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Philippines Says Phase 3 Trial of Sinovac’s CoronaVac May Start in November
By Rajaneesh K. Gopinath, Ph.D.
China-based Sinovac Biotech may initiate a Phase 3 clinical trial of its inactivated COVID-19 vaccine, CoronaVac, in the Philippines as early as next month. Philippine FDA Commissioner Eric Domingo said that a formal application from the company is expected within two weeks. If it passes the review process, which will take about 21 days, the trial will start in November at the earliest. Without mentioning the timeframe, a spokesperson of Sinovac mentioned that the company has provided materials to relevant officials in the Philippines and hopes to start the Phase 3 trial as soon as possible.
CoronaVac’s Phase 1/2 double-blinded, randomized clinical trial was approved by the National Medical Products Administration (NMPA) of China on August 10. The trial is expected to recruit adolescents and children between the ages of 3 and 17 to administer low-dose (300SU/dose) and medium-dose (600SU/dose) with an interval of 28 days.
On the other hand, the company also recruited 18 to 59-year-old adults and the elderly over 60 years old in Jiangsu and Hebei for the Phase 1/2 clinical trial of CoronaVac. The results demonstrated that the subjects’ seroconversion rates are higher than 90%, and there are no serious adverse reactions related to the vaccine.
Unlike the DNA or RNA vaccine candidates, CoronaVac is based on an inactivated pathogen. The attenuated virus loses the ability to replicate, and it is produced with an adjuvant. Due to the traditional manufacturing method, the inactivated virus vaccine can only induce a humoral immune response. If the manufacturing process is not handled properly, the virus may still pose a risk of spreading the disease.
Testing of Vaccine Candidates from China and Russia
As the country with the highest number of infections in Southeast Asia, the Philippines is also evaluating COVID-19 vaccines of Russia’s Gamaleya Research Institute and Johnson & Johnson’s Janssen. Besides, it is also in contact with Pfizer and Moderna. In July, Philippine President Rodrigo Duterte made a plea to Chinese President Xi Jinping with hopes that the Philippines could become the first wave of beneficiaries after China successfully produced COVID-19 vaccines. Duterte also authorized Manila to purchase vaccines from Southeast Asian countries. On October 15th, he reiterated the Philippines’ desire to introduce COVID-19 vaccines developed by China or Russia.
In addition to the COVID-19 vaccine, Sinovac’s main vaccine product line includes enterovirus71 (EV71), hepatitis A, hepatitis B, seasonal influenza, and quadrivalent influenza (Quadrivalent Influenza vaccine, QIV). Besides, there are vaccines for H5N1 poultry, Influenza (H5N1 pandemic influenza, avian flu), H1N1 influenza (H1N1 influenza, swine flu), tetanus, and mumps.
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