UK Regulator Finds Pfizer Guilty of Violating Three Sections of British Pharmaceuticals Code of Practice
A complaint against Pfizer pharmaceutical was filed to the UK’s Prescription Medicines Code of Practice Authority (PMCPA), the regulator responsible for policing promotions of prescription medicines in the UK.
The complaint centred on an interview that was conducted by a medical editor at the BBC, in which Pfizer’s CEO Albert Bourla made comments that were “misleading” about COVID shots for children.
In the BBC interview, Bourla said it was up to the regulatory agencies to determine whether to approve and distribute vaccines to children under 11, but he thought that “immunising that age group in the UK and Europe would be a very good idea,” according to the PMCPA case report published last week.
At the time, no COVID-19 vaccines had been approved by the U.K.’s Medicines and Health products Regulatory Agency (MHRA) for children under 12, so the panel found Bourla’s comments were in breach of code.
Citing possible disruptions in schooling and the potential for long COVID, Bourla also said, “So, there was no doubt in my mind that the benefits completely were in favour of doing it [vaccinating children against COVID-19].” He added, “I believe it’s a good idea.”
The panel found these strong opinion statements could lead the public to infer there was no need to be concerned with potential side effects or that the benefits of vaccination outweigh the risks, which had not been determined by the health authorities.
The complaint was filed on Dec. 11, 2021, by Us For Them, “a parent-led campaign group calling for children’s needs to be prioritized during the Covid pandemic response.”
The Us For Them organization believes that children “must be placed front and centre in all decisions impacting them. The wellbeing of children should be a guiding principle of public policy making.”
Case Summary
The complainant made specific allegations about statements and claims made in the promotional piece relating to children.
1. ‘Immunising that age group [children under the age of 11] in the UK and Europe would be a very good idea.’
The complainant alleged that by recommending vaccinating healthy British children under the age of 11 against Covid-19, the Pfizer CEO was making a claim for the clinical efficacy and safety of Pfizer’s product and its risk/benefit balance, even though the vaccine had not yet been included in the emergency use temporary approval for use in children this young in the UK.
2. ‘Covid in schools was thriving’. ‘This was disturbing significantly the educational system and there were kids that would have severe symptoms.’
The complainant stated that severe Covid-19 was rare amongst children and school age in the UK and while the virus did circulate in schools, schools had typically reflected community transmission throughout the pandemic. Neither had Covid-19 itself had a significant impact on disturbing children’s education in the UK. The ‘disturbance’ to the UK educational system had resulted from political decisions made by governments, not the virus. Indeed, the complainant knew that the UK had the second highest rates of school closures in Europe, except for Italy – a result of political decisions.
The complainant stated that there was simply no evidence that healthy school children in the UK were at significant risk from the SARS-COV-2 virus and to imply that they were was disgracefully misleading.
3. ‘So, there was no doubt in my mind that the benefits completely were in favour of doing it.’
The complainant alleged that this was probably the most egregiously false and misleading of the Pfizer’s CEO’s statements. It completely neglected to consider that there were potential risks to healthy children associated with administration of the Covid-19 vaccine. The complainant referred to a number of documents including a Pfizer leaflet listing side effects; Latest government advice regarding myocarditis to healthcare workers detailing rates of myocarditis in hospitalised children; and latest adverse events reported for Pfizer.
The complainant stated that the tone, content and means of dissemination of this article and the associated video were extremely promotional in nature. The complainant strongly believed that it was not appropriate for Pfizer to promote its product in this way. The complainant referred to three earlier cases against Pfizer for promoting its Covid-19 vaccine illegitimately online.
The UK’s Prescription Medicines Code of Practice Authority (PMCPA) found Pfizer guilty of violating three sections of the pharmaceutical code (Breach clauses: Clause 6.1, Clause 6.2 and Clause 26.2). The final ruling was posted on its website on Jan. 27, 2023. The rulings were appealed by Pfizer but were unsuccessful.
