ProQuad: The new vaccine on the block.

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http://www.redflagsdaily.com/yazbak/2005_sep26.phpDr. Yazbak, a pediatrician, now devotes his time to the research ofautoimmune regressive autism and vaccine injury.ProQuad: The new kid on the blockBy Red Flags Columnist, F. Edward Yazbak, MD, FAAP(tlautstudy) ------------------ On Sept. 6, 2005, the Food and Drug Administration (FDA) approved ProQuad™by Merck. It is a combined attenuated live virus vaccine containingmeasles, mumps, rubella and varicella viruses for use in children aged 12months to 12 years. The vaccine was also approved for use “if a second

doseof measles, mumps and rubella vaccine is to be administered.” The vaccine, usually referred to as MMR-V has been renamed the ProQuad because parents now associate the MMR vaccine with autism.------------------What is ProQuad? 1. A glorious four-wheeling experience in Southern France? 2. A fast roller skate? 3. A titanium fishing lure? 4. A new vaccine? 5. All of the above?If you answered number 5, you are correct.In the hills of southern France, sightseers use four-wheel, all-terrainvehicles to enjoy the breathtaking scenery of the “Cotes du Luberon” duringthe day and relax with the wonderful meals and wines of the region in theevening. “This is the real Provence, full of character. A sweet dolce vitaof a climate and pure clean air which just

breathes the incrediblecontrasts between a rich, and variable natural environment: the bluestrides of lavender, the subtle nuances of green in the forests, theflamboyant and blinding colors of the cliffs of ochre, or the austere whiteof the limestone hills.” (1, 2)Roller skates called 429 Pro Quad are supposed to be fast and provide firmankle support, “soft-touch” comfort lining and a deluxe padded collar. (3) In a bait shop, the Titanium Pro Quad Spinnerbait lure is recognized by itsfour hammered 24-carat gold or nickel plated blades — available in twoshapes — which simulate

baitfish and precede the well-known multicoloredlure.(4)Only experienced and well-informed adults, taking every possibleprecaution, use these toys.The French ATV riders (in the photos) are protected from head to toe byhigh-impact helmets, safety goggles, heavy clothing, gloves and boots. Anyreasonable roller skater would never consider lacing up without afirst-class helmet and reliable elbow, knee and shin pads. And it is nosecret that fishing lures are handled with extreme caution by anglers, whoalways have their “fisherman tool” handy, just in case of a “lure in thefinger” emergency. (5)Unlike the new vaccine, the ProQuad ATVs, roller skates and lures are usedonly by mature and consenting individuals, who are fully informed abouttheir dangers and “adverse events.”Parents dealing with vaccination decisions, on the other hand, seem to begoing on faith alone, when they allow their

one-year-old children toreceive multiple vaccines together in an attempt to protect them againstdiseases that have disappeared or are so rare that medical students startand finish their training without ever seeing a case.On Sept. 6, 2005, the Food and Drug Administration (FDA) approved ProQuad™by Merck. It is a combined attenuated live virus vaccine containingmeasles, mumps, rubella and varicella viruses for use in children aged 12months to 12 years. The vaccine was also approved for use “if a second doseof measles, mumps and rubella vaccine is to be administered.”ProQuad™, which is, in fact, a combination of MMR II (measles, mumps andrubella) and Varivax (varicella) vaccines, was reported to be similar toits components in immunogenicity, antibody persistence, safety and adverse events. (6)By an incredible coincidence, when I first saw the ProQuad information,there was a fact box beside it on FAMVIR®, or famciclovir, an antiviraldrug used to treat acute herpes zoster (shingles). (6)It is now well known that a nationwide increase in the incidence ofshingles has occurred since the introduction of the chicken pox vaccine in1995 and that a new vaccine, Zostavax, also by Merck, is being tested tocontrol the recent iatrogenic outbreak of shingles. (7-11)Although there may be justification for the administration of the measlesvaccine in the second year of life, the need for mumps, rubella and chickenpox vaccinations at

