Summary in English: GlaxoSmithKline (GSK) and the Finnish governmental THL working under a 10 million euro contract for GSK have made an error in a clinical trial of Synflorix. The results is that ca. 200 children have been given an incorrect vaccine series - forexample, instead of having a hepatitis vaccine after an initial Synflorix pneumococcal series, they've been given a second Synflrox series. Families with children suffering from long-term health consequences suspected of being caused by incorrect vaccines have been reported by the media and Rokotusinfo already after the few days that THL has reported the problem. The Finnish news reporting based on THL's reports has reported the extra doses given, but has neglected to report that as a result of the error, by a rough estimate ca. 100 children didn't receive the hepatitis vaccine their parents had wanted them to have.

Rokotusinfo says that after a BCG vaccine adverse event case in the 2000's involving hundreds of cases and the Pandemrix narcolepsy cases (over a hundred in Finland), realization of uncontrolled risks taken by THL is a recurring event. According to Rokotusinfo, if a primary principle of medical research ethics (the Helsinki declaration) would have been respected, the blunder wouldn't have happened. The Helsinki declaration states that primarily the best profylactic available should be used for a trial. GSK and THL didn't use the Prevnar pneumococall vaccine for the comparison group (which would have been a natural control according to the ethical rule), but instead used hepatitis A and hepatitis B vaccines. There have also been other problems with the trial's ethical issues: informed consent and no permission has been sought from both parents as should have been as required by Finnish law according to the Parliamentary Ombudsman, a supreme oversight official.

According to Rokotusinfo, the decisions are the result of the current Director General's decisions and direction and the legally very questionable practices have been accepted by the Director General Pekka Puska. Rokotusinfo points out that despite the recurring problems, nothing seems to change, and instead of making sure changes are made, the Director General Pekka Puska just throws a tantrum in public, swearing and saying he's "very angry" about the incident.

Links: GSK press release - THL press release

Lapset jäivät vaille hepatiittirokotetta - THL ja GSK eivät noudattaneet tutkimusetiikan periaatteita

Ikäviä kokemuksia tutkimuksesta

Virhettä ei olisi tapahtunut, jos tutkimusetiikkaa olisi noudatettu

THL salaa tutkimusta koskevia tietoja vedoten liikesalaisuuteen

Ongelmia kerta toisensa jälkeen

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