- PH records 4,933 new cases
- DILG to hire 50,000 contact tracers
Congress has approved a provision waiving a Phase 4 clinical trial requirement to hasten the procurement of a coronavirus vaccine under the Bayanihan to Recover as One Act 2 that was ratified by the Senate last week as infections continue to surge, with the total reaching 187,249 on Saturday with 4,933 new cases.
“Once the medication and vaccine are available, we will do everything and we will really go out of our way to make sure that our kababayans can access them. We can’t allow the medication and vaccine to be affordable only to the rich and well-to-do,” said Speaker Alan Cayetano.
The Department of Health said it will do away with the fourth and final phase of clinical trials for COVID-19 drugs and vaccines, a requirement set by the Universal Healthcare Law.
The approved provision of Bayanihan 2 waives the Phase 4 trials under the following conditions:
• the medication and vaccine are recommended by the World Health Organization (WHO) and/or other internationally recognized health agencies; and
• minimum standards for the distribution shall be set by the Food and Drug Authority (FDA) and the Health Technology Assessment Council (HTAC), as may be applicable.
The provision shall remain in effect three months after December 19, 2020.
“Like I always say, we have to adapt, innovate, and manage in the new normal. So, this early we are preparing for the vaccine). We can’t start looking for the funding only when the vaccine becomes available. We have to be equipped,” Cayetano said.
Phase IV clinical trial involves the post-market monitoring of the effects of a new drug and is usually done to a few thousand patients.
The DOH said waiving the Phase 4 trial requirement “is 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,” the department said in a statement.
When the Dengvaxia anti-dengue vaccine was administered to Filipinos, mostly children, during the past administration, it was still on Phase 4 clinical trial.
The vaccine had already been administered to the close to a million people, the manufacturer, Sanofi Pasteur of France, found out that instead of preventing dengue, Dengvacia will exacerbate symptoms of people who were injected the drug but have not had dengue fever before.
The country on Saturday reported 4,933 new COVID-19 cases, the fifth consecutive day where more than 4,000 cases have been reported.
The National Capital Region reported the highest number of new cases with 2,845 cases, followed by Cavite with 461, Laguna with 288, Rizal with 167, and Bulacan with 152.
Total recoveries rose to 114,921 after 436 more patients recovered from the illness while the death toll stood at 2,966.
Meanwhile, the Department of the Interior and Local Government said it is targeting to start the hiring of 50,000 contact tracers in September once the additional P5-billion appropriation under the Bayanihan 2 is released.
Interior Undersecretary Jonathan Malaya said the mass hiring will allow the government to meet the recommended ratio for contact tracing of Baguio City Mayor Benjamin Magalong, the country’s contact tracing czar, of a 1:30 or 1:37.