NHS chief attacks anti-vax “fake news” for falling uptake
BMJ 2019; 364 doi: https://doi.org/10.1136/bmj.l1000 (Published 04 March 2019) Cite this as: BMJ 2019;364:l1000
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In a recent FOIA disclosure, Boots the chemist provided their Standard Operating Procedure (SOP) for pharmacists when administering flu vaccine in their stores.
In complete compliance with what is stated by the vaccine manufacturer, Boots instruct their pharmacists to “give” the Patient Information Leaflet (PIL) to the patient before carrying out the vaccination, “highlight any possible side effects” and “allow time for questions” before confirming that the patient still wishes to “proceed with the service”.(1)
They also stated that Boots “provides NHS pharmaceutical services under The National Health Service
(Pharmaceutical and Local Pharmaceutical Services) Regulations 2013.”
It is very encouraging to see that Boots complies with the manufacturers instructions in the PIL, acknowledges patient autonomy, and takes all possible steps to ensure informed consent. Boots have implemented a policy which goes way beyond the instruction in the NHS Patient Group Direction to pharmacists to merely “offer” the PIL to the patient (2) raising questions over why the NHS is not respecting patient autonomy in the same way as Boots. How can there be such a glaring anomaly between the procedures implemented by a pharmacy contracted under The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations of 2013, and the instructions issued by the NHS?
Dr Richard Smith, in a recent article, provided us with a first hand account of how he received vaccines from a nurse who “gave him no information at all” and told his wife that “there were no side effects”. Unfortunately, he subsequently developed some unpleasant symptoms and now raises the question “Who is most likely to have side effects to flu vaccine”(3)
The PIL accompanying flu vaccine (and many others) includes a guide to the frequency with which certain adverse reactions are rep[orted in specific age ranges. Although this is not patient specific it does allow the patient insight as to which reactions are most likely to affect them and the frequency with which they are likely to occur.
It appears that Dr Smith wasn’t provided with the relevant PIL’s but even more concerning is the fact that he attributes the lack of information to his professional status and the fact that he “didn’t ask”.
A publication by Jim Duffy in the Medical Defence Union Journal “Informed Consent: a year on from Montgomery” considers the implications of the Judgement from the case of Montgomery vs Lanarkshire Health Board and concluded that…..
“there is no need for the patient to prompt the flow of information through questioning”. (4)
The fact that Dr Smith is a doctor, and didn’t ask specific questions, did not absolve the nurse from a duty to supply the PIL before administering the vaccine and providing relevant additional information. The Judgement from Montgomery makes it very clear that the onus is not on the patient, irrespective of their personal situation, to ferret out information, but on the health care practitioner to volunteer it.
Had the PIL been provided, as it should have been, it would have been clear to both Dr Smith and his wife from the outset, that there were a number of potential adverse reactions. The information contained in the PIL would have helped answer his question re who is most likely to have side effects to the flu vaccine.
(1) https://www.whatdotheyknow.com/request/553820/response/1331272/attach/ht...
(2) PGD for the administration of inactivated influenza vaccine by pharmacists delivering the community pharmacy seasonal influenza vaccination advanced service.
NHS England gateway number: 08379
(3) https://blogs.bmj.com/bmj/2019/03/13/richard-smith-who-is-most-likely-to...
(4) https://mdujournal.themdu.com/issue-archive/issue-4/informed-consent-a-y...
Competing interests: No competing interests
Fake news is not the exclusive province of radical anti-vaxxers; vaccine officialdom purveys its own brand of fake news by exaggerating the threats of target diseases, exaggerating vaccine benefits, and by making claims for vaccine safety that are not warranted by the evidence. Vaccines are licensed on the basis of evidence for short-term efficacy; once on the market there is little effort to discover rare but serious adverse effects that may become manifest months or years later.
I share the frustration of Wendy Stephen, Jackie Fletcher, Noel Thomas and John Stone with the NHS’s dismissive attitude regarding strong circumstantial evidence for devastating vaccine adverse effects in individual cases. The same attitude prevails in US officialdom.
Years ago, Paul Fine pointed out that, as vaccines reduced the risks of target diseases, vaccine adverse effects assumed increasing importance in balancing risks and benefits of vaccines. (Fine, “Non-specific effects of vaccines.” Trop Med Int Health 2007;12:1) In the US, at least, this principle has been ignored. Exclusive attention has focused on the decline in target diseases, but the adverse effects of vaccines have been ignored. There has been a concerted effort to mandate every vaccine on the schedule for every child in the US.
