Vaxelis: The first hexavalent vaccine is approved in the US, and antivaxers don’t like it

I’ve been away from the blog nearly two weeks (other than a brief Christmas message and a bit of a retread of a post yesterday); so it always interests me what’s been going on in my absence. It turns out that on the day after Christmas there was actually a news story that, had I not been on vacation from the blog, I most definitely would have done a post about. Of course, one advantage of not writing about a story right away is that sometimes waiting gives the cranks a chance to do what it is they do best and attack science. So on December 26, FDA approval of a new vaccine was announced, Vaxelis. It’s a hexavalent vaccine. To put it simply (or perhaps simplistically, but close enough for purposes of this discussion) the valence of a vaccine tells you the number of diseases it protects against; so a hexavalent vaccine like Vaxelis protects against six diseases, specifically diphtheria, tetanus, pertussis (whooping cough), polio, hepatitis B, and Haemophilus influenzae type B (Hib). The vaccine will be available in the US in 2020

Interestingly, this vaccine was the product of a collaboration between two pharmaceutical companies, Sanofi and Merck, who issued a joint press release. Of course, although this is the first hexavalent vaccine approved for marketing in the US, it’s not the first hexavalent vaccine. Indeed, Vaxelis was approved in the European Union in December 2015 and was marketed there beginning in 2016. Indeed, as our feathery scaly friend has recounted, Sanofi, Merck, and GlaxoSmithKline have produced various formulations of this particular hexavalent vaccine and marketed them outside of the US for quite a few years now. Merck and Sanofi submitted an application for FDA approval in the US after a phase III trial with over 1,400 infants that demonstrated that the new vaccine was not inferior in terms of safety and effectiveness to the older series. I don’t know enough history to know why hexavalent vaccines haven’t been approved in the US before.

In any event, Vaxelis is intended as a three-dose series, at 2, 4, and 6 months, although the first dose can be administered as early as at 6 weeks. While these three doses of Vaxelis do constitute a primary immunization course against diphtheria, tetanus, Hib, and polio, and the vaccine can be used to complete the immunization series against hepatitis B. However, this three-dose series does not constitute a primary immunization series against pertussis. An additional dose of a pertussis-containing vaccine is required to complete the primary series. As you can see, the advantage of hexavalent vaccines is, of course, fewer shots to achieve the same protection, which is, of course, beneficial to the child. No child likes getting multiple shots in one visit. Those of us who advocate for children’s health are, of course, happy to see a new vaccine that has the potential to decrease the number of sticks babies have to endure while providing the same immunity.

Antivaxers, on the other hand, are not so happy. For instance, over at Vaxxter, the antivaxers are not happy that this is a hexavalent vaccine:

The warnings and precautions page details numerous warnings and risk that could possibly be associated with Vaxelis.

The news immediately prompted concern from groups that aim to improve vaccine safety. Many believe that a 6 in 1 shot is too heavy for a small baby. Additionally, when things go wrong, it is difficult to determine what caused the issue.

Whenever you see an antivaxer write that “vaccine safety” groups “believe” that a shot is “too heavy” or “too much” for a small baby, a good rule of thumb is to substitute “antivaccine” for “vaccine safety” (because these groups are antivaccine, not vaccine safety advocates, no matter what they claim). Hilariously, Vaxxter uses one of the laziest antivaccine tropes of all, the appeal to the package insert. Here’s a hint. Package inserts are legal, not scientific, documents. They list every bad thing that’s happened associated with the vaccine, regardless of whether the vaccine is likely to have caused it or contributed to it or not. Add to that the “too many too soon” antivax trope (which is not supported by science), and it’s almost as though Vaxxter isn’t even trying.

I was curious what the wandering band of antivax propagandists over at my longtime chew toy for skepticism, that wretched hive of scum and quackery, Age of Autism. Sure enough, Teresa Conrick is not at all happy that Vaxelis was approved by the FDA. Just get a load of how she frames it:

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.

Yes, to antivaxers, it’s all a conspiracy. It’s always a conspiracy and always about vaccines. Notice how Conrick assumes that the FDA, Merck, and Sanofi “know” that vaccines are dodgy, so that they all apparently conspired, the FDA to issue its approval and the pharmaceutical companies to publish their press release, around the holidays in order to “bury” the story. Either that, or these three organizations fear antivaxers so much that they tried to downplay the story by releasing the information around the holidays. That’s how antivaxers think. And, of course, anyone who is happy about this news and approval must be a “pharma lapdog”:

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.

