FDA Approves 6 in 1 Combo Vaccine for Babies

FDA Approves 6 in 1 Combo Vaccine for Babies

Story Highlights

  • On Dec. 21, 2018, the U.S. Food and Drug Administration (FDA) approved a new combination hexavalent vaccine (Vaxelis) that includes antigens for six diseases to be given in three doses to infants and children between six weeks and four years of age.
  • Manufacturers Sanofi Pasteur and Merck jointly developed Vaxelis, which combines diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and haemophilus influenza type B vaccines into one shot, and the new combination vaccine is expected to be commercially available in the U.S. in 2020.
  • The FDA has only approved Vaxelis to be given to infants for the first three doses, usually given at two, four and six months, and children will have to get a separate dose of DTaP vaccine to complete the primary pertussis vaccine before age four. 

On Dec. 21, 2018, the U.S. Food and Drug Administration (FDA) approved a new combination hexavalent vaccine (Vaxelis) that includes antigens for six different diseases: diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive haemophilus influenza type B.1 Vaccine manufacturers Sanofi Pasteur and Merck jointly developed Vaxelis, which is approved to be given in three doses to children between six weeks and four years of age but children will have to get a separate dose of DTaP vaccine to complete the primary pertussis vaccine series before age four. The new combination vaccine is expected to be commercially available in the U.S. in 2020.2

Sanofi provided the antigens for diphtheria, tetanus, pertussis, and poliomyelitis for Vaxelis production and Merck provided antigens for H. influenzae type b and hepatitis B.3 Vaxelis has been approved by government regulators in the European Union since 2016.4

Monovalent vaccines include only one antigen, while multivalent or polyvalent vaccines like Vaxelis include either more than one strain of a microorganism or more than one type of microorganism. Widely used multivalent vaccines include the live attenuated measles, mumps and rubella vaccine (MMR) and the inactivated diphtheria, tetanus and acellular pertussis vaccines (DTaP for children under age seven and Tdap for older children and adults). Separate vaccines for measles, mumps, rubella and pertussis are not available in the U.S., while tetanus and diphtheria vaccines are only available as a combination (DT or Td) vaccine.

Drawbacks of Combination Vaccines

Combination vaccines have been created by manufacturers to purportedly reduce the number of shots a child must receive to be in compliance with government recommended childhood vaccine schedules and to simplify ordering, transport and storage of vaccines.5

Drawbacks to the multivalent vaccines include a higher risk of pain and swelling at the injection site and, and for Merck’s MMRV (mumps, measles, rubella, varicella) vaccine in particular, a higher incidence of febrile seizures in children under age four.7 The product manufacturer package insert for the new hexavalent vaccine states that Vaxelis is contraindicated in children with a history of severe allergic reaction to any of the ingredients of the vaccine, or to any “other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, or H. influenzae type b vaccine.”

According to the Vaxelis product insert, contraindications include “a history of encephalopathy (coma, decreased levels of consciousness, prolonged seizures) within 7 days of a previous dose of pertussis-containing vaccine, that is not attributable to another cause” and “a history of progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy until a treatment regimen has been established and the conditions has stabilized.” Warnings and Precautions include temperature over 105F within 48 hours not attributable to another identifiable cause; collapse or shock-like state (hypotonic-hyporesponsive episode (HHS) within 48 hours; persistent, inconsolable crying lasting more than three hours within 48 hours; and seizures with or without fever within three days.

The product insert reports high rates of adverse reactions among children receiving the experimental hexavalent vaccine in clinical trials: “Rates of adverse reactions varied by number of doses of Vaxelis received. The solicited adverse reactions 0-5 days following any dose were irritability (≥55 percent), crying (≥45 percent), injection site pain (≥44 percent), somnolence (≥40 percent), injection site erythema (≥25 percent), decreased appetite (≥23 percent), fever ≥38.0°C (≥19 percent), injection site swelling (≥18 percent), and vomiting (≥9 percent).”1


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45 Responses to "FDA Approves 6 in 1 Combo Vaccine for Babies"

