Dengvaxia ban likely to extend for more than a year – DOH

Marje Pelayo   •   December 11, 2018   •   3777

FILE PHOTO: The controversial dengue vaccine, Dengvaxia

MANILA, Philippines – The Food and Drug Administration (FDA) is likely to extend the ban on marketing and sales of Dengvaxia, according to the Department of Health (DOH).

December 29 this year marks the first year since the license of French pharmaceutical giant Sanofi Pasteur was suspended; banning its sale of Dengvaxia in the country.

The DOH believes that since the controversy on the anti-dengue vaccine is not yet closed, the ban on sale of Dengvaxia still remains.

“Iyong one-year suspension ng Dengvaxia CPR is not yet lifted and I do not see it being lifted anytime soon. We still have a lot of pending issues with the vaccine and at this time we do not see it being registered and allowed for marketing in the Philippines…regulatory issues and cases in Court,” said DOH Spokesperson Usec. Eric Domingo.

It will be recalled that the FDA suspended Sanofi for not submitting its post-marketing authorization requirements which were supposed to prove that the products manufactured by the pharmaceutical company are safe to use.

Sanofi also couldn’t assure the safety of Dengvaxia, according to DOH.

The DOH noted that in November 29, 2017, Sanofi released a statement that Dengvaxia is not advisable to be administered to seronegative recipients —children or adults—who never had dengue infection prior to injection for the reason that their cases are likely to develop into severe dengue.

“It cannot be used without testing for children if they had dengue before. And there are no available testing kits commercially to do that. We don’t see naman any use for the vaccine at this time,” Domingo said.

The DOH also argued that the even regulatory agencies in the world that were granted with licenses to use Dengvaxia such as in Brazil, have set restrictions on the use of Dengvaxia on children who never had dengue infection prior to injection.

Hindi na rin sila magbibigay without screening,” Domingo said.

Based on the latest findings of the DOH, about 24 to 25 cases of dengue infection led to death due to severe dengue.

“We’ve seen talagang meron tayong patients who have, na ang mortality nila was due to severe dengue and I think probably from talagang seronegative patients iyon,” the health official said.

Meanwhile, the DOH is still waiting for the approval of Congress regarding the supplemental budget for vaccinees from the refund that Sanofi gave which reached P1.16-B.

Domingo said before the end of the year, the Office of the Solicitor General is likely to file a case against Sanofi Pasteur in line with the Dengvaxia controversy. – Marje Pelayo (with reports from Aiko Miguel)

FDA warns against risks of UV emitting devices for disinfection against COVID-19

Marje Pelayo   •   November 26, 2020

MANILA, Philippines — The Food and Drug Administration (FDA) strongly advises against the use of ultraviolet (UV) light near or on human body parts for disinfection against coronavirus disease (COVID-19). 

The FDA through Republic Act 9711 or the FDA Act of 2009 is mandated to regulate radiation devices such as UV emitting devices. 

According to the World Health Organization (WHO), UV radiation can cause skin irritation and damage to eyes due to exposure.

Additionally, the International Commission on Non-Ionizing Radiation (ICNIRP) does not recommend the use of UV lamps for consumers or personal use.

UV radiation is typically classified into three wavebands with varying effects to human health specified as follows:

  • UV-A (100-280 nm) classified as soft UV with health effects associated with skin aging and other effects; 
  • UV-B (280-315 nm) associated with sunburns, skin cancer and cataracts;
  • UV-C (100-280 nm) commonly used in ‘germicidal’ or disinfection lamps, also associated with sunburns and eye injury – a condition known as ‘photokeratitis’.

The agency advised the public to follow disinfection protocols from the Department of Health (DOH) like proper handwashing, coughing and sneezing etiquette and physical distancing as best preventive measures against the virus.

FDA warns public against purchase of SM Bonus sugar, other unregistered products

Marje Pelayo   •   October 28, 2020

MANILA, Philippines – The Food and Drug Administration (FDA) has issued an advisory warning healthcare professionals and the general public against purchase and consumption of unregistered food products including a common brand of sugar.

FDA Advisory No. 2020-1927 released Wednesday (October 28) named the following products as unregistered:

  • Melvan Ginger Brew With Turmeric And Lemongrass, 250g
  • Sweet Valley Freeze Dried Cranberry Coated With Milk Chocolate
  • Lorenzo Farm Dark Chocolate, 55g
  • SM BONUS Brown Sugar
  • SM BONUS Refined Sugar

Based on the agency’s post-marketing surveillance (PMS) activities, the said products were verified to have not been issued with Certificate of Product Registration (CPR).

Thus, the FDA said it cannot guarantee their quality and safety.

It told the public to not purchase the aforementioned violative products.

As per the report, the agency further urged the public to be vigilant against food products that might not be duly registered with FDA. 

Also, the agency warned establishments not to advertise, distribute or sell the said violative food products until CPR is issued.

Failure to secure product authorization has its corresponding penalty and sanction, the FDA said.

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)

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