MANILA, Philippines – Health Secretary Francisco Duque III on Tuesday said an agreement between the government and private sector with AstraZeneca may be voided should the pharmaceutical giant fail to pass the evaluation of the country’s regulatory bodies.
Under the agreement, AstraZeneca will provide the country 2.6 million doses of its vaccine for COVID-19. Sold at cost, the vaccine is worth $10 (P500) for two doses, with the bill to be footed by the private sector.
But before that, the British-Swedish pharmaceutical company would need to undergo “stringent evaluation and analysis” by the Philippine vaccine expert panel and Food and Drug Administration (FDA).
“Part of the agreement is that they would follow all of the Department of Health’s rules and standards because it is the government’s mandate to ensure that the vaccine to be used is safe, of quality, effective and practical to implement,” Duque said.
Should AstraZeneca fail to meet these standards, it’s “possible” for the agreement to be voided because, according to Duque, “there’s a violation of the agreement … There are obligations under the agreement and it is clear what each party’s mandates are.”
Meanwhile, the clinical trials for the COVID-19 vaccine being developed by Chinese firms Sinovac Biotech and Clover Pharmaceuticals can begin this month or early next year provided they can immediately reply to the questions posed by the country’s ethics review committee and the FDA.
“If they are able to answer quickly the questions of the ethics review board and the FDA, they will most likely be the first to be approved to conduct a clinical trial. If the plans are followed and there will be no problems along the way, it could start this December or early January,” Jaime Montoya of the Philippine Council for Health Research and Development said at an online briefing on Monday.