French pharmaceutical company Sanofi Pasteur is the largest company devoted entirely to vaccines, with 2016 sales of over $5 billion. With 13,000 employees, the company spends $1 million per day on its research and development programs.
This past week Sanofi announced that its highly promoted dengue vaccine —Dengvaxia—could lead to more serious infections if used in the wrong setting. Unfortunately, the “wrong setting” is what the company promoted the drug for in the first place. Sanofi now says: “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. For individuals who have not been previously infected by dengue virus, vaccination should not be recommended.”
Ironically, almost exactly two years ago on December 12, 2015 we wrote about “killing dengue.” We provided the background of the new drug. “The search for a vaccine against dengue fever has been ongoing for 86 years. Mexico approved the drug [Dengvaxia] after trials on 40,000 people in 15 nations [including the Philippines]. These tests showed that vaccine reduced the risk of hospitalization by 80 percent and lowered the possibility of developing the severest, hemorrhagic form of the disease by 93 percent.”
“Both the Department of Health [DOH] and the Philippines’s Food and Drug Administration are pushing to fast-track approval and include the drug in its vaccination program in 2016. A study done in 2012 estimated that the annual cost to the nation could run as high as P15 billion considering the cost of diagnosis, treatment and income loss for patients and caregivers.”
Then-President Benigno S. Aquino III attended the launching of the drug by the DOH on April 5, 2016. Since then, over 700,000 Filipino children have been vaccinated and it is probable that they are now potentially exposed to a serious health risk, if they have not previously contracted dengue.
The Aquino administration spent P3.5 billion on the program maybe with the best of intentions. Aquino critics are asking: “Was the Dengvaxia vaccination rushed in time for the 2016 presidential campaign to boost Mar Roxas’s candidacy?” And comments like, “A giant pharma company connives with a corrupt government to force a vaccine of dubious efficacy upon an unsuspecting populace.”
This may be over-the-top political commentary, but there is no doubt that the previous administration was alone in its speed to use the vaccine. Malaysia waited until April 2017—one year later than the Philippine launch—to approve Dengvaxia for a two-year study involving only volunteers, not in the general population. Thailand was part of the initial testing program and in December 2016 began offering Dengvaxia but not forcing people to take it.
Only in the Philippines was there a national immunization program. So significant was the program that when Sanofi reported poor sales of the dengue vaccine for the first quarter in May 2017, it specifically cited the Philippine government purchases of Dengvaxia, saying, “The Philippines continues its public vaccination program. The vaccine has notched more than a dozen approvals around the world but hasn’t been included in nationwide vaccination programs outside of the Philippines.”
While the actual risk to the 700,000 children has not been qualified, there is no doubt that the previous administration rushed this vaccination program for whatever reason. Was this good intention gone wrong or something more sinister?
Sen. Joseph Victor G. Ejercito, chairman of the Senate health committee, on Saturday said he would open an inquiry. Those involved in this vaccination decision must provide thorough explanations, he said. Ejercito better make sure that there’s no cover up. The parents of those vaccinated children are watching.
Image Credits: Jimbo Albano