Do vaccines cause autism? We can neither confirm nor dismiss the statistical possibility that a vaccine or a combination of vaccines cause autism without having unbiased, randomized trials comparing vaccinated and unvaccinated groups of children. Innumerable observational studies have been reported showing no association, but they are mostly of low scientific caliber and do not prove the case one way or the other. When there is strong circumstantial evidence in an individual case, it is typically rejected by US vaccine authorities. This is what happened in the highly publicized case of Hannah Poling. (Offit, NEJM 2008;358:2089)
Lately, we have become aware of the possibility that vaccine injections may be co-factors in the causation of acute flaccid myelitis/AFM, a paralytic disease identical to poliomyelitis, probably caused by non-polio enteroviruses. (Cunningham, BMJ rapid responses from January 2015 to 24 February 2019) US public health/vaccine authorities have steadfastly avoided any mention of this possibility, another example of their tendency to look for the good news but not the bad news about vaccines.
Measles vaccine is at the top of my list of truly lifesaving vaccines for American children, followed by diphtheria and polio vaccines. I wish the acellular pertussis vaccine was more effective, but would never go back to the whole cell vaccine, which was dangerous. Hepatitis B vaccine is at the bottom of my list because the risk of the disease for the vast majority of American children is virtually non-existent. Other vaccines have value, but not enough to justify the rigid mandates authorities try to impose. In trying to balance vaccine risks and benefits, I believe a case can be made for waiting until after 4 to 5 months of age to begin vaccinating; furthermore, I question the safety of giving a whole bunch of vaccines all at once, contrary to what we are told by the authorities.
Failing to tell the truth, the whole truth and nothing but the truth about vaccines amounts to “fake news”, whether you’re an “anti-vaxxer” or a public health vaccine advocate.
ALLAN S. CUNNINGHAM 13 March 2019
Competing interests: No competing interests
Mr Stevens recognises that……….
“ the government had a responsibility to explain to parents that vaccines not only benefit their own children but other children as well through herd immunity.”
The Government have many responsibilities when it comes to vaccines which extend way beyond merely explaining to individuals, the benefits to their children, and the wider community.
They also have a responsibility to explain to parents alongside the benefits of vaccination, the potential risks and adverse reactions.
Mr Stevens recognises the benefits to the wider community when individuals have vaccines. The overall contribution to herd immunity was recognised in May 1978 when the Central Health Services Council and the JCVI, considered the report of the Royal Commission on Civil Liability and Compensation for Personal Injury noted that the proposals allowed for a tax free lump sum to be paid to “any child or adult who since 4th July 1948 had been severely damaged by vaccination recommended for the benefit of the community”. A responsibility to those, who in having vaccines, (thereby benefiting society as a whole), but who suffered lasting injuries because of it, was established, or so it seemed.
Some forty years on, we are reminded by Mr Stevens of the benefits not just to the individual, but also the community in having vaccinations, a meaningful contribution which today, with regard to the pitifully small number of payments provided to those who suffer vaccine damage, appears to have been conveniently forgotten. The obvious intention back in 1978 to provide financial assistance to those who had made a contribution to herd immunity in having vaccines but had unfortunately suffered a lasting disability appears to have been lost along the way. Since the beginning of 2017 the Vaccine Damage Payments Unit have made a mere four awards, three of which were in respect of Pandemrix vaccine and the subject of court intervention.
This does not mean that only four individuals have been damaged by vaccines during this period, but that only four individuals have been accepted as vaccine damaged and granted an award. Many more will have been refused outright and some will have been acknowledged as vaccine damaged but refused on the basis that they have failed to meet the 60% threshold of disability required to qualify.
Since the scheme began, a total of 125 individuals have been in this position, ie acknowledged as vaccine damaged but refused a payment on the basis that they do not meet the 60% threshold of disability required. (1)
We in the UK have a system which, at one and the same time, acknowledges vaccine induced injury but simultaneously dismisses claims on an argument that the applicants are not disabled enough. All vaccine damaged applicants have contributed equally to the “benefit of the community” and share causality ie vaccines, irrespective of the level of disablement suffered.
