8 applications for COVID-19 vaccine clinical trials so far approved — DOST

FILE PHOTO: A health worker prepares a booster dose of a coronavirus disease (COVID-19) vaccine, as vaccinations jump in Italy after the government made inoculation mandatory for all workers, in Rome, Italy, September 21, 2021. REUTERS/Yara Nardi

MANILA, Philippines — The Food and Drug Administration (FDA) has so far approved eight applications for COVID-19 vaccine clinical trials in the country, while six other applications are still being reviewed, the Department of Science and Technology (DOST) said Tuesday.

According to DOST, the FDA has approved the conduct of clinical trials by the following applicants:

• IP Biotech
• Janssen Vaccines & Prevention B.V.
• Clover Biopharmaceuticals AUS Pty Ltd
• WestVac Biopharma Co., Ltd. and West China Hospital of Sichuan University
• Shenzhen Kangtai Biological Products Co., Ltd. and Beijing Minhai Biotechnology Co., Ltd.
• Livzon Mabpharm Inc.
• Inovio Pharmaceuticals, Inc.
• Department of Health and World Health Organization

The application of IP Biotech was approved in January but was withdrawn to change the target population from adults to the pediatric population, according to DOST data released to the media.

Meanwhile, Janssen and Clover are currently conducting monitoring or follow-up of participants. Their applications were approved in December 2020 and January 2021, respectively.

Recruitment is ongoing for the clinical trials of WestVac, Shenzhen, and Livzon, while Inovio Pharmaceuticals is finalizing the proposed trial sites, according to DOST.

“As soon as the DOST, DOH, and the Philippine Solidarity Trial Vaccine Team (SVT) receive final instructions from WHO for the global launching, the clinical trial implementation in the Philippines under the SVT will officially start,” the DOST also said.

Meanwhile, applications from the following manufacturers are still being evaluated by the FDA:

• Sinovac Life Sciences Co., Ltd.
• Clover Biopharmaceuticals AUS Pty Ltd
• Yuxi Walvax Biotechnology Co., Ltd. and Walvax Biotechnology Co., Ltd., and Suzhou Abogen Biosciences Co., Ltd.
• Clover Biopharmaceuticals AUS Pty Ltd (for individuals with HIV)
• Beijing Wantai Biological Pharmacy
• Enterprise Co. Ltd.
• SK Bioscience Co., Ltd and International Vaccine Institute (IVI)

According to DOST, the clinical trial to be conducted by Sinovac Life Sciences is for those aged six months to 17 years old, while Clover is proposing to conduct a clinical trial for 12 to 17 years old.

Jaime C. Montoya, Executive Director of the DOST – Philippine Council for Health Research and Development (PCHRD), said that the manufacturers are expected to present data on the efficacy of their vaccines against COVID-19 variants of concern.

“Even if it’s not a requirement, they are bound to present data that will involve efficacy against variants, especially against Delta variant… This is one of the data that will be reviewed,” he told reporters.

Montoya also said that the Inter-Agency Task Force for the Management of Emerging Infectious Diseases approved the DOST’s proposal to limit the clinical trials in the country to vaccines that will be used for “new indications.”

“For example, hindi na tayo masyado tatanggap ng mga (We will no longer accept) trials that will look at the usual age populations, kasi marami na tayo non (we have many like that). What we are going to prioritize are trials that will look at special groups, for example children, high risk groups, healthcare workers, and also the new generation vaccines, which have been developed to address the new variants,” he added.

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