Happy New Year to Sanofi Merck from the FDA
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:
General Facts
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 [21].....These patients have a greatly increased risk of developing rhinoconjunctivitis or asthma due to animal epithelia.
Safety Concerns
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.
Greg and All,
Please go to Table 2 on pgs 7 and 8 of the manufacturer's insert. "Percentage of Infants with Solicited Adverse Reactions Occurring within 5 days following Vaxelis or control Vaccines Administered Concomitantly at Separate Sites with Prevnar 13 and RotaTeq in Studies 005 and 006".
Shows % of study infants having certain reactions for each of the 3 series doses. Multiply those % by an estimated 4 million yearly birth cohort. The figures are shocking.
Under fever, there are 3 categories - more than or equal to 100.4 F, more than or equal to 101.3 F, and more than or equal to 103.1 F. After the first dose in 4 million babies, 8,000 would have a fever of 103.1 F or more, 2nd dose - 28,000 babies, 3rd dose - 60,000 babies. Who in their right mind would do that to a 6 week old?
The second fever category - 101.3 or more - 212,000 after the first dose, 460,000 after the second dose, 528,000 after the third dose. That's more than 1/2 million babies with a fever of 101.3 or more. How many end up in the ER getting all kinds of testing including a spinal tap? Virtually all of these babies will be given acetaminophen that has been linked to autism.
After the first dose, 744,000 will cry for more than 1 hour, 144,000 will cry for more than 3 hours. Numbers are in that range for the second and third doses.
I don't understand how this is approved for use on infants or anyone. A fever above 103 in a 6 week old to make him healthy? It doesn't make any sense.
Posted by: Linda1 | January 06, 2019 at 01:53 AM
BAM they already do call measles different things since the vaccine.
Roseola and 5th disease amongst others.
Indeed, every apparent vaccine success is just calling it other things. Including smallpox, tetanus, diphtheria the whole lot.
Posted by: Rtp | January 04, 2019 at 09:05 PM
SORRY -hexavalent sids (typo)
Vaccine-induced-death-syndrome
VIDS
Can aoa interview or survey undertakers to hear how many have been told by grieving parents vaccines killed their child, and how much the rates have increased? This is so tragic.
Posted by: Kyles mom | January 04, 2019 at 06:45 PM
Doublespeak: dont administer to anyone who has had serious reaction to pertussis toxin. And yet in California, doctors are attacked and ridiculed and attacked for 1) reporting any reaction 2) believing parents who ask to be exempted due to a previous reaction their dr refused to report
How many more hexaleny-sids cases are going to happen before the world wakes up?
Posted by: Kyles mom | January 04, 2019 at 06:42 PM
6 vaccines in one shot is the evolution of a failed business model. I keep expecting them to replace the whole mess with normal saline - so the damage disappears but the myth of safe vaccines and the bread and butter profit it brings to pharma lives on. They are perfectly capable of renaming measles just as polio is now called AFM.
