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

Marje Pelayo   •   July 30, 2020   •   842

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)

Philippines posts 37,070 new COVID-19 cases; active tally at 290K

Robie de Guzman   •   January 17, 2022

MANILA, Philippines – The Philippines on Monday logged 37,070 additional cases of COVID-19, the Department of Health (DOH) said, pushing the country’s total confirmed cases to 3,242,374 since the pandemic started.

Data released on Monday showed that about 36,001 of the new cases occurred between January 4 to January 17.

Most of the cases were recorded in Metro Manila, CALABARZON, and Central Luzon.

This is the sixth straight day that the country logged more than 30,000 new infections, and the fourth day that it announced record-high cases – 39,004 cases last Saturday, 37,207 on Friday, and 37,154 on Sunday.

The new tally brought the number of active infections to 290,938, the DOH said.

Of the newly reported cases, 9,187 were asymptomatic, 277,020 were mild, 2,947 were moderate, 1,480 were severe, and 304 were in critical condition.

The positivity rate was at 46% based on 77,410 tests administered on January 15.

The DOH reported 23 more fatalities, pushing the number of COVID-related deaths to 52,929.

There were 33,940 more recoveries, raising the total number to 2,898,507.

Twelve laboratories were not able to submit their data on time. These facilities contribute on average 5.1% of the samples tested and 5.1% of positive cases.

The utilization rate of intensive care units in use nationwide was at 49% while 58% in the National Capital Region (NCR).

Isolation beds being utilized across the country was at 47%, and 48% in NCR.

Ventilators in use in the capital region was at 22% and 30% in the capital region.

OCTA: COVID-19 growth rate in NCR slows down to -1%

Robie de Guzman   •   January 17, 2022

MANILA, Philippines – The growth rate of COVID-19 is decreasing in Metro Manila, the OCTA Research group said on Monday.

OCTA Research fellow Dr. Guido David said the daily growth rate of the seven-day moving average in the region has slowed down to -1 percent.

“Base sa datos kahapon na may 15,959 cases ay bumaba ang daily growth rate to negative 1 percent from 2 percent. So ibig sabihin, naging negative na, mukhang pababa na ng kaunti,” David said in a televised public briefing.

“Pero again di pa tayo pwedeng mag-celebrate,” he added as he stressed the need to closely monitor the case trends in the coming weeks to see if figures are really declining in the NCR.

In a post on Twitter, David said that the growth rate over the past four days, in order, were 11%, 5%, 3%, and 2%.

The region’s COVID-19 reproduction number also went down to 2.67 from around 6.16 recorded last January 2. The rate refers to the number of people infected by one positive case.

While this trend is encouraging, and suggesting the possibility that cases in the NCR have peaked, David said that the possibility still remains that visibility of the situation in the region is clouded because of limitations in testing.

And though the peak may be nearing in the NCR and other nearby areas, David noted that there are many areas outside in the country that have shown an increase in COVID-19 cases.

“Actually, all over the country now, we’re starting to see an increase in cases, kaya makaka-affect ito sa sinasabi nating peak kung pinag-uusapan buong bansa,” he said. “Pero possible na sa NCR, tsaka Cavite, Bulacan, Rizal ay baka malapit na ang peak o nagpi-peak na tayo.”

David urged those in the provinces to get vaccinated or boosted against COVID-19 to protect themselves from hospitalization and severe form of the disease.

He also advised the public to continue adhering to public health protocols such as the proper wearing of face mask, social distancing, and refrain from unnecessary travel to help curb COVID-19 transmission. (with details from Correspondent Rosalie Coz)

COVID-19 among leading causes of death in PHL in 2021 – PSA

Robie de Guzman   •   January 17, 2022

The novel coronavirus disease (COVID-19) is among the top three causes of death in the Philippines in 2021, according to data released by the Philippine Statistics Authority (PSA) on Monday.

The PSA said that from January to October 2021, the leading causes of death in the country were ischaemic heart diseases, cerebrovascular diseases, and deaths due to COVID-19.

The agency said that during this period, ischaemic heart diseases were the top cause of death with 110,332 cases or 18.3 percent of the total deaths in the country.

“This indicated an increase of about 28.0 percent from the 86,164 deaths or 16.9 percent of the total deaths in the same period of 2020,” it added.

The second top cause of death is cerebrovascular diseases with 58,880 deaths (9.7% share of the total) during the said period.

The PSA said this is 10.9 percent higher than the 53,082 cases recorded in the same period in 2020.

Deaths due to COVID-19 with virus identified was ranked as the third leading cause which accounted for 51,514 deaths (8.5% share), rising from rank 15 with 7,357 deaths (1.4% share) in the same period of 2020.

The PSA, however, noted that it separated COVID-19 cases under two classifications — COVID-19 with virus identified and COVID-19 virus not identified. Both were included in the top 10 leading causes of death in the country.

Registered deaths due to COVID-19 with virus not identified accounted for 23,771 or 3.9 percent of the total deaths from January to October 2021, making it the 8th leading cause of death.

Registered deaths due to COVID-19 accounted for a total of 75,285 deaths or 12.5 percent of the total registered deaths from January to October 2021.

 

Figure 1. All Causes of Mortality (Top 20), Philippines, January to October, 2020 and 2021

The PSA said that the National Capital Region (NCR) registered the highest number of deaths due to COVID-19 with 18,044 or 24.0 percent of the total COVID-19 deaths from January to October 2021.

CALABARZON ranked second with 16,630 deaths or 22.1%, while Central Luzon came in third with 14,252 deaths (18.9%).

Figure 3. COVID-19 Deaths in NCR Jan to Oct 2021

Other top leading causes of death in the country are neoplasms or cancer with 48,937 recorded cases from January to October 2021, and diabetes mellitus with 38,584 cases, the PSA said.

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