Among the 8.6 million people who live in New York City, there’s been 359 cases of measles since last September. On March 9, Mayor Bill de Blasio leading the charge, the city mandated the MMR (measles, mumps, rubella) vaccine in four densely populated zip codes in Brooklyn, neighborhoods where many Hasidic Jews reside. With 294 cases in Williamsburg, the outbreak has been centered in that community. (55 cases have hit another largely Hasidic community in Brooklyn, with ten cases elsewhere in the city.)
Should the city learn that an unvaccinated person in the crowded, insular community has been exposed to measles, they and their family have a matter of days to get the single MMR vaccine or pay a fine.
In Oregon, on the other hand, there’s been 10 cases of measles statewide in 2019 – six cases in the county that includes Portland, and four in the rest of the state. Of Oregon’s 36 counties, 32 have seen no measles at all. It’s a bag of shells compared to what’s happened in Brooklyn.
Yet Oregon state legislators, primarily Democrats and with the backing of the state’s Democratic governor, are proposing to pass legislation, HB 3063, mandating full vaccination for any child in the state who wants to attend any school or day care, public or private – or even, in most cases, go to church with their family.
Should the law pass, any child lacking a medical exemption for a specific vaccine, an exemption that is approved by the local health department and tough to get, must get up to date on the seven mandated vaccinations – six for children age 5 or older. Up to date on shots to guard against diphtheria, tetanus, pertussis (that is, whooping cough), polio, measles, mumps, rubella (German measles), haemophilus influenzae type b (Hib: a rare disease, primarily in children under age 5, that can lead to meningitis), hepatitis A and B, and varicella (chicken pox).
Get all your shots, and once the law’s in place, get them quick. That or stay home for the cobbled-together education and socialization available there.
(This is unfolding in the context of vaccine-maker Merck & Co., Inc. paying $5,146,000 from 2016 to 2018 in 21 separate grants to three doctors’ professional associations that have a formal role approving the federal vaccine schedule, according to the Centers for Disease Control and Prevention. A good slice of that $5-million went to promote acceptance and use of Merck’s controversial human papilloma virus vaccine, Gardasil, including, for instance, a payment of $219,000 on July 23 of last year to one of the groups, the American College of Obstetricians & Gynecologists. The Merck spread-sheet indicated the money funded an “HPV Immunization Web Program.”
Also peering over the shoulder of the current debate is the issue of what vax-compliance registry experts – the Immunization Information Systems folks – refer to as inter-operability: the coming ability of various state vaccine-status registries to communicate with each other so as to, one day, create a full national registry of vaccine noncompliant Americans. CDC guidelines as well as a registry vendor I interviewed, indicate that this information is available to health insurers (“stakeholders,” that is) – perhaps the future route for higher insurance premiums or denial of coverage for those not fully vaccinated. Several academics pushing full vaccination have called for insurance penalties for the noncompliant.
More on Williamsburg, Merck’s payments to doctors’ groups, the future tracking of Americans’ vaccine status and the press’s role in the vaccine-debate miasma in a future article.)
Along with New York’s four-zip-code, one-shot agenda, statehouse action in Washington also comments on Oregon lawmakers’ overarching ambitions. Unlike Oregon, Washington has experienced an actual measles outbreak, one confined to Vancouver, the city across the Columbia River from Portland. There’s been 73 cases in Vancouver’s Clark County along with one in the Seattle area.
Yet, as in Brooklyn’s ‘emergency’ order, Washington’s pending legislation will require only the MMR shot. On Thursday, largely on party lines with Democrats in favor, the bill passed a closely divided state senate and is expected to make it into law. The rarely used religious exemptions will still apply in Washington.
Though the media conflate the two states, constantly referring to “the measles outbreak in Oregon and Washington,” with a population of 807,000, Multnomah County – that is, Portland and some suburbs – has seen six cases total.
Nonetheless, with Democrats and a few Republican lawmakers in a tizzy, Oregon is reaching for the stars. Should the bill pass, the state will mandate the entire schedule of shots mentioned above. That or no school or day care, public or private.
