GSK Document Appears to Show Vaccine Committee Chair Used Position to Favour Own Product
By John Stone
The chairman of the Joint Committee on Vaccination and Immunisation (JCVI), the British equivalent of the ACIP (Advisory Committee on Immunization Practices), Prof Andrew J Pollard spoke this September at an event sponsored by vaccine manufacturer GlaxoSmithKline "Evening of Evidence/Vaccination Science to Policy: Introduction of new vaccines to the UK vaccine schedule with limited evidence of efficacy (sic): Meningococcal Group B and maternal pertussis vaccination". Prof Pollard spoke on the subject of Meningitis B vaccine which he helped to develop and latterly seems to have superintended the process of having it added to the United Kingdom vaccine schedule as chairman of the JCVI – his talk was entitled: "JCVI decision-making process informing the recommendation for the introduction of Bexsero to the UK vaccination schedule". Bexsero vaccine was developed by Novartis but their vaccine division was acquired by GSK earlier this year, following the approval of Bexsero vaccine by the JCVI (negotiations began within days of the JCVI approval). A deputy chair of the JCVI, Dr Andrew Riordan, spoke at the same meeting on the subject: "Evidence considered by the JCVI to recommend antenatal pertussis vaccination in the UK". GSK also manufacture Boostrix – in fact a pertussis, tetanus and diphtheria vaccine – which is the product currently given to pregnant women in the UK, which also has an aluminium adjuvant.
Last week members of the Scottish Parliament heard how Prof Pollard apparently chaired a session of the JCVI in March 2014 which recommended Bexsero for British infants, though the committee under a different chairmanship had rejected it months earlier. It was not disclosed on the records of the committee that Prof Pollard was “named in patents in the field of meningococcal vaccines” and was contracted in continuing research relating to Bexsero. The JCVI revised Code Of Practice requires that the Chair “cannot have any interests that may conflict with his or her responsibilities to JCVI” and also that “the JCVI Chair and Sub committee chairs cannot have interests that could conflict with the issues under consideration by the JCVI or Sub Committee respectively”. Prof Pollard also heads the Oxford Vaccines Group, which though an agency of the National Health Service owes its existence to accepting contracts from pharmaceutical manufacturers and other bodies trying to promote vaccines.
It is disturbing to note that every single one of the eight speakers at the GSK sponsored event, hosted by the Royal College of Child Health and Paediatrics were in some way employees of the British state including bodies such as Public Health England (which is supposed to provide independent scientific advice) and the MHRA (the UK licensing authority). The drinks interval was nudgingly billed on the flier as “Refreshments and Networking”.
That the Bexsero Meningitis B vaccine is at the very least controversial is underlined by its rejection by the Australian Pharmaceutical Benefits Advisory Committee:
- The PBAC rejected the re-submission requesting listing of the 4CMenB vaccine on the NIP Schedule for the prevention of meningococcal B disease in infants and adolescents. The basis of the rejection was that 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, that the use of optimistic assumptions about the extent and duration of effect and herd immunity as raised by the PBAC in previous consideration of this vaccine were not addressed, and the unacceptably high and uncertain ICER, presented in the re-submission.
- The PBAC reaffirmed its November 2013 and July 2014 conclusions that the vaccine is effective in inducing antibodies against the component antigens of 4CMenB. However, 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.
- The PBAC noted that the submission had not addressed the previous concerns of the PBAC in regards to the model, namely uncertain and optimistic assumptions about the extent and duration of effect and herd immunity. The PBAC was also concerned with the discounting rate applied in the model that considerably favoured the 4CMenB vaccine. The PBAC considered that none of the proposed program options were cost effective as presented in the submission.
It should be noted that Bexsero vaccine has commonly unpleasant side-effects. An FDA package insert records:
The most common solicited adverse reactions observed in clinical trials were pain at the injection site (≥83%), myalgia (≥48%),erythema (≥45%), fatigue (≥35%), headache (≥33%),induration (≥28%), nausea (≥18%), and arthralgia (≥13%)...
