The approval by the US Food and Drug Administration of Dengvaxia for use only on previous victims of the disease proves that the mass inoculation of children during the administration of President Benigno Aquino III was a major blunder, a congressman said on Friday.
Surigao del Sur Rep. Johnny Pimentel said: “after going over the US 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.”
“The US FDA disapproved the vaccine for use in children who never had dengue infection,” Pimentel said.
“But in our case, children were vaccinated wholesale, regardless whether they had or did not have prior dengue infection.”
Pimentel is a former chairman of the House committee on 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.
Dengvaxia, which was developed by Sanofi Pasteur of France, is the only vaccine against dengue.
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 who were given Dengvaxia shots anyway, had an increased risk of hospitalization and a severe case of the debilitating mosquito-borne disease from the third year after vaccination.
The US FDA’s May 1 press statement reads as follows: “The US FDA announced today 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 nine through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas. Dengue is endemic in the US territories of American Samoa, Guam, Puerto Rico and the US 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,” the statement said.
“This is because in people who have not been infected with the 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.
“Therefore, health care professionals should evaluate individuals for prior dengue infection to avoid vaccinating individuals who have not been previously infected by the dengue virus. This can be assessed through a medical record of a previous laboratory-confirmed dengue infection or through serological testing [tests using blood samples from the patient] prior to vaccination,” the US drug regulator said.
The Philippine government is spending another P213 million this year to deploy an additional 425 nurses to monitor the school children who received Dengvaxia shots, according to Pimentel.
Pimentel said the nurses will visit public schools to check on the health condition of the vaccinees, while others will be assigned to hospitals to keep close tabs on the admissions of vaccinees.
The P213 million is on top of the P1.16 billion that Congress earmarked in 2018 “to provide the necessary health and medical assistance to Dengvaxia vaccinees,” Pimentel said.