FDA: Sanofi Pasteur did not disclose negative effects of Dengvaxia if administered prior to dengue infection

admin   •   February 27, 2018   •   4433

FILE PHOTO: A logo is seen in front of the entrance at the headquarters French drugmaker Sanofi in Paris October 30, 2014. CREDIT: REUTERS/CHRISTIAN HARTMANN

MANILA, Philippines — The Food and Drugs Administration (FDA) said that the French pharmaceutical company, Sanofi Pasteur did not initially disclose the negative effects of Dengvaxia vaccine on people who have not had dengue infection.

“We visited some of the documents of Singapore recently. With their publication, they already announced that it is not to be used for patients who haven’t had dengue,” said FDA Director General Nel Acharade Puno.

“This means they should have had known about it since December 22, 2015, and they should have told the Philippine government that this anti-dengue vaccine cannot be injected to children without prior dengue infection,” added the official.

This has also been the claim of former President Benigno Aquino III in his first appearance in the inquiry of the Lower House on the controversial anti-dengue vaccine.

Aquino explained that he approved the use of the Dengvaxia due to the information he received from Sanofi that the anti-dengue vaccine was safe and approved by the FDA.

The former chief executive sent his condolences to the families of the children whose deaths are being linked to Dengvaxia.

Nevertheless, Aquino said he and his former officials should not be blamed for the incident.

“Dito may dumating na impormasyon noong November 2017. Baliktad sa hinarap sa aming impormasyon noong kami ay nagdedesisyon ,” said Aquino.

(In this case, an information came in November of 2017. It was opposite of the information presented to us when we decided on its approval.)

Aquino also made insinuations about an unnamed individual who, he said, was pretending to be a health expert while examining the alleged victims of Dengvaxia.

“Lalo na po yung isang maingay na ang certification ay tila isang antas lang ang lamang sa nabibiling diploma sa Recto ,” said the former president.

(Especially this one who is too loud, but whose certification seems to be just one rank above a diploma that can be bought in Recto.)

Although the former president did not give a name, Public Attorney’s Office (PAO) chief Persida Acosta defended her forensic expert Dr. Edwin Erfe.

“Siya po ay forensic and medical evidence analysis forensic examiner. May certificate po siya sa Harvard. Hindi naman po mabibili yan talagang paghihirapan mo po yan,” said Acosta.

(He is a forensic and medical evidence analysis forensic examiner. He has a certificate from Harvard that can’t be bought, you must work hard for it.)

In the House inquiry, Department of Health (DOH) Sec. Janette Garin insisted anew that they allowed the use of the Dengvaxia anti-dengue vaccine under the Aquino administration due to the rising number of dengue cases in Regions III, IV-A and National Capital Region (NCR).

“Layunin po ng progama na ito na hindi lang pigilan ang mga namamatay at patuloy na namamatay sa dengue kundi pigilan ang pagkakasit ng dengue,” said Garin.

(This program aims not just at preventing deaths due to dengue but also at stopping stopping dengue fever.)

Incumbent Health Sec. Francisco Duque III meantime seeks for the immediate conclusion of the House inquiry, noting it only created fear among the public against other vaccination programs of the agency.

“Are we ready to have outbreaks of measles, of diphtheria, pertussis, hepatitis, of HPV? I think we have to be mindful of the implications of a very prolonged investigation,” said Duque. — Grace Casin | UNTV News & Rescue

FDA approves use of 5 rapid COVID-19 test kits

Robie de Guzman   •   March 30, 2020

MANILA, Philippines – The Food and Drug Administration (FDA) on Monday (March 30) said it has approved the use of five rapid test kits for novel coronavirus disease (COVID-19) in support of efforts to address the pandemic.

In a statement, the FDA said these point-of-care test kits are registered for use in countries with reliable regulatory agencies such as China and Singapore.

“We approve kits that are registered and used in countries with advanced technology and wide experience with COVID 19,” FDA Director General Eric Domingo said.

Domingo said the rapid test kits will yield a faster result compared with PCR-based kits, but he stressed that its results should be evaluated and interpreted by a trained health professional.

“We have to be very cautious in using these rapid test kits because they measure antibodies and not the viral load itself,” he said.

