A tale of two vaccines
BMJ 2018; 363 doi: https://doi.org/10.1136/bmj.k4152 (Published 04 October 2018) Cite this as: BMJ 2018;363:k4152
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Fiona Godlee's point concerning the disgraced former doctor Andrew Wakefield - that his spectre shouldn't deter scruitiny of vaccine safety - is clearly right. But nor should such scrutiny be an occasion for the publication of attempts to revisit the Wakefield saga with inaccurate information, as in the case of a rapid response from Noel Thomas, a retired GP.
Firstly, in May 2010 Wakefield was struck off the medical register over a multitude of charges, including one that his own QC described as a charge of "fraud". Others included dishonesty, the misrepresentation of the status of child research subjects, the misleading of an ethics committee, and the concealment of large sums of money (more than £425,00, at hourly rates agreed two years before his retracted Lancet paper) paid to him by a lawyer attempting to make a case against the MMR vaccine. Contrary to Dr Thomas's claims in his rapid response, none of this was previously disclosed.
Thomas also recites another standard Wakefield gambit: the claim that, because Wakefield's associate in the affair, John Walker-Smith, was restored to the GMC register after both men were struck off by the GMC fitness to practise panel, Wakefield was therefore, by inference, exonerated.
The case against Walker-Smith was quashed because the GMC panel failed to properly set out its reasoning in its judgment. This issue had then only recently been considered in the Court of Appeal, where Leveson LJ had ruled in the case of Dr David Southall and the GMC.
Leveson criticised the GMC panel in Southall on grounds that the practitioner had found himself in a position where he couldn't properly understand how the panel came to their conclusion on a particular critical matter (I recall that it concerned a meeting, regarding which two people said one thing, and one person said something else). Leveson (look it up for the precise detail) made it clear that panels must give more information: not just that they DID reach a conclusion, but WHY they reached it: in short, give their REASONING.
This is what judges do at the end of trials and, in those days - when GMC panels were both judges and juries - panels had a practice of issuing rulings with with mere one- or two-line snippets by way of information on sometimes very complex charge sheets.
This is what went wrong in the case of Waker-Smith - just weeks after Leveson's ruling. Unlike Wakefield, Walker-Smith was a clinician (a professor of pediatric gastroenterology). In a GMC case that was originally scheduled to run for about 10 weeks, framed around evidence that Wakefield, Walker-Smith and another doctor were carrying out research without valid ethics approval, the hearing suddenly changed direction when the defendants changed their story from what they'd publicly maintained, including in formal statements, for more than three years. The hearing then ran for about 200 days.
In the end, the panel found Walker-Smith guilty of the career-devastating charge of researching on children without valid approval, but failed to explain why they had reached this conclusion.
The question at issue was did Walker-Smith believe he was involving himself in a research project devised by Wakefield, or did he think he was purely engaged in clinical care, out of which Wakefield then did his own research?
The panel took the view that Walker-Smith was doing research. But, when the music stopped, Walker-Smith was left not knowing - as he was entitled to know - precisely why they took this view. The panel had failed to set out its reasoning. That doesn't mean it didn't HAVE reasoning, only that it didn't tell Walker-Smith what it was. The decision to strike him off was thus squarely caught by Leveson's ruling from the Court of Appeal.
After hearing Walker-Smith's appeal of the GMC case in the High Court, Mitting J expressed the nub of the matter in the conclusion to his judgment: "The panel had no alternative but to decide whether Professor Walker-Smith had told the truth to it and to his colleagues, contemporaneously. The GMC's approach to the fundamental issues in the case led it to believe that that was not necessary – an error from which many of the subsequent weaknesses in the panel's determination flowed. It had to decide what Professor Walker-Smith thought he was doing: if he believed he was undertaking research in the guise of clinical investigation and treatment, he deserved the finding that he had been guilty of serious professional misconduct and the sanction of erasure; if not, he did not, unless, perhaps, his actions fell outside the spectrum of that which would have been considered reasonable medical practice by an academic clinician. Its failure to address and decide that question is an error which goes to the root of its determination."
Contrary to Noel Thomas's protestations, the ruling had no bearing on Wakefield's position. He wasn't a clinician. And he faced numerous other charges, found proven. As Walker-Smith himself said in a statement on 18 February 2012:
"My case related to entirely different issues to those that concerned Dr Wakefield... They focused fundamentally concerning whether I was investigating the children for clinical need... or for pure research to investigate Wakefield's hypothesis."
