This is an update of my article ‘UK Department of Health Deliberately Exposes Vulnerable Population to Flu Infection’ of May last year as the British government rolls out the program to entire school population this autumn (a product called Fluenz identical with Flumist used in the US). Recent draft minutes of the government advisory committee, the Joint Committee on Vaccination and Immunisation, show it to be in a double-bind over asthma cases and uncertain about egg allergy: “extrapolating findings on injectable vaccines to Fluenz® was problematic as nasal administration may be a more reactogenic route than intramuscular injection". (See HERE.) They will still be testing this with program in full gear.
The other problem they have is that the vaccine is “contraindicated for severe asthma” so they have to devise formal guidelines for which asthma sufferers should have the vaccine and which should not, but it begs the problem that the more severely affected asthma sufferers will be exposed to the viruses (which they might well not otherwise have come into contact with) by their schoolmates shedding them, turning on the head the proposition that they are protecting the vulnerable by vaccinating the fit. While the ethical problem is not stated it surely hovers silently above their deliberations and calls into question the very principles of the program (other than making lots of money for someone). The relevant portions of the text of the JCVI minutes follow that of my article as originally published.
UK Department of Health Deliberately Exposes Vulnerable Population to Flu Infection
By John Stone, first published on 10 May, 2013
Is the vaccine program there to prevent harm or to foist commercial products on a captive market at the public expense? The parrot cry of health officials trying to bully citizens into vaccinating is that they are putting other people at risk, but it is very easy to call their bluff when they pursue a contradictory policy over nasal flu vaccine and children, a vaccine which sheds and will put in harm's way immune-compromised people and younger siblings. From September this year in the United Kingdom children above the age of two are to be offered a nasal influenza vaccine ‘Fluenz’ which is the same as the ‘Flumist’ many American children already get, and this is to be rolled out for all schoolchildren next year. Here is the text of my recent letter to the British Medical Journal, so far unpublished:
It is deeply disturbing that this senseless project ploughs forward regardless. While government seems to have seized the agenda over influenza vaccination by unwarranted claims of (influenza) mortality [1,2] there are definable risks to the use of nasal influenza vaccine. Manufacturer's product information states among other things :
"FLUENZ should not be administered to children and adolescents with severe asthma or active wheezing because these individuals have not been adequately studied in clinical studies.
"Do not administer FLUENZ to infants and toddlers younger than 12 months. In a clinical study, an increase in hospitalisations was observed in infants and toddlers younger than 12 months after vaccination (see section 4.8).
"Vaccine recipients should be informed that FLUENZ is an attenuated live virus vaccine and has the potential for transmission to immunocompromised contacts. Vaccine recipients should attempt to avoid, whenever possible, close association with severely immunocompromised individuals (e.g. bone marrow transplant recipients requiring isolation) for 1-2 weeks following vaccination. Peak incidence of vaccine virus recovery occurred 2-3 days post-vaccination in clinical studies. In circumstances where contact with severely immunocompromised individuals is unavoidable, the potential risk of transmission of the influenza vaccine virus should be weighed against the risk of acquiring and transmitting wild-type influenza virus."
 John Stone, 'Re: Author's response' 26 December 2009, http://www.bmj.com/rapid-response/2011/11/02/re-authors-response-2
 John Stone, 'Discrepancies in published data' 2 February 2010, http://www.bmj.com/content/340/bmj.c613
 Annex I, Summary of product characteristic (Fluenz) http://ec.europa.eu/health/documents/community-register/2011/2011012793189/anx_93189_en.pdf
 Jefferson T, Di Pietrantonj C, Rivetti A, Bawazeer GA, Al-Ansary LA, Ferroni E.,
'Vaccines for preventing influenza in healthy adults' http://www.ncbi.nlm.nih.gov/pubmed/20614424
Check lists and consent forms published the United States government and associated bodies present a remarkable list of issues which ought to be addressed before the decision to administer this vaccine is given. The very project of mass administration - say 10 million young people in a population of just over 60 million – poses the question of good sense. Here is an example from Immunize Action Coalition (which is funded by the Centers for Disease Control)):
1. Is the person to be vaccinated sick today?
2. Does the person to be vaccinated have an allergy to eggs or to a component of the influenza vaccine?
3. Has the person to be vaccinated ever had a serious reaction to intranasal influenza vaccine (FluMist) in the past?
4. Does the person to be vaccinated have a long-term health problem with heartdisease, lung disease, asthma, kidney disease, neurologic or neuromuscular disease, liver disease, metabolic disease (e.g., diabetes), or anemia or another blood disorder?
5. If the person to be vaccinated is a child age 2 through 4 years, in the past 12 months, has a healthcare provider ever told you that he or she had wheezing or asthma?
