Garin: Decision on Dengvaxia based on 'data available at the time'


MANILA, Philippines — Former Health Secretary Janette Garin insisted that there was no corruption involved in the purchase of the dengue vaccines, which have been found to be potentially harmful to those who had no prior dengue infection.

“It’s not a midnight deal. Everything was above board. The integrity management committee report of the DOH [Department of Health] will show that,” Garin said in a press briefing before the Senate probe into the Dengvaxia controversy Monday.

The former Health chief noted that the purchase of Dengvaxia was not hastily implemented. She added that the decision to procure Dengvaxia was not a personal decision, but an “institutional decision.”

“We decided based on the data available at the time with the desire to fight dengue,” Garin said.

France-based Sanofi Pasteur, in a November 29 disclosure, said that post-clinical trial study of Dengue Tetravalent Vaccine (Live, Attenuated) indicated an increased risk of hospitalization for dengue and “severe” dengue, “predominantly Grade I or II Dengue Hemorrhagic Fever”, for patients not previously infected by the virus, which is spread through mosquito bites.
The World Health Organization classifies the severity of dengue fever into four grades.
Grade I is characterized by “fever accompanied by non-specific symptoms” although patients will show hemorrhaging through a tourniquet test or through being easily bruised.
Grade II is characterized by spontaneous bleeding aside from the fever and easy bruising. 
“In individuals who have been previously infected by dengue virus, there is a clear and sustained benefit of being vaccinated with the dengue vaccine up to six years following the first injection,” Sanofi Philippines said in a statement on December 4.

The DOH, under the leadership of Garin, launched the dengue immunization initiative in Regions III, IV-A and National Capital Region—regions with high infection rates—in April 2016.

More than 860,000 people have been vaccinated with Dengvaxia. Over 830,000 children were vaccinated with Dengvaxia in schools and communities, while another 32,000 people were immunized in private hospitals. 

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The Food and Drug Administration approved the vaccine for the prevention of diseases caused by all four dengue types in individuals from nine to 45 years old but has since ordered a stop to its sale and distribution

Despite its approval, the Formulary Executive Council of advisers cautioned the DOH over the vaccine because its safety and effectiveness had not been established.

In an interview on ANC Friday night, Garin admitted that she met with the executives of Sanofi Pasteur in Paris to discuss Dengvaxia, the world’s first anti-dengue vaccine. She earlier denied that she met with the officials of the pharmaceutical giant.

She, however, maintained that there was “no malice.” 

DOH immediately placed the government’s dengue vaccination program on hold following the announcement of French pharmaceutical firm Sanofi Pasteur that the vaccine poses risks to those who were not infected by dengue virus before.

The FDA last week ordered to stop the sale and distribution of Dengvaxia and the withdrawal of stocks.

The government spent P3.5 billion for the purchase of the vaccines. 

DOH Secretary Francisco Duque III said he will demand the refund of the amount paid for the Dengvaxia and an indemnification fund from Sanofi to cover the treatment of all children who might contract severe dengue after being immunized.

READDOH suspends dengue immunization program over potential health risk

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