Serious Adverse Events Overall, in clinical studies, among 3,058 participants 10 through 25 years of age who received at least 1 dose of BEXSERO 66 (2.1%) participants reported serious adverse events at any time during the study. In the 3 controlled studies.. (BEXSERO N=2716, Control N=2078), serious adverse events within 30 days after any dose were reported in 23 (0.8%) BEXSERO recipients and 10(0.5%) control recipients.
But these side-effects were noted in a study group of 10-25 year-olds whereas the JCVI has recommended the vaccine for use in infants only two months old, who will receive it in conjunction with DTaP, IPV, HiB, a 13 strain pneumococcal vaccine (Prevenar) and the recently added equally controversial oral rotavirus vaccine also manufactured by GSK. They will receive it again with several vaccines at 4 months and 12-13months.
At the time of writing the presence of Prof Pollard and Dr Riordan at the GSK sponsored event had not been added to the draft minutes of the October meeting of the JCVI. In 2009 a law – itself of dubious legality - entered the statute book (unopposed in the English Parliament) placing an obligation on the Secretary of State for Health to follow the recommendations of the JCVI in England and Wales. It seems like every basic rule of human society, of good government and safe medicine has been elbowed aside.
John Stone is UK Editor for Age of Autism.
Elizabeth
You don't surprise me. I suppose one one of the oddities is the prime vulnerable population for the disease are adolescents and young adults but once again they are targetting infants with the probability that any benefits of the vaccine will have worn off by the time they get to that age. We don't even know whether they might become more susceptible to the disease as a result, but of course they are much easier to target than people who can speak up if the vaccine makes them ill (and this vaccine meakes virtually everyone ill).
Posted by: John Stone | December 17, 2015 at 12:32 PM
For some more background on the adoption of GSK's Bexsero meningococcal b vaccine in the UK, see this FierceVaccines article: "GSK finally seals U.K. Bexsero deal for £20 per dose" which notes: "For £20 per dose, Bexsero will be added to the country's national immunization schedule, enabling the annual protection of 800,000 babies at a cost of £16 million, the Daily Mail reports. Britain will become the first country in the world with a nationwide meningitis vaccine program, Health Secretary Jeremy Hunt said, according to The Guardian."
and
"Bexsero's history in the U.K. has been testy; it's been a year since the Joint Committee on Vaccination and Immunisation added it to the nation's vaccine program, sparking pricing negotiations with Novartis that weren't resolved until the Basel-based drugmaker's asset swap with GSK. During negotiations with Novartis, Hunt said the drugmaker was holding the country "to ransom". Glaxo, though, had some incentive to wrap things up, as it needs Bexsero to deliver--and quickly. After shipping off its drugs to Novartis and picking up most the former's vaccines, GSK is counting on vaccines to deliver 14% of its sales going forward."
Link to FierceVaccines article, which includes links to related articles: http://www.fiercevaccines.com/story/gsk-finally-seals-uk-bexsero-deal-20-dose/2015-03-30
Posted by: Elizabeth Hart | December 17, 2015 at 07:48 AM
John, the Australian Technical Advisory Group on Immunisation (ATAGI) is the body which makes recommendations for the Australian National Immunisation Program. You can see ATAGI Terms of Reference via this link: http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/atagi
ATAGI appears to have a cosy relationship with the vaccine industry. For example, in regards to meningococcal b vaccines, the ATAGI Bulletin 49th Meeting 11-12 October 2012 notes: “ATAGI held a meningococcal B industry day on 10 October 2012 with Novartis Vaccines and Pfizer Australia attending. The industry day was held to foster constructive, open discussions between the ATAGI and representatives from interested pharmaceutical companies on the use of meningococcal B vaccines in Australia.” http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/atagi-meet49bulletin
It appears ATAGI subsequently endorsed the Novartis meningococcal b vaccine (now owned by GlaxoSmithKline), see for example ATAGI Bulletin 52nd Meeting: 10-11 October 2013: http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/atagi-meet52bulletin
(Has ATAGI ever knocked back a vaccine product…?)