Available information does not reflect how incredibly difficult it is to obtain a payment from the VDPU and the fact that the 60% threshold (calculated by VDPU appointed assessors) in all but a handful of cases is nigh on impossible to meet. The revered Green Book chapter on the VDPU, has shrunk from three pages in June 2014 to five lines on one page in an updated 20th December 2018 version.(2) Most parents are unaware of how severe the level of disablement needs to be in order to get help from the VDPU. Individuals can have disabilities which will significantly impact on their lives leaving them seriously disadvantaged when compared to their peer group and struggling to cope with everyday activities.
The parents upon whom Mr Stevens bestows an entitlement to information about the benefits of vaccination from the Government, will be the very same parents who when their children suffer a vaccine induced injury, more likely than not, will be advised that they are not damaged enough so as to be provided with an award by the VDPU, and left to shoulder the entire burden themselves.
When it comes to vaccines and responsibilities, a good starting place might be to revisit the provisions in the Vaccine Damage Payments Act of 1979 (as requested over and over of the government but consistently denied) to provide a reassurance to parents that all established claims of vaccine induced disability, irrespective of severity, will be provided with an award. A reputation for failing to assist all those who suffer vaccine damage, while contributing to the greater good, is not going to encourage parents to think favourably about vaccines.
(1) Remedies for Damage Caused by Vaccines: A Comparative Study of Four European Legal Systems*
Eleonora RAJNERI, Jean-Sébastien BORGHETTI, Duncan FAIRGRIEVE & Peter ROTT**
European Review of Private Law 1-2018 [57–96] © 2018 Kluwer Law International BV, The Netherlands.
https://www.kluwerlawonline.com/abstract.php?area=Journals&id=ERPL2018004
(2) https://www.gov.uk/government/publications/vaccine-damage-payment-scheme...
Competing interests: I have a relative who is one of the 125 quoted in the article
Simon Stevens, the head of NHS England, said he was concerned by stalling vaccination uptake and the dangers that 'fake messages' posed to children.
I would like to know how he has determined the messages are fake.
I am the mother of a son who is severely brain-damaged by vaccines given when he was thirteen months old and this has been accepted by the Government's vaccine damage tribunal service.
It was because of my son’s experience and meeting other parents in hospitals who complained that their children's lives had changed following MMR vaccinations that I founded the support group JABS (Justice, Awareness & Basic Support). Many parents have shared their children's vaccine experiences online to try to help others to make safer choices.
Many of the parents in our group say their children, who were previously healthy, have reacted with symptoms known to the manufacturers in the recognised incubation periods and have developed long-term problems also reported in the vaccine-makers' patient information sheets, regardless of the age when given.
Since JABS was set up in 1994 we have had meetings with ministers at the Departments of Health and Work & Pensions in the interests of obtaining justice and recognition for the damaged children. Equally important, we hoped to improve the safety of the vaccination programme to safeguard children in the future.
We have called for clinical investigation of the children; for all suspected serious reactions to be reported and routinely followed-up; for the ever expanding vaccination schedule to be safety tested in its entirety; for parents to be allowed to make an informed consent; and for a proper compensation programme to help families whose children have paid the price for the community.
We have been criticised for:
having the audacity to point out the failures in the national vaccination programme; why should it have to be one-size-fits-all?
questioning the lack of pre-licence vaccine trials against true inert placebos
questioning why government ignores established and new scientific evidence illustrating the potential side effects of vaccine ingredients and manufacturing methods
And for our efforts we get labelled as ‘anti-vaxxers'.
Robert F Kennedy, Jnr recently stated: "It's quite stunning to watch liberals applauding censorship, particularly the muzzling of the bullied mothers of injured children in order to protect pharmaceutical products from criticism."
I believe parents should have every right to share information on a subject which affects every family in the UK. I was under the impression we lived in a democracy and had the right to freedom of expression and engagement to challenge those who make the decisions with regard to childhood vaccine policy when that policy is so deeply flawed and dangerous for many children.
Trust as well as truth is at the heart of all aspects of the democratic process. For democracy to work people need to trust those in positions of power and that they are acting in the best interests of our children’s health and not beholden to public/private partnerships or other corporate interests.
Forcing public health policies that trample on personal human rights, for the claimed greater good, also threatens the liberties of the individual which are the very foundation of a civilised democratic society. All medical interventions, which include vaccines, require free and informed consent by those directly affected.