  1. Colorado   January 3, 2019 at 6:41 pm

    Being that we did not vaccinate our children at all, what’s the flip side? Anything to worry about? With side effects like mentioned above, who needs to get sick? Requesting an article that details the real world effects of all the pathogens, one by one, vs the real world effects of the vaccines meant to handle that particular issue. This is so far out of control at this point. We would have requested limited vaccinations, but only for life threatening diseases. As regular laymen consumers we rejected all vaccinations because of the conflicts of interests and obvious deception where we’re supposedly required to be vaccinated for everything under the sun including ailments which would cure on their own without medical interjection. The risk of being vaccinated is obviously greater than the reward. How about some more articles for parents like us whom have refused to vaccinate out of principal and an abundance of caution. If I’m reading the above correctly, nearly half of all infants would have side effects and one in ten would get so sick they threw up? Absurd expectations to think parents will give anything to their child with even a 1 in 10 chance of making them sick or ill in any way what so ever. 8 years later and our oldest gets top grades and is regarded as one of the smartest 2nd graders in the school. Teachers are still surprised when I tell them we did not do anything special except hold to a strict gmo free and sugar free diet, and did not vaccinate. But if you want your child to be in a zombie like then hyperactive state with no rhyme or reason to it and have attention deficit disorders, be sure to give them all the vaccinations and feed them glyphosate enriched non organic cereals and be sure to save a dollar on non organic sugar filled milk products. Still hoping for an NVIC printed newsletter because we will leave that at doctors offices… Thank you.

    Reply
    • Cynthia   January 4, 2019 at 12:45 am

      AMEN! I am so fed up with our government, the FDA, the CDC, and the BS. Fact is vaccines aren’t a one size fits all. There is no medical reason for combo shots physicians will tell you. But the evil empire of Big Pharma does this on purpose because they are greedy. And they’re allowed to do this in our America! Who wants to inject neurotoxins & poisons into their children. Most Americans do because they do’t know any better. I was one of them & my son and our family suffers on a daily basis. I have let go of the guilt but not the pain. I let the pain drive me to help educate others on truth. I once met a epidemiologist that had worked at the CDC. The sweetest man really, yes I asked him that big question & you’d be astounded w/ his reply. He stated that many who work within the walls of the CDC DO NOT vaccinate their children, grandchildren etc… As God is my witness. Why would he tell me this? A divine appt!

      Reply
    • Bob   January 4, 2019 at 8:48 am

      Colorado, probably if parents actually read the list of side effects, they would be much more cautious, but most just listen to their doctor who tells them that there are no problems and you are a dangerous parent if you don’t vaccinate on their schedule. People rarely see or ask to see the inserts that come with the product. Ignorance is bliss…and a life of dealing with a child with auto-immune disease of some kind.

      Reply
    • Valerie   February 28, 2019 at 6:47 pm

      Colorado: I just wanted to thank you for your comment. I commend you for not vaccinating your children and for giving them the BEST chance for a healthy life by feeding them a wholesome diet. I am 61 y/o and vaccine-injured with a 31 y/o daughter who has extremely fragile health…due to vaccines, chronic infections, allergies, FOOD allergies, and the overuse of antibiotics and inhaled steroids(“breathing treatments.”) She carries an Epipen and is only able to eat a handful of foods. My father and 2 uncles were CIA-trained MD’s within the allopathic/Big Pharma “system,” and they shot us all full of toxins from birth. I’m having to stand by and WATCH my 3 y/o great-nephew become sickly, hyperactive and autistic, and it literally breaks my heart. I SAW him regress after each vaccine. His mother is a brainwashed Nurse Practitioner within this same evil “system,” and she disregards any information I share about the “flip side” of vaccines. I’m afraid that we’re now living in a world FULL of hyperactive, brain-damaged Zombies…where people have LOST the ability to think. They simply follow orders and stay glued to their cell phones. It’s really sad and a lot more dire than people realize.

      Reply
      • Jennifer   March 2, 2019 at 11:18 am

        Im sorry, are you really claiming, in 2019, that vaccines cause autism and hyperactivity??

