NOTE: Seems the swamp is full to flooding in Pharmaland. Vaxelis, a 6 in 1 vaccine, is now approved.
By Teresa Conrick
It was a Friday, four days before Christmas, when the FDA sent out an approval letter to Sanofi about their VAXELIS, a SIX-in-ONE vaccine. It is the brainchild of a joint-partnership between Sanofi and Merck. The letter was totally ignored until the day after Christmas when Sanofi sent out a press release .That is probably the most obscure day to post a news item with the hope it will be buried, just like the wrapping paper and yucky fruit cakes in the piles of garbage across the USA. VAXELIS is the first vaccine with multiple (6!) vaccinations wrapped up in one product. The targeted USA commercial supply will be for infants, from 6 weeks up to their 5th birthday.
This news is slowly being pushed, first by the lap dogs like Forbes . You would think they were talking about popsicles for a sunny, summer day instead of a heavy duty, injectable recipe of viral, bacterial, and chemical pharmaceuticals. Adverse reactions were only really recorded for five to maybe thirty days and there is a tortuous court process if any serious reactions do occur and forget about this even being listed in the famous “TABLE” as it is so new.
Here are some highlights you may not get from any of the press releases coming out. You can peruse the www and find additional info:
The European Medicines Agency - 17 December 2015, EMA/CHMP/72003/2016 -- Committee for Medicinal Products for Human Use (CHMP) -- Assessment report -- Vaxelis, which was originally approved in the EU --
- Vaxelis or PR5I is a hexavalent paediatric combination vaccine for primary and booster immunization of infants and toddlers above the age of 6 weeks.
- Vaxelis is referred to as PR5I throughout the report.
- It is designed to provide active immunization against diseases caused by Corynebacterium diphtheria, Clostridium tetani, Bordetella pertussis, poliovirus types 1, 2, and 3, Haemophilus influenzae type b (Hib), and hepatitis B virus.
- PR5I is a combination vaccine containing components of vaccines currently licensed in the US, the EU, and other countries. It contains the same DTaP as PENTACEL (US) and PEDIACEL (EU) and therefore 5 acellular pertussis components (PT, FHA, pertactin, fimbriae types 2 and 3) in combination with IPV (from Vero cells), polyribosylribitol phosphate (PRP, a Hib antigen) conjugated to outer membrane protein complex of Neisseria meningitidis to form PRP-OMPC, and recombinant hepatitis B surface antigen (HBsAg).
- Excipients (Aluminium phosphate and aluminium hydroxyphosphate sulfate used as adjuvants
- Merck Aluminum Adjuvant (AAHS) is a proprietary aluminum hydroxyphosphate sulfate formulation that is both physically and functionally distinct from traditional aluminum phosphate and aluminum hydroxide adjuvants.
- VAXELIS is to be administered as a 3-dose series at 2, 4, and 6 months of age. The first dose may be given as early as 6 weeks of age. Three doses of VAXELIS constitute a primary immunization course against diphtheria, tetanus, H. influenzae type b invasive disease and poliomyelitis
- A 3-dose series of VAXELIS does not constitute a primary immunization series against pertussis; an additional dose of pertussis-containing vaccine is needed to complete the primary series.
- raw materials including of animal- human origin…..a substance of human hair origin…. poultry feathers…. a soy source for routine manufacture….below, you will also see bovine serum albumin listed. This can include both milk or beef extracts, so more allergen concerns, as well as asthma
- BSA is used as a component of many vaccines [16,17], such as MMR, MMRV, Varicella, and Zoster
- Cow’s milk allergy is one of the most common food allergies,,,,, majority of patients with persistent milk allergy are also allergic to bovine serum albumin .....These patients have a greatly increased risk of developing rhinoconjunctivitis or asthma due to animal epithelia.
Chicken and soy are allergens for many children. Receiving them at 6 weeks of age in an injected vaccination may be Russian Roulette. Could they induce lifetime allergies and/or cause life threatening reactions? There is no data regarding this medical phenomenon on the package insert but it should be known:
- If you're allergic to chicken, you may also be allergic to... chicken feathers
- Eight types of food account for over 90% of allergic reactions in affected individuals: milk, eggs, peanuts, tree nuts, fish, shellfish, soy, and wheat (1,2). Reactions to these foods by an allergic person can range from a tingling sensation around the mouth and lips and hives to death, depending on the severity of the allergy
- Food allergy among children in the United States is becoming more common over time
- Children with food allergy are more likely to have asthma or other allergic conditions.