that age is less obvious.Mumps is a benign illness in childhood and administration of the mumpsvaccine shortly before puberty to those boys who did not havedisease-acquired immunity is much more reasonable.At present, there is no rubella in the United States and the administrationof the rubella vaccine to boys and girls at the age of one in order toprotect susceptible adults seems at least questionable if not strange. (12)Vaccinating girls shortly before puberty is more logical and would providesuperior and longer-lasting immunity.The administration of the chicken pox vaccine to all U.S. children does nothave valid clinical reasons. Its alleged economical benefits — often citedas the real reason for the national recommendation — have now, asdemonstrated by G. S. Goldman, PhD, been eclipsed by the larger cost ofcontrolling the resulting shingles outbreak.After my recent column, “Trust me. I have the

statistics to prove it” (7),a Red Flags reader reminded me that the CDC (Centers for Disease Controland Prevention) has actually stated that shingles occur more frequently inindividuals who developed chickenpox before the age of 18 months. (13)It is only reasonable to suspect that the live attenuated vaccine would mimic the natural illness and likewise lead to an increase in the incidenceof shingles as demonstrated in several studies, including one sponsored bythe CDC.The CDC’s decision to recommend the administration of the

chicken poxvaccine at the age of one appears therefore problematic and merits attention.Whether the Institute of Medicine (IOM) immunization safety reviewcommittee is the right body to investigate the recommendation is anotherstory. (14)It is widely expected that the CDC will deny any guilt and will simplystate that it followed the recommendation of the Advisory Committee onImmunization Practices (ACIP), a group of 15 experts selected by theSecretary of Health and Human Services “to provide advice and guidance tothe Secretary, the Assistant Secretary for Health, and the Centers forDisease Control and Prevention (CDC) on the most effective means to preventvaccine-preventable diseases.” (15) Such an excuse is not valid because the two organizations have historicallybeen very close. ACIP’s official information is available on the CDC’sNational Immunization Program Web site; its email address is ACIP;and its mailing address is Centers for Disease Control and Prevention,National Immunization Program, Division of Epidemiology and Surveillance,Mail Stop E61, 1600 Clifton Road, NE Atlanta, Georgia 30333The CDC will undoubtedly also claim that nothing can be done now that thechickenpox vaccine has been incorporated in ProQuad™— again supposedly “onthe ACIP recommendation” — and because we must protect children frommeasles “a disease that kills thousands in Africa.” * * *What’s in a name?When first licensed, the chickenpox vaccine was to be administered at least a month after the MMR vaccine. Later, pediatricians were told thatadministering the two vaccines in different sites on the same day wasacceptable. However, if the chickenpox vaccine was not given with the MMR,it had to be delayed at least a month.For years, pediatricians have known that there were plans to combine theMMR and Varivax vaccines and that clinical testing was ongoing.Consistently, the new combination vaccine was referred to verbally as MMRVand in written documents as MMRV or MMR-V.The registered names of the previous monovalent “single” Merck live virusvaccines were Attenuevax (measles), Mumpsvax (mumps),

Rubeovax I and II(rubella) and Varivax (chickenpox).Registered names of the previous combined Merck live virus vaccines weresimply the initials of their components: MM (measles–mumps), MR(measles-rubella) and MMR I and II (measles, mumps and rubella I and II)vaccines.There were obviously many meetings and reviews concerning MMR-V and itseemed clear that its endorsement by the ACIP and its licensure by the FDAwere assured.A launch in the fall of 2005 was actually anticipated but what was notexpected was a sudden change of the vaccine’s name from MMR-V to ProQuad™sometime during the summer. (16)The word “makeover” has recently become quite popular in the United States.On TV, we see individuals and homes transformed in front of our eyes inless than an hour. But a vaccine makeover was certainly a new experiencefor many. Not being fortunate enough to be included in the “inner circle,”I have no idea

why the name of the new vaccine was suddenly changed to astrange and non-traditional name shortly before licensure. # Could it be because of the initials MMR and theon-going crisis about MMR vaccination and autism? # Could it be because any vaccine containing those three initials would not be readily acceptable, particularly in the U.K.,where substantial national malaise still persists?

