AUTH/3519/5/21 - Member of the public v Pfizer

Misleading press release

  • Received
    27 May 2020
  • Case number
  • Applicable Code year
  • Completed
    19 February 2022
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

A complaint was made about a press release issued by Pfizer Limited and BioNTech dated 2 December 2020.

The complainant provided a link to a recent peer reviewed article in the Lancet which pointed out that the efficacy claims being made for the Covid-19 vaccines were based on relative risk reduction (RRR) and not absolute risk reduction (ARR) which was a vastly smaller number.

The complainant provided links to two UK press releases including one from Pfizer in which efficacy results from its study were discussed. The complainant noted that only the RRR results were presented, with no mention of ARR in breach of the Code which specifically required that any discussion of RRR must include presentation of ARR results too. The complainant further alleged that this was information to the public which had not been presented in a factual and balanced way.

The complainant believed the relevant ARR results were in the order of 0.84% for the Pfizer study.

The detailed response from Pfizer is given below.

The Panel noted Pfizer’s submission that it recognised that absolute risk reduction could be helpful when individuals were considering if they wanted/needed to be vaccinated or not. Nonetheless, the Panel also noted Pfizer’s submission that the development of its vaccine BNT162b2, presented a unique issue; the key efficacy trial took place over a period of approximately 3.5 months at sites in six different countries (USA, Argentina, Brazil, South Africa, Germany, Turkey) when the second wave of the SARS-CoV-2 pandemic was beginning with the epidemic curve rapidly rising. At the time, the risk of an unvaccinated person acquiring the virus was therefore dynamic and increasing with time (and continued to increase after the trial concluded). Furthermore, the risk of acquiring the virus also varied between countries participating in the trial, depending on the extent to which local lockdowns were enforced and specific containment strategies used. It was therefore challenging to attribute a meaningful risk of acquiring COVID-19 for unvaccinated participants in the context of the trial and could be misleading at a time of a global pandemic with continuously changing epidemiology.

Whilst noting Pfizer’s submission about the difficulties associated with the calculation and inclusion of ARR, the Panel considered that the relevant supplementary information, ‘reference to absolute and relative risk’, and compliance with it should be interpreted in light of its associated clause which required that materials etc should not be, inter alia, misleading and material must be sufficiently complete to enable the recipient to form their own opinion of the therapeutic values of the medicine.

In the Panel’s view, whilst noting Pfizer’s submission that the press release included reference to the absolute number of events upon which the first primary objective analysis was based and, as such, provided context to the scale of the trial and the vaccine efficacy data, the Panel considered that further details, such as the number of cases and subjects in each arm, would help certain sectors of the ultimate audience to interpret the absolute risk and form their own opinion of the efficacy of the medicine. In addition, the Panel noted that the status of the ultimate audience was relevant and it was particularly important to be clear about such matters in circumstances where the ultimate audience might include members of the public. The Panel considered that, in the absence of any explanation in the press release, some readers such as members of the public might assume that the efficacy rate was, in effect, an absolute rate and that was not so. A breach of the Code was ruled.

The Panel noted that the press release explained that Pfizer’s Covid-19 vaccine had been granted a temporary authorisation in the UK to permit its supply, the vaccine had not been granted a marketing authorisation and so had not been legally classified as a prescription only medicine when the press release was issued. The Panel noted that Clause 26.2 only applied to prescription only medicines and on that very narrow technical point, no breach of the Code was ruled.

The Panel noted its comments and rulings above and consequently ruled a breach of the Code as high standards had not been maintained.

The Panel noted the unique circumstances of the Covid-19 pandemic and the trial and therefore did not consider that the particular circumstances of this case warranted a ruling of a breach of Clause 2 which was a sign of particular censure and was reserved for such use and no breach was ruled.