Nope, not just the MMR shot, like the jurisdictions that actually have more than a smattering of measles cases. It seems almost vindictive somehow, a punishment perhaps of the Oregon parents (and their children) who followed current state law and legally opted out. Among K – 12 students, there’s 31,474 Oregon kids statewide whose parents declined at least one of the shots listed above, including two combination injections covering three diseases each.
So, two states with bona fide, albeit limited – certainly quite limited geographically and demographically – measles outbreaks. One, New York, is mandating MMR shots solely in four zip codes for those thought to be exposed. In practice, it appears that contact tracing will be largely limited to Hasidic Jews, the same folks who’ve gotten ill with what, in rare instances, can be a serious, life-altering disease.
The other state, Washington, is looking to enact a statewide mandate, but solely for the MMR vaccine.
“Newsworthy,” But Not an Emergency
Oregon, on the other hand, is not facing a measles emergency, not remotely. As one Oregon official told me, “It’s nice that it’s newsworthy, but I don’t consider measles an emergency.”
The concept of outbreaks’ utility was echoed by Phoenix-area pediatrician Dr. Chris Hickie on a rigorously pro-vax blog. Decrying what he rather amazingly termed big medical associations’ supposed apathy towards nonmedical exemptions, Hickie wrote, “[W]e are then relying on further Disneyland-type vaccine-preventable infectious disease outbreaks to do the work we should have been doing these last 10+ years.”
The reference is to the late-2014 measles outbreak at Disneyland that served as a catalyst for California revoking personal belief exemptions. California an American bellwether for generations, a well publicized outbreak there closed the gates on nonmedical exemptions. Now in 2019, seizing the opportunity presented by an outbreak in Washington, Oregon lawmakers are proposing to mandate seven different vaccines for 11 diseases.
The law will particularly affect the 17,700 Oreogn children who’ve received no shots at all. That’s 15,737 K – 12 students in 2018 and, I estimate after parsing state records, approximately 2,000 more in preschool.
For an unvaccinated Oregon 3-year-old, say – should the child get 4 DTaP shots and not 5 – that would add up to 21 needles (six of them being combination shots). And, no, the momentary discomfort of the jabs is not the issue.
The CDC defines an antigen as, “A live (e.g., viruses and bacteria) or inactivated substance capable of producing an immune response.” And the Institute of Medicine describes antigens as “those portions of a foreign substance that trigger an immune response.”
Research sponsored by the CDC and published in 2018 in JAMA: The Journal of the American Medical Association (see ETable3), discussed the number of antigens in the multiple doses of the vaccines Oregon is proposing to mandate (six for children age 5 or older, the Hib vaccine dropped for them).
If the 17,700 totally unvaccinated children are to follow a full catch-up schedule – as Oregon is proposing – the total number of antigens, including viruses and bacteria, is between 285 and 295 according to the JAMA study.
The number varies depending on which brand of DTaP is used. For children 5 or older, the total is between 277 and 287 antigens (again, depending on the DTaP choice) after subtracting the 8 total antigens contained in the two Hib doses they don’t get.
Note that this antigen total is certainly reduced from the days when whole-cell pertussis and smallpox vaccines were routinely used.
A Super-Majority Plows Ahead
The Democrats in Salem, the Oregon capital, enjoy super-majorites in both houses: 18 Democrats to 12 Republicans in the Senate, and 38 to 22 representatives in the House. They can do, more or less what they like.
And as they plow ahead, they did embrace a broader view in one respect. Of the dozen and more amendments offered on the bill, they passed one, Amendment 13, that extended the deadline for complying with the proposed new law out till next summer. Unvaccinated children, therefore, will not be barred from school or day care until August 1, 2020. And, yes, that is indeed something.