As noted previously, the Pharmaceutical Benefits Advisory Committee (PBAC) subsequently rejected the addition of this vaccine to the National Immunisation Program (rejected three times…so far…)
Also for information, see this ATAGI Statement re the use of Bexsero meningococcal b vaccine: http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/1C08CC86CFF8FE00CA257E29000F7E06/$File/ATAGI-advice-bexsero.pdf
Posted by: Elizabeth Hart | December 17, 2015 at 07:35 AM
Lactation is just beginning to be established by the end of the 2nd and 3rd month after birth. The baby's milk supply is completely dependent on his ability to stimulate his mothers milk making hormones through his frequent, vigorous, effective (neurologically coordinated) suckle, and removal of milk, around the clock. Any disruption in feeding effectiveness or frequency, whether it's because the baby is unwell and unable or unwilling to suckle or the suckle is weak after these asinine shots, will send a message to the mother's body to make less milk.
If these idiots had half a brain among them, they would understand that making a nursling SICK is not only a bad idea because it is blatant CHILD ABUSE, but because it will threaten the milk that is his REAL, SAFE AND EFFECTIVE, NATURAL IMMUNIZATION.
But of course, Pharma's other branch, the formula industry, which brings in over $7 billion a year, will be very happy to swoop in like vultures to take care of the resulting inevitable lactation failure. No doubt there will be an increase in UK formula sales.
IDIOTS.
Posted by: Linda1 | December 17, 2015 at 12:22 AM
Thanks Elizabeth
I see that Robert Booy was given praise in this GSK Press Release from two years ago:
"Professor Robert Booy, who is Head of the Clinical Research team at the National Centre for Immunisation Research and Surveillance (NCIRS) welcomed the development saying that reducing “needle burden” was important in overcoming barriers to better immunisation rates..etc"
http://au.gsk.com/en-au/media/press-releases/2013/new-gsk-additions-to-the-national-immunisation-program-nip/
In a 2004 declaration he did consultancy work for GSK:
http://scientific-misconduct.blogspot.co.uk/2007/11/memory-hole-12-november-corruption-of.html
In this recent paper on severe febrile siures in children following influenza vaccination funding is disclosed from
bioCSL
Roche
Abbott
Sanofi
GlaxoSmithKline (GSK)
Novartis
Pfizer
Children's Hospital at Westmead
http://onlinelibrary.wiley.com/doi/10.1111/irv.12337/abstract
R. Booy has received funding from bioCSL, Roche, Sanofi, GlaxoSmithKline (GSK), Novartis, and Pfizer to conduct sponsored research or attend and present at scientific meetings; any funding received is directed to a research account at the Children’s Hospital at Westmead.
http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=21159
Every good Booy deserves favour?
Posted by: John Stone | December 16, 2015 at 05:07 AM
John, as you note in your post above, the Australian Pharmaceutical Benefits Advisory Committee has rejected the Bexsero meningococcal B vaccine (three times).
Despite this rejection, ‘experts’ in Australia continue to agitate for this GSK vaccine to be added to the national vaccination schedule.
An article titled “Meningococcal B vax objection a bad move: expert”, published on the Medical Observer website on 24 August 2015, reports:
QUOTE:
“A leading immunisation researcher says rejection of funding for the meningococcal B vaccine suggests the government’s advisory committee isn’t accurately estimating the cost of the disease to the community.
Pediatric infectious diseases specialist Professor Robert Booy has criticised the Pharmaceutical Benefits Advisory Committee (PBAC) for rejecting listing of MenBV, also known as 4cMenB (Bexsero, GSK), pointing out that the UK is adding the vaccine to its childhood schedule.
“Whatever reservations the PBAC has, they are not shared globally,” he says.
The third rejection of meningococcal B vaccine, which costs $140 per dose privately, was among a swag of July decisions on PBS submissions released last Friday.
