December 14, 2017, 4:42 am
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Sale of dengue vaccine suspended

THE Food and Drug Administration (FDA) yesterday suspended the sale of controversial dengue vaccine Dengvaxia and ordered its withdrawal from the market.

This as government assured that people will be held accountable for the mess created by the dengue vaccine that was provided to more than 730,000 children through the government’s mass immunization program.

The FDA, in its Advisory No. 2017-318, ordered vaccine manufacturer Sanofi Pasteur, Inc., “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.”

The agency said the order is in response to the latest advisory issued by Sanofi regarding the potential adverse effect of the dengue vaccine.

“The advisory contained information on the completion of a post-clinical trial study of the said product indicating potential risk to patients who have not had dengue prior to immunization,” said FDA.

The World Health Organization supported the Philippines’ suspension of dengue vaccinations.

In a statement, the WHO said: “Like many others in the Philippines, WHO is awaiting the expert analysis of new data and advice about its implications for use of the vaccine. In the meantime, WHO supports the Philippines Department of Health’s (DOH) decision to suspend the ongoing vaccination program until more information is available. This is appropriate in the circumstances,” it said.

Health Secretary Francisco Duque III said there will be an extensive probe on who should be held liable for the erroneous dengue vaccine program given the latest advisory issued by its manufacturer.

“Once it is proven that there were information that were not fully disclosed but were factors in these latest developments, someone will surely be held accountable,” said Duque in a radio interview.

“There will be cases filed,” he added.

Duque said DOH legal services is going through the DOH-Sanofi contract to see if there are any legal implications of the controversy.

The National Bureau of Investigation has been ordered to probe the dengue vaccine controversy.

Duque said private individuals also have the option to file class suits against individuals whom they believe should be held liable.

“I heard there were already those planning to file class suits in behalf of the children, who have been vaccinated and their worried parents,” he said.

REFUND?

Duque said the DOH could also push for a refund of the P3.5 billion public funds spent in procuring the dengue vaccines from Sanofi.

He said DOH has a stockpile of about P1.4 billion worth of dengue vaccines.

The vaccines, which are stored at the Research Institute for Tropical Medicine, are set to expire between 2018 and 2019.

Senate President pro tempore Ralph Recto said the DOH could demand a refund, citing the Government Procurement Law, or Republic Act 9184.

“RA 9184 has an anti-lemon provision. It is discussed extensively in Section 62, which deals with faulty, defective substandard goods and services. The bottomline is that the government is entitled to restitution,” Recto said.

“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,” he added.

Recto said this is a standard clause in all government contracts.

“Kung wala ito sa kontrata sa pagbili ng bakuna, may natulog sa pansitan.”

If the supplier ignores the demand, Recto said section 65 says “that its properties shall be subject to attachment or garnishment proceedings to recover the costs.”

Recto noted that many corporations have been paying huge fines upon orders of regulatory bodies, “a path Sanofi should follow if it wants to retain public goodwill.”

“Uber, Metrobank, RCBC, PAL are some of the companies which have willingly paid a fine, or settled obligations, for operational oversights committed,” he said.

SYMPTOMS

Duque, meanwhile, raised doubts on claims made by Sanofi that having “severe” cases of dengue are not as bad as the public’s belief.

He noted how the picture painted by the pharmaceutical firm is under a controlled environment.

“Sanofi’s definition of severe is under controlled circumstances, which are under their close supervision.

But that is different from what is happening on the ground, from reality, from those that are in far-flung areas. Of course they cannot supervise everyone,” stressed Duque.

According to Sanofi officials, the severe case they have been referring to are only fever of two days, having bruises, and nose bleeding.

Duque also said they cannot just disregard the remaining 10 percent, who were given vaccines but have not had dengue, therefore has the chance of being afflicted with a “severe dengue case.”

The Department of Education said it has not received any report of untoward reactions to Dengvaxia dengue vaccine from public school students.

Education Secretary Leonor Briones said: “We are looking into the breakdown on whether these 700,000 are all students or if they are from the communities and adults because the DOH itself has its own health programs wherein this vaccine was also utilized, so we want to look at that.”

“We need to inform the parents, further inform the parents of the situation. They have to help us monitor the children because we, the children are only under our care during weekdays, during school time,” she said. – With Evan Orias, JP Lopez, Jocelyn Montemayor and Reuters
 
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