Phase 3 of COVID-19 vaccine trials set in November, says DOH

In this picture taken on April 29, 2020, a package of the experimental vaccine test for the COVID-19 coronavirus is pictured at the Quality Control Laboratory at the Sinovac Biotech facilities in Beijing. Sinovac Biotech, which is conducting one of the four clinical trials that have been authorized in China, has claimed great progress in its research and promising results among monkeys. Photo by NICOLAS ASFOURI / AFP

MANILA, Philippines — The Phase 3 of the vaccine trials for the coronavirus disease, which has stricken more than 330,000 people nationwide, will start this November, the Department of Health (DOH) revealed on Saturday.

“The Inter-Agency Task Force’s (IATF) Sub-Technical Working Group (sub-TWG) on COVID-19 Vaccine Development led by the Department of Science and Technology (DOST), together with other government agencies, is gearing up for the conduct COVID-19 vaccine phase 3 clinical trials in the country which are set to begin this coming November,” DOH said in a statement.

For the Phase 3 of clinical trials, thousands of patients will be injected to evaluate the safety and effectivity of the COVID-19 shots.

On Thursday, the government disclosed that it is reviewing the application of three international drug makers to participate in the phase 3 of the trials. These companies are China’s Sinovac, Russia’s Gamaleya Research Institute, and the Belgium-based Janssen Pharmaceutical Companies, a subsidiary of Johnson & Johnson.

The DOH did not reveal yet the progress of the three companies’ application to conduct phase 3 clinical trials in the country.

DOST, which will lead the clinical trials, will also be assisted by government agencies including the Department of Foreign Affairs (DFA), Department of Trade and Industry (DTI) and Food and Drug Administration (FDA), the health department said.

DOH said the DFA will work with the bilateral partnerships related to vaccine trials. The foreign department will also coordinate with the DTI and its attached agency, National Development Company (NDC), for possible production of the vaccines in local pharmaceutical companies.

The DOH, vice chair of the sub-TWG, will administer logistics as well as manage hospitals that would participate in the vaccine trials.

The FDA was tasked to monitor the facilities and manufacturers allowed to conduct clinical trials, DOH said.

The agency “will also approve vaccines that will be released and sold to the public,” DOH added.

EDV