Mixed signals in clinical trials for COVID-19 vaccine

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    THE Philippines is participating in clinical trials for various COVID-19 vaccines, which should be good news because this means the nation is one step closer to having access to such panacea for the dreaded pandemic that has killed many people, including Filipinos.

    Senator Francis “Tol” Tolentino on Wednesday gave his senator colleagues and the public a preview on what these clinical trials are all about. In a privilege speech, Tolentino said Phase 1 of clinical trials involves a small group of less than 100 healthy participants to evaluate safe dosages and identify side effects, if any. Phase 2 involves follow up of studies for samples that passed the previous phase, with a larger group of human subjects, perhaps more than 100 COVID-19 patients to monitor and correct adverse effects.

    Phase 3 is conducted in various countries and regions, with thousands of participants, resulting in country approvals and start of actual usage. Phase 4 will run from 3 to 5 years, after nations have approved the product and have institutionalized its use.

    ‘The senator has asked the right questions, and it is now up to the IATF and the secretaries of the DOH, DOST, and DILG, and the director of the FDA to provide the answers.’

    Philippine contribution in this unprecedented global effort is in the World Health Organization’s Solidarity Trials, and the Inter-Agency Task Force (IATF) has authorized the Department of Science and Technology (DOST) to take charge of this participation. The DOST has in fact signed 6 confidential data agreements (CDA) with big pharma companies in Taiwan, Russia, China, Australia and US for six different kinds of vaccines. This is a big stride since the days when the DOST was thinking only of virgin coconut oil and lagundi as possible medicines for COVID-19.

    What pricked Senator Tolentino’s inquisitive mind is the news that the Department of Health (DOH) has signed another agreement with the University of the Philippines for clinical trials on the vaccine Avigan of Japan. Tolentino pointed out that it would seem the DOH and the DOST are not on the same page, and probably using different road maps that might again be another formula for a grand failure.

    Tolentino, a lawyer who can practice law in the country and in the US, said RA 3720, the Food and Drug Devices and Cosmetics Act and all implementing rules and regulations, executive orders and related issuances command the DOH to be on top of these activities.
    Senator Tol called on these government agencies to get their act together and work hand-in-hand to ensure the smooth conduct of clinical trials, especially because lives of hundreds of Filipino volunteers are at stake here, with the corresponding P89.1 million in expenses to be shouldered by the government.

    As chair of the Senate Committee on Local Governments, Tolentino also called on the government to come up with a clear communication plan to help local government units understand their roles in these clinical trials.

    The senator has asked the right questions, and it is now up to the IATF and the secretaries of the DOH, DOST, and DILG, and the director of the FDA to provide the answers.