Food and Drug Administration evaluates China’s Sinovac COVID-19 vaccine pending its approval from the Ethics Review Board, the Department of Health said Monday.
“ON FDA evaluating Sinovac, that is an internal agreement between the Task Group composed of the FDA, DOST, and DOH. Sistema ito na kapag na-approve na ng VEP ang produkto, FDA can initially evaluate iyong mga dokumento para hindi makatagal [sa proseso], while we wait for the Ethics Board [approval],” Health Undersecretary Maria Rosario Vergeire.
Vaccine Experts Panel (VEP) under the Department of Science and Technology (DOST) reviews the Phase 1 and 2 clinical trials of a candidate vaccine. Meanwhile, the Ethics Board evaluates the selection of participants for human clinical trials.
Vergeire, however, noted that the FDA would disapprove of Sinovac if it could not secure approval from the Ethics Board.
“Hindi po magkakaroon ng FDA approval if the regulatory process is not complied with,” Vergeire added.
Last week, Health Secretary Francisco Duque III said regulators in the Philippines are validating reports accusing Chinese firm Sinovac of a “bribing history” to get fast approval of its vaccines.
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FDA evaluating China’s Sinovac COVID-19 vaccine
A Washington Post reported that Sinovac’s founder and chief executive Yin Weidong admitted in 2016 that the company bribed regulatory authorities in China for $83,000 from 2002 to 2011 to hasten their vaccines’ approval.
Washington Post also reported that at least 20 government officials and hospital administrators admitted they accepted bribes from the firm’s employees from 2008 and 2016 in their testimonies in court.
Meanwhile, Malacañang said the Philippines’ top choice for a COVID-19 vaccine is still China’s vaccine despite the firm’s “bribery history.”
“Consistent po tayo na papayagan lang nating magamit ang mga bakuna na napatunayan nang ligtas at mabisa laban sa COVID-19,” Palace Spokesperson Harry Roque told reporters.
“So pagdating po diyan sa mga allegations on bribery, tingin ko po ay hindi mangyayari iyan sa Pilipinas.”
Roque added the “target remains that Sinovac will be the first that we can use to vaccinate our people, and it will be in the first quarter of next year.”