FDA’s report proves anti-dengue drug shouldn’t be used on children without prior infection

Photo: US Department of Health and Human Services Food and Drug Administration (consumerreports.org)

By Macon Araneta i FilAm Star Correspondent

The U.S. Food and Drug Administration’s finding of Dengvaxia supports that Philippine health authorities and Sanofi Pasteur (maker of the world’s first anti-dengue vaccine) blundered in pushing for the indiscriminate mass inoculation of Filipino school children, Surigao del Sur Rep. Johnny Pimentel said.

“After going over the U.S. FDA’s official press statement announcing the approval of Dengvaxia, it is clear that they approved the vaccine for use only in children previously infected with dengue,” Pimentel said.

He said the U.S. FDA disapproved the vaccine for use in children who never had dengue infection.

But he noted that the children in the country were vaccinated wholesale, regardless whether they had prior dengue infection.

Pimentel is former chairman of the House Good Government and Accountability Committee, which conducted a joint inquiry with the House Health panel into the Philippines’ controversial anti-dengue vaccination program using Dengvaxia.

Some 730,000 school children received Dengvaxia shots under the program that was launched in April 2016 but eventually abandoned in December 2017.

A study published in the New England Journal of Medicine later confirmed previous findings that children who never had dengue infection but given Dengvaxia shots had an increased risk of hospitalization and a severe case of the debilitating mosquito-borne disease from the third year after vaccination.

The U.S. FDA’s May 1 press statement said, “The U.S. FDA announced the approval of Dengvaxia, the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas. Dengue is endemic in the U.S. territories of American Samoa, Guam, Puerto Rico and the U.S. Virgin Islands.”

“Dengvaxia is not approved for use in individuals not previously infected by any dengue virus serotype or for whom this information is unknown. This is because, in people who have not been infected with dengue virus, Dengvaxia appears to act like a first dengue infection – without actually infecting the person with wild-type dengue virus – such that a subsequent infection can result in severe dengue disease,” the statement added.

“Therefore, health care professionals should evaluate individuals for prior dengue infection to avoid vaccinating individuals who have not been previously infected by dengue virus.

This can be assessed through a medical record of a previous laboratory-confirmed dengue infection or through serological testing (using blood samples from the patient) prior to vaccination,” the U.S. drug regulator said.

The Philippine government is spending another PHP 213 million this year to deploy an additional 425 nurses to monitor school children who received Dengvaxia shots, according to Pimentel.

The lawmaker said the nurses will visit public schools to check on the health condition of vaccinees, while others will be assigned to hospitals to keep close tabs on admissions of vaccinees.

The PHP 213 million is on top of the PHP 1.16 billion that Congress earmarked in 2018 “to provide the necessary health and medical assistance to Dengvaxia vaccinees,” Pimentel said.