In this feature Peter Doshi, associate editor, The BMJ discussed the “delicate balance”:
https://www.bmj.com/content/356/bmj.j661.full
“Good journalism on this topic will require abandoning current practices of avoiding interviewing, understanding, and presenting critical voices out of fear that expressing any criticism amounts to presenting a “false balance” that will result in health scares.
It does matter if the vast majority of doctors or scientists agree on something. But medical journalists should be among the first to realize that while evidence matters, so too do the legitimate concerns of patients. And if patients have concerns, doubts, or suspicions—for example, about the safety of vaccines, this does not mean they are “anti-vaccine.” Anti-vaccine positions certainly exist in the world, but approaches that label anybody and everybody who raises questions about the right headedness of current vaccine policies—myself included (9) —as “anti-vaccine” fail on several accounts.
Firstly, they fail to accurately characterize the nature of the concern. Many parents of children with developmental disorders who question the role of vaccines had their children vaccinated. Anti-vaccination is an ideology, and people who have their children vaccinated seem unlikely candidates for the title.
Secondly, they lump all vaccines together as if the decision about risks and benefits is the same irrespective of disease—polio, pertussis, smallpox, mumps, diphtheria, hepatitis B, influenza, varicella, HPV, Japanese encephalitis—or vaccine type—live attenuated, inactivated whole cell, split virus, high dose, low dose, adjuvanted, monovalent, polyvalent, etc. This seems about as intelligent as categorizing people into “pro-drug” and “anti-drug” camps depending on whether they have ever voiced concern over the potential side effects of any drug.
Thirdly, labeling people concerned about the safety of vaccines as “anti-vaccine” risks entrenching positions. The label (or its derogatory derivative “anti-vaxxer”) is a form of attack. It stigmatizes the mere act of even asking an open question about what is known and unknown about the safety of vaccines.
Fourthly, the label too quickly assumes that there are “two sides” to every question, and that the “two sides” are polar opposites. This “you’re either with us or against us” thinking is unfit for medicine. Many parents who deliberate on decisions regarding their children’s health ultimately make decisions—such as to vaccinate or not vaccinate—with lingering
uncertainty about whether they were right. When given a choice, some say yes to some vaccines and no to others. These parents are not zealots, they are decision makers navigating the gray, acting under conditions of uncertainty in perpetual flux.
And among those uncertainties are the known and unknown side effects that each vaccine carries. Contrary to the suggestion—generally implicit—that vaccines are risk free (and therefore why would anyone ever resist official recommendations), the reality is that officially sanctioned written medical information on vaccines is—just like drugs—filled with information about common, uncommon, and unconfirmed but possible harms.(10 11) Although MMR and autism have dominated journalistic coverage of this issue, and journalists have correctly characterized the scientific consensus that rejects any such link, most journalists have insufficiently acknowledged the fact that bodies such as the Institute of Medicine have “found convincing evidence of 14 health outcomes—including seizures, inflammation of the brain, and fainting—that can be caused by certain vaccines, although these outcomes occur rarely.”(12) And for 135 other adverse events investigated, the committee concluded “the evidence was inadequate to accept or reject a causal relationship” with vaccines.
Medical journalists have an obligation to the truth. But journalists must also ensure that patients come first, which means a fresh approach to covering vaccines. It’s time to listen—seriously and respectfully—to patients’ concerns, not demonize them.”
Feature: Medicine and the Media
Medical response to Trump requires truth seeking and respect for patients
Competing interests: Mother of vaccine-damaged son
One potential solution to the problem of parents being influenced by fake vaccine news or instructions not to vaccinate their children, would be to ensure that, current information, in the form of a Patient Information Leaflet (PIL), is given to individuals for consideration before consent is sought and the vaccine is administered. In this way, vaccine specific information, provided by the manufacturer, and authorised under Directive 2011/83/EC, requiring all medicinal products authorised in the EU to have a PIL, would be conveyed to the public, satisfying the need for information and ensuring the circulation of factually accurate information.
The public, understandably, seek out vaccine information and it seems only logical, in view of the problems ascribed to fake news etc, that every opportunity to provide accurate vaccine information via the PIL, be pursued.
As far back as 2005 a report by the Committee On Safety of Medicines Working Group On Patient Information, acknowledged patient expectations and the merits of disclosing appropriate information.………….
