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

admin   •   February 27, 2018   •   4174

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

Number of dengue cases in NCR exceeds alert threshold – DOH

Maris Federez   •   August 16, 2019

A child suffering from dengue fever receives medical treatment at an isolation ward of a government-run hospital in Manila, Philippines, 16 July 2019. (Photoville International)

The National Capital Region (NCR) has recorded more than 11,000 dengue cases from January to August 10 this year.

This is 33% higher than what was recorded in the past five years.

“It’s starting to rise and just like the other regions that began with the alert levels, naging epidemic level na sila [they’ve reached the epidemic level]. Pwede pa ring sumipa ang dengue. Kaya hindi ho tayo pwedeng magpahinay-hinay [Dengue case can still go up. That’s why we should not be complacent],” Department of Health (DOH) Secretary Francisco Duque said.

The cities in the NCR where dengue cases have spiked include Paranaque, Malabon, Taguig, Makati, and Mandaluyong.

The DOH clarified that no medicine, supplement, or vaccine had been proven to cure dengue.

The health department also supports the move of the Department of Science and Technology (DOST) to fund the distribution of food supplements which may help increase an individual’s platelet count to avoid dengue.

“Wala namang gamot ang dengue. Wala ring bakuna. At kung meron man sila ng inaalay na makakagamot, hindi po totoo iyan. Ito po ay food suppmement lamang at kinakailangan merong FDA certificate of product registration [There is no medicine for dengue. No vaccine either. And if there are some who offer something that’s supposed to cure dengue, it’s not true. It’s just a food supplement and it needs to have FDA certificate of product registration],” Duque added.

The health official then reminded the public to clean their surroundings and eradicate dengue-mosquito breeding areas through the 4 o’clock habit using the 4S strategy:

  • Search and Destroy
  • Self- Protection
  • Seek Early Consultation
  • Support Space Spraying

This is to further prevent the number of dengue cases in Metro Manila to further exceed the health department’s alert threshold. (from the report of Aiko Miguel) /mbmf

Ombudsman probes PAO’s Acosta, Erfe for alleged corruption

Robie de Guzman   •   August 16, 2019

Public Attorney’s Office (PAO) chief Persida Acosta

MANILA, Philippines – The Office of the Ombudsman on Friday confirmed it is investigating Public Attorney’s Office (PAO) chief Persida Acosta and Forensic Laboratory chief Dr. Erwin Erfe for alleged graft and corruption.

In a statement, the Ombudsman said it is currently conducting preliminary and administrative adjudication against Acosta and Erfe on corruption allegations within PAO including the controversial Dengvaxia vaccine issue.

The case stemmed from the complaints filed early this year by lawyer Wilfredo Garrido Jr. who sought for the suspension of Acosta and Erfe for allegedly committing corruption, falsification, malversation and illegal use of public funds or property.

The two PAO officials supposedly made money in alleged illegal purchases of office supplies for their crusade against Dengvaxia in 2018.

Acosta was also accused of using PAO budget to hold seminars at luxury hotels as she supposedly receives a commission for every gathering.

The Ombudsman said that after Garrido’s complaints were evaluated and docketed in April 2019, an order was immediately issued, directing the respondents to file their respective counter-affidavits.

“Records from the criminal and administrative cases show that respondents are facing criminal charges for violation of Sections 3(e) and 3(j) of Republic Act No. 3019 (Anti-Graft and Corrupt Practices), Falsification by Public Officer, Malversation and Illegal Use of Public Funds or Property,” the statement read.

Administrative charges for Grave Misconduct, Serious Dishonesty, Grave Abuse of Authority and Conduct Prejudicial to the Best Interest of the Service, were also leveled against Acosta and Erfe,” it added.

Acosta and Erfe have denied the allegations in a consolidated counter-affidavit they filed last April 30.

The Office of the Ombudsman said several other pleadings were filed by the respective parties during the course of the investigation, including the one signed by alleged “DOJ PAO lawyers.”

The Ombudsman said that as of August, the parties were directed to file their respective verified position papers containing their positions, supporting evidence and defenses.

“The corruption allegations against the high-ranking PAO officials will be judiciously scrutinized and the cases shall be resolved solely on the basis of the evidence presented by the parties,” Ombudsman Samuel Martires said.

Malacañang earlier said it will not interfere with the case.

Batch of Similac Tummicare One Infant Formula recalled over label, scoop difference – FDA

Robie de Guzman   •   August 16, 2019

📷 FDA Facebook page

MANILA, Philippines – Abbot Laboratories, the maker of One Infant Formula, Similac Tummicare, has voluntarily recalled a batch of the product due to differences in the label instructions and scoop size, the Food and Drugs Administration (FDA) said.

In an advisory, the FDA said the 820-gram packs of Similac Tummicare with batch no. 03518QU, manufacturing date of March 2019 and expiration date of March 2022 “contained a smaller red preparation scoop compared to the white preparation scoop that is shown on the label instructions.”

Abbot Laboratories was prompted to issue a recall order after receiving an inquiry from a customer regarding the consistency.

“The product is safe to consume, however, if the red scoop is used to prepare the formula according to the label instructions and provided to an infant as a sole source of nutrition, it would not provide sufficient nutrition to support normal growth,” the FDA said in an advisory issued Wednesday.

Although Abbott Laboratories has not received any adverse events from the incident, the company “has decided to proceed with caution and voluntarily recalled the product from the market.”

The firm also clarified that the recall applies only to the product with batch no. 03518QU and no other Abbott Laboratories products are affected by this recall.

For information on how to obtain either a replacement product or full refund, consumers are advised to contact Abbott Laboratories hotline at telephone no. (02) 995-1555 (Manila) or 1800-10-995-1555 (Province) or email familyties.ph@abbott.com.

The public may also email the FDA at info@fda.gov.ph for any question or additional information regarding the recall.


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