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 Friday.
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.
Code breakers are charged for administrative costs, but the self-regulatory body does not have the power to impose fines or other legal sanctions.
Bourla was initially found to have also breached the code for promoting the Pfizer-BioNTech vaccine in the 5–11 age group when it was not authorised by the MHRA, but the appeal board overturned the ruling, agreeing with Pfizer that its CEO was asked a specific question and it was not unreasonable to talk about the issue in principle. The board also noted that two other COVID-19 vaccines were also under investigation for the age group.
The appeal board also overturned previous rulings that said Pfizer had failed to maintain high standards and brought discredit upon the industry.
In a previous statement to The Telegraph in November 2022, when the newspaper obtained the unpublished ruling, a spokesman for Pfizer said the company was “committed to the highest levels of integrity in any interaction with the public.”
“We are pleased the UK’s PMCPA Appeal Board found Pfizer to have maintained high standards and upheld confidence in our industry, the two most serious rulings in this complaint from a UK campaign group,” the statement reads.
“In the UK, we have always endeavoured to follow the principles and letter of our industry Code of Practice throughout. We will review the case report in detail when we receive it, to inform future activity,” it added.
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Author: RTM Staff
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