The PBAC says the bid for including Bexsero on the National Immunisation Program was rejected because of the sponsor’s “optimistic assumptions” on the extent and duration of the vaccine’s effect and herd immunity, as well as lack of cost effectiveness.
But Professor Booy, from the University of Sydney and the Children’s Hospital at Westmead, says the PBAC is underestimating the impact of the disease on disability.
“I am treating patients who are still experiencing health impacts from meningococcal B more than 10 years down the line,” he says.
END OF QUOTE
Note that Booy says “Whatever reservations the PBAC has, they are not shared globally”, a reference to the UK adding Bexsero meningococcal B vaccine to the schedule.
This is what I call the ‘domino effect’, i.e. where one country adds a new vaccine product to the schedule, and then this is used to motivate others to follow…like sheep…a very useful process for the vaccine manufacturers developing massive global markets for their vaccine products, assisted I presume by the influential network of members of vaccination committees across these countries.
There are similarities here with the fast-tracked adoption of HPV vaccination around the world. The Gardasil HPV vaccine product was originally rejected by the PBAC in Australia, but was subsequently added to the Australian vaccination schedule after interference by senators and other politicians, and vested interests, with then Prime Minister John Howard insisting the Gardasil HPV vaccine product be added to the schedule in the run-up to the 2007 election.
HPV vaccination (Merck’s Gardasil and GSK’s Cervarix) was subsequently fast-tracked for children all around the world, despite the fact we have no idea of the long-term consequences of this vaccine product.
Many children are receiving up to three doses of this aluminium-adjuvanted vaccine product, and do not know they are part of a massive experiment. Any notion of ‘informed consent’ before this vaccination is a joke, particularly in Australia where vaccination is being made compulsory for children of all ages to access financial benefits from January 2016.
(For more background on the questionable international fast-tracking of HPV vaccination, see my letter to Irish senator Paschal Mooney, who has spoken out on behalf of young girls and women in Ireland suffering adverse events after Gardasil HPV vaccination. My letter to Senator Mooney, dated 4 November 2015, is accessible via this link: http://bit.ly/1PlXG08 )
Back to the Bexsero meningococcal B vaccine product, Booy says: “I am treating patients who are still experiencing health impacts from meningococcal B more than 10 years down the line…”
Apparently the PBAC rejected the Bexsero meningococcal B vaccine “because of the sponsor’s “optimistic assumptions” on the extent and duration of the vaccine’s effect and herd immunity”, so there’s no guarantee this vaccine product will prevent all further cases of this rare disease.
It seems to me this rare disease does not warrant mass vaccination, particularly as there is the potential for ‘unintended consequences’ if there is artificial interference in the natural progression of this disease, which currently poses little risk to the population.
In this regard we should keep in mind what is happening with pertussis, i.e. pertussis vaccination being implicated in the spread of the disease via vaccinated individuals.(1)
I suggest there is much that is unknown about vaccination and immunisation, and it would be useful if so-called ‘experts’ exhibited a little more humility and caution in this area.
We should also keep an eye on the PBAC in Australia, and see if there are further moves to over-turn the rejection of GSK's Bexsero meningococcal B vaccine product…
Reference:
1. See for example FDA study helps provide an understanding of rising rates of whooping cough and response to vaccination. FDA News Release, 27 November 2013: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm376937.htm and Jason M Warfel et al. Acellular pertussis vaccines protect against disease but fail to prevent infection and transmission in a nonhuman primate model. PNAS, 22 October 2013: http://www.pnas.org/content/111/2/787.full.pdf
Posted by: Elizabeth Hart | December 16, 2015 at 12:46 AM
Fear of upsetting the profit making apple cart makes the working world rely on someone outside the tent to dig around and find out the ugly truth, there's so much COI these days.
John you are an astonishing investigator - honest and independent.
I hope the world hears you.
This shocker should go out on the news wire.
