Chinese candidate vaccine a step away from clinical trial in PH

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    Vaccines in Indonesia. Airport personnel in Bandung, West Java spray disinfectant on boxes of COVID-19 vaccines from China’s Sinovac Biotech Ltd., the first shipment of the vaccine to arrive in Indonesia, on Monday. REUTERS PHOTO

    CLOVER Biopharmaceuticals of China has obtained approval from two government panels for planned clinical trials in the country of its candidate vaccine for the coronavirus disease (COVID-19).

    The last hurdle is the Food and Drug Administration.

    Health Undersecretary Maria Rosario Vergeire, in a press briefing, said Clover’s bid for clinical trial has been approved by the Single Joint Research Ethics Board (SJREB) of the Department of Health, weeks after it passed the evaluation of the Vaccine Experts Panel (VEP) of the Department of Science and Technology.

    To be allowed to hold clinical trials in the country, a vaccine manufacturer must be able to pass parallel evaluation and assessment from the VEP, the SJREB, and the FDA.

    “You need to be approved by the VEP and the SJREB before you can seek approval from the Food and Drug Administration,” Vergeire said.

    The SJREB earlier gave its approval to AstraZeneca of United Kingdom and Janssen Pharmaceutica of Belgium.

    Sinovac Biotech Ltd. of China was approved by the VEP ahead of Clover.
    Aside from the four companies, also looking to conduct clinical trials in the Philippines is the Gamaleya Research Institute of Russia.

    Vergeire said the FDA can gather initial information from the prospective applicants for clinical trials even without endorsements from the board and the experts panel.

    “The FDA can actually gather initial evidence so that they can already begin their evaluation of the documentary requirements,” said Vergeire.

    The government earlier said it expects a clinical trial for COVID-19 vaccine to start sometime in late December or early January.

    FDA Director General Eric Domingo has said holding clinical trials locally is vital as people of different ages, races, and ethnicities may react differently to medical products, such as vaccines.

    The independent clinical trials of pharmaceutical firms are separate from the Solidarity Trial for COVID-19 Vaccine set to be held by the World Health Organization (WHO), with the Philippines among the participants.

    The Department of Science and Technology earlier said the WHO trial may start in January, with two still unnamed candidate vaccines on tap.

    Chosen as hospital sites for the WHO trial are the Philippine General Hospital, Research Institute for Tropical Medicine, Manila Doctors Hospital, San Lazaro Hospital, St. Luke’s Medical Center-Quezon City, St. Luke’s Medical Center-BGC, Lung Center of the Philippines, The Medical City, Makati Medical Center, De La Salle University Medical Center Health Sciences Campus in Cavite, Baguio General Hospital and Medical Center, Vicente Sotto Memorial Medical Center, Southern Philippines Medical Center, and Western Visayas Medical Center

    Communities chosen for the WHO trials are eight barangays in Manila — four in Pasay City; one in Taguig City; two in Itogon, Benguet; one in Tuba, Benguet; five in Baguio City; and four in Davao City.

    Lance Gokongwei, president and CEO OF JG Summit Holdings, said the private sector pledged P800 million for the procurement of some three million doses of vaccine.

    Gokongwei said half of this will be donated to the Department of Health while the half would go to the private sector.

    In November, the government and the private sector had signed an agreement with pharmaceutical firm AstraZeneca for 2.6 million doses of COVID-19 vaccine. – With Jocelyn Montemayor