In the no-liability context enjoyed by vaccine makers in the U.S., combination vaccines are already quite popular. In fact, market watchers and health economists praise the jumbo shots as being a catalyst for positive industry trends and a “key to commercial success.”
Thus, financial analysts expect Vaxelis to “garner significant patient share following its [U.S.] launch” — predicting that it will account for almost a third of U.S. DTaP vaccinations by 2028 — or $841 million in annual sales.
These predictions represent good news for Merck and Sanofi, two of the “big four” pharma giants that dominate the childhood vaccine market in the United States. Merck is already doing a booming vaccine business, recently reporting annual sales growth of 14.8% for its pneumococcal vaccine (Pneumovax 23) and 5.4% for its human papillomavirus (HPV) vaccine Gardasil-9.
However, Merck also faces proliferating Gardasil-related lawsuits — including legal actions alleging that the company knew about and ignored life-changing adverse events from the get-go, many of which (when not fatal) have involved autoimmunity and chronic pain. In fact, before the advent of emergency use COVID vaccines (responsible for an alarming escalation of vaccine-related adverse events), Gardasil had had “more side effects reported than all other vaccines combined.”
Sanofi, too, is embroiled in thousands of lawsuits worldwide — notably for its disastrous and sometimes fatal dengue vaccine. As with Merck, this has not dampened overall vaccine sales growth, which continues its strong upward trajectory, likely to be further strengthened by the U.S. Vaxelis rollout.
Aluminum secrecy and grandfathered ingredients
Merck’s proprietary, “super-powered” aluminum adjuvant — amorphous aluminum hydroxyphosphate sulfate (AAHS) — which is believed to play a significant role in Gardasil’s risk profile, is also present in Vaxelis.
After Merck developed AAHS, it began to “preferentially” feature AAHS in its vaccines even though, as Danish scientists outlined last year, the company appears to have disregarded procedures ordinarily required for approval of new adjuvants.
According to the Danes, at the time AAHS appeared, it represented a “new type of aluminium adjuvant with excipients that [had] not been used earlier in [European Medicines Agency] authorised vaccines.” It should have been — but apparently was not — tested against an inert placebo. For this and other reasons, the Danish scientists question the ethical underpinnings of the Gardasil clinical trials.
In noting that Merck also “seems to have prevented independent studies of AAHS,” the Danes repeated a critique aired by world-famous aluminum expert Christopher Exley in 2018. In an extensive discussion of different aluminum-based adjuvants and their immunological mechanisms of action, Exley and co-authors emphasized the importance of studying aluminum adjuvants one by one, as each is “chemically and biologically dissimilar with concomitantly potentially distinct roles in vaccine-related adverse events.”
Concerningly, the Vaxelis liquid suspension is adjuvanted onto not just AAHS, but also another aluminum adjuvant — aluminum phosphate). The package insert disingenuously shorthands the combination of adjuvants as “aluminum salts.”
How this double whammy of aluminum (319 micrograms per vaccine dose) interacts with the vaccine’s six antigens, or Vaxelis’s numerous other ingredients, or the heavy aluminum load in other childhood vaccines is largely unknown.
According to the Vaxelis package insert, the vaccine also includes: polysorbate 80 (an ingredient flagged for its propensity to induce hypersensitivity reactions); glutaraldehyde and formaldehyde (problematic chemicals deemed necessary to inactivate pertussis toxin); bovine serum albumin (often harvested from bovine fetuses when female cows are found to be pregnant at slaughter); three different antibiotics (neomycin, streptomycin and polymyxin B); ammonium thiocyanate (also a rust inhibitor, weedkiller and defoliant); and yeast protein (associated, notably in hepatitis B vaccines, with autoimmune reactions).
Regulatory loopholes allow manufacturers to “grandfather” ingredients into new vaccines if the components are already present in other licensed vaccines — regardless of how inadequate the original safety testing may have been.
Thus, Merck and Sanofi perceived no need to test Vaxelis for DNA-damaging or cancer-causing effects, and conducted no studies of the ingredients’ pharmokinetics (i.e., how the substances move “into, through, and out of the body”).
The main cautionary note sounded in the meager Vaxelis patient information sheet is to not give Vaxelis to children if they are “allergic to any of the ingredients.”
For thee and thee … but not for me?
The CDC seems to be particularly interested in ensuring that poor and non-white children get Vaxelis. The agency began laying the groundwork to offer Vaxelis through the Vaccines for Children (VFC) Program — the agency’s vaccine program for the poor — over two years ago, in March 2019.
At its September 2019 meeting, CDC outlined another topic deemed important for discussion in the near future — raising the issue of whether Vaxelis should be “preferentially recommended” for the American Indian/Alaskan Native (AI/AN) pediatric population.
The tenuous rationale, according to the meeting notes, was because, “in the pre-vaccine era” (more than 35 years ago), “Hib disease occurred at a younger age among the AI/AN population compared to the general population.”
Wave of the future?
Judging from its website, the CDC perceives combination vaccines to be the wave of the future, and has signaled its strong endorsement of Vaxelis by incorporating the new vaccine into its 2021 vaccine schedule.
As if exposure to six antigens were not enough, FDA and CDC also say it is okay for healthcare providers to administer the six-in-one shot at the same time as other vaccines.
These agencies’ characterization of the Vaxelis safety profile as “acceptable” indicates they have either not done their due diligence, or are willing to accept a high level of collateral damage in exchange for the “convenience” of six-in-one shots.
Read more at: ChildrensHealthDefense.org