Competing interests: I investigated the Wakefield affair for The Sunday Times, Channel 4 TV, and The BMJ. My book is expected to be published next year.
Dr Philip Bryan writes in https://www.bmj.com/content/363/bmj.k4152/rr-11 :
“We believe that the safety of both Pandemrix and Arepanrix vaccines have been scrutinised entirely appropriately”
Not true. Wraith et al.(1) and Verdier(2) suggested in 2003 that bioinformatics analysis be performed to avoid antigens in vaccines that have molecular mimicry to human self antigens. Where is the analysis?
Wraith et al. called for autoimmune serology in clinical trials. Where is that data?
The nucleoprotein (NP) sequence for A/Puerto Rico/8/1934, the backbone of X-179A that was used in Pandemrix, became available in 1985(3). The human hypocretin receptor 2 (HCRTR2) sequence became available in 2000.(4)
Even a quick bioinformatics analysis would have identified autoimmunity risk of NP in the vaccine. A detailed analysis may have even predicted sequence alignment to HCRTR2 as a narcolepsy risk. And this could have been done long before the pandemic because it is relevant to seasonal influenza vaccine safety as well.
References
1. Wraith DC, Goldman M, Lambert P-H. Vaccination and autoimmune disease: what is the evidence? Lancet (London, England). England; 2003 Nov;362(9396):1659–66.
2. Verdier F. Chapter 14 - Preclinical Safety Evaluation of Vaccines A2 - Thomas, John A. In: Fuchs RLBT-B and SA (Third E, editor. San Diego: Academic Press; 2003. p. 397–412.
3. Beklemishev AB, Blinov VM, Vasilenko SK, Golovin SI, Karginov VA. [Synthesis, cloning and determination of the primary structure of a full-size DNA copy of the NP protein gene from influenza virus type A]. Bioorg Khim. Russia (Federation); 1985 May;11(5):636–40.
4. UniProt: the universal protein knowledgebase. Nucleic Acids Res. 2017 Jan 4;45(D1):D158–69.
Competing interests: No competing interests
In 2005 the House of Commons Health Committee stated in its report 'The influence of the pharmaceutical industry' [1]:
"The industry is by no means solely to blame for the difficulties we describe. The regulators
and prescribers are also open to criticism. The regulator, the Medicines and Healthcare
products Regulatory Agency (MHRA), has failed to adequately scrutinise licensing data
and its post-marketing surveillance is inadequate. The MHRA Chairman stated that trust
was integral to effective regulation, but trust, while convenient, may mean that the
regulatory process is not strict enough. The organisation has been too close to the industry,
a closeness underpinned by common policy objectives, agreed processes, frequent contact,
consultation and interchange of staff. We are concerned that a rather lax regime is
exacerbated by the MHRA’s need to compete with other European regulators for licence
application business. "
As I noted in a previous response to Doshi an MHRA web page in 2013 stated ""The costs of medicines regulations are met by fees from the pharmaceutical industry" [2,3].
Evidently, the MHRA [4] acknowledge no conflicts but that may seem paradoxical to others.
[1] House of Commons Health Committee, 'The Influence of the Pharmaceutical Industry
Fourth Report of Session 2004–05', p.4, https://publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf
[2] John Stone, 'The funding medicines licensing', 29 September, https://www.bmj.com/content/362/bmj.k3948/rr-15
[3] 'Frequently asked questions about the MHRA' , 22 October 2013, https://web.archive.org/web/20140604072443/http://www.mhra.gov.uk/Search...
[4] Philip T Bryan, June Raine, Ian Hudson, 'MHRA response to BMJ Editor's Coice - 'A tale of two vaccines' 10 October 2018,
https://www.bmj.com/content/363/bmj.k4152/rr-11
Competing interests: No competing interests
We fully agree with Fiona Godlee (“Editor's Choice - A tale of two vaccines”) [1], that public trust in vaccination programmes is easily undermined by misinformation, and that the “spectre of Andrew Wakefield should not deter us from proper scrutiny and openness about vaccine safety”. However, diligence and objectivity are also paramount when investigating and communicating vaccine safety issues. We believe that the safety of both Pandemrix and Arepanrix vaccines have been scrutinised entirely appropriately, and the extensive materials published by the European Medicines Agency (EMA) and national authorities are evidence of such openness.