“We live in a society rich in information sources. Patients increasingly expect to be able to access information to enable them to make informed decisions about their health. Good information helps patients participate fully in concordant decision making about the medicines prescribed for, or recommended to, them by health care professionals.”(1)
A July 2012 MHRA publication, “Best Practice Guidance on Patient Information leaflets” concluded from the results of a survey, that patients wanted more information than was currently available to them, and that the PIL was very highly regarded.
“Survey findings tell us that patients want more information than they currently receive and that they value the PIL which comes with the medicine more highly than any other source of information except doctors and pharmacists”
In the same report, it was recognised that a “key government objective” with regard to self care and decision making, was heavily dependant on patients having “high quality information”.
“Self-care a key government objective relies heavily on patients having sufficient high quality information on which to base their decision-making.” (2)
A more recent 2014 publication “Study on the Package Leaflets and the Summaries of Product Characteristics of Medicinal Products for Human use” again recognised the importance of the PIL not merely as the “only mandatory piece of information about a medicine for patients” but also as “an important source of information”
“The PIL is an important source of information for patients as it is the only mandatory piece of information about a medicine for patients. Delivery to the patient is assumed to be guaranteed, because of its presence inside the medicine pack.” (3)
Several things seem glaringly obvious. Members of the public need, and are legally entitled to, quality information and when it is not forthcoming, will pursue it for themselves where ever they can.
Ensuring that the PIL is routinely and consistently shared with patients is key in meeting the need for information and may reduce the dependency on other sources, thereby reducing the risks from vaccine misinformation and fake news etc.
One must question why, with vaccine misinformation featuring high on the list of reasons for vaccine hesitancy and refusal, healthcare professionals are not being routinely advised via Patient Group Directions (PGD) to give the PIL to patients before seeking consent and administering a vaccine.
Delivery of the PIL to the patient before any treatment commences is not guaranteed, despite the fact that it is present inside every medicine pack and the manufacturer’s instruction to read the entire document before treatment commences, is very clear.
A number of 2019 PGD’s merely contain the instruction to “offer” the PIL to patients and doesn’t state that it should be given, not merely offered, before treatment commences.(4)(5)(6)
There appears to be an unmistakable reluctance to ensure that the PIL is routinely provided to the public at the appropriate time, and one is left wondering why that is, particularly in light of the problems with vaccine misinformation.
(1) https://assets.publishing.service.gov.uk/government/uploads/system/uploa...
23 Mar 2005
REPORT OF THE COMMITTEE ON SAFETY OF MEDICINES WORKING GROUP ON PATIENT INFORMATION
(2) Best Practice Guidance On Patient Information Leaflets MHRA 2012
(3) https://ec.europa.eu/health/sites/health/files/files/committee/75meeting...
(4)
https://www.england.nhs.uk/mids-east/wp-content/uploads/sites/7/2018/06/...
(5)
https://www.england.nhs.uk/mids-east/wp-content/uploads/sites/7/2019/02/...
(6)
https://www.england.nhs.uk/south/info-professional/pgd/south-west/downlo...
Competing interests: No competing interests
Another ‘anti -vax “fake news” ‘ headline for a news item on the BMJ, heralding outspoken comments from the chief executive of NHS England, in turn helping post-Freudians to smile at another example of persons protesting about the faults of others, while doing no better themselves.
Stevens’ initial suggestion that “telling parents not to vaccinate their children was as bad as telling them not to watch when they crossed the road“ is unusual enough to prepare us for some other reported remarks from Stevens.
Do his medical advisors not keep abreast of the vaccine literature, or at least of the links and references provided recently in the one sided exchanges on this website, where no one has come forward to defend the increasing vaccine load on very young children, the misunderstood nature of herd immunity, nor the dysfunctional state of our vaccination consent system - epitomised by the Public Health England Green Book on Immunisation, which cites advice about consent and professional liability that is four years out of date? (1,2)
Working abroad, I was sometimes gently reminded that if a point of view is to be respected and acted upon, it must enjoy at least three supports, as a stool has three legs, or as a cooking pot rests on three stones.
Hence Stevens, and everyone below him on the NHS ladder, needs to be reminded that a stable, respected, vaccination policy must, at the vey least, rest on:
1 Attention to, and respect for, the law of the UK, regarding valid informed consent. Made plain in the Montgomery judgement in 2015, and in subsequent guidance from the defence bodies.