Of course, that’s not how it works. Notice the inflammatory “scare language” about the vaccine. “Heavy duty, injectable recipe of viral bacterial, and chemical pharmaceuticals”! Oooh! Scary! Of course, this isn’t how it works, either. If you read the actual package insert for Vaxelis, you’ll see that the FDA evaluated six clinical trials of Vaxelis to assess its safety. Two of these studies encompassed nearly 4,000 children and ere carried out in the US. They showed the usual low rate of injection site pain, swelling, or erythema, as well as fever, decreased appetite, crying, irritability, somnolence, and vomiting. As far as more serious adverse reactions, the two trials reported them in 0.1% (four infants), including pyrexia and, in one of the four, vomiting followed by pallor
and lethargy on the day of the first study vaccinations and again 2 days later. There were also six deaths, none of which were assessed as being vaccine-related, with causes ranging from asphyxia, hydrocephalus, unknown cause, sepsis and two cases of sudden infant death Syndrome. Across all six studies there were no deaths judged to be potentially due to the vaccine. Not that that stops antivaxers in the comments from doing what antivaxers do and trying to cast aspersions on studies as a conspiracy to cover up deaths from SIDS as due to Vaxelis.

The next order of business is to try to point out some scary-sounding ingredients. For instance:

  • 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.

BSA is bovine serum albumin, a serum protein found in cows. (Humans have their own version of albumin in their serum.) Interestingly, one of the references linked to comments on how unusual an allergy to serum albumins are, noting that, although “serum albumins are not considered to be major allergens, they are unusual ones.” Of course, Conrick is trying to link the very tiny amount of BSA that might be in some vaccines to milk allergies, thus bolstering the frequent antivax claim that vaccines cause food allergies. It is an incredibly tenuous connection, particularly given that BSA is a much more potent respiratory allergen than by other routes of administration. (Serum albumin is also found in animal hair and thought to be part of what makes dander and hair allergens to some people, particularly for cat hair.)

Then, of course, Conrick invokes more “toxins”:

  • 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.

Note the units used. ng = nanograms, as in 10-9 grams of BSA, which is an incredibly small amount. Ditto all the other horrible sounding things like glutaraldehyde. Does Conrick even know how small these amounts are? As for the polysorbate 80, that’s basically an emulsifier, and, contrary to the claim, 50 micrograms is not a large amount. It’s used to stabilize aqueous formulations of medications and has a number of applications in soaps, cosmetics, and foods. (It’s used in many ice creams as a smoother and to increase resistance to melting.) It’s quite an innocuous chemical, the efforts of antivaxers to show that in Gardasil it causes premature ovarian failure notwithstanding. Basically, it takes large doses in rats to injure the ovaries, and antivaxers, being antivaxers, extrapolate such animal studies to humans.

Now here’s the amazing thing. Conrick’s objection seems to be this:

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.

It’s not an “excuse.” It really is better, both for children and parents, to need fewer needlesticks in order to receive the same immunity. It almost makes me want to cite The Science Post’s satirical piece, FDA approves new 18 in 1 childhood vaccine:

While the vaccine has not been thoroughly tested, Merck (the manufacturers of the vaccine) donated $35 million to the FDA and assured them it will be fine.

The only side effect known at this point is that it will most likely cause autism. In the one study which was actually done, over 80% of the children given the vaccine developed autism, which is much higher than the standard 50-60% autism rate of most vaccines.

“We’re very excited about this new vaccine and are very happy that children will only need one shot instead of several throughout their young life,” said Merck spokesman Mark Shillington. “Of course they will almost all get autism or maybe even die, but at the end of he day our shareholders will be happy.”

The new vaccine is expected to cost around $1250 per dose.

This really is the way antivaxers think. It’s virtually impossible to parody, at least in a way that isn’t a poe, where it’s hard to distinguish what antivaxers really say from parody or satire like that of the Science Post. Just look at Teresa Conrick’s post if you don’t believe me. After all, she’s the same antivaxer at AoA who’s blamed mass shootings on psychiatric drugs. As I say, it’s hard to parody these graduates from the Dunning-Kruger College at Google University.