On Russia Vaccine, Philippines Must Be 'Very Careful' with Trials: FDA

The Philippines needs go be "varey careful" should it decide to participate in the clinical trials for the COVID-19 vaccine from Russia, following a dengue vaccine controversy several years ago, the Food and Drug Administration said Thursday.

Authorities must first rebuild public confidence in immunization that was tarnished by  Dengvaxia, which was found to induce more severe symptoms of dengue among those who took it for the first time, FDA Director General Eric Domingo said.

“The urgency is a little different. Everybody’s scared, everybody can get it. Kaya talagang (This is why) we have to be very careful. We have to make sure before we roll out a vaccine that it’s safe and effective,” he told ANC.

On Tuesday, President Vladimir Putin said Russia developed the world's first COVID-19 vaccine. However, final stage testing for the drug only started this week.

It’s not common practice to skip the third phase of trials, but Domingo said Russia has the right to do so and to permit its military to use the vaccine.

Dr. Nina Gloriani, the head of the Philippines' vaccine search committee, told reportr that human trials are crucial to ensure that the resulting vaccine will be effective and safe for use. There are 3 phases of clinical trials, and a potential vaccine must pass the third phase of trials before it can be mass-produced and made commercially available.

Phase 3 of testing in the Philippines could involve some 15,000 to 30,000 COVID-free participants, and another 2 to 3 months to observe any side effects, Domingo said.

The Philippines is a good site for clinical trials as areas with community transmission can be selected. Frontliners and health workers would make good trial participants since they are exposed to the virus every day, he said.

While those are the recommended figures and timeline for the trial, the final number of participants still depends on manufacturers and authorities, Health Undersecretary Rosario Vergeire told ANC in a separate interview.

President Rodrigo Duterte earlier thanked Russia after being told vaccines would be supplied to the Philippines. Duterte also volunteered to take the vaccine first before anyone else to check if it’s safe to use.

The Philippines is also set to participate in the clinical trials for Japanese anti-flu drug Avigan, a potential treatment for COVID-19. Tablets have been sent from Japan, and 100 Filipinos are expected to take the drug and observe effects.