FDA Licenses Dengvaxia Vaccine After Students Die in Philippines

FDA Licenses Dengvaxia Vaccine After Students Die in Philippines

The U.S. Food and Drug Administration (FDA) announced on May 1, 2019 its licensing approval of Sanofi Pasteur’s Dengvaxia vaccine, which was designed to prevent a mosquito borne viral infection known as dengue fever.1 Symptoms of dengue range from mild (or none at all) to high fever along with headache, body pain, nausea, vomiting and pain behind the eyes, with most people recovering within a week.2 According to an FDA news release, dengue fever is endemic in the U.S. territories of American Samoa, Guam, Puerto Rico and the U.S. Virgin Islands.1

The FDA confined the license for the live virus vaccine only to children aged nine to 16 years who have had a prior laboratory-confirmed prior dengue fever infection and who live in areas where the disease occurs regularly throughout the year. According to the FDA, Dengvaxia is not approved for use in individuals without lab confirmation of previous infection by any dengue virus serotype or for whom this information is unknown. This is because in people who have not been previously infected with dengue virus, the live virus Dengvaxia vaccine appears to act like a first dengue infection and increases the odds for severe complications if the vaccine fails to protect against a subsequent infection with wild type dengue virus.1

According to Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research:

Infection by one type of dengue virus usually provides immunity against that specific serotype, but a subsequent infection by any of the other three serotypes of the virus increases the risk of developing severe dengue disease, which may lead to hospitalization or even death.” He adds that, “As the second infection with dengue is often much more severe than the first, the FDA’s approval of this vaccine will help protect people previously infected with dengue virus from subsequent development of dengue disease.1

Earlier this year, Sanofi asked the FDA to approve Dengvaxia for people between the ages nine and 45 but the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) decided that the vaccine was not effective in preventing the disease in adult patients living in endemic regions who have been previously diagnosed with dengue. The VRBPAC vote was 7-6 and one abstention.3

However, in patients between nine and 16 years old living in endemic areas with a previous diagnosis, the panel voted 13-1 supporting the vaccine’s efficacy in preventing forms of the disease caused by serotypes 1-4.3 According to Pharmafile, when considering the vaccine’s safety, the panel voted 7-7 against its use in adults but voted 10-4 in favor of its use for younger patients.3

The vaccine has had a controversial history since its launch in the Philippines in 2015. Dengvaxia was administered to over 700,000 Filipino students in a school-based government vaccination program in April 2016. In late 2017, Sanofi Pasteur announced that its dengue vaccine, Dengvaxia, could possibly lead to more severe cases of dengue fever in some people who get infected with the virus after being vaccinated. Studies revealed that giving the vaccine to people who had never contracted the disease leaves them vulnerable to severe complications if they subsequently contract the disease.4

This announcement came after 700,000 children were already given the vaccine in the Philippines. According to Sanofi, those who had never been previously infected with the dengue virus were at greatest risk. The government of Philippines suspended the use of the vaccine amidst concerns about its safety.4

On Mar. 1, 2019, the Department of Justice in the Philippines announced that it had found probable cause to charge six officials from French vaccine manufacturer Sanofi Pasteur, 10 Philippine health officials and officials of the country’s Food and Drug Administration and its Research Institute for Tropical Medicine with reckless impudence leading to the death of students. Ten students, who had never had dengue fever, were given Sanofi’s Dengvaxia vaccine and subsequently became infected with the dengue virus and did not survive.4


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8 Responses to "FDA Licenses Dengvaxia Vaccine After Students Die in Philippines"

  1. Joy   May 9, 2019 at 7:49 pm

    Isn’t it wonderful, population control is coming in a vaccine near you.

    Reply
    • Deborah   May 10, 2019 at 8:59 am

      Wow. I hadn’t thought about it like that…

      Reply
  2. Malinda Barker   May 10, 2019 at 9:30 am

    You will never see a story like this in the US. Never see anything negative regarding vaccines on mainstream media. Sad.

    Reply
  3. j   May 10, 2019 at 12:59 pm

    What a vast malaise of government AND privates being bought off, by bigger privates.
    What a sad ocean of ignorance in the American populace to promote communism, communitarianism (Agenda 21, l”sustainability” Real ID Act, Green crap, et al.), and dangerous substances old government would never have allowed to be sold–let alone forced upon We The Poor People. (That humming sound you hear is The Founders spinning in their graves.)
    _ The FDA was earliest our most incompetent Executive Branch alphabet ‘Agency,” at least that could directly harm the public, first.
    BUT NOW CORRUPTION IS THE ONLY GOV-APPROVED “SCIENCE.” The Leftist media publicizes ONLY the propaganda.
    CDC insiders exposed vaccines (2013) as causing autism (known, since ~2000, and they filmed their meeting to cover it up), only to be re-/more-covered up. FDA released the xxxxGLIFLOZIN drugs (SGLT2), notably as if to help “Type 2” Diabetes, knowing since 2013 it would give your balls gangrene. ONE LIE AFTER THE NEXT. But ever since the HIV-AIDS hoax, they KNOW how to grow the drug-sales demographic. Now they hype HPV vaccine for uterus-free boys. Did you know, mom, dad? Fake mom’s voice, “I knew….”
    OAFBAMARXCARE MAKES US BUY OVERPRICED INSURANCE VIA GOV. Since 1985, VACCINE MAKERS CANNOT BE SUED FOR NEGLIGENCE OR INTENT.
    _ Gov branches are getting rich filthy, along with the drug co’s, chemical co’s (Monsanto, etc.), and too bad if your Boeing jet plane is designed to auto-crash without training the pilots how to resist.
    (GIVE THESE BAD DRUGS TO CATHOLIC “PRIESTS” AND MAKE THEM FLY THE JETS.)
    _ This is not your father’s outsourced, crashed Oafsmobile.

    THE SILENT MAJORITY NO LONGER HAS A VOTE, at least thanks to Electronic Voting Machines (EVMs), BUT SOON CRIMINALS & ILLEGALS WILL.
    We might as well have a retarded “royalty” ruling us, instead of the corporate fascist oligarchy. Or we could stand in the street and wave little flags, for emperor or dictator.
    _ But we’re too brainwashed to riot, anymore. We know NOTHING, Sgt. Schultz (from when there were only 3 TV channels). “Your” “Representatives” “souled-out.” YOUSE ARE NOT “REPRESENTED.” DO WE CARE? Will we only preach to the choir?
    Oh, I have to get this twit text.

    Reply
  4. Eh   May 11, 2019 at 7:16 am

    …then why is it that only the Philippines out of the 8 countries its used in has children dying?

    Sounds like somethings wrong on their end and it’s not the vaccine.

    Reply
    • Jas   May 15, 2019 at 12:10 am

      It was launched in the Phillipines. Nowhere in this article does is say it was used anywhere else unless I’m missing it. If it has, we don’t know if there were complications/harm just because it isn’t mentioned in this article.

      Reply
  5. mary59   May 11, 2019 at 11:05 am

    Dengue Fever comes and goes in Hawaii Island. There are no cases currently, but it can cause very serious symptoms and can be fatal. One of our friends contracted it and was ill but fortunately was very healthy and recovered. His wife is well versed in botannical medicine and he took Papaya leaf and Goldenseal to help with his recovery.

    Reply

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