Fiona Godlee asks the question “When do public health officials have a duty to warn the public over possible harms detected through pharmacovigilance? How much detail should the public be provided with, and who should provide it?”. These are important and valid questions. Public health authorities and regulators should act, and alert health professionals and the public, as soon as scientific evaluation of the available evidence suggests that a risk is reasonably possible. The detail should be sufficient to allow informed choices to be made and risks to be minimised. Health professionals also have an important role in communicating and minimising such risks.
The theme of Peter Doshi’s article [2], and his response to MHRA [3], is that public health authorities and regulators were not transparent about what he perceives as ‘early warning signs’ about the safety of Pandemrix during late 2009/early 2010. He also questions whether “proper investigations were ever done”. We consider it important to highlight here the evidence that proper investigations of the suspected adverse reactions (ADRs) were in fact done.
In addition to its weekly publication of suspected ADR reports for Pandemrix over this time, the EMA issued a public report that described its licensing evaluation of Arepanrix [4]. This public report detailed not only the evaluation of suspected ADR reports during the time period in question, but also a comparison of adverse events from a head-to-head clinical trial of Pandemrix and Arepanrix (H1N1-017). The conclusion was “Overall the safety profiles appear to be comparable”. The EU product licence for Arepanrix also referred to this comparative safety review from the trial [5]. The evidence, reviewed thoroughly at the time, did not indicate a “higher rate of serious adverse events” for Pandemrix, as claimed in Fiona Godlee’s article [1].
In response to our entirely plausible explanation that the higher post-marketing reporting rate of suspected ADRs for Pandemrix compared to Arepanrix was most probably an artefact of different passive reporting systems [6], Peter Doshi also asks [3] “where are the data that should lead us to believe that these explanations are anything more than hypotheses”. The above information, which has long been available on the EMA’s website [7], answers this question.
For the reasons already outlined [6], it is clear that there was no suggestion of a safety concern with Pandemrix at the time and no justification for communicating to the public what was actually a very low spontaneous reporting rate of suspected ADRs for Arepanrix, a vaccine that was not being used in Europe.
Dr Philip Bryan; Head of Vaccine Safety, Vigilance and Risk Management of Medicines (VRMM), Medicines and Healthcare products Regulatory Agency (MHRA)
Dr June Raine; Director, VRMM-MHRA
Dr Ian Hudson; Chief Executive, MHRA
Competing interests: None
1. https://doi.org/10.1136/bmj.k4152
2. https://www.bmj.com/lookup/doi/10.1136/bmj.k3948
3. https://www.bmj.com/content/362/bmj.k3948/rr-13
4. https://www.ema.europa.eu/documents/assessment-report/arepanrix-epar-pub...
5. https://www.ema.europa.eu/documents/product-information/arepanrix-epar-p...)/
6. https://www.bmj.com/content/362/bmj.k3948/rr-2
7. https://www.ema.europa.eu/en/human-regulatory/overview/public-health-thr...
Competing interests: No competing interests
Fiona Godlee and Noel Thomas refer to the "spectre of Andrew Wakefield".
Certainly the spectre of Andrew Wakefield has provided a useful distraction for those intent on expanding vaccination schedules, and destroying the right to informed consent before the medical intervention of vaccination, as has happened in Australia with the enactment of the coercive No Jab, No Pay law.
The Australian Federal Government's No Jab, No Pay law demands parents have their children vaccinated to access financial benefits[1], and denies them the right to freely consider the risks and benefits of each of these interventions, in direct contravention of The Australian Immunisation Handbook, which states the criteria for consent to be legally valid, i.e. including that "It must be given voluntarily in the absence of undue pressure, coercion or manipulation", and that "It can only be given after the potential risks and benefits of the relevant vaccine, the risks of not having it, and any alternative options have been explained to the person".[2]
There is an obvious conflict between the Australian Federal Government's No Jab, No Pay law, and the right to legally valid consent which has not as yet been resolved, and which is ignored by politicians and doctors in Australia. It is shocking that doctors have stood by and allowed this to happen. How does this sit with the 'informed consent' issues raised by Wendy Stephen?
In Australia, children have to have all the vaccinations on the early childhood vaccination schedule to access financial benefits[1], a schedule which has continued to increase since the enactment of the No Jab, No Pay law in January 2016, with yet another diphtheria, tetanus and pertussis shot added at 18 months (now up to six doses for children), plus the combination meningococcal ACWY vaccine product being recently added for 12 month old babies: https://beta.health.gov.au/health-topics/immunisation/immunisation-throu...