2 Awareness of the inadequacy of safety testing of vaccine constituents, of the serious if rare side effects identified in the Patient Information leaflets, and of the very different immune responses to natural and vaccine induced immunity.(3,4,5)
3 Respect for patients’ and parents’ opinions and uncertainties, which follow on from the above. Hesitancy is not a weakness, it is as likely a sign of discernment, needing more informed discussion.
Certainly not the type of irritated reaction, embodying a ‘Doctor Knows Best‘ approach, all too common in the past.
1 https://www.bmj.com/content/364/bmj.l739/rapid-responses
2 https://www.bmj.com/content/364/bmj.l739/rapid-responses
3 Mary Holland J.D et al., The HPV Vaccine on Trial. Skyhorse Publishing, 2018. Chapter 22. HPV Vaccines, Autoimmunity and Molecular Mimicry.
4 Shoenfeld, Y., et al., eds., Vaccines and Autoimmunity, WILEY Blackwell, 2015
5 Richard Moskowitz, MD., Vaccines, a reappraisal. Skyhorse Publishing, 2017.
Competing interests: No competing interests
In view of recent correspondence in these columns regarding informed consent [1] I wonder what steps Simon Stevens [2] proposes to take to ensure that the terms of the Montgomery ruling are complied with [3]. Should not patients for example be informed of the uncertainties regarding HPV vaccines which have been highlighted in BMJ journals [4,5,6]?
I am not sure that anyone has the right to claim a monopoly on the truth, or that citizens are necessarily to blame for trying to inform themselves.
[1] Responses to Owen Dyer, 'Philippines measles outbreak is deadliest yet as vaccine scepticism spurs disease comeback', https://www.bmj.com/content/364/bmj.l739/rapid-responses
[2] Abi Rimmer, 'NHS chief attacks anti-vax “fake news” for falling uptake', BMJ 2019; 364 doi: https://doi.org/10.1136/bmj.l1000 (Published 04 March 2019)
[3] MDU, 'Montgomery and Informed Consent', https://www.themdu.com/guidance-and-advice/guides/montgomery-and-informe...
[4] Jørgensen L, Gøtzsche PC, Jefferson T.'The Cochrane HPV vaccine review was incomplete and ignored important evidence of bias', BMJ Evid Based Med. 2018 Oct;23(5):165-168. doi: 10.1136/bmjebm-2018-111012. Epub 2018 Jul 27
[5] Nigel Hawkes, 'Cochrane director’s expulsion results in four board members resigning', BMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k3945 (Published 17 September 2018)
[6] Lars Jørgensen, Peter Doshi, Peter Gøtzsche, Tom Jefferson, 'Challenges of independent assessment of potential harms of HPV vaccines', BMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k3694 (Published 24 September 2018)
Competing interests: No competing interests
Re: NHS chief attacks anti-vax “fake news” for falling uptake
The Boots standard operating procedure (SOP) for administering an influenza vaccine, as accounted under Freedom of Information [1,2], poses some interesting questions. While no one should be bullied by health administrators, politicians or journalists over medical decisions there is a legal question over the advice dispensed by medical doctors in public and the media regarding vaccination.
This is the present UK vaccine schedule to 12 months [3].
DTaP, Polio, HiB, HepB+Rotavirus+13 Strain Pneumococcal+MenB (8 weeks)
DTaP, Polio, HiB, HepB+Rotavirus (12 weeks)
DTaP, Polio, HiB,HepB+13 Strain Preumococcal+MenB (16 weeks)
13 Strain Pneumococcal+MMR+HiB, MenC (12 Months)
Listing all contraindications and side-effects of these products would lie well beyond the scope of a Rapid Response. This is from the Patient Information Leaflet for a current version of MMR (Merck VAXPRO) on its own [4]:-
Do not use M-M-RVAXPRO:
- If you or your child are allergic to any of the components of this vaccine (including neomycin or
any of the other ingredients listed in section 6)
- If you or your child are pregnant (in addition, pregnancy should be avoided for 1 month after
vaccination, see Pregnancy)
- If you or your child have any illness with fever higher than 38.5°C; however, low-grade fever
itself is not a reason to delay vaccination
- If you or your child have active untreated tuberculosis
- If you or your child have a blood disorder or any type of cancer that affects the immune system
- If you or your child are receiving treatment or taking medicines that may weaken the immune
system (except low-dose corticosteroid therapy for asthma or replacement therapy)
- If you or your child have a weakened immune system because of a disease (including AIDS)
- If you or your child have a family history of congenital or hereditary immunodeficiency, unless
the immune competence of your or your child is demonstrated.
