While the deaths of 129 children due to the new dengue vaccine Dengvaxia are being investigated, and charges are being filed against Ministry of Health and Sanofi officials in the Philippines, the European Medicines Agency approved Dengvaxia in December 2018, and the US FDA gave Dengvaxia an abbreviated review (as a priority) last October, with a licensing decision due on May 1, 2019. Both EMA and US FDA were aware of the deaths in the Philippines when they made their Dengvaxia decisions.
From Drugs. com:
"Dengue is endemic in the US territories of Puerto Rico and the US Virgin Islands. In 2010, Puerto Rico experienced the largest outbreak when more than 12,000 cases were confirmed. Incidence remained high in subsequent years, particularly in 2012 and 20131,2. Dengue represents a health and economic burden in Puerto Rico with total annual associated costs reaching an estimated $160.2 million.3"
From Drugs. com:
"Dengue is endemic in the US territories of Puerto Rico and the US Virgin Islands. In 2010, Puerto Rico experienced the largest outbreak when more than 12,000 cases were confirmed. Incidence remained high in subsequent years, particularly in 2012 and 20131,2. Dengue represents a health and economic burden in Puerto Rico with total annual associated costs reaching an estimated $160.2 million.3"
Was Dengvaxia going to be the next mandated vaccine on the childhood schedule in Puerto Rico, US Virgin Islands, Florida and Texas, all of which have cases?
From the Philippines Star:
From the Philippines Star:
The Department of Justice (DOJ) panel of investigating prosecutors yesterday found probable cause to file eight counts of reckless imprudence resulting in homicide against former Department of Health secretary Janette Garin and nine other current and former DOH officials for the alleged deaths of children linked to the Dengvaxia vaccine.
The prosecutors, led by Senior Assistant State Prosecutor Ma. Emilia Victorio, also recommended the filing of reckless imprudence resulting in homicide against Dr. Vicente Belizario Jr., Dr. Kenneth Hartigan-Go, Dr. Gerardo Bayugo, Dr. Lyndon Lee Suy, Dr. Irma Asuncion, Dr. Julius Lecciones, Dr. Maria Joyce Ducusin, Dr. Rosalinda Vianzon and Dr. Mario Baquilod of the DOH.
The 127-page resolution covers the investigation on some of the Dengvaxia-related complaints filed by the Public Attorney’s Office (PAO). Aside from Garin and the nine DOH officials, the DOJ also recommended eight counts against Dr. Socorro Lupisan and Dr. Maria Rosario Capeding, both from the Research Institute for Tropical Medicine; and Carlito Realuyo, Stanislas Camart, Jean Louis Grunwald, Jean Francois Vacherand, Conchita Santos and Jazel Anne Calvo from the Dengvaxia-manufacturer Sanofi Pasteur Inc. (SPI).
Meanwhile, four counts of reckless imprudence resulting to homicide were recommended against Ma. Lourdes Santiago and Melody Zamudio of the [Philippines] Food and Drug Administration (FDA).
In a statement, the panel said it found “Garin and the other respondents to have exhibited ‘inexcusable lack of precaution and foresight’ when they facilitated, with undue haste, ‘the registration and purchase of Dengvaxia’ and used the vaccine in implementing a school-based dengue mass immunization program.”
It also said that Garin and the other respondents reportedly circumvented various regulations in the purchase of P3.5 billion worth of the anti-dengue vaccine that constituted proof of their reckless imprudence.
The DOJ panel said that at the time of purchase, the Dengvaxia vaccine was reportedly not yet listed in the Philippine National Drug Formulary (PNDF). A purchase request for the vaccine was only made in March 2016.
It was also learned that clinical trials for Dengvaxia were not yet completed when it was purchased and rolled out for use in the mass immunization program.
Despite the ongoing clinical trials, the [Philippines] FDA reportedly approved the vaccine’s registration.
Sanofi, on the other hand, reportedly submitted its application for the registration of Dengvaxia in January 2015. By December 2015, the FDA approved the marketing of Dengvaxia and issued its product registration, well before the completion of the two clinical trials.
Thereafter, Garin and the other respondents allegedly fast-tracked its exemption from the PNDF-listing requirement, purchased the vaccines and used it to vaccinate school children through the government’s mass immunization program.
It added that Sanofi reportedly failed to monitor and did not conduct close surveillance of the Dengvaxia recipients, nor did it extend any medical assistance to the victims or their families even after reports of serious adverse reactions surfaced...
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