        Reply
        • Susan   March 23, 2019 at 7:00 am

          I think that’s exactly what she is saying because she has lived it. Do you think everyone with a reaction testimony is lying??? They’re not.

          Reply
        • Valerie Griner   April 10, 2019 at 1:49 pm

          Okay, Jennifer. Let me rephrase this for you. Vaccines cause “autoimmune diseases,” including ASIA, PANS, PANDAS, POTS, and most other “syndromes.” Does leaving out the word “autism” make you feel better? I would also like to add that my background is in medicine and (regrettably), I worked for 4 major pharmaceutical companies for 25+ years. I research medical journals from around the world…topics that the average layperson would not understand. Do you have any more questions for me?

          Reply
  2. Doug   January 3, 2019 at 6:50 pm

    Crimes Against Humanity Should Be Treated Same As Treason Against United States !

    Reply
  3. Dr. Lawrence Kahn   January 3, 2019 at 6:57 pm

    Sanofi should be brought up on charges of crimes against humanity and prosecuted to the fullest extent of the law.

    Reply
    • Jo   January 13, 2019 at 1:21 pm

      Only Sanofi? This goes back to I.G. Farben, Bayer, and the ever present “philanthropists”, the Rockefeller Bros., along with many others. The list of criminals is quite long.

      Reply
  4. Karen   January 3, 2019 at 7:25 pm

    This is insanity y

    Reply
  5. CATRYNA WHITE   January 3, 2019 at 7:26 pm

    ” new combination hexavalent vaccine (Vaxelis) that includes antigens for six different diseases: diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive haemophilus influenza type B.”

    And, yet upon checking into this vaccine they found no antigens at all….NONE! What you get is lots of obnoxious poisons and filth that can
    make you very very ill……or dead!

    Reply
  6. INGRID C DURDEN   January 3, 2019 at 7:30 pm

    And they will let children get this vaccination ? With all these adverse reactions ? I hope parents get to read all this. If I had a young child, I would probably move to another country, where there are a lot less vaccinations to be had.

    Reply
    • Valerie Griner   April 10, 2019 at 1:56 pm

      I agree with you…it would be safer to MOVE. They are injecting pregnant women now…which is causing a huge rise in IUFD(intra-uterine fetal demise), miscarriages, premature births, stillborn babies…MATERNAL deaths. It’s not even safe to be pregnant in the U.S. I also read on the IAC website how they are training medical personnel to vaccinate newborns against the wishes of parents(with Vit K and Hep B). There’s hardly ANY chance of raising a healthy, unvaccinated child in this country. Is there an agenda? YES.

      Reply
  7. David   January 3, 2019 at 8:32 pm

    Just say no to all vaccines! Always refuse.

    Reply
    • steven jacobs   January 4, 2019 at 4:01 pm

      Parents tried that in Boston a few years back-they and their children were marched(surrounded by armed police) in front of a judge who gave them a choice-.Welcome to Progressive/Socialist/Stalinist America.

      BTW-President Trump is NOT for mandatory vaccination.

      Reply
  8. Marene Mayer   January 3, 2019 at 8:40 pm

    This is so disturbing on so many levels…….I am almost speechless. I can only Pray for all the Newborns and their Parents.

    Reply
    • Valerie Griner   April 10, 2019 at 1:59 pm

      Me, too, Marene. I pray with all my heart EVERY day for God to stop this crime against babies and children. It is so evil that it’s hard to comprehend. They inject pregnant women now…which was unheard of when I was pregnant in 1987. I don’t understand why people can’t SEE and do their own research.

      Reply
  9. Diane Maupin   January 3, 2019 at 8:43 pm

    Scary! Risky too! I hope loving and thinking moms will think twice about allowing this vaccine to be given to their children…

    Reply
  10. Andreas   January 3, 2019 at 9:23 pm

    Did the publish any safety studies before approval?
    Any double blind studies?

    Nazi Sociopaths doing unconsented experimentation and population degradation- When will someone stop these criminals?!!