As a safety precaution, the FDA requires all rapid test kits to have the following product inserts or label: “This product is strictly for medical professional use only and not intended for personal use. The administration of the test and interpretation of results should be done by a trained health professional. Confirmatory testing is required.”

“The body takes time to develop antibodies and this might give a negative result for patients who have been infected but antibodies have not yet developed antibodies,” Domingo said.

“A positive result due to cross reaction with other bacteria or viruses is also possible, which is why a confirmatory PCR based test is still required,” he added.

The FDA also announced it has approved the SARS Cov2 kit by Gene Xpert from Abbott Laboratories.

This PCR-based test kit, the latest in the 17 kits approved for commercial use, can detect the virus within five minutes, according to the agency.

No available COVID-19 test kits in Phl yet — FDA

Maris Federez   •   March 15, 2020

MANILA, Philippines — The Food and Drug Administration (FDA) has reiterated that there are no registered COVID-19 diagnostic test kits that are now available to the public yet.

In a statement issued on Sunday (March 15), the FDA said this is so “because no company has complied with the minimum set of requirements.”

The FDA added that they are only asking for a License to Operate (LTO) as a distributor and a Certificate of Product Registration (CPR) from a reliable and mature national regulatory agency (NRA) such as FDA counterparts in the United States, Japan, Singapore, South Korea, Europe, among others, from those who want to import test kits.

In the absence of such, a Certificate of Prequalification or Emergency Use Listing from the World Health Organization (WHO) is also admissible.

As of Sunday, the FDA said, no company has submitted these.

The agency also denied that there is a delay in the approval of the test kits, adding that as soon as proper documents are submitted to the FDA, the certification will be immediately released.

The FDA stressed that the submission of proper documents relative to the test kits will safeguard the public interest and ensure that the available test kits for use are safe and will give useful results.

“Many companies have been marketing test kits since the start of the COVID outbreak, however, the source and reliability of these devices are yet to be verified,” the statement reads.

Director-General Eric Domingo explained, “We cannot vouch for its safety and efficacy by merely accepting the stated claims of a testing kit without the proper regulatory certification from the country of origin and a reliable NRA. These kits may give false positive and false negative results which may affect the response to this pandemic. They may also be counterfeit products that will not test for the novel coronavirus at all.”

The FDA added that the only COVID-19 diagnostic test kits used now are PCR based lab kits at the Research Institute of Tropical Medicine (RITM) which were donated by the WHO, and the University of the Philippines National Institutes of Health (UP NIH) and Department of Science and Technology (DOST) developed test kit which is scheduled to start field testing on Monday, 16 March 2020.

The FDA ensures that it is committed to staying true to its mandate of safeguarding public health.

“During these difficult times, we strongly request everybody to cooperate and to be vigilant. This is not the time to take advantage of the scarcity of resources by allowing unregulated items into the system. Let us continue to look after each other’s safety.” DG Domingo concluded. — /mbmf

FDA allows use of COVID-19 test kits developed by local scientists

Robie de Guzman   •   March 10, 2020

test kit

MANILA, Philippines – The Food and Drug Administration (FDA) on Tuesday approved the use of test kits, which were developed by local scientists, to confirm cases of novel coronavirus disease (COVID-19) in the country.

In a statement, the FDA said it has issued a certificate of exemption for the SARS-CoV2 PCR test kits developed by the University of the Philippines-National Institute of Health (UPNIH), which was funded by the Department of Science and Technology.

The SARS-CoV 2 is the official name of the rapidly spreading novel coronavirus strain.

“This supports the CODE RED status raised by the Department of Health (DOH) and the recent declaration of President Rodrigo Duterte of a state of Public Health Emergency,” the FDA said.

Duterte earlier declared a public health emergency amid the rising cases of COVID-19 infections in the Philippines.

The DOH also raised Code Red Sublevel 1 after confirming the country’s first case of coronavirus local transmission.

FDA Director General Rolando Enrique Domingo said the test kits will help accommodate the growing number of people suspected to have contracted the virus.

“The increasing number of reported COVID 19 cases will require immediate diagnosis and monitoring. This will provide our laboratories with technological reinforcement to accommodate the growing number of patients to be tested and aid in early screening of positive cases. Furthermore, this will provide greater access to a less costly diagnostic procedure,” he said.

As of Monday, March 9, the Philippines has recorded 24 confirmed cases of novel coronavirus infections.

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