Should the bill pass sometime in the next several weeks, parents paying attention to state politics will have a year and more to catch their kids up. That, of course, doesn’t include the large percentage of folks out there who ignore politics in favor of the finer things in life like skee-ball or skittles. There are people who don’t engage in the polity, or only follow the far-off orbs that suck all the air out of the room.
Additionally, the ‘grace period’ till next August may be of little solace to parents who entirely oppose some or all vaccines. If you think your child might be harmed – which is certainly a real, albeit rare possibility; if your child already has been harmed; or has a sibling who’s been harmed, having a year to accomplish the task means little. That’s why there were several mothers shedding quiet tears as the bill was voted out of the House committee, its first step towards potential passage.
There’s a lot of uncertainty at play about how all the various vaccines interact with each other. The well respected Institute of Medicine, one of the National Academies of Sciences, Engineering, and Medicine, published a volume in 2013 entitled, The Childhood Immunization Schedule and Safety: Stakeholder Concerns, Scientific Evidence, and Future Studies.
And it delved deep into the issue of the safety of the entire vaccine schedule. The summary chapter noted, “First, the concept of the immunization ‘schedule’ is not well developed. Most vaccine-related research focuses on the outcomes of single immunizations or combinations of vaccines administered at a single visit…. Thus, key elements of the entire schedule—the number, frequency, timing, order, and age at administration of vaccines—have not been systematically examined in research studies.”
What’s more – and here’s one of the key issues the article you’re now reading addresses – once the law takes full effect next August, according to the state expert steering how it all shakes out, all Oregon families with unvaccinated children will be under intense pressure to meet the state’s new requirements quickly.
Then consider this real-world scenario, one that might grace the stage after August 2020:
Mom and Dad have been sailing along, the happy parents of three-year-old Henry, one parent taking care of him at home, Henry the recipient of no vaccines. He’s at home when he’s not digging in the park’s sandbox or flapping his arms at the chickens in the yard down the block trying to get them to fly, life proceeding apace.
Then, boom! – a different life intrudes.
Mom heads for the hills with some Uber driver. Or Dad disappears with the local laundromat attendant. It happens. So the parent saddled with Henry, the parent who’s been stay-at-home Mom or Dad, now has to find work and slap Henry in day care right quick.
It’s worth noting divorce’s economic effect, which is typically harsher on women. (Sainted Mom true to her vows, her ex is the one leading the high-life off counting quarters from all the driers). The CDC notes (page 4) that for whites (remember, we’re talking Oregon here), the percentage of toddlers aged 19 – 35 months who had all their shots averaged more than 13 percent lower, from 2012 to 2016, for children living below the Census Bureau’s poverty thresholds compared to children living at or above that income level.
If the bill passes, it’ll be in full force come next summer. After that, how quickly will woebegone Mom be required to get that kid vaccinated? For the most part, that will be left up to the good graces of the Oregon Health Authority, which means it’ll be the determination – to a large degree – of Paul R. Cieslak, MD, OHA’s Medical Director, Communicable Diseases and Immunizations.
His assessment: six months. Yup, safe – and immunologically efficacious, too – in his considered professional judgement for Henry to get 21 shots in six months.
Leading Oregon legislators by the hand, more than once during public testimony March 14 right before Democrats on the Oregon House Committee on Health Care voted to move the bill along to a joint House-Senate committee, Cieslak stated that entirely unvaccinated children could safely be caught-up to full compliance in a matter of months.
With no mention of the 17,700 or so totally unvaccinated Oregon kids potentially affected, state representatives asked Cieslak (starting at the 29:00 mark of the video) how quickly totally unvaccinated children could get the many shots needed to comply with Oregon law.
His expert (unsworn) testimony: six months.
Recall the exhaustive IOM research effort quoted above: “[K]ey elements of the entire schedule – the number, frequency, timing, order, and age at administration of vaccines – have not been systematically examined in research studies.” [Emphasis added.]
Cieslak’s statement contrasts with the current de facto system in Oregon. School children whose parents have not exercised the current personal-beliefs exemption might be given an injection at the local health department in February and basically told to return in a year for any needed booster shots.