6. Does the person to be vaccinated have cancer, leukemia, HIV/AIDS, or any otherimmune system problem; or, in the past 3 months, have they taken medications that weaken the immune system, such as cortisone, prednisone, other steroids, or anticancer drugs; or have they had radiation treatments?
7. Is the person to be vaccinated receiving antiviral medications?
8. Is the child or teen to be vaccinated receiving aspirin therapy or aspirin-containing therapy?
9. Is the person to be vaccinated pregnant or could she become pregnant within the next month?
10. Has the person to be vaccinated ever had Guillain-Barré syndrome?
11. Does the person to be vaccinated live with or expect to have close contact with a person whose immune system is severely compromised and who must be in protective isolation (e.g., an isolation room of a bone marrow transplant unit)?
12. Has the person to be vaccinated received any other vaccinations in the past 4 weeks?
However, with ten million children and young people out there how much care will be taken over this? How will people even know about the medical vulnerability of all the people these children will come into contact with (what about chance encounters)? How will children of compromised health be protected in schools from the recently vaccinated?
Would it not actually be infinitely wiser not do it at all?
From the Draft Minutes of the UK Joint Committee on Vaccination and Immunisation (JCVI) June 4, 2014
38. A presentation on the results of the SNIFFLE study on the safety of Live Attenuated Intranasal Vaccines (LAIV) in individuals with egg allergy was provided for the Committee by Dr Mich Erlewyn‐Lajeunesse. The Committee noted that:
• an ovalbumin content of less than 0.12 micrograms per ml for injectable flu vaccines was considered low and safe for egg allergic individuals;
• Fluenz® was licensed with an ovalbumin content of 0.12 micrograms per ml but that data provided by AstraZeneca from batch testing ovalbumin content showed wide variation, although the majority of batches were below the 0.12 micrograms low ovalbumin cut off;
• batches used in the Sniffle study had undetectable levels of ovalbumin;
• data on safety of low ovalbumin content flu vaccines came from studies on injectable vaccine and only one study had looked at the safety above the 0.12 low ovalbumin cut off;
• extrapolating findings on injectable vaccines to Fluenz® was problematic as nasal administration may be a more reactogenic route than intramuscular injection; and
• a second study was planned for the 2014/15 flu season which would involve the use of Fluenz® with detectable ovalbumin content, if available.
39. The chair requested that AstraZeneca be contacted as to whether they could consistently produce low ovalbumin content batches which could be selected for the UK programme and would better reflect the data being accumulated by the SNIFFLE studies Action: Secretariat to contact AstraZeneca on the consistency of ovalbumin content in Fluenz®. Advice
40. The Committee concluded that until the results of the second SNIFFLE study were available, no firm conclusion could be made on the safety of Fluenz® use in egg allergic individuals and current advice in the Green Book on the use of Fluenz in egg allergic individuals should remain. However, the data presented were encouraging in the context of low ovalbumin content vaccines as used in the first SNIFFLE study. Definition – Asthma as a contraindication for Fluenz
41. The Chair noted that immunisation teams delivering vaccinations in a school environment had found it challenging to interpret Green Book guidance about severe asthma being a contraindication to use of LAIV. Current guidance was that those children on British Thoracic Society (BTS) step 4 or above should not receive LAIV, but it had proven difficult to obtain information to make an informed decision on whether the child was BTS Step 4 or above in a school setting. 42. The Committee noted:
• the SPC for Fluenz states it is contraindicated for severe asthma without giving a definition and that BTS Step 4 was chosen as the definition to use in the Green Book;
• advice from an expert in respiratory paediatrics, indicated a cut off of 800mcg for the inhaled steroid budesonide or equivalent could be used as a guideline to distinguish between mild to moderate asthma and severe asthma
• 800mcg or more of budesonide (or equivalent) was the official definition of severe asthma;
• maintenance oral steroids would likely be too high a level of severity;
• expert advice that a clinical definition such as ‘recent admission’ or ‘under the care of a respiratory physician’ without reference to dosage criteria would indicate a sign of acute exacerbation rather than asthma severity.
43. The Committee supported the reasoning that as many asthmatic children as possible, children who are at a higher risk than healthy children from the consequences of influenza infection, should receive Fluenz which offers greater protection than the injectable vaccines in children. The Committee agreed that the definition should be:
“The live attenuated influenza vaccine (Fluenz Tetra®) is not recommended for children with: − a history of active wheezing at the time of vaccination (until at least 7 days after wheezing has stopped) or − who are currently taking or have been prescribed oral steroids in the last 14 days for an exacerbation of asthma or − who are currently taking a high dose inhaled steroid - Budesonide > 800 mcg/day or equivalent* (e.g. Fluticasone > 500 mcg/day) because of limited safety data in these groups. * In children aged 5-12 years, the definition of severe asthma corresponds to the British Thoracic Society BTS Sign Step 5.
John Stone is UK Editor for Age of Autism.