AstraZeneca vaccines need to get FDA approval, says Duque; supply agreement could still be discarded

Published November 30, 2020, 4:11 PM

by Vanne Elaine Terrazola

Health Secretary Francisco Duque III on Monday allayed concerns over the Philippine government’s tripartite agreement with the private sector on the use of the vaccines from British pharmaceutical firm AstraZeneca, saying this could still be discarded should the vaccine fail to get the approval of the Food and Drug Administration (FDA).

In this file photo taken on July 21, 2020 a general view is pictured of the offices of British-Swedish multinational pharmaceutical and biopharmaceutical company AstraZeneca PLC in Macclesfield, Cheshire. (Photo by Paul ELLIS / AFP / MANILA BULLETIN)

During Monday’s Laging Handa briefing, Duque maintained the vaccine supply deal recently signed by the national government, private firms and AstraZeneca is “just an agreement” and does not waive the requirements for the vaccine’s use in the country’s immunization against COVID-19.

He said the agreement, in fact, contained provisions that the AstraZeneca vaccines should undergo a “stringent evaluation [and] analysis” by the Philippines’ vaccine experts panel and the FDA, as any other candidate vaccines.

The UK-based has also been required to conduct Phase 3 clinical trials in the country, he said.

“So hindi sapat na nakapag-clinical trial sila Phase 3 sa ibang bansa kundi kailangan dito sa Pilipnas magsasagawa din po (it’s not enough that they conducted Phase 3 clinical trials abroad, they also need to conduct their trials in the Philippines),” Duque maintained.

“So huwag mag-alala, dahil yan ay agreement pa lang (the public should not worry, because it is just an agreement). Nakapaloob sa agreement na talagang susunod po sila lahat ng pamantayan, panuntunan ng DOH (The agreement provides that they should follow all the criteria and guidelines of the DOH),” he assured.

Asked if the government could void its agreement should the AstraZeneca vaccine fail he evaluation, Duque said: “Posible ‘yan, syempre, dahil may violation ng agreement (That’s possible, of course, because there would be a violation of the agreement).”

The Department of Health chief also assured: “Mahihirapan pong makalusot ‘yan kung mayroon pong makikita po sila na hindi magandang resulta at pwedeng makaapekto sa pagiging ligtas, dekalidad at epektibo ng bakuna (They will have a hard time being approved if results are poor, and the safety, quality, and efficacy of the vaccine is affected).”

He said the vaccine’s procurement will also be shouldered by the private sector, at “no cost to the government”.

AstraZeneca last week announced that its COVID-19 vaccine is 70 to 90 percent effective only to admit days later that it needs further study.

US scientists reportedly discovered by accident that the higher rate of effectiveness of the vaccine applies to those given half-doses during the clinical trials. A lower effectiveness rate was found in those who were administered full doses. The composite findings on effectiveness reportedly do not represent either of the doses.

Aside from AstraZeneca, other firms that have applied for government review and clinical trials in the Philippines were Gamaleya Research Institute from Russia, China’s Sinovac Biotech and Clover Biopharmaceuticals and Belgium’s Jannsen Pharmaceuticals, among others.