It was rather breathtaking. Asked again by a somewhat incredulous lawmaker, Cieslak repeated his assertion as to the half-a-year safe time-frame.
The Big Kahuna
An MD and the state’s designated expert, who according to his LinkedIn page has been managing communicable disease prevention at OHA since 1995, Cieslak’s safe six-month window lies at a far remove from the CDC’s official guidelines, the “General Best Practice Guidelines for Immunization,” as promulgated by the CDC Advisory Committee on Immunization Practices. ACIP is the big kahuna of vaccination policy; when media reports refer to federal guidelines, they’re typically referring to what ACIP puts out. Most states follow suit.
ACIP has 15 voting members, mostly med-school professors, who vote on the Best Practices. They’re aided by eight “ex officio members” representing federal entities such as the Food and Drug Administration and National Institutes of Health. Then there’s the “30 non-voting representatives of [various pro-vax] liaison organizations.”
(Of note are the representatives of three doctors’ professional associations who, as mentioned, also have a role in approving the CDC’s vaccine schedule. As will be discussed in a future article, these three groups – the American Academy of Pediatrics (with two representatives), the American Academy of Family Physicians, and the American College of Obstetricians and Gynecologists – have received more than $5-million from vaccine maker Merck over the last three years, some of the money geared to promoting acceptance and use of Merck’s controversial HPV vaccine.)
Oregon indicates that the first of its 12 criteria when establishing its schedule is whether a vaccine is recommended by ACIP – often the determining factor.
As to Mom having to stash Henry in day care so she can get a job and keep a roof over their heads: the CDC calls for eight months to elapse before the child can get four DTaP shots – not Cieslak’s six months. And should the timing of Henry’s age work out that he gets five DTaP shots, what’s referred to as the Minimum Interval is 14 months – not six.
In the same vein, the minimum time between the polio shots is also eight months, not six.
And those are just the absolute Minimum Intervals.
ACIP’s “Recommended Intervals,” however, are a horse of another color; they’re the elapsed time indicated for maximum immunological efficacy. As to safety – lowering the risk of adverse events after vaccination – as the IOM research suggests, the data is lacking.
The AICP Best Practice guidelines come down hard on eschewing the Minimum Intervals and spacing vaccines out according to the Recommended Intervals. Thus, the CDC argues for Oregon lawmakers and parents alike to ignore Cieslak’s putative six-month safe-window for up to 21 shots containing up to 289 antigens.
The guidelines state, “Vaccination providers should adhere to recommended vaccination schedules.” Only when a child who is behind schedule needs “rapid protection,” or in the event of impending foreign travel, should the intervals be shorter than the Recommended Interval.
There’s certainly scant case to be made in Oregon that any child needs “rapid protection” against chicken pox or polio.
The Three Mavens
Mark Sawyer, MD, professor of clinical pediatrics at UC San Diego, has served on ACIP and is also chair of the California Immunization Committee – a vaccine maven, obviously. He said, “There’s not a lot of data to support the use of minimum intervals; only small groups have been studied.”
The ACIP guidelines add on Page 2 that, “Doses administered too close together or at too young an age can lead to suboptimal immune response.” In other words, rush the gun on subsequent doses – as Cieslak assured lawmakers was OK – and health officials might shoot themselves in the foot. On Page 10, ACIP reiterates, “Vaccination providers should administer vaccines as close to the recommended intervals as possible.”
Jose R. Romero, MD, a professor at University of Arkansas for Medical Sciences and the current ACIP chair – Maven Number Two – said, “Ideally, yes, you stick as close as possible to the Recommended Intervals.”
Asked about a statewide campaign catching up thousands of children, Romero said, “I don’t know that I’d used accelerated intervals.” It’s more individualistic than that, he added. “I would say if the family will bring the child back at the appropriate time, I would stick with the Recommended Intervals…. It requires some thought by the health department.”
