How will the Philippines run COVID-19 vaccine trials?

Arianne Merez, ABS-CBN News

Posted at Sep 07 2020 05:18 PM

This handout picture taken on August 6, 2020 and provided by the Russian Direct Investment Fund shows the vaccine against the coronavirus disease, developed by the Gamaleya Research Institute of Epidemiology and Microbiology. Russian Direct Investment Fund, Handout/AFP

MANILA-- Barangays (villages) with the highest number of coronavirus infections will serve as the primary recruitment hub for the Philippines' clinical trials of COVID-19 vaccines as the government prepares to test vaccine candidates on Filipinos.

The Philippines will prioritize vaccine trials under the World Health Organization Solidarity Trial program, the government's pandemic task force said in a resolution dated Sept. 3.

Manila has ongoing vaccine discussions with Beijing and Moscow, with Russia's COVID-19 vaccine already approved for human clinical trials in the Philippines. President Rodrigo Duterte even volunteered himself to be inoculated in public with the Russian drug.

Phase 3 human clinical trials are large-scale testing to check the efficacy and safety of vaccines on thousands of people. It is often the last step before a vaccine gets regulatory approval from the country.

WHO CAN JOIN?

Authorities will "recruit" volunteers for vaccine clinical trials from the top five villages reporting the highest number of COVID-19 cases based on attack rates per 1,000-population per barangay, Science Secretary Fortunato Dela Peña said on Monday.

"Importante po ito kasi gusto nating ma-testing iyong kagalingan ng vaccine or iyong efficacy. Kaya iyon ay iti-testing natin doon sa lugar na mataas ang cases ng COVID-19," he said in a Palace press briefing.

(This is important because we want to test the efficacy of vaccines in areas where there are high cases of COVID-19.)

The villages with the highest number of coronavirus infections will be identified based on data from the Department of Health's Epidemiology Bureau. The said office will also manage the database on information on clinical trials once these begin.

Temporary residents are discouraged from volunteering for the clinical trials unless they could show proof that they will be staying in the area of the trial site for the next two years since participants need to be monitored after inoculation.

Trial sites will be at the barangay level, and randomization will be by households, Dela Peña said.

In the event that participants in a certain barangay are not enough, Dela Peña said the government could recruit in adjacent villages that also report high COVID-19 infections.

HOW WILL PRIVATE COMPANIES RUN VACCINE TRIALS?

Private vaccine companies that need to run human clinical trials will be assigned separate trial zones "such that they are equally and rationally distributed to avoid competition in subject recruitment."

In cases of outbreaks in select areas, clinical vaccine trials can be conducted in such places as long as there are facilities for the storage of vaccines, Dela Peña said.

"In that case, iyong halimbawang kulang pa rin ay puwede silang pumunta sa adjacent barangays," he said.

(In that case, the deficit can be fulfilled from adjacent barangays.)

For transparency purposes, the government's pandemic task force recommended a memorandum of agreement between the Department of Science and Techonology, and the Department of the Interior and Local Government.

Dela Peña said the science department has also prepared a communication plan for the COVID-19 vaccine clinical trials to help the public understand the project better.