DOH to do away with last stage in vaccine trials

MANILA, Philippines — The Department of Health (DOH) opted to do away with the requirement of a Phase 4 or final stage in the clinical trials for potential vaccines against the coronavirus disease (COVID-19), as the national caseload inched closer to 200,000.

Based on its discussions with the Health Technology Assessment Council, Food and Drug Administration, and the Philippine Medical Association, the DOH said it chose to waive the final stage in the vaccine development process so the country could “accelerate our national response to the pandemic in terms of vaccine distribution.”

In a statement, the DOH said “This recommendation is also not without historical precedent. Accelerated clinical trials and regulatory approvals in response to threats such as Ebola and meningitis contributed to mitigating the spread of Ebola and decline in the incidence of meningitis in the sub-Saharan belt.”

Phase 4 of the clinical trials is otherwise known as the postmarketing surveillance stage, wherein more information on the safety and efficacy of a drug or vaccine is collected.

The Senate had earlier urged Health Secretary Francisco Duque III to waive this final stage in clinical trials for fear that the country might be left behind once a COVID-19 vaccine becomes available.

The DOH made the assurance that, even without this final stage, there are safeguards on the vaccine being tested to protect the public.

This includes safety and effectiveness surveillance following recommendations of the World Health Organization, the setting up of a database of recipients of the vaccine to help assess its outcomes, and pilot implementation and community engagement activities before mass rollout.

Virus case update

On Saturday, DOH recorded 4,933 new cases, bringing the national count to 187,249.

Of the new cases, 4,017 fell ill between Aug. 9 and 22, while 489 got sick between Aug. 1 and 8.

Metro Manila accounted for the majority of the new cases with 2,845, followed by Cavite (461), Laguna (288), Rizal (167) and Bulacan (152).

There are now a total 69,362 active cases, of which 91.5 percent are mild, 6.6 percent asymptomatic, 0.8 percent severe and 1.1 percent critical.

The total number of patients who have recovered from COVID-19 rose to 114,921 with the recovery of 436 patients.

The death toll, however, increased to 2,966, as 26 patients succumbed to the severe respiratory disease.

Of the newly reported deaths, 13 died in August, 10 in July, and one each in April, May and June.

Seventeen of the fatalities were from Metro Manila, three from Central Luzon, two from Caraga, and one each from Ilocos, Western Visayas, Zamboanga and Calabarzon.