In other words, according to the ACIP chair, not just the state of Oregon buffaloing through a blanket, one-size-fits-all program.
Another authoratative CDC source, now in its 13th edition, is the agency’s vaccination bible, commonly calle the Pink Book. It advises, “Accelerated schedules should not be used routinely.” And a program for 17,700 kids, by definition, has to be informed by routine, or it’ll devolve into chaos.
Formally titled, Epidemiology and Prevention of Vaccine-Preventable Diseases, the Pink Book’s General Recommendations chapter offers this large-font, pull-quote General Rule: “Decreasing the interval between doses of a multidose vaccine may interfere with antibody response and protection.”
What’s more – Oregon lawmakers please take note as you usher Cieslak’s six-month catch-up schedule to the door – it advises that, “Studies have demonstrated that recommended ages and intervals between doses of the same antigen(s) provide optimal protection or have the best evidence of efficacy.” [Emphasis added.]
Shorter, minimum intervals might be substituted for the recommended intervals pending international travel, the Pink Book advises. Or, “when an infant or child is behind schedule and needs to be brought up-to-date quickly….” But there’s no further guidance given as to when a quick catch-up might actually be indicated.
No rationale for when a quick catch-up might be called for.
Conversely, see the CDC material just above calling for adherence to the much longer Recommended Intervals. To repeat: “Decreasing the interval between doses of a multidose vaccine may interfere with antibody response and protection.” In other words, the kid gets the shots and risks the attendant adverse events for little or nothing.
Mandatory full-vax advocates, the Immunization Action Coalition, also advises following CDC’s Recommended Intervals. An IAC power-point presentation echoes ACIP: “Vaccination providers should adhere as closely as possible to the recommended vaccination schedules to provide optimal protection.” In other words, unless there’s a good reason otherwise, stick to the Recommended Intervals.
The IAC adds, “Administration of doses of a vaccine series using intervals that are shorter than recommended might be necessary in certain circumstances, such as impending international travel or when a person is behind schedule but needs rapid protection.”
The reference is to “a person” – singular. There’s no indication that a wide-scale immunization program for up to 31,000 students constitutes a population that needs “rapid protection.”
IAC Executive Director Deborah L. Wexler, MD declined to identify when a person – never mind tens of thousands of them – might need “rapid protection.” Though a physician who’s been at IAC for 29 years, Wexler emailed to say, “I am sorry that I am not a good source for answers to your other questions.” That’s a bit tough to swallow from a professional in the field for almost three decades.
Or is it the case that there’s no criteria at all indicating a need in a large population for “rapid protection”? No criteria supporting CDC’s hypothetical scenario of a child that, for unstated reasons, “needs to be brought up-to-date quickly.”
Statements by the expert quoted above, the current ACIP chair, Dr. Romero, as well one quoted below, Dr. Arthur L. Reingold of UC Berkeley, seem to underscore the lack of any good reason to go off half-cocked.
Some examples of the Recommended versus Minimum Intervals:
While the Minimum Interval for the two required MMR shots is within Cieslak’s six-month time-frame, ACIP’s Recommended Interval between them is 3 to 5 years. Immunity waning, that’s so the child will actually be protected when they head off to school.
For varicella, the Minimum Interval between the two doses is 3 months but the Recommended Interval is at least 3 years.
And for the four mandated polio shots, CDC’s Minimum Intervals add up to 8 months – longer than Cieslak’s safe window – but the Recommended Intervals are at least 40 months.
Full Catch-Up Necessary?
On a different front, UC Berkeley School of Public Health professor of epidemiology, Arthur L. Reingold, MD, who served on ACIP from 2013 to 2017 (Maven Three), questioned the doctrinaire need to catch-up with blind observance to the full immunization schedule. A vastly experienced expert, he, Sawyer and colleagues co-authored ACIP’s 2018 recommendations on pertussis, tetanus and diphtheria.
