Senators on Friday expressed alarm over the health dangers posed by Dengvaxia, a dengue vaccine the Department of Health (DOH) used in its school-based vaccination program, to patients who have not contracted dengue fever in the past.
A new data analysis has concluded that if Dengvaxia is given to individuals who haven't been exposed to dengue, they could get more serious infections when they encounter the virus naturally. Sanofi's revised label will no longer recommend vaccination in patients who were previously uninfected by dengue virus-but will instead limit its recommendation of the vaccine to patients in countries with high burden of dengue disease where potential benefits outweigh the potential risks.
Before the current analysis, a research team previous year found that the vaccine-if given to dengue-naïve individuals-"acts very much like a natural infection but without making recipients sick".
Based on the report, the Dengue vaccine has shown consistent and sustained benefit for those who were previously infected with the dengue virus.
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Philippine health officials began vaccinating over a million children in April past year (2016) with Dengvaxia, the world's first dengue vaccine, amid safety concerns expressed by public health advocates. In a press conference in March 28 of the same year, Garin said that Dengvaxia passed thorough clinical trials and was approved by the World Health Organization (WHO).
The health department, nonetheless, is reviewing its contract with Sanofi.
At least 730,000 children have already received the first of three doses of the vaccine as of Nov 17.
Sanofi's dengue vaccine-which took 20 years and $1.5 billion to develop-has come far short of initial blockbuster sales ambitions.
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Duque said the government will profile all those who received the vaccination and heighten its surveillance mechanisms. "So the value of that has to be preserved", said Duque. We want their official definition of what is "severe".
"The DOH and the Department of Education should also closely monitor the kids that were vaccinated and ensure that proper medical support will be provided to them", he added.
The DOH, on the other hand, said the pharmaceutical company must clarify their definition of "severe dengue".
The Food and Drug Administration will also halt the commercial sale of Dengvaxia in the country until Sanofi replaces its packaging with one that states a new warning.
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