# Was it simply because we will never have a drugcalled BIOXX or TIOXX? # Was it just a financial strategy? # Could it simply have been that someone at Merck wasafraid that people would get confused and think that this is a new andimproved fifth MMR just like MMR II was the second one out?Who knows?The fact is that there never was a hyphen in MMR II and Merck neverproduced an MMR III or IV; any confusion would, therefore, have beenunlikely. Besides everyone involved knew that MMRV and/or MMR-V simply andclearly indicated that there were four components in that vaccine: measles,mumps, rubella and varicella.Of note is the fact that the suffix “vax” was evident in all remainingMerck vaccines intended for U.S. infants: Comvax, Pedvax-HIB and

RecombivaxHB.For reasons unknown, we now have ProQuad™ standing all alone, incognito. * * *Financial circles took quick note of the FDA approval of the new vaccine.On Sept. 6, 2005, MSN Money announced the news in a long and detailedreport. (17)The report included a relatively short note describing Merck as “a globalresearch-driven pharmaceutical company dedicated to putting patients first.Established in 1891, Merck discovers, develops, manufactures and marketsvaccines and medicines in more than 20 therapeutic categories. The companydevotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliverthem to the people who need them. Merck also publishes unbiased healthinformation as a not-for-profit service.”This was followed by the usual "forward-looking statements" as defined inthe Private Securities Litigation Reform Act of 1995: “These statementsinvolve risks and uncertainties, which may cause results to differmaterially from those set forth in the statements. The forward-lookingstatements may include statements regarding product development, productpotential or financial performance. No forward-looking statement can beguaranteed, and actual results may differ materially from those projected.Merck undertakes no obligation to

publicly update any forward-lookingstatement, whether as a result of new information, future events, orotherwise. Forward-looking statements in this press release should beevaluated together with the many uncertainties that affect Merck'sbusiness, particularly those mentioned in the cautionary statements in Item1 of Merck's Form 10-K for the year ended Dec. 31, 2003, and in itsperiodic reports on Form 10-Q and Form 8-K (if any) which the companyincorporates by reference.”The MSN report also included the following scientific statements aboutProQuad™: * “Moreover, according to the report "Combination Vaccines forChildhood Immunization," issued by the ACIP in 1999, "the use of licensedcombination vaccines is preferred over separate injection of theirequivalent component vaccines…. Potential advantages of combinationvaccines include reducing multiple injections, improving timely

vaccinationcoverage, reducing the costs of stocking and administration of separatevaccines for health care providers and reducing health care costs for extrahealth visits, according to the report.” * “Formal studies to evaluate the clinical efficacy of PROQUAD have not been performed. Efficacy of the measles, mumps, rubella and chickenpoxcomponents of PROQUAD was previously established in a series of clinicalstudies with the monovalent vaccines. A high degree of protection frominfection was demonstrated in these studies.” * “PROQUAD

had a safety profile similar to its components. In clinicaltrials, the safety of PROQUAD was compared with the safety of M-M-R II andVARIVAX given concomitantly at separate injection sites. PROQUAD wasadministered to 4,497 children 12 to 23 months of age without concomitantadministration with other vaccines. Children in these studies weremonitored for up to 42 days post-vaccination.” * “The persistence of antibody at one year after vaccination wasevaluated in 2,107 children enrolled in clinical trials. Antibodypersistence rates one year after a single dose of PROQUAD were 98.9 percentagainst measles; 96.7 percent against mumps; 99.6 percent against rubellaand 97.5 percent against chickenpox. These persistence rates are similar tothose observed at one year with the individual component vaccines, M-M-R IIand VARIVAX. The duration of protection from measles, mumps, rubella andchickenpox (varicella) infections

after vaccination with PROQUAD is unknown”. * “Vaccination with PROQUAD may not offer 100 percent protection frommeasles, mumps, rubella and chickenpox (varicella) infection.” * “Caution should be exercised in administering PROQUAD to persons witha history of cerebral injury, individual or family history of convulsions,or any other condition in which stress due to fever should be avoided. Thevaccination history of a prospective vaccine recipient should be obtainedto determine whether the individual had any previous reactions to anyvaccine including PROQUAD, VARIVAX or any measles, mumps or rubella.”containing vaccines. * “PROQUAD is available for ordering. The catalog price of ProQuad is $114.61 per dose purchased as a pack of 10 single-dose vials of lyophilizedvaccine with sterile diluent water or $120.25 if purchased as an individualsingle-dose vial of lyophilized vaccine with sterile diluent water.”* * *It appears, therefore, that the following facts about ProQuad™ areacknowledged by its manufacturer: # Efficacy studies were not done # Safety studies never exceeded six weeks # Protection against the four diseases is not 100percent # The

