DOH agrees with FDA decision to ban Dengvaxia in Phl

Maris Federez   •   August 22, 2019   •   1167

A Filipino nurse prepares to administer an anti-dengue vaccine during a nationwide vaccination at a school in the flood-prone city of Marikina, east of Manila, Philippines, 04 April 2016. (Photoville International / FILE)

The Department of Health (DOH) has rejected the request of Sanofi Pasteur to overturn the decision of the Food and Drug Administration (FDA) to ban the use of Dengvaxia vaccine in the Philippines.

With this, the DOH approved the ruling of the FDA to permanently revoke the certificate of product registration of Dengvaxia for Sanofi’s failure to submit the necessary post-approval requirements.

“The decision concerns Sanofi’s complete disregard of FDA regulations, which were precisely put in place by law to ensure safety,” DOH Secretary Francisco Duque III said in a statement.

Although Sanofi was able to submit the first two versions of its risk management plans (RMP), the pharmaceutical company failed to submit the third and final version of the plan.

The DOH said, however, that Sanofi may apply for a new certificate of product registration (CPR) for Dengvaxia but this must be in accordance with the FDA regulations.

“Given that Dengvaxia is an innovative drug, the importance of complying with these post-marketing commitments is critical to public safety,” the statement added.

Meanwhile, the department has assured that it continues to address the increasing cases of dengue in the country. /mbmf

FDA to expedite evaluation process for potential COVID-19 vaccines

Marje Pelayo   •   September 24, 2020

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)

Duterte: PH will purchase cheapest COVID-19 vaccine

Aileen Cerrudo   •   September 8, 2020

President Rodrigo Duterte said the Philippines will purchase the cheapest vaccine for the coronavirus disease (COVID-19).

During his public address Monday evening (September 7), the President said he is optimistic that a vaccine will be available this September.

“I think it’s Moderna. It’s a US company. I think they are ready by September,” he said.

Aside from China, Russia also offered their COVID-19 vaccine to the Philippines.

The President added that the government will choose the company that will offer the cheapest vaccine since the country has limited funds.

“Pare-pareho lang naman iyan. Parehong germs iyan. Kung sino lang ang nauna magbigay sa’tin na mura, doon tayo pupunta, kasi they know that we do not have enough money. Kung mahal masyado, we will go for the less expensive ones,” Duterte said. AAC (with reports from Rosalie Coz)

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

Marje Pelayo   •   July 30, 2020

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)

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