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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

Rapid Response:

Response to John Stone (2019 Jul 24)

Stone writes: “I must point out that the words which Joel Harrison's attributes to me were actually quoted from Christopher Exley.”

Stone uses Exley’s statement to make his point. And it was Stone who stated: “Surely if such trials were done and they had had favorable results we would not have difficulty locating them.”

Stone then goes on to write: “Other than that I do not see that position statements from the WHO are anything but misleading if double blind placebo safety testing of the products have never been done (or for some reason never published). The question remains: if we are to be reassured, where are the trials? Larson et al cite none.”

No, Larson et al’s RR didn’t cite any. So, what? My RR gave several and listed websites where, with a little effort, one can find many others. However, some vaccines are easier to find on one website or another. So, why does Stone ignore what I wrote and cite another RR as if it were the only one?

As for the WHO, I didn’t include any position papers, I only gave their paper on placebos. If Stone wants examples of WHO position papers on specific vaccines, how about: “In prelicensure placebo-controlled clinical trials of the quadrivalent vaccine, injection site reactions consisted of pain (84%), erythema (<25%) and swelling (25%), with pain occurring more commonly than in the placebo groups–both for saline-only placebo (pain 49%) and aluminium placebo (pain 75%) (WHO, 2014. p. 483).” or: “The frequency of adverse events following primary aP vaccination did not differ from that observed in the placebo group, regardless of the number of vaccine components included. However, after the primary series, the rate and severity of local reactions tend to increase with each successive DTaP dose. Transient, benign and painless swelling, sometimes involving the entire limb, occurs in 2%–6% of children who receive booster doses of DTaP vaccines. Similar swellings have rarely been associated with other childhood vaccinations. The swelling always subsides spontaneously without any sequelae (WHO, 2015, p. 448).” Note that after each is number to reference list for actual study. One can access the Weekly epidemiological review, all editions at: https://www.who.int/wer/en/ And, as I did, subscribe for free.

Just to make it clear, in order to be approved, vaccines MUST undergo pre-marketing placebo-controlled randomized trials, required by UK, US, and WHO; however, if a previous vaccine has undergone such, then a newer vaccine is compared with it, not a placebo that would subject kids to the actual disease. And, again, just to make clear, these pre-marketing clinical trials can be found on a number of websites, though one website may be easier to find one specific vaccine and another some other vaccine. All it takes is a little effort.

REFERENCES:

Harrison JA (2019 Jul 24). 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). BMJ Rapid Responses. Available at: https://www.bmj.com/content/365/bmj.l4291/rr-31

Stone J (2019 Jul 24). Re: 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). BMJ Rapid Responses. Available at: https://www.bmj.com/content/365/bmj.l4291/rr-32

WHO (2014 Oct 24). Human papillomavirus vaccines: WHO position paper, October 2014. Weekly epidemiological review; 89(43): 465-492. Available at: https://www.who.int/wer/2014/wer8943.pdf

WHO (2015 Aug 28). Pertussis vaccines: WHO position paper – August 2015. Weekly epidemiological review; 90(35): 433-460. Available at: https://www.who.int/wer/2015/wer9035.pdf?ua=1

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.