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Vaccine safety: British are less sceptical than Europeans, but younger people need assurance

BMJ 2019; 365 doi: https://doi.org/10.1136/bmj.l4291 (Published 19 June 2019) Cite this as: BMJ 2019;365:l4291

Response to John Stone’s Re: Vaccine safety: British are less sceptical than Europeans, but younger people need assurance. Where are the placebo controlled trials? (July 22, 2019)

Stone writes: “I am sure that Harrison will agree that an aluminium adjuvant is not a placebo. . . Surely if such trials [premarketing] were done and they had had favorable results we would not have difficulty locating them, but we do. A case in point is that Harrison’s primary example is a post-marketing study by Block et al in which the results in Table 1 for "serious AEs" the "non-aluminium containing" and "aluminium containing" placebos have been amalgamated, which is not transparent. . . None of the studies cited in the blog by "Kathy" seem to be pre-marketing safety studies related to the UK childhood schedule.”

In my paper I included in the references the WHO (2013) document on placebos in vaccine trials. No, in most cases, I don’t think aluminum adjuvant is a placebo and neither did I say so. The Block paper was not given as a “prime example” but addressed to Christopher Exley, whose focus is aluminum, as an example where a traditional placebo and aluminum were used. And I was addressing Exley’s claim that “There has not been a single vaccine 'safety study' on any vaccine given to children (up to the age of 18) there have only been vaccine efficacy studies.” Not preclinical, NO studies.

So, whether Kathy’s (2018) list included pre-marketing or not, she certainly gives 10 examples of valid placebo-controlled clinical trials and actually several are pre-marketing studies. Phase 1, Phase 2, and Phase 3 studies are pre-marketing studies. The reader can check them out.

What about difficulty in finding pre-marketing studies? Note that I found them on the American Academy of Pediatrics (AAP) website, the CDC, the FDA, WHO, and search on PubMed and even Google. Just a little effort needed.

How about the rotavirus vaccine? The decision to approve the rotavirus vaccine was based on pre-marketing placebo-controlled clinical trials (AAP, 2007; CDC, 2018; FDA, 2018; PubMed, 2019a). For instance, one pre-marketing placebo-controlled randomized trial looked at efficacy and safety, especially intussusception, 34,000 kids in each group (Vesikari, 2006).

How about chicken pox (varicella-zoster virus)? Check out: AAP, 2000; CDC, 2007; PubMed, 2019b). Note I couldn’t find FDA approval for original in 1995 (Altman, 1995); but check out Weibel (1985), a placebo clinical trial. A newer version has been approved.

Note I could do the above for ALL mandatory children’s vaccines! ! !

And how about the grand daddy of all placebo-based double-blinded randomized clinical trials, the Salk vaccine trials, the placebo randomized arm included over 450,000 kids (Francis, 1955; Marks, 2011; Meier, 1972). Maybe Stone or another antivaccinationist will respond describing the Cutter Incident, where one of the five companies producing polio vaccine produced a defective product, resulting in 200 paralyzed children. What antivaccinationists seem not to understand is any defective product can have risks, e.g., e-coli in hamburgers, salmonella in chicken, etc. However, we don’t ask to remove these products from market, just ensure their safety. If we were to remove from market every medicine, every food, every product that ever was improperly produced, we would have little left. And, once a new protocol was developed following the Cutter Incident, cases of polio paralyses plummeted from well over 6,000 to ever fewer and fewer (e.g., Harrison, 2018). Note that I am working on a 4-Part series on Polio and Polio Vaccine, Part 1 available (Harrison, 2018) which will refute with numerous references claims by antivaccinationists of misdiagnosis, other direct or contributing causes, etc.

And though one gets a hodgepodge of results, I searched Google (search words: double blind placebo controlled vaccine study) and scrolling down pages found numerous pre-marketing studies).

So, I was responding to Exley’s focus on aluminum and claim no placebo-controlled randomized trials of safety have been conducted, not specifically pre-marketing studies; but Kathy’s list does include pre-marketing studies.. And I had NO problem finding pre-marketing placebo-controlled randomized trials of vaccines, available on numerous websites.. Placebo-controlled randomized clinical trials, looking at both efficacy and SAFETY, exist for ALL mandatory childhood vaccines.

And we don’t stop with pre-marketing clinical trials; but continue with the most extensive post-marketing surveillance of safety of any product on the market (Harrison, 2019b).
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REFERENCES:

NOTE: I have the full articles and those not available online were easily obtained by going to a local university library, either in the book stacks or their in-house computers.

Altman LK (1995 Mar 18). After Long Debate, Vaccine For Chicken Pox Is Approved. New York Times. Available at: https://www.nytimes.com/1995/03/18/us/after-long-debate-vaccine-for-chic...

