FDA to expedite evaluation process for potential COVID-19 vaccines
Marje Pelayo • September 24, 2020 • 228
MANILA, Philippines — The Food and Drug Administration (FDA) is preparing for the evaluation process of potential vaccines for coronavirus disease (COVID-19) once approved.
Before a vaccine is released for public consumption, it has to go through screening by the FDA, the country’s health product regulatory agency.
The agency assured it can expedite the process so the public can benefit from it at the soonest time possible.
According to FDA Director General Eric Domingo, the evaluation process is usually completed in one month’s time but the FDA is aiming to finish it in two weeks.
“ Bibilis kasi yung evaluation natin for COVID-19 (Our evaluation for COVID-19 will become faster) because unlike with other vaccines before, ngayon meron tayong (this time we have a) vaccine experts panel with DOST who will already be doing like a pre-screening,” Domingo explained.
“Titingnan na nila yung (They will look at) Phase 1 and Phase 2 clinical data then if it fails, it will not proceed to FDA,” he said.
The official further assured that despite the speedy process, the safety of the public will not be compromised.
“We cannot compromise safe for speed. The FDA will expedite the process but no step shall be skipped kasi there are things worse than no vaccine,” he said.
“A bad vaccine is worse than no vaccine and an unsafe or an ineffective vaccine is worse than no vaccine, iyon ang laging sinsabi sa atin ng WHO,” he added.
The FDA is currently dealing with 12 vaccine manufacturers and their vaccines will go through strict evaluation before they receive a certificate of product registration.
“We never said that we will reduce the time for any particular vaccine. All of the vaccines will be checked expeditiously and will be evaluated expeditiously. There will be no special treatment for any of the vaccines,” Domingo said.
Meanwhile, due to still evolving information on COVID-19, experts advise that even after being vaccinated, one should continue to observe minimum health protocols such as proper hand hygiene and wearing of face mask.
“How does it last? We don’t know everything as of now. Our knowledge is evolving so we have no idea yet. Even those who developed actively COVID-19 in previous studies it has been shown that the antibodies wane. Would it be the same with the vaccine? That is something to be seen. We cannot tell yet,” said Dr. Josefina Carlos, a clinical trialist. MNP (with reports from Aiko Miguel)
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:
Sinopharm- Wuhan Institute of Biological Products
Sinopharm- Beijing Institute of Biological Products
Astrazeneca- University of Oxford
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.
“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)
MANILA, Philippines — Some ‘minor defects’ have been seen in the test kits made by the University of the Philippines – National Institute of Health (UP-NIH), according to the Food and Drug Administration (FDA).
This prompted the agency to order the recall of all locally-made coronavirus disease (COVID-19) test kits and stop its use in medical facilities until the problem is resolved.
Specifically, FDA Director Eric Domingo said evidence of contamination had been traced in the reagents that were used in the test kits of UP-NIH; hence, they should not be sold or used for now.
The said locally-made test kits were approved for use by the FDA in April.
Nonetheless, Health Spokesperson Undersecretary Maria Rosario Vergeire ascertained that the UP-NIH is soon to complete correcting the deficiencies in their test kits.
“They are in the final stages of correcting the identified deficiencies of the kits by RITM and hopefully by next week they can be re-validated by RITM and we can already use the UP testing kits,” Vergeire said.
As regards the rapid antibody test kits, Malacañang maintained that local government units (LGU) may still use the said kits despite claims by medical societies that the use of such would be a waste of resources when they only give false results.
According to Presidential Spokesperson Secretary Harry to Roque, the LGUs just need to confirm the results of the rapid antibody test kits through real-time reverse transcription polymerase chain reaction (rRT-PCR) test within the succeeding 14 days.
“Sa ngayon po, dahil po wala pa tayong sapat na kakayahan at dahil tayo po ay nagbi-build up pa lang ng capacity ng PCR testing, siguro naman walang mawawala kung ira-rapid testing natin ang gusting magpa-rapid testing at yung mga positive, ipa-verify natin sa PCR [For now, since we do not have enough capacity yet and we are still building up our PCR testing capacity, there’s no harm if we still proceed with rapid testing to those who request it, and if it yields a positive result, then have it confirmed through PCR],” Roque explained.
FDA-approved rapid test kits costs around P3,500 and up depending on the source company and the country of origin. MNP (with reports Aiko Miguel)
MANILA, Philippines – Regulations on processed meat such as well-loved Filipino delicacies tocino and longganisa should be tightened by the Food and Drug Administration (FDA), according to the Department of Agriculture (DA).
According to Agriculture Undersecretary for Consumer Affairs Ernesto Gonzales, consumers cannot be complacent on buying these processed products especially if they are not sure of the source or origin of the raw meat.
Gonzales added that it is difficult to determine if the pork meat is contaminated with African Swine Fever (ASF) once it is processed.
He added that even ‘botcha’ or double-dead pork meat can be made into meat delicacies without the consumer noticing it because of colorings and extenders used in the process.
The official said the best way to determine if the pork meat is safe for consumption is to know the source of the raw meat, and if it is certified by the National Meat Inspection Service (NMIS).
“Kapag na-issue-han na ang karne from slaughterhouse ng meat inspection certificate (once meat from the slaughterhouse is issued with meat inspection certificate), definitely that meat is safe to eat,” Gonzales said.
However, the DA admitted that the government is lacking when it comes to regulations on processed meat so the coordination of the local government units (LGUs) is of utmost importance.
“Iyang problema natin yung mga maliliit na food processors na gumagawa ng mga longanisa, tocino, ang regulation hindi ganoon ka-strict ( The problem with small-time food processors or makers of longanisa and tocino is that the regulation is not that strict), ” Gonzales noted.
If ever the processed meat is infected with ASF, Gonzales said, it is still safe to eat, provided that it went through the proper cooking procedure of 30 minutes under 70’C temperature. – MNP (with details from Rey Pelayo)
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