Warnings and precautions
Talk to the doctor or pharmacist before you or your child receive M-M-RVAXPRO if you have
experienced any of the following:
- If you or your child have an allergic reaction to eggs or anything that contained egg
- If you or your child have a history or family history of allergies or of convulsions (fits)
- If you or your child have a side effect after vaccination with measles, mumps, or rubella vaccine
(in a single component vaccine or a combined vaccine, such as the measles, mumps, and rubella
vaccine manufactured by Merck & Co., Inc., or M-M-RVAXPRO) that involved easy bruising
or bleeding for longer than usual
- If you or your child have infection with Human Immunodeficiency Virus (HIV) but do not show
symptoms of HIV disease. You or your child should be monitored closely for measles, mumps,
and rubella because vaccination may be less effective than for uninfected persons (see section
Do not use M-M-RVAXPRO). ...
4. Possible side effects
Like all vaccines and medicines, this vaccine can cause side effects, although not everybody gets them.
The following side effects were reported with the use of M-M-RVAXPRO:
Frequency Side effect
Very common (may
affect more than 1 in
10 vaccinees)
Fever (38.5°C or higher).
Injection-site redness; injection-site pain; injection-site swelling.
Common (may affect
1 to 10 in 100
vaccinees)
Rash (including measles-like rash).
Injection-site bruising.
Uncommon (may
affect 1 to 10 in 1,000
vaccinees)
Nasal congestion and sore throat; upper respiratory tract infection
or viral infection; runny nose.
Diarrhoea, vomiting.
Hives.
Injection-site rash.
Not known
(Frequency cannot be
estimated from the
available data)*
Aseptic meningitis (fever, feeling sick, vomiting, headache, stiff
neck, and sensitivity to light); swollen testicles; infection of the
middle ear; inflamed salivary glands; atypical measles (described
in patients who received a killed measles virus vaccine, usually
given before 1975).
Swollen lymph nodes.
Bruising or bleeding more easily than normal.
Severe allergic reaction that may include difficulty in breathing,
facial swelling, localised swelling, and swelling of the limbs.
Irritability.
Seizures (fits) without fever; seizures (fits) with fever in children;
walking unsteadily; dizziness; illnesses involving inflammation of
the nervous system (brain and/or spinal cord).
An illness consisting of muscle weakness, abnormal sensations,
tingling in the arms, legs, and upper body (Guillain-Barré
syndrome).
Headache; fainting; nerve disorders which can cause weakness,
tingling, or numbness; eye nerve disturbances.
Discharge and itching of the eyes with crusting of eyelids
(conjunctivitis).
Inflammation of the retina (in the eye) with changes in sight.
Deafness.
Cough; lung infection with or without fever.
Feeling sick (nausea).
Itching; inflammation of the fatty tissue under the skin; red or
purple, flat, pinhead spots under the skin; hardened, raised area of
the skin; serious illness with ulcers or blistering of the skin, mouth,
eyes, and/or genitals (Stevens-Johnson syndrome).
Joint pain and/or swelling (usually transient and rarely chronic);
muscle pain.
Burning and/or stinging of short duration at the injection site;
blisters and/or hives at the injection site.
Generally feeling unwell (malaise); swelling; soreness.
Inflammation of blood vessels.
*These side effects were reported with the use of M-M-RVAXPRO or with the measles, mumps, and
rubella vaccine manufactured by Merck & Co., Inc., or with its monovalent (single) components,
during post-marketing use and/or during clinical studies.
[1] Wendy E Stephen, 'Re: NHS chief attacks anti-vax “fake news” for falling uptake', 25 March 2019, https://www.bmj.com/content/364/bmj.l1000/rr-6
[2] https://www.whatdotheyknow.com/request/553820/response/1331272/attach/ht...
[3] https://www.nhs.uk/conditions/vaccinations/childhood-vaccines-timeline/
[4] https://www.medicines.org.uk/emc/files/pil.6307.pdf
Competing interests: No competing interests