Philippines eyes Sinovac trial as early as November — FDA
FILE PHOTO: A worker performs a quality check in the packaging facility of Chinese vaccine maker Sinovac Biotech, developing an experimental coronavirus disease (COVID-19) vaccine, during a government-organized media tour in Beijing, China, September 24, 2020. REUTERS/Thomas Peter/File Photo
MANILA, Philippines — Sinovac Biotech may start late-stage trials of its coronavirus vaccine in the Philippines as early as next month, the food and drugs agency chief said on Thursday, after it hurdled the initial stage of the country’s screening process.
The Food and Drugs Administration (FDA) expects to receive the Chinese drug maker’s formal application for phase three clinical trials within two weeks and regulators will make a decision after their evaluation, FDA head Rolando Enrique Domingo said.
Domingo told reporters a November trial start was “possible.”
Philippine President Rodrigo Duterte repeated on Wednesday that he preferred that his country source its COVID-19 vaccines from either China or Russia.
He also said he wanted the entire population vaccinated and has previously said he would not reopen schools until a vaccine was available.
A Sinovac spokesman confirmed that materials had been provided to the Philippines in the hope of starting Phase 3 trials, but gave no timeframe.
Jaime Montoya, a member of an expert panel screening applications for clinical trials and medications, told Reuters a technical evaluation of Sinovac had been completed and results already submitted to an ethics board for review.
The Philippines is also evaluating COVID-19 vaccines of Russia’s Gamaleya Research Institute and Johnson & Johnson’s Janssen for late-stage trials and is talking to U.S. drug maker Pfizer Inc and Moderna Inc as potential suppliers. The Southeast Asian nation has 346,536 confirmed COVID-19, the highest in the region, and 6,449 deaths.
JPV
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