Asked about CDC’s stated preference for following the Recommended Intervals rather than the Minimum ones, Reingold said, “You raise a really important question.” Taking my question and running with it, he added, “Clearly for a number of the vaccinations in question, even one dose offers reasonable protection.” For instance, Reingold said, one shot of Hep A vaccine offers “good protection.”
Reingold said, “We want kids in school. And we don’t want the shots too close together. They’re not valid,” he said, if too close, “and you won’t get the same level of immunity.”
Reingold added that from a public health viewpoint, “It’s reasonable that if you get one MMR vaccine, you could wait on the second. Or the second may not be necessary. That’s another example of one dose being OK to get kids in school.” A pragmatic man, it seems, Dr. Reingold.
For his part, Sawyer said, “For measles, a single dose does a pretty good job; there’s less pressure to accelerate to the minimum intervals.” That’s less true for mumps, Sawyer added. But mumps are not the issue here in Oregon; mumps aren’t driving legislation.
As to polio, Reingold said, “One dose of the injectable polio vaccine provides reasonable efficacy.” Especially since, “The risk of contracting polio is vanishingly small in Oregon. So one dose is an OK starter.” Contrast that view with the four polio shots Cieslak and Oregon lawmakers want to pound home in six months.
Unless international travel is anticipated, Sawyer said of the polio vaccine, “There’s no need for accelerated administration. I would go with the Recommended Interval. At this point, the risk of polio is minimal or zero.”
In other words, in the opinion of these two nationally recognized experts – doctors steeped in the making of federal vaccine policy – violating the CDC’s Minimum Intervals by forcing kids to get four polio shots within six months to satisfy some crack-the-whip notion of compliance is of little utility and less sense.
Yet Cieslak expressed none of this to legislators about to vote a bill out of committee and on its way, perhaps, to becoming their own whip forged of ignorance, unaccountable partisan momentum and bad advice from the state expert ‘testifying’ before them. (Maybe if Oregon had sworn testimony, state experts might bone up a bit on what they impart.)
Regarding Hep B, Reingold expressed his personal opinion that one shot should suffice for most of childhood. “If you don’t get it from your mother at birth, a child is reasonably safe till adolescence.” For the most part, in his view, that’s when the next likely exposure might occur.
Official Approval for Delay
In fact, just delaying the shots, spacing them out, as many parents wish to do as a step far short of vaccine refusal, receives official approval. According to the Pink Book, the CDC bible, “[A]available data indicate that intervals between doses longer than those routinely recommended do not affect seroconversion rate or titer when the schedule is completed.” Titer refers to a blood test of the number of antibodies, which indicates the level of immunity.
In a bold-faced, large-font pull-quote, this official reference states: “General Rule: Increasing the interval between doses of a multidose vaccine does not diminish the effectiveness of the vaccine.* The asterisk says, “after the series has been completed.” Yet the meaning of this General Rule is clear.
Finally, as a bullet point in a box so as to emphasize the statement, the Pink Book adds, “Available studies of extended intervals have shown no significant difference in final titer.”
Nor does an organization roasting marshmallows round the mandatory full-vax campfire, the Immunization Action Coalition, which receives funding from both the CDC and pharmaceutical companies, shy from delay.
Its power-point states, “Doses given even years later than recommended are still valid because the body has ‘immunologic memory.’ The real problem with longer than recommended intervals is not the validity of the doses or their immunologic effect. It is that, until the series is complete, the person may remain susceptible to the associated vaccine-preventable disease.”
Chances are good, quite good given the large Democratic majorities in both houses of the state legislature, that Oregon will pass some sort of a bill restricting exemptions. Opponents might hope that, as in Washington, the stricture might be limited to the MMR vaccine. Or perhaps some lawmaker a bit better versed in the complexities of the vaccine schedule – having taken the time to do some reading – might offer an amendment with specific, written caveats about adhering to the CDC’s Recommended Intervals and not the Minimum Intervals. And certainly not Cieslak’s wildly aggressive six-month window once the bill potentially takes hold next summer.