Posted by: Alli Edwards | December 15, 2015 at 02:18 PM
John,
From the CDC Pink Book: Since 2005, declines have occurred among all age groups and in all vaccine-contained serogroups. In addition, incidence of disease attributable to serogroup B, a serogroup not included in the quadrivalent vaccine, declined for reasons that are not known.
http://www.cdc.gov/vaccines/pubs/pinkbook/mening.html
The FDA licensed Trumenba , the Wyeth Group B Meningococcal Recombinant vaccine in December 2014, a month before Bexsero.
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm421020.htm
Price: Trumemba $115.75/dose and Bexsero $160.75/dose
Posted by: Ed Yazbak | December 15, 2015 at 11:53 AM
This is from the Parliamentary record:
"Bexsero
"James Wharton: To ask the Secretary of State for Health (1) what representations he has received on making Bexsero form of the Meningitis B vaccine universally available on the NHS; [143707]
"(2) what estimate he has made of the cost of making Bexsero form of the Meningitis B vaccine available on the NHS. [143708]
"Anna Soubry: Since Bexsero received market authorisation by the European Commission on 22 January 2013, the Department has received five representations on making Bexsero vaccine available as part of the national health service immunisation programme. These include correspondence or meeting requests from hon. Members, the Meningitis Research Foundation, the vaccine manufacturer—Novartis, and a member of the public.
"The Joint Committee on Vaccination and Immunisation (JCVI), the independent expert advisory committee to the Government on vaccination, is currently evaluating possible meningococcal B vaccination strategies, including their impact on the burden of disease and cost-effectiveness and is anticipated to be in a position to provide the Department with advice later this year.
"The estimated costs of providing Bexsero as part of a national immunisation programme would depend on JCVIs advice and the price negotiated with the vaccine manufacturer.
"27 Feb 2013 : Column 564W"
So, the people who have lobbied the government are the manufacturers, the Meningitis Research Foundation (ie people involved in the development of the vaccine like Prof Pollard who was affiliated to the charity at the time) and one member of the public.
Posted by: John Stone | December 15, 2015 at 10:07 AM
Ed
It ia very good point. I can find almost no meaningful data on the risk to infants from the disease in the UK.
This is from the minutes of the meeting where the vaccine received its recommendation nearly two years ago but oddly still in draft:
"35. The committee noted that the pattern of MenB disease incidence in relation to age had remained consistent over time, with peak incidence occuring at 5 months of age, and around a third of all disease in children occuring under one year of age. 520 laboratory-confirmed cases had been seen in those less than 20 years during 2012/13. It was noted that case fatality increased with age, with an average case fatality of 5% in children compared to 18% in older adults. The increase of case-fatality with age was considered likely associated with an increased incidence of case-morbidity as opposed to age-related impact of different clonal complexes."
https://app.box.com/s/iddfb4ppwkmtjusir2tc/1/2199012147/18992168807/1
So there is a lot of shifting around of categories here. According to this one third of children getting the disease will be infants (ie under one year) with highest incidence being at 5 months but we don't know how many that is: the 520 is for people under 20 but traditionally it is the group who are not children (ie adolescents and young adults) who are commonly susceptible. We then learn that the highest mortality is in older adults (what age range is that?) because of con-commitant diseases.
Clear information is not available. This is the Meningitis Research Foundation website:
http://www.meningitis.org/facts
Posted by: John Stone | December 15, 2015 at 09:49 AM
Meningitis b has already been mandated in New York State for students entering 7 and 12 grades in September. The governor signed the bill before the vaccine was even approved in the United States. My research tells me this is an extremely uncommon disease.
Posted by: LindaL | December 15, 2015 at 09:46 AM
John:
Thanks for this article.
This industry is corrupt to the core.
Louis
Posted by: Louis Conte | December 15, 2015 at 09:33 AM
African Children Still Paralyzed After Vaccines, Government Says “All in Their Head”
http://healthimpactnews.com/2013/african-children-still-paralyzed-after-vaccines-government-says-all-in-their-head/#sthash.tpuik0Qc.dpuf
Report on the African (Chad) paralysis tragedy:-
Extract:- "The MenAfriVac vaccination will likely be given to millions more third world children across Africa. The vaccination of children with pre-licensed and unlicensed vaccines, which may be life-threatening, needs to cease. This is not health care, but a total disregard for human life in the name of profit."
