Pfizer chief executive Albert Bourla has been reprimanded by a pharmaceutical watchdog for making “misleading” statements about children’s Covid vaccines, according to a report.
In early December 2021, Dr Bourla used an interview with BBC Breakfast to claim that the virus was “thriving” in schools and “there is no doubt in my mind that the benefits, completely, are in favour of” giving five-year-olds the vaccine.
“This is disturbing, significantly, the educational system, and there are kids that will have severe symptoms,” he said.
At the time, the country’s vaccine watchdog was still deciding whether the jabs should be approved for children aged five to 11.
It wasn’t until February 2022 that the Joint Committee on Vaccination and Immunisation (JCVI) approved the vaccine for that age group.
By March 2022, some data were showing the effectiveness of the children’s vaccine plummeted to just 12 per cent within weeks of inoculation.
Dr Bourla said in the BBC interview that the main benefit of immunising children was “the indirect protection of adults”.
“The extent to which we can do that and protect adults by avoiding them being infected by children with the current vaccines is still quite uncertain,” he said.
“So, that’s the balance — we clearly want to protect children as much as possible and we’ve got good evidence now that this vaccine, even at a low dose, produces a really good protective immune response in children and produces many fewer side effects because of the lower dose.
“The question really is that should that be our focus right now. Or should we really be focusing on adults who are the ones that much more commonly get seriously ill.”
Shortly after the interview was published, parent lobby group UsForThem lodged a formal complaint with the Prescription Medicines Code of Practice Authority (PMCPA).
The complaint alleged Dr Bourla’s remarks were “disgracefully misleading” and “extremely promotional in nature”, breaching several clauses of the Association of the British Pharmaceutical Industry’s (ABPI) code of practice, The Telegraph reported.
“There is simply no evidence that healthy schoolchildren in the UK are at significant risk from the SARS COV-2 virus and to imply that they are is disgracefully misleading,” the complaint said.
A code of practice panel convened by the PMCPA found Pfizer had breached the code in a number of different ways, including by misleading the public, making unsubstantiated claims, and by failing to present information in a factual and balanced way, according to The Telegraph.
Pfizer appealed the findings, arguing Dr Bourla’s remarks were based on “up-to-date scientific evidence” and could be substantiated by the “publicly available independent benefit-risk assessments”.
An appeal board panel met in November, where the breaches relating to misleading the public, making unsubstantiated claims and the lack of balance were upheld.
The more serious findings, including that Pfizer had brought discredit to the industry, had encouraged irrational use of a medicine and had failed to maintain high standards, were overturned.
The full case report will be published in coming weeks.
Pfizer has been contacted for comment.
Earlier this year, Pfizer executive Janine Small told the European Union Parliament that the drugmaker did not test whether its vaccine stopped transmission of the virus before the rollout.
“No … we had to really move at the speed of science to really understand what is taking place in the market,” she said.
After the comments went viral, fact checkers said the vaccine was never intended to stop transmission of the virus but to prevent severe disease.
“To be fair, some officials have overstated the transmission protection provided by the vaccines,” FactCheck.org wrote.
“But studies did find that vaccinated people were much less likely to spread the virus, either because they were protected from getting infected in the first place, or by being less contagious if infected.”
In Australia, Pfizer’s paediatric vaccine received final approval in December 2021 with the rollout beginning in January 2022.
Last month, the Australian Technical Advisory Group on Immunisation (ATAGI) recommended a booster dose for vulnerable children three months after their second.
Only 40 per cent of children aged five to 11 — or around 910,000 — have received two doses of a Covid vaccine as of November 17, Health Department figures show.
More than two thirds children in the ACT are fully vaccinated, while Queensland has the lowest paediatric vaccination rate at just under 32 per cent of children five to 11 with two doses.
The Therapeutic Goods Administration (TGA) says it has received around 1650 adverse event reports in five- to 11-year-olds as of November 13, from approximately 2.3 million doses of Pfizer and Moderna.
“The most common reactions reported included chest pain, vomiting, fever, headache and abdominal pain,” the TGA says.
“We have received 39 reports of suspected myocarditis and/or pericarditis in this age group. Following review of the reports, four were likely to represent myocarditis and another seven reports were likely to represent pericarditis.”
The TGA says children and adults are more likely to experience side effects after a second vaccine dose, but most reactions are “mild and temporary”.
“Children aged five to 11 years report fewer side effects than older Australians following a second dose,” the TGA adds.
“There have been no deaths in children or adolescents determined to be linked to Covid-19 vaccination.”
frank.chung@news.com.au