    Reply
  11. Dede   January 3, 2019 at 10:47 pm

    Please DEAR GOD somebody listen. Look at the ingredients, and the excipients list. NO ONE EVER gets assaulted with all the diseases at the same time to have to mount an immune response to each of 6 different germ combinations.
    They don’t study these things for safety like everyone thinks they do. and if you read NVIC you know about the no true placebo studies. AND how in the heck is a 2mth old supposed to know if it’s allergic to any of the ingredients when there are so many combined.
    This is COMPLETELY ILL ADVISED AND HAS NOTHING TO DO WITH THE HEALTH AND SAFETY OF OUR CHILDREN.

    Reply
  12. Richard Winkel   January 3, 2019 at 11:29 pm

    Multiple vaccines at once risk genetic recombination and new pandemics:

    http://thoughtcrimeradio.net/2018/01/multiple-vaccines-at-once-risk-genetic-recombination-and-new-pandemics/

    Reply
  13. Marie   January 3, 2019 at 11:31 pm

    Manufacturers développés combo vaccines not for fewer shots but to have the hep b vaccines included ( all patents of hep b iare now Glakso Smith GSK owned). Any vaccines associated with hep b is protected by the patent and vaccines will cost more. Vaxelis is the response to InfanrixHexa . It is a joint venture bc only Merck has rights ( paid) to GSK for US markets.

    Reply
  14. Jo   January 4, 2019 at 12:13 am

    surely they laugh to themselves, HOW MANY DOES IT TAKE, TO KILL BABIES, Anyway!?!?

    THEY CAN’T BE SUED OR HELD ACCOUNTABLE. THEY WORK OUTSIDE THE LAW, far worse than teh CIA and some real military groups.
    _ It’s like the old war days, when godless tyrant killer psychopath dictators had special army divisions of psycho troops, to murder everyone.
    THAT’S THE COUP “OUR” EXECUTIVE BRANCH HAS REACHED, and the corporations who bought them.
    _ How SICK is the CONgress to allow this?? HOW PAID OFF? HOW “SOULED-OUT”??

    Reply
  15. Marie49125   January 4, 2019 at 12:15 am

    Benitec just got a patent approved for hep b and is partnering with Merck for US market ( prior all patents hep b were granted only to glakso smith GSK). They will only put in the market for 2020. Vaxelis is Merck and Sanofi response to InfanrixHexa he a from GSK. The only reason they do combo shots is for money. Anything added to hep b vaccine is protected under its patent.

    Reply
  16. Hanane Benjelloun   January 4, 2019 at 1:32 am

    It breaks my heart to think that as I am writing this an innocent baby is suffering in pain from a side effect of a vaccine that he or she probably didnt even need in the first place and their poor uninformed parent is feeling helpless and unable to console them:(
    I just pray that this insanity stops soon.

    Reply
  17. Amber B   January 4, 2019 at 8:25 am

    Who in the world put their kids in the “clinical trials?” Barbaric!

    Reply
  18. John   January 4, 2019 at 9:27 am

    I WANT to be in the herd…but: https://medium.com/@dougweight/i-want-to-be-in-the-herd-76c58848f55d

    Reply
  19. Dan Andrews   January 4, 2019 at 10:21 am

    Why do we continue to allow these greedy, willfully ignorant people in our government, and the heartless, evil makers of these potentially dangerous and aggregeous pharmaceutical companies to continue to put these harmful chemicals into our children?
    What is it going to take to get us to stand strong against this madness?
    Like everything else in this God forsaken country, we have to wait until its too late, and our children have been victimized for generations before w’ell
    take decisive actions to try to reverse the years of injustice. INSANITY, is the only word to fully describe this time in history!

    Reply
  20. steve   January 4, 2019 at 12:22 pm

    Let’s everyone, all humanity,look at some empirical data. Why should anyone (except a few 10,000s of people making money selling vaccines) be afraid to do a retrospective vaxxed versus unvaxxed study to see if vaccinations are likely contributing to chronic problems. Mawson already did a pilot study that showed this was the case. Let’s now do a followup study. See https://www.facebook.com/groups/mawsonstudy/

    Reply
  21. Jackie   January 4, 2019 at 4:18 pm

    They’ve got to be kidding!!!

