FDA prepares for clinical trials on six COVID-19 vaccine candidates

Marje Pelayo   •   July 30, 2020   •   212

MANILA, Philippines – The Food and Drug Administration (FDA) is set to launch the clinical trials on six drugs that are candidates for the treatment of coronavirus disease (COVID-19).

According to FDA Director General Eric Domingo, the selected drugs are based on the updates from the Department of Science and Technology (DOST), the agency that has been helping the FDA in searching for a potential vaccine for COVID-19.

The FDA, however, has not disclosed the details on the six candidate vaccines.

In addition to these, Domingo said the Philippines is now preparing to join the Phase 3 Clinical Trials together with other participating countries.

“Posibleng mag-apply at magsasagawa ng Phase 3 Clinical Trials on candidate COVID-19 vaccines sa bansa [We may apply and conduct a Phase 3 Clinical trials on candidate COVID-19 vaccines here in the country],” Domingo said. 

“Pinag-uusapan na rin ang pakikilahok ng Pilipinas sa gagawing Solidarity Vaccine Trials ng World Health Organization [There are also discussions on the participation of the Philippines in the upcoming Solidarity Vaccine Trials by the World Health Organization],” he added. 

Five of the 166 COVID-19 candidate vaccines that are already in the Phase 3 Clinical Trials include:

  • Sinovac
  • Sinopharm- Wuhan Institute of Biological Products
  • Sinopharm- Beijing Institute of Biological Products 
  • Astrazeneca- University of Oxford 
  • Moderna/ NIAD

The FDA clarified that though the agency is not involved in the clinical trials, it is the one that regulates the clinical products such as vaccines for public use.

Kapag napatunayan na ligtas at epektibo ang mga produktong ito, puwede na silang mag-apply for registration sa FDA upang maging available ang mga ito sa merkado,” Domingo explained.

[Once a product is proven safe and effective, the owner may apply for registration to the FDA so it may be available to the market.]

In his state of the nation address, President Rodrigo Duterte mentioned that a vaccine for COVID-19 may soon be out specifically by September this year. 

The FDA clarified, however, that developing a vaccine may take months to years, not to mention the strong scientific evidence from clinical trials and the effectiveness and safety of the product for human consumption. 

Nonetheless, the FDA is prioritizing the review of a number of applicants for potential vaccine and treatment for COVID-19.

The agency stressed, however, that there is no vaccine or drugs that have been approved yet to be taken by COVID-19 patients.

All drugs that have been selected for trial are still on trial stage and undergoing experts’ evaluation.

“Wala pa pong bakuna kontra COVID-19, kahit saang bansa [There is no vaccine yet for COVID-19 anywhere in the world],” he added.

The official advised the public to report to the agency any anti-COVID product that is being sold online through its email covidresponse@fda.gov.ph or at ereport@fda.gov.ph.

“Ipakita ninyo po sa amin. Ipadala ninyo po sa amin ang mga detalye at bahala po ang mga ahente namin na manghuhuli dahil mga manloloko po iyan [Show us the product. Send the details to us and our agents will track them and process their arrest because those are fraudulent],” Domingo stressed. –MNP (with reports from Aiko Miguel)

Gov’t offices under lockdown reach 153; over 10K gov’t workers, COVID-19 positive

Aileen Cerrudo   •   August 6, 2020

Government offices that have been put under lockdown now reached 153, while over 10,000 government employees tested positive for COVID-19.

Among the offices include the Government Service Insurance System office in Pasay City and Quezon City which will remain closed until Friday (August 7). However, the GSIS advisory states that its online facilities will still remain open for members and pensioners.

The main office of the Commission on Elections (Comelec) in Intramuros, Manila will remain closed until August 16 for extensive disinfection and decontamination.

GOVERNMENT OFFICES UNDER LOCKDOWN

NCR – 108
Region IV – 16
Region VII – 11
Region I – 5
Region V – 4
CARAGA – 3
Region IX – 2
CAR – 1
Region II – 1
Region XI – 1
Region XII – 1

TOTAL: 153

Civil Service Commission (CSC) Commissioner Atty. Aileen Lizada advised that the head of department or agency should have a concrete internal protocol to prevent the further spread of the virus. This includes swab testing, disinfection, and other health protocols.

So we need to see, dapat meron kayong ganoong internal protocol para ho na everyone is guided accordingly (So you should have internal protocols so that everyone is guided accordingly),” she said.

Meanwhile, a total of 10,344 government employees tested positive for COVID-19 as of August 5.

Lizada said employees will have free medical services if they wish to be treated in government facilities and hospitals.

She also calls on head of the agencies to continue providing salaries to Job Orders.