- PR5I is highly reactogenic and nearly all subjects reported some local and systemic reactions after a dose.
- Repeat dose toxicity studies have not been conducted.
- The following important potential risks were identified: hypersensitivity including anaphylactic reactions; convulsions, including febrile convulsion; hypotonic-hyporesponsive episode; encephalopathy/Encephalitis; apnoea (in premature infants less than or equal to 28 weeks gestation); extensive limb swelling.
- Missing information -- Infants less than 6 weeks of age , Premature infants less than 28 weeks of gestation at the time of birth, Immunocompromised patients, Use in children > 15 months of age, Duration of protection with pertussis antigens
- Rates of adverse reactions varied by number of doses of VAXELIS received..
- The solicited adverse reactions following any dose were irritability (≥55%), crying(≥45%), injection site pain (≥44%), somnolence (≥40%), injection site erythema (≥25%), decreased appetite (≥23%), fever ≥38.0°C (≥19%), injection site swelling (≥18%), and vomiting (≥9%).
- Data are not available on the safety and effectiveness of using VAXELIS following 1 or 2 doses of a DTaP vaccine from a different manufacturer.
- VAXELIS may be used to complete the hepatitis B vaccination series following 1 or 2 doses of other hepatitis B vaccines, in infants and children born of HBsAg-negative mothers and who are also scheduled to receive the other antigens in VAXELIS. However, data are not available on the safety and effectiveness of VAXELIS in such infants and children.
- Administration of VAXELIS following previous doses of Inactivated Polio Vaccine (IPV) VAXELIS may be administered to infants and children who have received 1 or 2 doses of IPV and are also scheduled to receive the other antigens in VAXELIS. However, data are not available on the safety and effectiveness of VAXELIS in such infants and children.
- Administration of VAXELIS following previous doses of Haemophilus b Conjugate Vaccines VAXELIS may be administered to infants and children who have received 1 or 2 doses of H. influenzae type b Conjugate Vaccine and are also scheduled to receive the other antigens in VAXELIS. However, data are not available on the safety and effectiveness of VAXELIS in such infants and children.
- Hypersensitivity Do not administer VAXELIS to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to a previous dose of VAXELIS, any ingredient of VAXELIS, or any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, or H. influenzae type b vaccine
- Encephalopathy Do not administer VAXELIS to anyone with a history of encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis-containing vaccine
- Progressive Neurologic Disorder Do not administer VAXELIS to anyone with a history of progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy
- Vaccination with VAXELIS may not protect all individuals.
- VAXELIS has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility
- Across Studies 005 and 006, within 30 days following any infant dose vaccination, 68 participants (2.0%) who received VAXELIS and concomitant vaccines versus 19 participants (2.2%) who received Control and concomitant vaccines experienced a serious adverse event.
- Other ingredients per 0.5 mL dose include <0.0056% polysorbate 80 and the following residuals from the manufacturing process: ≤14 mcg formaldehyde, ≤50 ng glutaraldehyde, ≤50 ng bovine serum albumin, <5 ng of neomycin, <200 ng streptomycin sulfate, <25 ng polymyxin B sulfate, ≤0.125 μg ammonium thiocyanate and ≤0.1 mcg yeast protein (maximum 1% relative to HBsAg protein).
- A related phenomenon regarding the polysorbate 80 and aluminum: “The HPV vaccine formula contains aluminum (225 e 500 μg/each dose in Gardasil® and Cervarix®, respectively) but also high polysorbate 80 (50 mcg) concentration that might also induce a greater meningeal permeability leading to a facilitated entrance of many substances to the CNS.
- NO testing past 15 months of age. Why?
Parents are going to be skeptical of this vaccine. Imagine using the excuse of "parental laziness" to not want to make additional trips to the doctor versus a 6 in 1 cocktail of pharmaceutical ingredients to inject in their babies at one time? Today’s moms and dads are way too smart for this bad marketing scheme. Vaccine safety concerns will continue into the new year and onward.
Teresa Conrick is Science Editor for Age of Autism.