Deal’s off with AstraZeneca if vaccine fails to get FDA approval — DOH

FILE PHOTO: Vials with a sticker reading, “COVID-19 / Coronavirus vaccine / Injection only” and a medical syringe are seen in front of a displayed AstraZeneca logo in this illustration taken October 31, 2020. REUTERS/Dado Ruvic

MANILA, Philippines — The recently-signed tripartite agreement between the Philippine government, the private sector, and British pharmaceutical firm AstraZeneca may be deemed void if the drugmaker’s COVID-19 vaccine failed to secure approval from the Food and Drug Administration (FDA).

“Posible iyan (na ma-void) dahil ibig sabihin may violation ng agreement,” Health Secretary Francisco Duque III said during Monday’s Laging Handa Public Briefing.

The Philippine government and private companies signed a supply agreement with AstraZeneca involving at least two million doses of its vaccine last week.

National Task Force Against COVID-19 chief Carlito Galvez Jr., who is also the country’s designated vaccine czar, said the private sector would shoulder the cost of the vaccines.

AstraZeneca is currently under fire for previously claiming its vaccine was 90% effective and then admitted an error on the data for the tests.

Dr. Jaime Montoya, executive director of the Department of Science and Technology’s (DOST) Council for Health Research and Development, said AstraZeneca has already signed a Confidentiality Data Agreement (CDA) which allows the country’s vaccine experts panel to review the firm’s clinical trials documents.

“Ang kailangan po nating gawin dito is we have to wait for the official publication of the data that we have been talking about. For now, ang vaccine experts panel are basing their evaluation on the documents submitted to them by AstraZeneca,” Montoya said.

“So let us wait for the evaluation of the data,” he added.

AstraZeneca is one of the five drugmakers that have applied to conduct Phase 3 of clinical trials of their candidate COVID-19 vaccine in the Philippines.

Chinese firms Sinovac Biotech and Clover Biopharmaceuticals are the first ones to pass the evaluation of the vaccine experts panel. They are now seeking the approval of the Single Joint Research Ethics Board as well as the FDA.

The other firms that applied to conduct late-stage trials here are the Gamaleya Research Institute from Russia and Jannsen Pharmaceuticals from Belgium.

EDV