Posted by: Jenny Allan | December 15, 2015 at 08:25 AM
John,
Thank you for another great article.
Are there any UK statistics re the incidence of meningococcal meningitis group B in infants younger than 6 months of age?
Are results of British clinical trials of the vaccine in infants under 6 months readily available for review?
In the United States, Bexsero (Novartis Vaccines and Diagnostics, Inc) was approved by the FDA on January 23, 2015 for “Active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.”
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm431374.htm
According to GSK, “between 110 and 188 cases of meningococcal group B disease occurred annually in patients <1 to ≥65 years of age in the US between 2008 and 2012 (0.04-0.06/100,000 population)”.
BEXSERO is a vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. BEXSERO is approved for use in individuals 10 through 25 years of age.
Approval of BEXSERO is based on demonstration of immune response, as measured by serum bactericidal activity against three serogroup B strains representative of prevalent strains in the United States. Vaccination with BEXSERO may not provide protection against all meningococcal serogroup B strains. Vaccination with BEXSERO may not result in protection in all vaccine recipients. https://www.gsksource.com/pharma/content/gsk/source/us/en/brands/bexsero/pi/po.html
It would be nice to know why this specific vaccination program was deemed to be so necessary at this time.
Posted by: Ed Yazbak | December 15, 2015 at 08:20 AM
Under the 2010 Bribery Act, here in the UK the SFO has powers to investigate and prosecute corruption at home or abroad. Of course if the offenders act as soon as they are aware offit its damage limitation.
Syria
http://www.telegraph.co.uk/finance/newsbysector/pharmaceuticalsandchemicals/11027538/Serious-Fraud-Office-opens-criminal-investigation-into-GlaxoSmithKline.html
Also we can include, China, Iraq, Jordan, Lebanon, Poland, the list goes on.
Yet our Politicians and Civil Servants defend them as honest Joes.. don’t they make me larf..
MMR RIP
Posted by: angus files | December 15, 2015 at 07:57 AM
"Cameron probably still pats himself on his humanitarian 'save the children' back, but he has unwittingly and unscupulously been 'used' by greedy pharma interests. It would seem this continues unabated. Am I alone in regarding this as corruption
I don't know anything about politics in the U.K. or Scotland .. but .. to me .. allowing oneself to be 'unscrupulously and unwittingly" being "used" .. is the very definition of corruption .. as I understand it.
Posted by: Bob Moffitt | December 15, 2015 at 07:40 AM
From UK Prime Minister's speech at the June 2011 World Vaccine Summit:-
https://www.gov.uk/government/speeches/speech-at-vaccine-summit
Extract:-
"GAVI is quite simply a great organisation. It was set up by people who wanted to do aid in a different way and to my mind that is exactly what it’s achieved. GAVI was one of the very top performers in our root-and-branch review of the agencies that deliver British aid. Why? Well, because it delivers tangible results - saving lives with excellent value for money. How does it do this? First, it brings together national governments, private companies and donors, with the mechanisms they need to deliver vaccines to children. Second, GAVI uses innovative finance to generate additional sources of revenue for vaccines. And third it pools demand - creating strong buying power to drive down the cost of vaccines. Only last week the Serum Institute and Panacea Biotec agreed to lower prices for the life-saving pentavalent vaccine, which protects against five deadly diseases. GlaxoSmithKline offered the rotavirus vaccine to GAVI at $2.50 a dose - cutting the lowest available price by more than two-thirds. As a result of all this, over a decade, GAVI has helped prevent 5.4 million deaths and has helped immunise more than 288 million children in 72 of the world’s poorest countries. That, in my view, is a record worth investing in.
