FDA permanently revokes Dengvaxia’s certificate of registration

admin   •   February 19, 2019   •   2704

FILE PHOTO: The controversial dengue vaccine, Dengvaxia

The Food and Drug Administration has permanently revoked anti-dengue vaccine Dengvaxia’s certificates of product registration (CPR) due to the continued failure of manufacturer, Sanofi Pasteur Inc. to submit post-approval commitment documents.

FDA Director General Nela Charade Puno on Tuesday cited in a statement the French pharmaceutical firm’s disregard of the agency’s rules and regulations as reason for its CPRs’ cancellation.

“Its brazen defiance of FDA’s directives and its continued failure to comply leaves us no other recourse but to impose the maximum penalty of revocation of the CPRs covering the Dengvaxia products,” Puno said.

The revocation of the Dengvaxia’s CPR makes its importation, sale and distribution illegal in the Philippines, according to the FDA.

Dengvaxia’s CPR was initially suspended for a year since December 29, 2017 after Sanofi’s failure to comply with post-marketing requirements.

Prior to the lapse of the one-year suspension on December 17, 2018, Sanofi failed to comply with post-marketing authorization requirements. The company has since then suspended the sale and marketing of the vaccine. — Robie de Guzman

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FDA warns vs unsupervised use of Dexamethasone drug linked to COVID-19 treatment

Robie de Guzman   •   June 19, 2020

MANILA, Philippines – The Food and Drug Administration (FDA) on Friday warned the public against the use of steroid drug Dexamethasone without a prescription, following reports on its potential to treat novel coronavirus disease (COVID-19).

In an advisory, the FDA reminded the public that misuse or unsupervised chronic use of dexamethasone may lead to serious adverse reactions such as:

  • Immunosuppression or impairment of the body’s ability to fight infection
  • Gastrointestinal bleeding and ulcers
  • Electrolyte imbalance
  • Osteoporosis
  • Muscle weakness
  • Poor wound healing
  • Prolonged use of the drug may cause suppression of growth among infants and children
  • Obesity

If stopped abruptly, it may cause withdrawal symptoms such as hypotension, shock and coma.

“Dexamethasone is a steroid drug and is prescribed by a licensed physician based on the patient’s medical condition,” the FDA said.

“All are enjoined to report the dispense and/or use of the drug without a valid prescription to FDA Center for Drug Regulation and Research e-mail at cdrr.od@fda.gov.ph,” it added.

The agency also urged those using the drug to report any adverse reactions through this link.

The FDA warned that violators will be dealt with legal actions.

IATF approves Phl participation in COVID-19 vaccine clinical trials

Maris Federez   •   May 24, 2020

MANILA, Philippines — Upon the recommendation of the Department of Science and Technology (DOST), the Inter-Agency Task Force for the Management of Emerging Infectious Diseases (IATF-MEID) has approved the proposed participation of the Philippines in clinical trials that seek to formulate a potential vaccine against coronavirus disease 2019 (COVID-19).

Based on IATF Resolution No.39 dated May 22, 2020, the task force has also ordered the creation of a sub-technical working group which will be led by the DOST.

The group will be coordinating with the four collaborating organizations composed of the Department of Health (DOH), the Food and Drug Administration (FDA), the Research Institute for Tropical Medicine (RITM), and the World Health Organization (WHO) with regard to the said clinical trials.

The IATF has also issued a directive to the FDA to facilitate the processing of necessary permits for the conduct of the clinical trials in the country.

The collaborating organizations for the clinical trials are the Adimmune Corporation, Academia Sinica, Chinese Academy of Science- Guangzhou Institute of Biomedicine and Health, the Sinopharm – Wuhan Institute of Biological Products, and the Beijing Institute.

Once the clinical trials are undertaken, these will be included in the FDA’s requirements for the registration process for the vaccine and the application for certificate of registration to make the vaccine available in the market.

The Philippines has initially participated in the WHO’s clinical trials, which include the testing of off-label drugs that show potential of being effective against COVID-19.

Meanwhile, the IATF has also approved the plans of the DOST to construct research centers for the local vaccine research development.

These include the Virology S&T Institute at the New Clark City in Tarlac and the reactivation of the Pharmaceutical Development Unit of the DOST-Industrial Technology Development Institute. —(from the report of Rosalie Coz) /mbmf

DOH admits COVID-19 testing capacity still below 8,000 to 10,000 daily target

Marje Pelayo   •   April 29, 2020

MANILA, Philippines — The Department of Health (DOH) on Wednesday admitted that the country’s testing capacity for coronavirus disease (COVID-19) is still below the target.

The Department had planned to expand its mass testing to 8,000 – 10,000 tests daily starting Thursday (April 30).

But, according to Health Undersecretary Maria Rosario Vergeire, they may not be able to achieve the target as scheduled.

Mukhang hindi po aabot dito sa walong libo for April 30, though sinusubukan natin dahil ngayon po dumating na ang cartridges natin for GeneXpert [I don’t think we can achieve the 8,000 target for April 30 though we are trying, especially with the arrival of the cartridges for GeneXpert,]” the official said.

The DOH was able to conduct a total of 6,320 tests on Tuesday (April 28) in 19 licensed testing laboratories across the country. 

Vergeire noted the recent scaling down of operations at the Research Institute for Tropical Medicine (RITM) as one reason for the delay in testing of samples which left the processing of results pending for about a week.

The RITM has just resumed full operations on Sunday after more than 30 of its COVID-19 positive medical staff recovered from the disease.

With the use of GeneXpert test kits, the DOH expects the results to be out within 45 minutes which will definitely improve the country’s testing capacity and hopefully achieve its daily target.

“But ngayon po itong ating goal ay pilit na maabot, aabutin [We will try hard to achieve our goal in] the coming days as all the resources had been falling in coming from private side and coming from the government,” Vergeire said.

Meanwhile, the Food and Drug Administration (FDA) has added a polymerase chain reaction (PCR) test kit from Singapore and two brands of rapid antibody test kit from Germany and China among the list of approved test kits that may be used in hospitals across the country.

To date, the country has a total of 33 FDA-approved PCR-based test kits and 24 rapid antibody test kits. 

The DOH reminds the public, however, that these test kits may only be administered by licensed doctors and experts who are also authorized to interpret test results. –MNP (with details from Aiko Miguel)

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