duration of protection is unknown # Risks exist # Cost considerations are the primary advantages ofcombined vaccinesOf note is the statement that the only efficacy studies listed were thoseof the monovalent measles, mumps, rubella and chickenpox vaccines and notthose of the actual components of the new vaccine namely MMR and Varivax,which would have been more appropriate. This also appears to raisequestions about whether such studies were ever done before the existingcombinations namely MM, MR and MMR were licensed.ProQuad™ does not make much financial sense either. The CDC currently buysMMR II for $16.67/dose and Varivax for $52.50/dose. The total cost of$69.17 is about 60 percent of the cost of a proposed dose of ProQuad™.(18)*

* *In Europe, GlaxoSmithKline/Belgium has also been testing a European version of MMRV, a combination of PriorixÔ and VarilrixÔ (GSK). Apparently“attempts to develop such a vaccine were made nearly 20 years ago but werenot

successful.”So far the new vaccine is still referred to as MMRV. (19)Forging ahead and starting in April 2005 — before even filing for a licensefor ProQuad™ — Merck has embarked on yet another new study “to demonstratethat ProQuad™ may be administered concomitantly with a fourth dose ofPrevnar™ and a third dose of IPOL™ without impairing the safety orimmunogenicity of vaccines for measles, mumps, rubella, varicella, 7serotypes of S. pneumoniae or 3 serotypes of poliovirus.” (20)If interested in enrolling your baby in that study, the toll free number is1-888-577-8839And so it goes…References 1. http://www.proquad.com/actulub.asp 2. http://www.provenceweb.fr/e/groupes/luberon/luberon.htm 3. http://www.skatemall.com/1103.htm 4. http://www.jawbreakerlures.com/proquad.asp 5. http://www.shop4gerber.co.uk/mp600fisherman.html 6. http://www.medscape.com/viewarticle/512412 7. http://www.redflagsdaily.com/yazbak/2005_aug17.php 8. Goldman GS. Varicella susceptibility and incidence of herpes zosteramong children and adolescents in a community under active surveillance. Vaccine. 2003 Oct 1;21(27-30):4238-42 9. Goldman GS. Incidence of herpes zoster among children and adolescentsin a community with moderate varicella vaccination coverage. Vaccine. 2003 Oct

1;21(27-30):4243-9 10. Goldman GS. Using capture-recapture methods to assess varicellaincidence in a community under active surveillance. Vaccine. 2003 Oct 1;21(27-30):4250-5. 11. Goldman GS. Cost-benefit analysis of universal varicella vaccinationin the U.S. taking into account the closely related herpes-zosterepidemiology. Vaccine. 2005 May 9;23(25):3349-55 12. http://www.redflagsdaily.com/yazbak/2005_aug03.php 13. http://www.cdc.gov/nip/publications/pink/def_pink_text.htm [Chapter 13] RECURRENT DISEASE (HERPES ZOSTER) Herpes zoster, or shingles, occurswhen latent VZV

reactivates and causes recurrent disease. The immunologic mechanism that controls latency of VZV is not wellunderstood. However, factors associated with recurrent disease includeaging, immunosuppression, intrauterine exposure to VZV, and varicella at ayoung age (<18 months) 14. http://www.redflagsdaily.com/yazbak/2005_may16.html 15. http://www.cdc.gov/nip/ACIP/default.htm 16. http://www.vdh.state.va.us/imm/pdf/June.July%202005.pdf 17. http://news.moneycentral.msn.com/ticker/article.asp?Symbol=US:MRK & Feed=BW & Date=20050906 & ID=5088911 18. http://www.cdc.gov/nip/vfc/cdc_vac_price_list.htm 19. http://www.vzvfoundation.org/26.html 20. http://www.clinicaltrials.gov/ct/gui/show/NCT00109343 "In conclusion, vaccines are a perfect manifestation of everything that is satanic. They represent an adulterous and arrogant tampering with divine creation, based on the intellectual conceit of "perfecting" creation. They are poisonous, containing derivatives from metals such as mercury and aluminum, and from formaldehyde. They are made from the

cell lines and viruses of biblically unclean animals such as monkeys, cats, etc. Worst of all, they are made from the cell lines of premeditatedly murdered children. " Bob Sperlazzo Christian Digest 11/29/2002

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