“Although there is no employer-employee relationship, I personally believe that the head the agencies must continue paying the salaries of JOs and COS. They were forced to not work because of this virus,” she said. -AAC (with reports from Vincent Arboleda)

PSA: Philippine economy suffers -16% drop in GDP in Q2

Marje Pelayo   •   August 6, 2020

MANILA, Philippines – The country’s economy has suffered a big blow since the beginning of the coronavirus disease (COVID-19) pandemic. 

The extension of strict community quarantine further burdened the economy that government officials believe the Philippines is now in an economic recession. 

According to the latest report of the Philippine Statistics Authority (PSA), the country’s recorded gross domestic product (GDP) plummeted from -0.7% in the first quarter to -16.5% in the second quarter specifically from April to June this year.

This is the lowest ever recorded since the year 1981. 

The country’s economy had been very strong in the past two decades until this year’s COVID-19 health crisis that caused world trade and investments to suffer heavily.MNP (with inputs from Rosalie Coz)

Lawmakers question PhilHealth’s claim that fund may not be enough for next year

Marje Pelayo   •   August 6, 2020

MANILA, Philippines — The Philippine Health Insurance Corporation (PhilHealth) claims that the agency’s actuarial life or fund will last only until next year due to the coronavirus disease (COVID-19) pandemic. 

PhilHealth’s senior vice president for actuary, Nerissa Santiago said the pandemic has delayed members from remitting their contributions. The agency has also been shelling out more funds due to the increase in the number of COVID-19 patients.

PhilHealth estimates that around 209,000 patients will be needing financial support from the agency this year.

This could lead to further depletion of PhilHealth funds by the start of next year. 

But Marikina Representative Stella Quimbo questioned this saying PhilHealth should still have P112-billion and that support for COVID-19 patients shouldn’t reach that much amount.

Quimbo noted that based on global measures, only about 20 percent of COVID-19 patients are expected to be admitted to hospitals and this will not cost PhilHealth an amount of P45 billion.

“I use the global distribution for mild, severe and moderate, and computation ko lang po dyan maximum na is maximum P3.2 billion only. Hindi po talaga aabot iyan ng P45 billion,” Quimbo said.

“Ang worry ko po is, sa kaka-project ninyo ng napakalaki ay nagkakaroon ng mas malaki leeway sa fraud,” she added noting that there is a problem with the implementation of the agency’s case rate program.

She added that PhilHealth’s actuarial life should still be enough for up to 10 years according to the Department of Health (DOH) projection in August last year.

If your case rate is properly computed, wala po tayong problema ng overpayment nor underpayment,” Quimbo said.

PhilHealth President R/Gen. Ricardo Morales claims that PhilHealth’s fraud rate is at 7.5 percent and to address this he said upgrading the agency’s IT system would be key to reducing it.

Other lawmakers also questioned alleged irregularities in the agency’s case rate system.

PhilHealth started its case rate system in 2011 which provides health care institutions a corresponding amount for every illness like pneumonia, gastroenteritis, urinary tract infection (UTI), and now COVID-19.

Since the start of COVID-19, PhilHealth has allocated a 30 billion-peso-fund for the interim reimbursement mechanism.

Out of the said amount, the agency has already released about P14-B but only about P1-B has been liquidated. 

The agency has since been working on case rates like P15,000 for pneumonia; P6,600 for gastroenteritis; P7,000 for urinary tract infection (UTI).

For COVID-19 cases, PhilHealth has set P44,000 insurance for mild cases and up to P788,000 for critical cases.

Lawmakers asked PhilHealth officials why they have to pay for cases worth less than the amount of a particular case rate.

“Ano po ibig sabihin nito? Nagpunta ka ng ospital at ikaw po ay binigyan ng kaukulang atensyong medikal. Ang ginastos mo ay P20,000, ang babayaran pa rin ng PhilHealth sa ospital ay P43,000 under the case rate system?” asked the House Committee on Public Affairs Chair Mike Defensor.

“So tinuturing niyo na kita na ito ng ospital, kumbaga ay reward, dahil mas mura ang ginastos nila kesa doon sa case rate na ini-assign ng PhilHealth? Ganoon po ba iyon?” asked Bagong Henerasyon Partylist Rep. Bernadette Herrera-Dy.

Morales explained that what hospitals get from the agency is an incentive to make their services more efficient.

Magiging incentive na doon sa mga ospital nang maging efficient sila,” he said.

Morales added that the case rate will be transitioned to a global budget wherein funds will be entrusted to local government units as part of the Universal Health Care Law.

The Lower House will continue the hearing on the alleged irregularities in PhilHealth next week. MNP (with details from Rey Pelayo) 

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