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FILE PHOTO: In this illustration taken on October 31, 2020, vials with a label that reads “COVID-19 / Coronavirus Vaccine / Injection Only” and a medical syringe are seen in front of the AstraZeneca logo displayed. REUTERS / Dado Ruvic
MANILA, Philippines – The recently signed tripartite agreement between the Philippine government, the private sector and the British pharmaceutical company AstraZeneca may be considered void if the drug manufacturer’s COVID-19 vaccine failed to achieve Food and Drug Administration (FDA) approval .
“That is possible (to be null) because it means there is a violation of the agreement,” said Health Secretary Francisco Duque III during the Always Ready public conference on Monday.
The Philippine government and private companies signed a supply agreement with AstraZeneca that involves at least two million doses of its vaccine last week.
The head of the National Working Group against COVID-19, Carlito Gálvez Jr., who is also the designated czar of the country’s vaccines, said that the private sector will bear the cost of the vaccines.
AstraZeneca is currently under fire for previously claiming that its vaccine was 90% effective and later admitting a mistake in the test data.
Dr. Jaime Montoya, executive director of the Council for Health Research and Development of the Department of Science and Technology (DOST), said that AstraZeneca has already signed a Data Confidentiality Agreement (CDA) that allows the country’s panel of vaccine experts to review the firm’s clinical trial documents. .
“Ang kailangan points to gawin dito is that we have to wait for the official publication of the data we have been talking about. For now, the panel of vaccine experts is basing their assessment on the documents AstraZeneca sent them, ”Montoya said.
“So let’s wait for the data to be evaluated,” he added.
AstraZeneca is one of five drug manufacturers that have applied to conduct Phase 3 clinical trials of its COVID-19 candidate vaccine in the Philippines.
The Chinese companies Sinovac Biotech and Clover Biopharmaceuticals are the first to pass the evaluation of the panel of vaccine experts. They are now seeking approval from the Single Joint Research Ethics Board and the FDA.
The other companies that have requested last-stage trials here are the Gamaleya Research Institute of Russia and Jannsen Pharmaceuticals of Belgium.
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