So today we come together, because we have the chance to save another four million lives by funding vaccines against diseases like pneumonia and diarrhoea. Frankly the idea of children dying from pneumonia and diarrhoea should be absolutely unthinkable in 2011."
Since 2011 there have been several vaccine scandals involving GAVI, including a number of young girls dead and disabled after HPV trials in India, and children paralysed in Africa following a trial meningitis vaccine.
MAIL ONLINE INDIA
http://www.dailymail.co.uk/indiahome/indianews/article-2407569/Indian-Council-Medical-Research-endorsed-illegal-US-vaccine.html?ito=feeds-newsxml
Extract:-“It is established that PATH by carrying out the clinical trials for HPV vaccines in Andhra Pradesh and Gujarat under the pretext of observation / demonstration project has violated all laws and regulations laid down for clinical trials by the Government,” observed the Parliamentary standing committee reported tabled in the Rajya Sabha on Friday.
PATH had used cervical cancer vaccines provided by Merck Sharp & Dohme (MSD) in the Andhra Pradesh study, while GlaxoSmithKline (GSK) provided vaccines for the Gujarat study. The Indian Council of Medical Research (ICMR) played an advisory role to ensure adherence to protocols. And the project agreement had been signed in 2007. " (PATH is part of the Bill& Melinda Gates Foundation; both are part of GAVI)
Posted by: Jenny Allan | December 15, 2015 at 07:30 AM
J Infect. 2015 Dec;71(6):611-4. doi: 10.1016/j.jinf.2015.09.035. Epub 2015 Oct 2.
The introduction of the meningococcal B (MenB) vaccine (Bexsero(®)) into the national infant immunisation programme - New challenges for public health.
Ladhani SN1, Campbell H2, Parikh SR2, Saliba V2, Borrow R3, Ramsay M2.
Author information
Abstract
The United Kingdom is the first country to introduce Bexsero(®) (GSK Biologicals), a multicomponent, protein-based vaccine against meningococcal group B (MenB), into the national infant immunisation programme. This vaccine is like no other licensed vaccine and poses a number of implementation and surveillance challenges in England. From 01 September 2015, UK infants were offered a reduced two dose primary immunisation schedule at 2 and 4 months followed by a booster at 12 months. Because of high rates of fever post-vaccination, parents were advised to give their infants three doses of prophylactic paracetamol, with the first dose given as soon as possible after the primary MenB vaccination dose. Since the vaccine only protects against 73-88% of MenB strains causing invasive disease in England, clinical isolates and PCR-positive samples will require extensive characterisation by the Meningococcal Reference Unit (MRU) at Public Health England (PHE) in order to monitor vaccine effectiveness and identify potential vaccine failures. PHE is also conducting detailed clinical and epidemiological surveillance to assess the impact of the MenB immunisation programme on the morbidity and mortality associated with invasive meningococcal disease in infants and young children.
Copyright © 2015 The British Infection Association. Published by Elsevier Ltd. All rights reserved.
KEYWORDS:
Infant immunisation; Meningococcal B vaccine; Paracetamol; Post-vaccination fever
Posted by: John Stone | December 15, 2015 at 06:57 AM
Thanks for reporting this to our Scottish Government John. After the Murdoch phone hacking scandal, UK Prime Minister David Cameron, admitted his relationship with the Murdoch empire was 'a little too cosy'. Previously, dinner with James Murdoch, then boss at News International, AND on the board of GSK to 'promote' their public image, resulted in nearly £1billion of UK taxpayers cash handed to GAVI, for world vaccination programmes. GSK, very generously, (NOT!) offered to sell some vaccines half price, omitting to mention those same vaccines had been banned in Western countries. But then ANY dodgy vaccine is good for the 'third world', including full on mercury preservative (Thiomersal) banned elsewhere.
Cameron probably still pats himself on his humanitarian 'save the children' back, but he has unwittingly and unscupulously been 'used' by greedy pharma interests. It would seem this continues unabated. Am I alone in regarding this as corruption?
Posted by: Jenny Allan | December 15, 2015 at 06:52 AM