American Academy of Pediatrics (2000 Jan). Varicella Vaccine Update. Available at: https://pediatrics.aappublications.org/content/pediatrics/105/1/136.full...

American Academy of Pediatrics (2007 Jan). Prevention of Rotavirus Disease: Guidelines for Use of Rotavirus Vaccine. Pediatrics; 119(1): 171-181. Available at: https://pediatrics.aappublications.org/content/pediatrics/119/1/171.full...

CDC (2007 Jun 22). Prevention of Varicella: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMR; 56(RR04): 1-40. Available at: https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5604a1.htm

CDC (2018 Apr 23). Rotavirus Textbooks & Publications. Available at: https://www.cdc.gov/rotavirus/textbks-pubs.html [go to Vaccine Efficacy and Effectiveness]

FDA (2018 Mar 26). RotaTeq (Rotavirus Vaccine) Questions and Answers. Available at: https://www.fda.gov/vaccines-blood-biologics/vaccines/rotateq-rotavirus-... [go to “Has the risk for intussusception been evaluated for RotaTeq?”]

Francis T, Korn RF (1955 Jun). Evaluation of 1954 Field Trial of Poliomyelitis Vaccine: Synopsis of Summary Report. The American Journal of the Medical Sciences; 229(6): 603-12.

Harrison JA (2018 Nov 9). Wrong About Polio: A Review of Suzanne Humphries, MD and Roman Bystrianyk’s “Dissolving Illusions” Part 1. Science-Based Medicine. Available at: https://n1s1t23sxna2acyes3x4cz0h-wpengine.netdna-ssl.com/wp-content/uplo...“Dissolving-Illusions”-long-version.pdf

Harrison JA (2019a Jul 17). Response 2 to Christopher Exley’s “Re: Vaccine safety: British are less sceptical than Europeans, but younger people need assurance” (2019 Jul 3). BMJ Rapid Responses. Available at: https://www.bmj.com/content/365/bmj.l4291/rr-27

Harrison JA (2019b Jul 1). Wrong About Post-Marketing Surveillance of Vaccine Adverse Events. Response to Jacob Puliyel, John Stone, Allan Cunningham, etc. BMJ Rapid Responses. Available at: https://www.bmj.com/content/365/bmj.l2268/rr-7

Kathy (2018 Aug 6). There are no vaccine studies with saline placebo? Vaccinesworkblog. Available at: https://vaccinesworkblog.wordpress.com/2018/08/06/there-are-no-vaccine-s...

Marks HM (2011). The 1954 Salk Poliomyelitis Vaccine Field trials. Clinical Trials; 8: 224-234. Reference Available at: https://www.ncbi.nlm.nih.gov/pubmed/21478330

Meier P (1972). The Biggest Public Health Experiment Ever: The 1954 Field Trial of the Salk Poliiomyelitis Vaccine. Chapter 2 in Tanur JM et al. (Editors) Statistics: A Guide to the Unknown. Holden-Day. Available at: http://www.medicine.mcgill.ca/epidemiology/hanley/c622/salk_trial.pdf

PubMed (searched 2019a Jul 22). Search words: efficacy safety rotavirus vaccine randomized. Available at: https://www.ncbi.nlm.nih.gov/pubmed/?term=efficacy+safety+rotavirus+vacc... [note one has to go through to find premarketing, since gives ALL placebo trials.

PubMed (searched 2019b Jul 22). Search words: chicken pox children vaccine placebo trial [click on “Switch to our new best match sort order. gives all placebo trials, so have to search through to find premarketing]

Stone J (2019 Jul 22). Re: Vaccine safety: British are less sceptical than Europeans, but younger people need assurance. Where are the placebo controlled trials? BMJ Rapid Responses. Available at: https://www.bmj.com/content/365/bmj.l4291/rr-29

Vesikari T, Matson DO, Dennehy P et al. (2006 Jan 5). Safety and Efficacy of a Pentavalent Human–Bovine (WC3) Reassortant Rotavirus Vaccine. The New England Journal of Medicine; 354(1): 22-33. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa052664

WHO (2013). Expert Consultation on the Use of Placebos in Vaccine Trials. Available at: https://apps.who.int/iris/bitstream/handle/10665/94056/9789241506250_eng...

Weibel RE, Neff BJ, Kuter BJ et al. (29184 May 31). Live attenuated varicella virus vaccine. Efficacy trial in healthy children. New England Journal of Medicine; 310(22): 1409-15. ABSTRACT Available at: https://www.ncbi.nlm.nih.gov/pubmed/6325909

Competing interests: No competing interests

24 July 2019
Joel A Harrison
Long-Retired Epidemiologist
NONE: I have NEVER worked for the FDA, NIH, CDC, any pharmaceutical company, nor ever purchased pharmaceutical stocks
U.S.A.