It is really alarming to the see the number of combination vaccine products on the schedule now, and with compliance being coerced via the No Jab, No Pay law.
Was Andrew Wakefield's greatest crime in advocating for single vaccines[3], thereby casting a shadow over the remarkable advent of combination vaccines we see now? No wonder there was a campaign to discredit Wakefield...
The sheer number of vaccines being given to children is camouflaged by multiple vaccines being given in a single shot, e.g. the aluminium-adjuvanted diphtheria, tetanus, whooping cough (pertussis), hepatitis B, polio, and Hib shot given to 2, 4 and 6 month old babies in Australia, and the second dose of measles, mumps and rubella vaccine combined with varicella/chickenpox, on top of all the other combination and single vaccines, and revaccinations, children are coerced to have now.
Back in 2002, Tom Jefferson, the 'diligent reviewer' mentioned in Fiona Godlee's article, raised concerns about future vaccination programmes giving children "five, six even seven vaccines all at once". Jefferson said "For people like me, it is becoming more and more difficult to tease out what problems may be due to an individual vaccine...It is almost becoming impossible to do this. We have to think very carefully about how we will monitor these vaccines. We have a responsibility to these children - they are our future. It is no use having a situation where someone suggests a possible harm and everyone runs around frantically trying to find bits of evidence. What is required is good-quality information that has been systematically collated and assessed".[4]
Has anybody without vested interests thought "very carefully about how we will monitor these vaccines"? Has anybody thought very carefully about the startling number of vaccines and combination products and revaccinations given to children now, and the as yet unknown cumulative effect of all these interventions throughout life?
References:
1. "To meet immunisation requirements and be eligible for their full rate of Family Tax Benefit (FTB) Part A, children need to be immunised in accordance with the National Immunisation Program early childhood vaccination schedule, on an approved catch-up schedule or have an approved exemption." Immunisation and Health Check requirements for Family Tax Benefit. No Jab, No Pay - Immunisation Requirements: https://www.dss.gov.au/our-responsibilities/families-and-children/benefi...
2. The Australian Immunisation Handbook - Preparing for Vaccination - Valid consent: https://immunisationhandbook.health.gov.au/vaccination-procedures/prepar...
3. F. Edward Yazbak. The MMR and Single Measles, Mumps and Rubella Vaccines: The REAL Facts, 11 January 2005. Rapid Response on The BMJ article Dispatches. MMR: What They Didn't Tell You: https://www.bmj.com/rapid-response/2011/10/30/mmr-and-single-measles-mum...
4. Vaccines expert warns studies are useless. The Telegraph, 27 October 2002: https://www.telegraph.co.uk/news/uknews/1411417/Vaccines-expert-warns-st...
Competing interests: No competing interests
Regarding the letters of Noel Thomas [1] and Wendy E Stephen [2] the Cochrane Collaboration three times offered (2003, 2005, 2012) an ambivalent statement about MMR safety [3]. While recommending the continuation of vaccination policy it issued as a conclusion:
"The design and reporting of safety outcomes in MMR vaccine studies, both pre- and post-marketing, are largely inadequate."
The plain language version of that should perhaps have been:
"It is not known if MMR is safe, and present studies are inadequate"
That, according to most basic ethical principles, is surely what doctors should have been told to tell the public from 2003.
Nor were there, alas, clear safety signals in relation to autism [3], and the failure to find "adequate" studies remains troubling.
[1] Noel Thomas, 'Re: A tale of two vaccines', 8 October 2018, https://www.bmj.com/content/363/bmj.k4152/rr-6
[2] Wendy E Stephen, 'Re: A tale of two vaccines', 8 October 2018, https://www.bmj.com/content/363/bmj.k4152/rr-7
[3] John Stone, 'Response to David Oliver II (Risks of Vaccines)', 28 August 2018, https://www.bmj.com/content/362/bmj.k3596/rr-11
Competing interests: No competing interests
Would Dr Rajagopal of the World Health Organisation agree that:
the person to be “injected” should be individually advised about the risks of each vaccine being adninistered on that occasion, AFTER eliciting the appropriate history from the person to be immunised or his/her next of kin?
Simple question. The answer should be: YES or NO.
Competing interests: No competing interests
The grammar of vaccinology must surely, first and foremost, and above all other consideration, satisfy the legal requirements to ensure Informed Consent by the patient to vaccination. Recognising the right of the patient to be fully informed must surely take precedent over every other consideration with regard to the language used.
