, a senator said Friday.
Sinovac’s vaccine, described by some lawmakers as "more expensive" and with supposedly lower efficacy, will also need to undergo a screening process from the Health Technology Assessment Council (HTAC) despite the approval from the Food and Drug Administration (FDA), according to Sen. Nancy Binay.
“Actually, puwede pa naman siya dumating ng Feb. 20 pero hindi natin magagamit kasi there’s no guarantee na na-release na yung EUA from the FDA,” Binay explained in an interview on ABS-CBN’s Teleradyo.
(The vaccine can still arrive on Feb. 20 but we can’t use it unless it will be issued EUA by the FDA before the date, which has no guarantee.)
An EUA will allow a vaccine to be imported, distributed and administered in the country through a national immunization program.
“Ang magiging problema natin, after siya ma-approve ng FDA, dadaan pa siya sa isang committee, ‘yong HTAC, ‘yun yung magsasabi kung worth it ba na i-procure ng government ang bakuna na ito,” she said.
(It will also be screened by the HTAC, the committee which decides whether the vaccine is worth to be bought, even if it is approved by the FDA.)
The senator also aired her frustration on the possibility of “wasting” money for the shots should the HTAC turn down Sinovac's vaccine.
Its approval could also take longer, she said, and the process for EUA could not be fast-tracked.
“Hindi puwede yung treatment with Pfizer is similar with Sinovac . . . Hindi ganoon ang magiging proseso, puwede siya matagalan,” Binay said.
(We cannot treat Sinovac like Pfizer, the process will be different. It can be delayed.)
Carlito Galvez Jr., Chief Implementer of the National Task Force COVID-19, earlier said that the country would authorize emergency use for the China-made vaccine before Feb. 20, amid mounting criticism.
But FDA Director General Eric Domingo said in a virtual briefing on Thursday that the documents submitted by the company for EUA application were incomplete, as they only included Phase I and Phase II clinical trial data.
Domingo pointed out that Phase III trial results are crucial in deciding whether the vaccine’s benefits outweigh its risks, as required by the EUA.
“Paano uumpisahan ng FDA ‘yung pag-aaral doon sa bakuna kung wala pa silang submission?” said Binay.
(How could the FDA study it without the submission?)
Sen. Sonny Angara had said the vaccine cost around P3,600 per 2 jabs. But administration officials allayed the public's concern about it, saying that Sinovac’s vaccine was offered to the Philippines at a lower price.