FDA recalls Dengvaxia

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THE Food and Drug Administration (FDA) of the Philippines has ordered the recall of Dengvaxia, the world’s first anti-dengue vaccine, over concerns that it may put those inoculated with it at risk.

The FDA ordered French pharmaceutical giant Sanofi Pasteur to suspend the sale, distribution and marketing of Dengvaxia and withdraw the vaccine from the market pending compliance with the directives of the agency.

NOT FOR SALE A health officer packs Dengvaxia vaccines in a box hours after the Food and Drug Administration stopped the sale and distribution of the dengue vaccine. PHOTO BY RENE H. DILAN

Sanofi was also directed to conduct an information dissemination campaign through advisories, Dear Doctor Letters and patient fora.

The FDA said it is closely coordinating with the Department of Health in monitoring cases or reports of adverse events or reactions from those who have been administered with the vaccine.


“All drug establishments, including consumers and [health care professionals]are enjoined to take part in the post marketing surveillance of Dengvaxia by reporting to FDA any incident that reasonably indicates that Dengvaxia has caused or contributed to the death, serious illness, or serious injury to a consumer, a patient, or any person,” FDA Director General Nela Charade Puno said in a statement.

Hours after FDA issued its order, Sanofi released a statement on Tuesday saying that the company will hold dialogues with the regulatory body on the matter.

“We were informed of the position of the Philippine Food and Drug Administration which was published on December 4, 2017 and will work with them to review the implementation of their direction. We will continue to seek constructive and transparent dialogue with them,” Sanofi said.

It reiterated that Dengvaxia does not cause dengue fever.

“We remind you that the dengue vaccine does not contain any viruses that can make people ill with dengue or severe dengue. If you have had no previous dengue infection before vaccination, the vaccine does not give you dengue,” the company said.

Earlier, Sanofi proposed to the FDA the relabeling the Dengvaxia to reflect the new findings on the medicine.
The vaccine controversy broke when Sanofi admitted that the vaccine, which has been administered to more than 700,000 individuals, may cause a more severe case of dengue for first-time patients. The admission prompted the government to suspend the dengue vaccination program.

Refund

Sen. Ralph Recto said the government may still get back the money it paid for the acquisition of the vaccine.
According to Recto, Republic Act 9194 or the Government Procurement Reform Act compels the government to demand reimbursement for the money paid to the drug manufacturer.

Recto noted that under RA 9184, Sanofi, who supplied vaccine worth P3.1 billion, is duty-bound to refund the government because all government purchases are covered by warranty.

“In fact, RA 9184 requires the supplier to post [a]‘retention money’, which the government shall hold on to until the warranty has lapsed, to ensure that goods supplied are free from defects,” the Senate president pro tempore said.

He added that if Sanofi wants to retain public goodwill, it should follow the examples of many corporations that paid huge fines upon orders of regulatory bodies.

“Uber, Metrobank, RCBC (Rizal Commercial Banking Corporation), PAL (Philippine Airlines) are some of the companies which have willingly paid a fine, or settled obligations, for operational oversights committed,” he said.

But Sen. Richard Gordon blamed the administration of former President Benigno Aquino 3rd for allowing the vaccines to be administered to school children before the World Health Organization (WHO) issued pre-qualification guidelines.

Sen. Francis Pangilinan meanwhile called on the public to listen to independent health experts before passing judgment.

“If lawyers have their own individual interpretations of the law, the same is true of the medical community, which will have different opinions on this health issue,” said Pangilinan, who is also the president of the Liberal Party.

He said ten countries have approved the use of the anti-dengue drug — Singapore, Thailand, Indonesia, Mexico, Brazil, El Salvador, Costa Rica, Paraguay, Guatemala and Peru.

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