Adverse reactions following immunization should be diligently published as a matter of openness and transparency so as to allow the public full access to all available information in the absence of any modification or consideration as to how the anti vaccine lobby might portray the information. The Patient Information Leaflet was designed for that purpose but is of course, entirely dependent on being continually updated to include relevant and accurate information.
The Medical Defence Union, a year after the Judgement in Montgomery identified one of the key aspects of the findings to be the language employed by a doctor when advising the patient as to the risks of a treatment. From the Judgement in Montgomery paragraph 87….
“In order to advise, the doctor must engage in a dialogue with the patient, who may not know there is anything to ask about. The information provided must be comprehensible, and the doctor's duty is not fulfilled by bombarding the patient with technical information which they cannot reasonably be expected to grasp. The duty is not discharged simply by obtaining a signature on a consent form”.(1)
The over riding concern has to be one where a doctor not only anticipates his patients requirements with regards to their understanding and circumstances but that he too, via adverse drug reaction reports, the relevant pharmacoepia, and other data at his disposal, can be aware of the risks and fully informed.
Quantifying risks is important, again to give the patient some idea of the significance of the risk they face with regard to their own personal set of circumstances. Merely contrasting the risk with that expected following the naturally occurring infection doesn’t satisfy the requirements in Montgomery.
“The significance of a given risk is likely to reflect a variety of factors besides its magnitude: for example, the nature of the risk, the effect which its occurrence would have upon the life of the patient, the importance to the patient of the benefits sought to be achieved by the treatment, the alternatives available and the risks involved in those alternatives. The assessment is therefore fact-sensitive, and sensitive to the characteristics of the patient.”(2)
If vaccines are to continue to save lives it is essential that the communication between the patient and the doctor reverts from scientific data to a more personal patient specific dialogue. It is also essential that the dialogue be primarily determined with regard to the Judgement in Montgomery and not as a result of any other influence or consideration. Regulating the substance of what is disclosed or tailoring the language so as to ensure the acceptability of a vaccine or to circumvent any negative usage by those who do not support vaccination, is not supported in law.
(1)(2)https://mdujournal.themdu.com/issue-archive/issue-4/informed-consent-a-y...
Competing interests: No competing interests
Godlee ends her piece with the hope that “The spectre of Andrew Wakefield should not deter us from proper scrutiny and openness about vaccine safety.”
Her choice of words is most appropriate.
A spectre is, after all, “ ..an apparition, phantom or ghost.... a phantasm of the brain....an object or source of dread or terror, imagined as an apparition “ (1)
For years it has suited the vast majority of commentators to replace the true historical narrative with the spectre that Wakefield, and his colleague John Walker Smith, were justly removed from its register by the GMC, for alleged unprofessional behaviour. Those commentators never mention that a UK Appeal Court judge, in 2012, quashed the GMC verdict against Walker Smith, restoring him to the register. The judge effectively demolished the GMC case against Walker Smith. The same case had been used by the GMC against Wakefield, who had moved to the USA a decade before, and was not a party to Walker Smith’s appeal. (2,3)
The other spectre, oft remarked by commentators, is of Wakefield as a fraud, for not revealing a financial competing interest. That allegation is disproved by his comments about that financial interest, in a 1998 letter to the Lancet. (4)
Furthermore, that alleged non disclosure of a competing financial interest by Wakefield, has interesting parallels with the thousands of vaccinations performed each week in NHS surgeries. How many of those procedures are recommended, and carried out, without the patient or parents being told that the practice income will benefit, when vaccination targets are met?
An informed discussion is desperately needed about the risks and benefits of vaccinations, so that fully informed consent, prior to vaccination, becomes the norm.
Is UK vaccination practice, which necessitates fully informed consent on every occasion, currently in denial about the implications of the Montgomery case? (5)
Spectral interpretations of the past must give way to respect for an accurate historical narrative.
1 The Shorter Oxford English Dictionary, volume 2. OUP
2 https://www.eastwoodslaw.co.uk/wp-content/uploads/2013/03/Walker-Smith.pdf
3 https://www.theguardian.com/society/2012/mar/07/mmr-row-doctor-appeal
4 https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(05)79083-8/fulltext?code=lancet-site DOI:https://doi.org/10.1016/S0140-6736(05)79083-8
5 https://www.themdu.com/guidance-and-advice/guides/montgomery-and-informe...