Posted by: Beleaguered Autism Mom | January 04, 2019 at 01:38 PM
I included Sanofi Pasteur's pentavalent vaccine, Pentacel, in my recent presentation in UT:
"14) Why is it legal to inject multivalent vaccines, meaning more than one vaccine in one syringe, and/or multiple vaccines at once, be they monovalent, multivalent, or a combination thereof? When an adverse reaction occurs, administering vaccines in such a haphazard, reckless way makes it impossible to trace it back to a specific vaccine. Babies and children are given a number of trivalent vaccines in the form of the MMR, DTaP, and Tdap vaccines, and worse, there are now pentavalent and hexavalent vaccines being given to infants and toddlers, which involve administering 5 or 6 vaccines via one syringe (DPT-HepB-Hib and DPT-polio-Hib-HepB). What are the effects of doing that? Unbelievably, they have not been studied in any meaningful way, if at all, but the results can be seen in the even higher rates of adverse reactions when multiple vaccines are given at once. For but one example of a meaningless and unethical “safety” study, the “control” used for Sanofi Pasteur’s Pentacel vaccine (DTaP + polio + Hib) was the same 5 vaccines (DTaP + polio + Hib) given via 3 shots. I am not making this stuff up! You can Google vaccinesafety.edu to find a listing of vaccines and their package inserts. I encourage you to read through just 1 per night for the next week to see for yourself the absolute proof that there is no proper or ethical studying or approving of vaccines…none. Furthermore, the majority of adverse reactions that are actually admitted are written off as of no importance. For example, more than 50% of those receiving Pentacel, following any dose during the 3-dose study, experienced fussiness/irritability and inconsolable crying. Those are the only means an infant has of communicating, and should be taken very seriously! They are signs that something is wrong, and should not be brushed off or categorized as not serious. More than 30%, following any dose of Pentacel, experienced injection site reactions, including tenderness and increased circumference of the arm. If your baby was bitten by a spider, would you write off tenderness and an enlarged arm as no big deal? No, these are symptoms that something harmful has happened. Other adverse reactions included fainting, changes in mental status, and seizures. The category “Serious Adverse Events” was not used until reactions such as bronchiolitis, dehydration, pneumonia, gastroenteritis, encephalopathy, asthma, and deaths, 5 of them in a relatively small sample group, were mentioned. Are those risks that any thinking parent would take if they were properly informed of them? Think of the careful consideration that is supposed to be given when a person is taking more than one drug at a time. Why is this same consideration and caution not taken when injecting multiple vaccines at one time, be they in 1 syringe, 3, or up to 8, as can happen at a “catch up” appointment? And bear in mind that for each infection that is being targeted, the vaccine for it might contain multiple strains of that infection, further increasing the viral and bacterial exposures for the child. When in nature is a human ever exposed to so many infections at once? How do you think an infant or toddler, whose immune system is immature and still in development, is going to handle such a barrage of toxic, viral, and bacterial assaults? More importantly, why is this legal?"
Below is the link to my entire presentation, which includes both the video link, and the full transcript with hyperlinks:
"Why Is This Legal?" by Laura Hayes
https://www.ageofautism.com/2018/11/why-is-this-legal-presentation-on-vaccines-by-laura-hayes.html
Posted by: Laura Hayes | January 04, 2019 at 11:47 AM
Greg: No. 6 in 1 means 6 in 1. They are putting existing licensed vaccines all together in a super duper wallop. In fact this will increase the toxic load because each victim will require two additional separate poisonings with the DTaP (there must be five of these to meet the profit projections).
Posted by: Gary Ogden | January 04, 2019 at 09:48 AM
Greg
We say toxic pharma double speak says excipients ..a quick look seems to suggest they have reduced the toxic load of Aluminium. Then any amount of aluminium will kill a fish in a tank of water a trace amount. Cumulatively I doubt pharma its short selling its soft kill in anyway.
About Diphtheria, Tetanus, and Pertussis Vaccination | CDC
https://www.cdc.gov/vaccines/vpd/dtap-tdap-td/hcp/about-vaccine.html
17 Dec 2018 - Each 0.5-mL dose of Tenivac® (Sanofi Pasteur) contains the following active ingredients: 5 Lf of tetanus toxoid and 2 Lf of diphtheria toxoid. Other ingredients per 0.5-mL dose include 1.5 mg of aluminum phosphate (0.33 mg of aluminum) as the adjuvant and ≤5.0 µg of residual formaldehyde.