    Reply
  22. Joe   January 5, 2019 at 12:50 am

    When you read the vaccine insert, you can bet it will tell you to not give it to infants.

    Reply
  23. Sandra Villarreal   January 5, 2019 at 11:34 am

    Trump administration sure seems to love Merk Pharmaceuticals.
    Remember this? ✔ @realDonaldTrump ‘Now that Ken Frazier of Merck Pharma has resigned from President’s Manufacturing Council, he will have more time to LOWER RIPOFF DRUG PRICES!’ (Then hands them/Merk the contract.)

    Mass HPV Vaccination Plan for the U.S.
    Published November 14, 2018 | The American Cancer Society (ACS) has set an aggressive goal to achieve an 80 percent uptake rate among American children with two doses human papillomavirus (HPV) vaccine by 2026. To gain that coverage, 14 million more preteen children would need to complete the two-dose series, for a total of 57.62 million doses above and beyond the number of vaccinations given to date.1 HPV vaccine is one of the most expensive vaccines on the CDC recommended childhood vaccine schedule, costing a pricey $168 to $204 per dose, with Merck being the sole producer of HPV vaccine (Gardasil) in the U.S.2 https://thevaccinereaction.org/2018/11/mass-hpv-vaccination-plan-for-the-u-s/

    Trump Administration seeks to relax (big pharma) federal kickback rules – “The administration is inviting companies in the health-care industry to write a ‘get out of jail free card’ for themselves, which they can use if they are investigated or prosecuted,” said James Pepper, a lawyer outside Philadelphia who has represented many whistleblowers in the industry. This month, the inspector general of the Department of Health and Human Services refused to approve a proposal by a drug company to give hospitals free vials of an expensive drug to treat a disorder that causes seizures in young children.’ – https://www.insurancefraud.org/IFNS-detail.htm?key=30007 They’re also going hard after toddlers to psychiatrically diagnose & drug, as they are teenagers now addicted to smart phones. And with Trump about to invest $10,000,000,000 [alone] for ‘Opioids Epidemic and Serious Mental Illness and Serious Emotional Disturbance Initiative’. Every man, women, child & baby will qualify for any one of the 350 mental illnesses listed in the DSM. It truly isn’t safe being a child in America today. It truly isn’t safe for anyone in America, anymore.

    Reply
    • Valerie   February 28, 2019 at 7:13 pm

      Sandra Villarreal: You hit the nail on the head….”it truly isn’t safe for anyone in America anymore.” Merck makes some of the most deadly, toxic vaccines ever produced. They have a particularly nasty type of aluminum in their vaccines, known as “AAHS”..amorphous aluminum hydroxyphosphate sulfate. Aluminum is one of the KNOWN NEUROTOXINS. 1 in 5 Americans is now diagnosed with an “autoimmune disorder.” It doesn’t take a rocket scientist to connect the dots. Do people not think it strange that Gardasil was originally for FEMALES within a specified age group…”allegedly” to prevent cervical cancer, but is now being mandated for BOTH sexes…from newborns(in some countries)… to MEN up to 45 y/o? Since WHEN did men get cervical cancer? People are obviously vaccine brain-damaged to the point of no return.

      Reply
  24. Hayley   January 5, 2019 at 4:25 pm

    Great article that supports a lot of everyone’s comments…
    http://thesciencepost.com/why-some-parents-are-choosing-to-delay-or-skip-vaccinations-for-their-children/

    Reply
  25. Wrusssr   January 5, 2019 at 6:49 pm

    Open Letter from International Organizations to the WHO (World Health Organization) on the Issue of Global Vaccine Safety

    http://vaccineimpact.com/2018/european-nations-send-open-letter-to-who-regarding-lack-of-vaccine-safety-studies/

    From: The European Forum for Vaccine Vigilance

    To: The World Health Organisation and those
    attending the meeting of the Global Vaccine Quality Control Laboratories
    Network (Rome 25th-27th September 2018).

    To: The European Parliament, the European
    Medicines Agency and the European Directorate for the Quality of Medicines

    Reply
  26. ellie   January 5, 2019 at 10:22 pm

    Does this double the risk of autism?

