Dengvaxia sale suspended
Parties involved in vaccine fraud to face full force of the law – Palace
The Food and Drug Administration (FDA) has suspended the sale, distribution, and marketing of dengue vaccine Dengvaxia, while Malacañang assured the public that the Duterte administration will not hesitate to use the full force of the law against those who will be found to have committed irregularities in the dengue
vaccine issue.
At the House of Representatives, congressmen decided to revive its probe into allegations of anomalies in the purchase of 13.5-billion anti-dengue vaccine from French pharmaceutical firm Sanofi Pasteur, Inc. (Sanofi).
Last Monday, the FDA said in a public advisory that it had pulled the vaccine from the market to “protect the general public”
“In order to protect the general public, the FDA immediately directed Sanofi to suspend the sale/distribution/ marketing of Dengvaxia and cause the withdrawal of Dengvaxia in the market pending compliance with the directives of the FDA. Sanofi was further directed to conduct an information dissemination campaign through ‘Advisories, Dear Doctor Letters and Patient’ fora,” stated FDA Advisory No. 2017-318 dated December 4 and signed by FDA Director General Nela Charade Puno.
The FDA took cognizance of the November 29, 2017 advisory of Sanofi “providing updated information on the Dengue Tetravalent Vaccine (Live, Attenuated), the drug locally registered as Dengvaxia. The advisory contained information on the completion of a postclinical trial study of the said product indicating potential risk to patients who have not had dengue prior to immunization.”
Full force of the law In a press briefing in Malacañang, Presidential spokesman Harry Roque urged the public to wait for the result of the probe being conducted by the Department of Justice (DOJ) on the issue.
“We would like to assure the public that we’re not taking the Dengvaxia issue sitting down. And that if there are people or if there will be culprits and if it is proven that there’s a cause of action against them, then this administration will not hesitate to use the full force of the law against them. But so far, let us wait for the (result of the) investigation,” Roque told reporters.
Dengvaxia, the first dengue vaccine to be licensed after being approved in Mexico back in December, 2015, was used in the Department of Health’s (DOH’s) dengue vaccination initiative that was launched in three highly endemic regions (Regions 3, 4-A, and National Capital Region) with over 733,000 individuals receiving at least one dose of the vaccine.
On Friday, Health Secretary Francisco Duque III announced that the health department is putting on hold the mass dengue immunization program following the new analysis on the Dengvaxia.
“In the light of this new analysis, the DOH will place the dengue vaccination program on hold while review and consultation are ongoing with experts, key stakeholders, and the WHO,” Duque said.
“The DOH is highly committed in strengthening and intensifying its ongoing surveillance and monitoring to evaluate the program and ensure safety,” he added.
He noted that there will be “mandatory history taking on the immunization of vaccines” and “mandatory reporting of hospital cases of vaccines regardless of the symptoms.”
Authorities have now ordered a blanket suspension for private use as well.
“‘Whether (the vaccine) is used in the public health program or used by a private practitioner, it is the same product that was licensed. Everyone is covered by the FDA advisory,” Health Undersecretary Gerardo Bayugo told AFP.
On the same day that FDA suspended the sale, distribution, and marketing of Dengvaxia, Sanofi allayed fears and clarified that the “severe dengue” which the vaccinated people might get without prior exposure to dengue, is not fatal.
“In individuals who have not been previously infected by dengue virus, there is an increased risk of hospitalization for dengue and severe dengue, predominantly Grade I or II Dengue Hemorrhagic Fever,” Sanofi Pasteur Global Medical Head Ng Se Peing explained.
The French drug manufacturer said that in contrast, the vaccine was found to be effective for those who had prior exposure to dengue.
While disclosing these findings, Sanofi noted the effects should not be widespread because of the high “seroprevalence” – the number of infected persons in a given population – in the three regions where public school children have been immunized.
With this development, the FDA assured that it is “closely coordinating with the DOH for any adverse events or reactions that may be reported by the recipients following their immunization of the Dengvaxia, and will immediately take appropriate measures to protect the public.”
“All drug establishments, including consumers and non-consumer user (e.g. healthcare professionals) are enjoined to take part in the post marketing surveillance of Dengvaxia, by reporting to FDA any incident that reasonably indicates that the anti-dengue vaccine has caused or contributed to the death, serious illness, or serious injury to a consumer, a patient, or any person,” the FDA added.
Dengue fever and dengue hemorrhagic fever, which are transmitted by a bite of an Aedes aegypti mosquito, are acute viral infections that affect infants, young children, and adults. An average of 200,000 cases of dengue is reported every year, according to the DOH.
Dengvaxia probe
The House Committee on Good Government has decided to reopen its probe six months after terminating the proceedings upon the assurance made by Sanofi that its Dengvaxia vaccine is safe and effective.
Committee chairman and Surigao del Sur Rep. Johnny Ty Pimentel said new developments on the Dengvaxia issue have prompted his decision.
Invited to appear in the December 13 hearing set by the House panel are former and incumbent government officials involved in the National Dengue Immunization Program (NDIP) that launched a Dengvaxia vaccination program for some 733,000 public school students.
Also asked to show up in the hearing are Sanofi officials, as well as private medical specialists who have knowledge about the tests and laboratory research results of the vaccine.
The House good government panel was the second body in the Lower Chamber to conduct a probe into the Dengvaxia controversies.
Nueva Ecija Rep. Estrellita Suansing, author of one of the five resolutions filed last year to probe the NDIP implemented by the Department of Health in 2016, noted that members of the House Committee on Health wanted the vaccination project of the Aquino administration stopped as early as January this year.
But the Committee on Good Government, after conducting two public hearings on the alleged irregularities of the 13.5-billion transaction, terminated its probe with the assurance from Sanofi that Dengvaxia is safe.
The purchase of the vaccine was approved during the past administration despite strong objections from medical experts for lack of certification from the World Health Organization (WHO).
The Dengvaxia deliveries were completed barely 15 days after Sanofi received the purchase order which was processed by the Philippine government in just nine days.
Pimentel said he is willing to reopen the probe “if there is new info or if there is a need.”
According to Suansing, a research they conducted indicated that the biggest number of dengue infections occurred in Mindanao.
NBI probe
Justice Secretary Vitaliano Aguirre II has asked parents to approach the government if their children have manifested adverse effects after receiving the anti-dengue vaccine Dengvaxia.
Aguirre made the appeal after he ordered the National Bureau of Investigation (NBI) to investigate the 13.5 billion purchase of the vaccine which was approved during the previous administration.
“Come forward to us. Give your information to the NBI,” said Aguirre.
“Kailangan malaman ng gobyerno natin ang nangyari lalo na yung may adverse effect lalo na sa mga bata na naturukan nitong vaccine (The government needs to know the adverse effects especially on the children who received the vaccine),” he pointed out.
Aguirre issued Department Order (DO) No. 763 on Monday which directed the NBI to conduct the probe.