MANILA, Philippines — Some 10,000 residents in Cavite province cannot take part in clinical trials for a potential vaccine against COVID-19 without the approval of the Food and Drug Administration (FDA) and an ethics review board, a health official said on Wednesday.
According to Health Undersecretary Maria Rosario Vergeire, before a clinical trial of any vaccine or drug can proceed, the one in charge must first comply with all regulatory requirements to ensure the safety of participants.
Violation of laws
“No clinical trial can start without the FDA and the ethics review [board’s] approval. If you do that, you are violating specific laws. You will be sanctioned and asked to stop,” she said.
“We have to remember that these clinical trials, especially for vaccines and new medicines, involve individuals. So the government must be able to regulate [these] to ensure that [they] will be safe for our countrymen,” she pointed out, adding that otherwise, these “might cause harm to our citizens.”
Last week, Cavite Gov. Jonvic Remulla Jr. announced that 10,000 residents would participate in the phase 3 trials of a vaccine being developed.
To be conducted with De La Salle Medical and Health Sciences Institute, the trials were scheduled to start in the next two weeks.
According to Vergeire, the Department of Health (DOH) has already met and discussed the process with the trial proponent, which promised to provide regular updates. On Wednesday, the DOH logged an additional 2,218 COVID-19 cases, bringing the current national tally to 226,440. Of the new cases submitted by 102 out of 110 accredited laboratories, 1,932 got sick between Aug. 20 and Sept. 2, and 223 others between Aug. 1 and 19.
NCR still epicenter
Metro Manila still accounted for the highest number of new infections at 1,163, followed by Laguna, 112; Cebu, 107; Iloilo, 82; and Negros Occidental, 81. To date, there are 64,207 active cases, 91.2 percent of which are mild, 6.4 percent asymptomatic, 1 percent severe and 1.4 percent critical.
A total of 158,610 people have now recovered from COVID-19 with the addition of 609 patients. The death toll, however, rose to 3,623 as 27 patients died of the severe respiratory disease.
Ten of the new fatalities were from Metro Manila, eight from Calabarzon, four from Western Visayas, two from Central Luzon, one each from Central Visayas and Eastern Visayas, and a lone repatriate.