FDA Approves 6 in 1 Combo Vaccine for Babies
- 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
1 Sanofi Pasteur. FDA Approves VAXELIS™, Sanofi and MSD’s Pediatric Hexavalent Combination Vaccine. Press Release Dec. 6, 2018.
2 Sheinin AG. FDA Approves New Children’s Vaccine. WebMD Dec. 28, 2018.
3 Hackett DW. Hexavalent Vaccine for Children Less Than 5 Years of Age Approved. Precision Vaccinations Dec. 27, 2018.
4 Vaxelis®, New Fully-liquid Paediatric Hexavalent Vaccine Approved in the European Union. Ciston PR Newswire Feb. 19, 2016.
5 Lee BY. How About 6 Vaccines In One? FDA Approves New Vaccine From Sanofi, Merck. Forbes Dec. 28, 2018.
In the above link, a confidential GlaxoSmithKline document revealed 36 infants died after another 6 in 1 shot called Infanrix Hexa. It also caused 1,742 adverse reactions, including 503 which were serious.
Another drawback not mentioned is the inability to track adverse reactions to any one particular vaccine since they are all thrown together. Secondly, when you consider that each of these vaccines has their own set of adverse reactions, one can only imagine the combined effect upon immature immune systems.
It’s sad that manufacturers are more concerned with convenience (ordering, transporting, and storage of vaccines) than with public health. This is a problem.
With increasing rates of childhood autism, neurological issues, and the polio-like condition known as acute flaccid myelitis (AFM), you’d think there would be extra caution taken regarding childhood vaccines not less. Yet, vaccine manufacturers and our government bullishly move forward despite increasing evidence of lack of vaccine safety studies and even proof of vaccine effectiveness.
Regarding AFM, the CDC has confirmed 158 cases in 36 states, and they’ve only been recording cases since 2014: https://thevaccinereaction.org/2019/01/cdc-reports-182-confirmed-cases-of-afm/ AFM causes inflammation of the spinal cord. As to cause, authorities bounce from a pathogen to an autoimmune syndrome (similarly to chronic Lyme). It’s been compared to Guillain-Barré Syndrome (GBS), in which the immune system attacks healthy nerve cells. Some believe AFM is caused by a virus.
Again, since there is an upsurge in AFM with cause unknown, prudence would err on the side of caution regarding vaccinations since retroviral contamination in vaccines has been discovered: https://madisonarealymesupportgroup.com/2017/10/15/vaccines-and-retroviruses-a-whistleblower-reveals-what-the-government-is-hiding/
https://madisonarealymesupportgroup.com/2018/06/23/the-role-of-retroviruses-in-chronic-illness-a-clinicians-perspective/ Retroviruses can be acquired (inhalation, blood-based products, physical contact) or the viruses already present in our DNA can be activated through influences such as a viral infection or chronic inflammation (Manghera and Douville, 2013).
For example, the Epstein Barr virus induces expression of the HERV-K envelope gene and the transactivation of MSRV, the Multiple Sclerosis retrovirus (Mameli et al, 2007; Sutkowski et al, 2001). Herpes simplex type-2 activates members of the HERV-W family. These and other mechanisms are likely responsible for the activation of HERVs seen in rheumatoid arthritis, SLE, Sjorgens disease, schizophrenia, autism, MS and cancer. Cell phone radiation has disabled many of our protective proteins (Fragopoulou et al, 2012) and so have many of the food-based toxins such as glyphosate (Seneff et al, 2017) and air-based inhalants (aluminium etc). An unintended source of retroviruses are some vaccines as reported in Frontiers in Microbiology in January 2011).
It’s all here in purple crayon yet isn’t making any mainstream news.
It is estimated that 6% of the U.S. population is harboring a retrovirus in their bodies that can develop into an acquired immune deficiency. This is not the well-known AIDS caused by HIV, but Acquired Immune Deficiency Syndrome (AIDS) associated with other retroviruses.
That’s 20 million Americans with a retrovirus that can be spread through inhalation, blood-based products, and physical contact.
Many are also including vaccines.
A simple tick bite could be one trigger that ignites the sleeping retrovirus giant.