InfanrixHexa, INN-Diphtheria, Tetanus, acellular Pertussis, Hepatitis B ...
www.ema.europa.eu/docs/en_GB/document_library/.../WC500032501.pdf
Excipients
1. 2-phenoxyethanol 2.5 mg Preservative
2. Sodium chloride (NaCl) 4.5 mg For isotonicity
3. Medium 199 (M199)
(including aminoacids)
1.15 mg
(0.09 mg)
IPV stabiliser
4. Lactose 12.6 mg Hib stabiliser
5. Water (H20) for injections q.s. ad 0.5 ml Solvent
Adjuvants
Aluminium 0.82 mg Adjuvant
0.5 mg as aluminium hydroxide (Al(OH)3)
0.32 mg as aluminium phosphate (AlPO4) 0.12mg from Hib
Pharma For Prison
MMR RIP
Posted by: Angus Files | January 04, 2019 at 09:14 AM
Hoping someone will assist me here... Seems with vaccines wbere serious adverse reactions are concerned, they're due from the adjuvants and preservatives. Would a 6-in-1 vaccine not reduce this toxic load over separate shots?
Posted by: Greg | January 04, 2019 at 07:20 AM
No one remembers it now, but there were no food allergies prior to the modern vaccines. The word itself dates to the beginning of the twentieth century. The closes thing to the allergies or anaphylaxis (another early 20th century word) was the bee sting reaction... which does happen after an injection. IMO the powers that be knew what they were doing. Injection + metals + viruses/bacteria + chemicals + human or animal tissue + who knows what else = fast or slow death for all of us. (Forrest Maredi has more on metals and disease connection on his channel).
Posted by: Natalie | January 03, 2019 at 05:21 PM
More desperate clustervack. CDC drinking in the last chance saloon and if they wont change (defo wont) Trump and co will change them but not fast enough.
FY2019 President's Budget Proposal NACCHO Priority Public Health ...
https://www.naccho.org/uploads/...resources/FY2019-Pres-Budget-summary-final.pdf
"Overview
The FY2019 President’s budget is not good news for public health or advocates of public health.
If the budget were to be enacted as written, the Centers for Disease Control and Prevention
(CDC) would see a $1.4 billion cut (20%), and the Health Resources and Services Administration
(HRSA) a $403 million cut. "
I also read he was looking to cut it by 80%.
Pharma For Prison
MMR RIP
Posted by: Angus Files | January 03, 2019 at 06:07 AM
BLIADHNA MHATH UR - A GOOD NEW YEAR !
The Economist Cover for 2019 shows a stork carrying a baby bundle with a bar code on it?
Does this mean that baby's birth certificates are to be traded on the open storck market the same way as coffee beans or orange juce futures profits? progetions?!
Their professional standards have been on "Sick Note Observation " for some considerable time!
Vioxx and Vaccinations
Rolo Elephant Ad Youtube
Posted by: Morag | January 02, 2019 at 04:06 PM
Vaxelis is a 6 in 1 brand new vaccine. It includes the ability to cause at least 8 deadly allergies to dairy, tree nuts, pine nuts, soy, eggs, fish, shellfish, and wheat. This includes anaphylactic shock and death. After exposing your child 3 times as directed, your baby starting as early as 6 weeks old will have had 18 true vaccine antigens and aluminum, as well as other serious toxins. Your children are Lab rats without the cage. The cage exists in the mind of the parents thanks to Forbes, the Pharmaceutical industry, Common Core, magazines and THE TIMES. Even though the vaccines includes something similar to the DPaT , it will still not be enough to protect them from Pertussis? So the mentally caged parents must still go out and get more DPaT shots as directed. Take a look; "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."
I am beginning to feel like the schedule of vaccines-from 72-79 seems like they are designed to replace a child's blood?
Posted by: Shelley Tzorfas | January 02, 2019 at 02:49 PM
The days of "Autism 1 in 10 kids" are not far away (due to "expanded criteria of diagnosis, better understanding of Autism, genetics,..." blah blah blah all junk reasons except the real culprit, the vaccines). I am not wishing the Autism to grow 1 in 10 kids, but it will happen thanks to 6 in 1 toxins. When you fast track vaccines, the Autism will also get fast tracked.