Scant Data on the Full Schedule
Yeah, it really might be best to go slow, given the paucity of research on the possible adverse effect of all those vaccines in the short time proposed, six months for maybe 21 shots. One issue regarding so many vaccines is that while individual vaccines have been studied, albeit often with small samples, there is limited research, according to the Institute of Medicine, on the entire vaccine schedule. Limited research on accelerated delivery of that passel of shots.
As the IOM research, The Childhood Immunization Schedule and Safety, quoted above – as far from fringe science as it’s possible to get, but unfortunately not updated in the six years since publication – put it, “[F]ew studies have comprehensively assessed the association between the entire immunization schedule or variations in the overall schedule and categories of health outcomes….”
It added, “Experts who addressed the committee pointed not to a body of evidence that had been overlooked but rather to the fact that existing research has not been designed to test the entire immunization schedule.”
Finally, the IOM committee stated its belief that, “although the available evidence is reassuring, studies designed to examine the long-term effects of the cumulative number of vaccines or other aspects of the immunization schedule have not been conducted.”
In an editorial in JAMA, two professors, one at Stanford, the other at the University of Colorado (and a big ACIP man) wrote of “the robust and safe childhood immunization schedule….” But they also noted the increase in routine vaccinations from the 8 typically given in 1994 to 2010’s total of 14. (Some not mandated by Oregon – not yet – though keep your eye on HPV.)
And then this in JAMA, “In 2013, the Institute of Medicine … called for increased research into the safety of the entire childhood immunization schedule. Although pre- and post-licensure studies had examined the safety and efficacy of individual vaccines separately and in combination with other vaccines, these studies did not examine the safety of the overall schedule.”
It’s a shot in the dark.
Oregon is proposing to embark on a grand experiment: from no-vaccines to full-vaccination, zero-to-60 in six months maybe, N = 17,700. (N is the number of subjects in a study.)
It’ll be a vast, bitter experiment under a cloud of uncertainty, lack of research, and steady amendation to the devilishly complicated vaccine schedule. For instance, the ACIP recommended schedule for 2019 noted, “changes in the 2019 immunization schedule for children and adolescents aged ≤18 years include new or revised ACIP recommendations” for HepA, HepB, influenza, Tdap, “as well as clarification of the recommendations” for polio. That’s in 2019! With the exception of any given year’s flu shot, none of these are new vaccines.
And though ACIP is treated as if handing down tablets from Mt. Sinai, things do get botched. Or, as CDC admitted, “errors occured.” For ACIP’s 2011 “General Recommendations on Immunization” (here) left out an entire category of vaccines that may cause the dreadful response known as the Arthus reaction. It’s named for the French immunologist Nicolas Arthus, who discovered it in 1903.
According to a different ACIP document, this from 2006, the Arthus reaction to vaccines (and other medical events), which may occur from 4 to 12 hours after vaccination, is “characterized by severe pain, swelling, induration [a hardened mass or loss of elasticity], edema [swelling], hemorrhage, and occasionally by necrosis.”
Necrosis refers to irreversible tissue death, in this case, typically around the injection site.
CDC did mention tetanus. But it left out an entire category of diphtheria containing vaccines that might also spark an Arthus reaction: the two “MCV4” meningococcal shots that are diphtheria conjugate vaccines. That means they use a form of diphtheria to help the meningococcal antigens do their job.
It took CDC six months in 2011 to issue an erratum here noting that “errors occured”regarding the danger the meningococcal vaccines represented to prior Arthus reaction patients. No way of telling, of course, how many children might have experienced severe pain and necrotic tissue death over those six months.
CDC Medical Officer and lead author of the 2011 “General Recommendations,” Dr. Arthur T. Kroger, told me that Arthus is indeed a serious reaction, one that, by definition, is “very painful.” But he couldn’t say what the long-term effect of necrotic tissue death might be. The CDC states that it occurs “occasionally” with Arthus. Asked, say, if such tissue death might affect the ability going forward of a young baseball player (of either gender) to throw a baseball or softball, he declined to answer. Kroger did say, “I guess it’s irreversible. You have to debride” the dead tissue. “It’s not deep. The arm’s not limp.”
