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P3-B immunization program

Findings show mass vaccination of children premature, says Gordon

/ 07:08 AM June 15, 2018

CALL FOR JUSTICE Members of the Coalition of People’s Right to Health seek justice for children immunizedwith the Dengvaxia vaccine during a picket outside the Department of Health in April. —GRIG C. MONTEGRANDE

Sen. Richard Gordon on Thursday said the findings of a new study on Dengvaxia sustained his position that the acquisition of Sanofi’s dengue vaccine by the Aquino administration was done in haste and without enough safety study.

Published in the New England Journal of Medicine on Wednesday, the analysis confirmed that Dengvaxia increases the risk of hospitalization and severe dengue in children who had not been previously infected by the mosquito-borne virus.

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In November 2015, the Aquino administration bought Dengvaxia supplies from Sanofi for P3 billion and launched a massive immunization campaign in April 2016.

But last November, the French pharmaceutical company issued a warning that Dengvaxia could increase the risk of severe dengue based on a new analysis of blood samples from thousands of children who had been immunized with it.

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Immunization drive halted

Three days after Sanofi’s announcement, Health Secretary Francisco Duque III halted the immunization program.

By then, more than 800,000 schoolchildren aged at least 9 had been vaccinated with Dengvaxia.

People are supposed to trust the Department of Health and its recommendations because it is the guardian of public health, Gordon, who headed the Senate inquiry into the Aquino administration’s purchase of Dengvaxia, said on Thursday.

But it did not do its job properly on Dengvaxia, he said.

“The findings of the journal show it has not been adequately tested. There is a flaw in [the] system, which can result in a situation with fatal consequences or additional expenses for the people,” he said.

Gordon said that while the study presumed everything was aboveboard, it could not be denied that when the Aquino administration bought Dengvaxia, there was violation of standard government procedure from beginning to end.

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Public not informed

The public was also not informed of the risks posed by the vaccine, he added.

Gordon said the Aquino administration could have postponed the purchase of Dengvaxia, as other countries were also developing vaccines to counter dengue.

As to the Aquino administration’s contention that threat to public health made the purchase urgent, Gordon said dengue was not like the deadly Ebola virus.

“People were not dying like flies, people were not totally scared,” he said.

Different groups have brought charges against former President Benigno Aquino III and three former members of his Cabinet over the acquisition of Dengvaxia.

Aquino, former Executive Secretary Paquito Ochoa Jr., former Budget Secretary Florencio Abad and former Health Secretary Janette Garin are facing graft and corruption charges in the Office of the Ombudsman and the Department of Justice for allegedly rushing the acquisition of Dengvaxia.

They are also facing charges in the Commission on Elections for launching the immunization campaign during election season.

PAO stance bolstered

Lawyer Persida Rueda-Acosta, chief of the Public Attorney’s Office (PAO), on Thursday said the findings of the study supported the stand of her office that Dengvaxia posed risks even to children with previous exposure to the dengue virus.

The PAO had counted 62 hospitalizations after immunization and found that three of the children died despite having been previously infected.

“The other 59 who have not been previously infected are at greater risk because of the higher chances of them getting adverse effect,” Acosta said.

Sanofi supported the new study, but Acosta said it was already late.

“That’s still risky. Even if you say only 2 percent or 4 percent are at risk of dying, those are still human beings. They are not pigs,” she said.

“That’s an experimental drug. Why did they use it withought screening?” she added.

Same as November notice

Sought for comment, Garin said the New England Journal of Medicine study was the same disclosure made by Sanofi last November.

“To reiterate what transpired in 2016, when we asked about the safety signals, Sanofi’s answer, as confirmed by [the World Health Organization], was that safety signals [were] in those 2-5 years old, that’s why the vaccine is recommended for those 9 and above. Meaning, they pointed at ‘age’ as a factor,” Garin said.

“But later on, after using a newly developed kit, they said it’s now ‘age and serostatus’ that is related to safety signals,” she said.

“However, the WHO, in December 2017, pointed out that the Philippine subnational immunization program in a setting where seroprevalence was above 85 percent (93 percent), the benefits were clear,” she said.

In a statement, Sanofi said on Thursday that the study confirmed Dengvaxia’s “potential to prevent dengue, particularly severe dengue (84 percent) and hospitalizations due to dengue (80 percent) for the five-year follow-up period of the study in individuals 9 years of age or older who have had a prior dengue infection.”

Sanofi also said that in  countries where Dengvaxia had been approved, the company had proposed an update to the prescribing information for the vaccine recommending use in people with prior infection and warning against vaccination of those without prior exposure to the virus.

“At present, several countries have already decided to move forward with the proposed label update and the rest are still reviewing it,” Sanofi said.

The company said it had “realized” the need to “communicate complex science in an understandable way to avoid unnecessary anxiety and correct any misunderstanding in the public about the safety or efficacy of our vaccines.”

But for Ian Colite of Imus City, Cavite province, the findings of the study were “good news.”

Colite’s 11-year-old son Zandro died last December, months after being immunized with Dengvaxia.

The Colites were among the first group of families that filed charges against Aquino and his three former Cabinet officials and Sanofi executives with the help of the PAO.

“That’s good news,” Colite said after learning about the results of the study. “That might help [strengthen] our case [against Sanofi].” —WITH REPORTS FROM TINA G. SANTOS, GABRIEL PABICO LALU AND MARICAR CINCO

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TAGS: Dengvaxia, immunization, Richard Gordon
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