Posted by: R Prasad | January 02, 2019 at 02:19 PM
Thanks Teresa ... So lets see, from a PDF referenced above
https://www.fda.gov/downloads/BiologicsBloodVaccines/UCM629109.pdf
4281 infants in 2 US trials ???
The CONTROL GROUP was a group of infants given "other vaccines" / not ZERO vaccines ???
7 deaths in 2 trials / none related to VAXELIS ???
That would equal about 6,500 deaths per the 4 million children born in the US each year.
... "In the 2 US studies, death was reported in 6 participants (0.2%) who received VAXELIS and in 1 participant (0.1%) who received Pentacel + RECOMBIVAX HB vaccines; none were assessed as vaccine-related. 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."
An "UNKNOWN CAUSE or SIDS" a few days after VAXELIS cannot be related to VAXELIS ???? ????? one just has to adore those who create our vaccines and do the safety trials
Posted by: go Trump | January 02, 2019 at 01:43 PM
That old depopulation agenda just wont go away will it :
https://www.breitbart.com/health/2018/12/31/abortion-leading-cause-of-death-in-2018-with-41-million-killed/?fbclid=IwAR3UYdQJnIVQBkFTpgT2TUNzz_FPId7F9hIYLHaOTDAYjbirLHXppcvW90I
Abortion Leading Cause of Death in 2018 with 41 Million Killed
Over a fifty year time frame, that rate of abortion would exceed 2bn people.
Its quite a number.
7 bn of us here now. Now that looks like its heading up to about 9bn but if we do a really good job on vaccination we can perhaps reduce that number by 15%. (which equals approx. 1.35 bn)
There is no conspiracy folks - just get your damn vaccine.
Now hear this.
Posted by: Hans Litten | January 02, 2019 at 12:30 PM
Aluminum is listed as an excipient in two forms AND as an adjuvant with Merck’s proprietary AAHS form for aluminum!
Depressing news for the new year :-(
Thank you Teresa & AoA!
Posted by: Harvard MD | January 02, 2019 at 11:40 AM
Did I miss it? I don't see the amount of Aluminum. Is it as high as the HPV shot? And does it contain the same nasty Merck form of aluminum in the HPV?
Posted by: Betty Bona | January 02, 2019 at 10:59 AM
The Guardian giving us good information FOR ONCE :
https://www.theguardian.com/world/2018/dec/21/rightwing-populists-ride-wave-of-mistrust-of-vaccine-science
Justyna Socha, an insurance agent and mother of four from Poznań, in north-west Poland, started to campaign after she was fined for refusing to vaccinate one of her children.
Socha is the president of Stop Nop (a Polish acronym for undesirable vaccine reactions). This year the group gathered more than 100,000 signatures calling for a change in the law on mandatory vaccination. The proposals were considered by the Polish parliament before being thrown out.
Socha and her supporters argue that the medical profession in Poland is engaged in a large-scale cover-up of the adverse effects of vaccinations on young children, a conspiracy they attribute to pressure from regulatory institutions and financial inducements from vaccine producers.
“We don’t identify as anti-vaccine, we are pro-patient,” Socha told the Guardian. “Doctors who try to report their concerns are threatened with medical tribunals and with losing their jobs, so it falls to me as a patient, and as a mother, to change the system.”...
Posted by: Hans Litten | January 02, 2019 at 10:46 AM
Are samples available for CORVELVA to test immediately ? I wonder
They'll probably find an Easter Bunny in there !
"Vaccine safety" you say. Just like "Herd Immunity" , there is no such thing in existence. Both myths.
Posted by: Hans Litten | January 02, 2019 at 09:56 AM
The newest horror show about to unfold. 2% serious adverse events? This is acceptable? Only 30 days monitoring? Mr. President, where is your vaccine safety commission? This was far and away your most important campaign pledge.
Posted by: Gary Ogden | January 02, 2019 at 08:31 AM