Some parents may wonder why they can’t just go get a measles vaccine alone – a monovalent vax. But there’s no stand-alone measles vaccine available. After a production hiatus, Merck terminated the three monovalent vaccines, including mumps and rubella, in 2009. This followed its licensing of a combined MMR-varicella vaccine in 2005.
Merck’s 2018 annual report states that global sales of ProQuad, its MMRV vax, were $593 million in 2018, up 20 percent from sales of $495 in 2016. The most recent annual increase was “driven primarily by higher volumes and pricing in the United States and volume growth” – not higher prices – in Europe. (The CDC indicates that in the “private sector,” the MMRV shot costs $214 a pop.)
The annual report adds that global sales of MMR were $430 million in 2018, up 22 percent from $353 million two years before in 2016. Up 20 percent and more the past two years, both products are enjoying remarkable growth.
Never mind that according to the CDC, post-licensure studies of MMRV versus separate, simultaneous MMR and varicella shots indicate that among kids aged 12-23 months, twice as many who got the MMRV shot experienced febrile seizures as did children that age who got simultanous but separate MMR and varicella injections. The CDC notes that Merck did its own post-licensure study. And while the absolute numbers were slightly less, the ratio of seizures remained two to one, MMRV vs. MMR and varicella shots during the same office visit.
Ball’s in Your Court, Oregon Lawmakers
Despite flying in the face of official federal vaccine scheduling guidelines as promulgated by ACIP’s experts, Cieslak still well might determine state policy. That’s his job, done competently or not. One wonders at his blithe contradiction of the 15-odd med-school professors who vote on ACIP’s Best Practices. Fifteen vax-mavens on one side versus one lonely OHA doctor on the other – though he’s the one calling the tune for Oregon legislators, the one potentially carrying the day down in Salem.
As currently written, the law leaves much to untempered bureaucratic initiative, lawmakers proposing to allow OHA to do what it will. The bill says, “The Oregon Health Authority shall adopt rules pertaining to the implementation,” etc.
Implementation – the when and how that any termination of nonmedical vaccine exemptions will affect many thousand Oregon children – is left to OHA’s discretion. Moving forward, Cieslak, his boss, OHA Director Patrick Allen (an administrator, not a scientist), and Allen’s boss, Governor Kate Brown, a Democrat, get to decide the nuts and bolts of Oregon’s immunization policy.
That is, unless some Oregon legislator takes the time to master a tough subject and write some amendments to HB 3063 to rein in Oregon’s unbridled – again, almost punitive – legislation. The bill currently before a House-Senate committee, the word afoot is that amendments remain a possibility even at this late date. So, some lawmaker might try to rein it in starting with Washington and New York’s more modest ambitions as a model and cracking the whip solely, perhaps, in regard to MMR – which will still dismay an awful lot of parents. And then that same, truly progressive lawmaker, will take it upon her or himself to convince enough Democratic colleauges to vote for restraint.
That, or maybe even take a step back and realize – all the media ballyhoo aside – that it is possible to cry halt to the frenzied, alarmist fandango that’s crowded the dance floor.
Daniel Forbes’s series of 20 articles in The Portland Mercury on toxic emissions from Portland glass factories helped drive state policy change. Won awards from such outfits as Columbia University’s J-School, published in a bunch of national publications such as Rolling Stone and The Nation, etc., and appeared on radio and TV a fair bit. (Cool when they send a big black limo, you exit the house in a suit, and the neighbors think someone’s died and send over free food.)
Testified before the U.S. House and the Senate at hearings he caused on the Clinton White House’s $24-million, sub rosa propaganda campaign to rewrite TV scripts to sway elections. His novel, Derail this Train Wreck, from Fomite Press, was sparked by a police assault that led to a successful, free-speech federal lawsuit against Lincoln Center and the NYPD.