Pfizer CEO Albert Bourla has made “misleading” and unsubstantiated statements on the merit of giving COVID-19 vaccines to young children, according to a case report published by a UK pharmaceutical watchdog on Jan. 27.
During an interview with the BBC published on Dec. 2, 2021, Bourla was asked whether he believed it was likely that 5- to 11-year-olds in the UK and Europe would be vaccinated against COVID-19 and whether it was a good idea.
The interview was published after the U.S. Food and Drug Administration authorised the use of the Pfizer-BioNTech COVID-19 vaccine for young children, but the UK’s medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), didn’t approve the product for the same age group until Dec. 22, 2021.
While acknowledging that it was up to the UK authorities to decide whether or not to approve and deploy the vaccines, Bourla replied, “I believe it’s a very good idea.”
He cited disruptions in education and the potential of developing so-called long-COVID, saying, “so there is no doubt in my mind about the benefits completely are in favour of doing it.”
Following complaints from UsForThem—a children’s welfare campaign group founded in response to the COVID-19 lockdowns—a panel from the Prescription Medicines Code of Practice Authority (PMCPA) ruled that Bourla’s statements breached a number of rules in the Association of the British Pharmaceutical Industry (ABPI) code of practice.
After Pfizer appealed against the ruling, an appeal board upheld five counts of breaches of three ABPI codes that require information and claims to be accurate, balanced, capable of substantiation, not raising unfounded hopes of successful treatment, and not be misleading with respect to the safety of the product.
The PMCPA described Bourla’s statements as being of a “strong unqualified nature.” It also said they inferred there was “no need to be concerned about potential side-effects of vaccination in healthy children aged 5-11” and that the implication was “misleading and incapable of substantiation.”
The PMCPA said it has received an undertaking from Pfizer to prevent similar breaches in the future.