Original artcle here.
Here we respond to some of the points made in Jane Hansen’s article where she strongly implies that Bexsero should be placed on the NIP schedule.
1. “The vaccine Bexsero has been rejected for the fourth time by the Pharmaceutical Benefits Advisory Committee, which cited cost as the main reason.”
The above statement is materially inaccurate. In fact, the most substantive reasons the PBAC gave for its decision to reject all four of GSK’s applications to have their Bexsero vaccine included on the schedule was that the manufacturer, even after repeated requests by the Advisory Committee, could not provide any evidence that this vaccine was effective or provided any herd immunity.
The Committee went even further in stating that GSK’s claims of effectiveness and herd immunity are “highly uncertain” given that the manufacturer’s own data suggests that the antibody response to the vaccine may be of such short duration as to render it clinically ineffective, and that it showed no clear relationship with protection against the infection. See the following quotes from the PBAC Outcome meetings:
In 2019: “The PBAC did not recommended listing for a broader population of infants or for adolescents due to the remaining uncertainties regarding the magnitude of clinical effectiveness of 4CMenB, and the lack of any herd protective effects”. [1]
In 2014: “the re submission did not address multiple uncertainties in relation to the clinical effectiveness of the vaccine against the disease when delivered in a vaccination program”. [2]
In 2013: “in the context of a population-based intervention against invasive meningococcal B disease, the Committee considered the clinical claim was highly uncertain because of the likely short persistence of the antibody response in children, uncertainty about the correlation between antibody responses and protection, the unknown effect on carriage of the bacteria, the overall uncertain long-term protective efficacy against infection and disease, and the unknown influence of projected herd immunity effects on overall disease burden. These issues were not addressed in the re-submission, although the PBAC acknowledged the limitations of the evidence base.” [2]
2. “Britain, which introduced Bexsero free of charge for babies in 2015, has reported a 42 per cent drop in the number of cases of meningococcal B disease.”
This statement is clearly intended to suggest a causal link between introduction of the free vaccine in Britain and a decline in the incidence of Meningococcal B. Such a proposed link is at best tenuous, and at worse, deliberately misleading in light of the actual data which clearly shows a steady drop in the number of cases from 2000 [3] (figure below), 15 years before the free vaccine was available, and in fact plateaued from 2015 rather than declining as you reported. Thus, the 42% drop you cited in fact occurred before the introduction of the free vaccine. This data is very clear and unequivocal and very easily obtainable from official Government sources. It is therefore more than disappointing that you reported such clearly incorrect information.
3. “Children will continue to die”.
According to Australia’s National Notifiable Diseases Surveillance System, the incidence of Invasive Meningococcal Disease (IMD) involving serogroup B infections has been declining every year since 2002, without the introduction of a serogroup B vaccine to the national schedule [4].
As quoted by Professor Peter McIntyre, director of NCIR: “It’s good news to say that for whatever combination of reasons, possibly related to how well Australia’s doing reducing smoking rates which is a factor in meningococcal disease, we’re seeing about half as much meningococcal disease, including B, as we were seeing 10 years ago,”. [5]
4. “There will be no herd protection”.
This statement infers that if Bexsero was added to the schedule, it would confer some unspecified level of herd protection to the Australian community. This is unequivocally untrue. In fact, the data provided by GSK with their application showed a “lack of any herd protective effects” [1].
5. “This safe effective vaccine”.
On the contrary. According to the Therapeutic Goods Association (TGA), in 2019 there were 333 cases of adverse events plus 1 death reported and in 2018 there were 311 cases of adverse events reported associated with Bexsero, including nervous system disorders, visual impairment and blood and lymphatic system disorders. Previous reporting indicated adverse events of cardiac disorders, febrile convulsions, and Kawasaki disease [6]. Note the TGA acknowledges that adverse events are greatly under-reported [7], [8]. Dr Alan Leeb states that, based on adverse events reported to SmartVax, Bexsero in Australia is highly reactive and 1 in 4 children have had an adverse reaction [9].
The UK findings of adverse events from the Meningococcal vaccine, since its introduction on the schedule in September 2015, found 13 deaths in a 3 year period. The vaccine was “offered as part of the routine vaccinations at 2 months, 4 months with a booster at 12 months of age” [10] (image below).
6. “Spokesperson from GSK ‘It is now apparent that the system has challenges in assessing the full value of preventive interventions such as vaccines’”.
In light of the readily available factual evidence, your reporting of the above statement from GSK is the most egregious and unacceptable aspect of your article.
The PBAC has rejected inclusion of this vaccine onto the schedule on four separate occasions; not because it can’t do its job, but because it can and is doing its job. They have repeatedly asked GSK for evidence to substantiate their claims that their vaccine is effective in protecting recipients from Meningococcal infection and provides broader herd immunity. The data provided by GSK to the PBAC unequivocally contradicts their own claims. This has left the PBAC with no choice but to decline their application.
Jane, your words matter. I believe that we are in a place in history where it has rarely been more important for journalists to seek the truth and to speak truth to power. It is an uncomfortable reality that you cannot assume that your sources will provide you with the level of candour your audience expects and needs. You therefore have a heightened responsibility to seek independent substantiation for the information provided to you from your sources. It is too important to the lives and wellbeing of too many for you not to do so.
In consideration of the serious inaccuracies presented in your article, we ask that you revisit the issue of the Meningococcal B virus with a new article that provides an evidence-based coverage of the topic including the official Government data provided here. In support of a genuine intent to inform and educate the Australian community about the Meningococcal B virus, additional information, aside from correcting the inaccuracies already discussed, that is crucial to include for a balanced coverage is,
i) the incidence of the virus i.e. how rare it is;
ii) how contagious it is; and
iii) known non-vaccine related factors strongly co-associated with contracting this virus.
All of this information is easily obtainable from official Government sources.