    Reply
  27. Karen   January 11, 2019 at 12:05 am

    And all of the blinded, brainwashed adults who still trust their doctors and the government will line up and give this shot to their poor innocent children between the ages of 6 weeks!! and four years thinking they are doing good and that anyone who does not vaccinate is crazy!! Walking zombies is what we will have one day if this continual increase in vaccines does not kill them!! Who knows what else experimental is in this vaccine. They will push and push until they have sickened the entire population for life!!

    Reply
  28. Mimi M Hughes   January 15, 2019 at 2:06 pm

    Why does a newborn need three flu shots, as this vaccine is given at 2,4,6 months old? I would like to see the ingredients. If the baby has a reaction, how will they be able to tell which in the combo the child had a reaction to? As a health care provider I would not recommend this to any of my patients.

    Reply
    • Valerie   February 28, 2019 at 7:20 pm

      You can easily find the ingredients on the CDC website as well as the FDA site, under BiologicsBloodVaccines. I’m studying all 80+ vaccine package inserts and then looking at published medical studies and reports on nih.gov/PubMed website. I DO know that in addition to toxic substances like formaldehyde, mercury and aluminum, they contain GE(genetically engineered/GMO) proteins, bacteria(like E.Coli), fungi, and parasites. In my opinion, nearly ALL “autoimmune diseases/syndromes” can be linked to vaccines.

      Reply
  29. Valerie   February 28, 2019 at 7:02 pm

    Everyone should research the Infanrix HEXA vaccine…it’s the same one mentioned in your article. An independent lab in Italy conducted the “Corvela Study” on a batch of this vaccine,and what they found is MORTIFYING. They found NONE of the 6 antigens that were supposed to be in the vaccine, and they found 65 contaminants in this batch. They also isolated “a real polymer macromolecule” of unknown origin that was “not in any protein databases” currently available. Their research used the most modern technology/analysis systems in the world. This is independent/non-governmental research! I highly suggest that anyone reading this post investigate this deadly, toxic vaccine. This is genocide…no doubt about it. Some other subjects I am studying are “molecular mimicry,” genetic engineering and autoimmune diseases/autoinflammatory diseases…like POTS and PANDAS. Also…there is something known as “dysautonomia,” which is related to these new autoimmune syndromes.

    Reply
  30. Krooney   March 5, 2019 at 10:48 am

    And DEATH: Deaths
    In the 2 US studies, death was reported in 6 participants (0.2%) who received VAXELIS. Causes of death among infants who received VAXELIS were asphyxia, hydrocephalus, unknown cause, sepsis and 2 cases of Sudden Infant Death Syndrome (occurring 1, 2, 10, 42, 44 and 49 days post-vaccination, respectively). Across all 6 clinical studies, there were no deaths assessed as related to VAXELIS.

    Reply
  31. Debbie Allsup   March 7, 2019 at 9:36 am

    It’s insane to give vaccines to a baby under a year old. When I was 6 months old, I had Rubella. The doctor warned my mother that because my immune system was so immature, I would get Rubella again. I did, at 2 1/2.

    If a baby can’t even get immunity from a natural disease when he or she is so young, how can a vaccine do anything positive?

    Reply
  32. Pulido   March 23, 2019 at 12:58 am

    I been vaccinated as a child but as I have been awaken my husband and I decided not to vaccinate our children. However, I’m now facing a problem, I’m currently on my final stage of my naturalization papers and I’m asked to get vaccines. How can I go against the system and still be able to obtain my residency for this country? Please help. I need to do this within the next month or so.

    Reply
    • Valerie Griner   April 10, 2019 at 2:13 pm

      I wish I had a good answer to your predicament. The only thing I can suggest is to get a religious, philosophical or medical exemption(if it is available in your state).Tell them that you do NOT take vaccines due to the aborted fetal cells and animal blood that is in them…and that it violates your religious beliefs. Contact your state politicians and plead your case. Do anything you can to avoid these toxic shots. Leave the country…if you have to.

      Reply

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