Competing interests: No competing interests
Re: A tale of two vaccines
A Tale Of Two Adverse Reaction Reporting Systems
On 26th March 2010 the MHRA published their final weekly running total of adverse reaction reports in respect of swine flu vaccines Pandemrix and Celvapan.(1) On June 2nd 2010, LAKEMEDELSVERKET, Medical Protection Agency in Sweden, (2) published their final report on adverse events for the Pandemrix vaccine, in the period between October 2009 and 16th April 2010.
The MHRA reported that………. “650,000 doses of H1N1 vaccines have been administered to healthy children aged less than 5 years in England to date (up to 14th March 2010). The safety profile of the vaccines in children is broadly consistent with that for seen for adults.”
It would become evident later that the incidence of narcolepsy would be far greater in children and young people than in adults.
The Swedish agency for virtually the same period stated that (in respect of Pandemrix only) ….. “700 000 doses have been used in children 6 months - 12 years of age. Preliminary data also indicates that about 421 000 children have received a second dose of the vaccine.”
The MHRA reported that they had “received a total of 440 reports of suspected adverse reactions to swine flu vaccines in children aged less than 16 years” and concluded that………….
“the majority of the reported suspected reactions in children are non-serious, recognised side effects of many vaccines including the swine flu vaccines, or can be attributed to the process of vaccination rather than the vaccine itself. These reactions include injection site reactions, flu-like illness, muscle aches and pains, rash, headache, dizziness, nausea, vomiting, diarrhoea and psychogenic reactions including faints”.
The Swedish MPA reported that………….
“In about one fifth of the reports concerning children (1-7 years of age) the reactions have been classified as serious, i.e. the same proportion as the reports for all ages” and that………………..
“The most frequently reported serious adverse events in children, reported from Health Care Professionals, were neurological reactions (82) ( e.g. febrile convulsions and syncope), immunological reactions (28) (e.g. anaphylactic reaction/allergic reactions) or general symptoms (26) (e.g. fever and influenza like illness).”
The MHRA not only stated that the “majority” of the ADR’s in children were “non-serious” but made no mention of an incidence of neurological reactions, something which was identified in Sweden as the most “frequently reported serious adverse event in children” following administration of the Pandemrix vaccine.
Sweden reported on 82 cases neurological reactions of febrile convulsions and syncope in the child cohort whereas the MHRA in their table of conditions reported on one case of “convulsion in childhood”. The MHRA tables make no mention of immunological reactions or anaphylactic reactions in children.
The most “commonly” reported ADR in Sweden was anaphylaxis.
“The most commonly reported immunological reactions have been anaphylactic/allergic reactions.”
The MHRA only reported one case overall (ie it is not known if it was in respect of a child) as “anaphylaxis treatment”.
Bearing in mind that the CHMP VARIATION ASSESSMENT REPORT for Pandemrix (3rd December 2009) included the fact that Pandemrix had only been licensed in May 2008 in respect of individuals between the ages of 18yrs and 60yrs, one has to wonder why it was that the MHRA (a) didn’t publish brand specific ADR tables in the final weekly report (b) didn’t collate and report on specific ADR’s in children and (c) didn’t identify the same serious ADR’s in children or the rate at which they were occurring to that identified in Sweden for the same period.
One explanation for the noticeable discrepancy between all aspects of the ADR reports in Sweden to that collated by the MHRA might lie in the fact that the MHRA system for ADR reporting in children was later identified in October 2014 to be potentially acting as a “barrier to reporting”.
“ADR reporting in children was "impractical for busy healthcare professionals and potentially acted as a barrier to reporting".(3)
Might this be a reason why, as the MHRA representatives pointed out, “there was no suggestion of a safety concern with Pandemrix at the time” ?.(4)
(1) http://webarchive.nationalarchives.gov.uk/20100709144106/http://www.mhra...
(2)
https://lakemedelsverket.se/.../Pandemrix%20ADRs%20in%20Sweden%2015%20april...
(3)https://www.hoganlovells.com/en/blogs/focus-on-regulation/uk-mhra-simpli...
(4) https://www.bmj.com/content/363/bmj.k4152/rapid-responses
Rapid Response provided by…….
Dr Philip Bryan; Head of Vaccine Safety, Vigilance and Risk Management of Medicines (VRMM), Medicines and Healthcare products Regulatory Agency (MHRA)
Dr June Raine; Director, VRMM-MHRA
Dr Ian Hudson; Chief Executive, MHRA
Competing interests: No competing interests