Influenza and Men C VaccinesSeptember 2013

Richard Smithson

Sinead McGuinness

Mary Loughrey

Maureen McCartney

Outline of TalkExtension of Flu vaccine to 2 – 16 year olds

Changes to Men C vaccine programme.

Key message - Extension of the seasonal flu programme to children (2 to 16 years of age inclusive)

•In 2012 the Joint Committee on Vaccination and Immunisation (JCVI) recommended that the seasonal influenza (flu) programme should be extended to all children aged 2 to 16 years of age inclusive, the phased introduction of this will begin in 2013.

•From 1st October 2013 the seasonal flu vaccination programme will be extended to all two and three year old children in Primary Care and to P6 children in school by school health service.

•The purpose of this extension to the flu vaccination programme is to reduce the impact of seasonal flu on children and reduce transmission of flu within the community.

•Registered healthcare practitioners have a key role in promoting increased uptake of flu vaccination in children through increasing awareness.

Contents

• What is flu?

• Why extend the seasonal flu immunisation programme to all children (2 to16 years of age inclusive)?

• Vaccination of children against flu.

• Resources.

• References.

What is flu?• Flu is a highly infectious viral illness.There are 3 types of influenza (flu) viruses:

A • Causes epidemics and pandemics; animal reservoir – wildfowl, also

carried by other mammals.

B• May cause epidemics;

• Predominantly found in humans.

C • Minor respiratory illness only.

Flu A virus

Two surface antigens:

Haemagglutinin (H)

Neuraminidase (N)

Different types of each:

The blue protuberances represent haemagglutinin and the red spikes neuraminidase.

Genetic material (RNA) in the centre

Flu virus

Genetic change – what this means

Antigenic drift:

• Small constant mutations of H and N

• Occurs in all types of influenza (flu) viruses

Flu virus- Antigenic shift

• Only occurs in Influenza A strains;

• A major change in one or both surface antigens, characteristic of Influenza type A viruses;

• It is due to genetic recombination when virus particles of more than one strain infect a cell simultaneously;

• It can result in a worldwide pandemic.

Features of flu• Transmitted by large droplets, small-particle aerosols and by hand to

mouth/eye contamination from an infected surface;

• Incubation period 1-5 days (average 2-3 days) though may be longer especially in hosts with immune deficiency;

• Acute viral infection of respiratory tract.

Common symptoms include:

• Sudden onset of fever, chills, headache, myalgia & severe fatigue

• Dry cough, sore throat and stuffy nose;

• In young children gastrointestinal symptoms such as vomiting and diarrhoea may be seen.

Possible Complications of flu

Common:• Bronchitis;

• Otitis media (children), sinusitis;

• Secondary bacterial pneumonia.

Less common:• Meningitis, encephalitis;

• Primary influenza pneumonia;

• Most serious illness in neonates, pregnant women, older people and those with underlying disease.

Current Flu Vaccination Programme in Northern Ireland

• In Northern Ireland, there is an annual vaccination programme which aims to reduce the impact (morbidity and mortality) of flu particularly in high-risk groups e.g. those over 65 years old, in clinical risk groups and in pregnant women.

Proposed extension to flu vaccination programme in Northern Ireland

• A live flu vaccine rather than the current injectable inactivated flu vaccine has been in use for many years in children in the USA;

• JCVI has recommended that our programme be extended to include annual vaccination of all children aged 2 to 16 years of age inclusive, primarily using Fluenz® (A live flu vaccine);

• Partial implementation will take place in 2013 and it is anticipated that in 2014/5 the programme will roll out to all pre-school and primary school children;

• The aim is that in autumn 2015 it will be rolled out to all children aged 2 to 16 years inclusive.

Details for 2013 - In schoolsAll P6 children will be offered the vaccine in school;

Includes “at risk” children as well as healthy children;

Fluenz will be offered to most children – those for whom contraindicated but who can receive injected vaccine will be offered injected vaccine in school;

School health teams will visit each school once only – no mop-up of those absent on day of visit;

Parents will be advised to contact GP if require vaccine – particularly important for “at risk” children;

Normal fee payable for all such children vaccinated by GP (Both “healthy” and “at risk”)

Details for 2013 - General Practice

All children aged 2 & 3 years on 1 September 2013 should be invited for flu vaccination. (DOB range: on and after 2 September 2009 and on or before 1 September 2011)

Children of all ages in risk groups – invited as normal – except those in P6 who will be offered vaccine in school DOB: 02/07/03 – 01/07/04

Children in P6 who miss vaccination in school, to be offered it if parents contact surgery requesting it.

Extension of seasonal flu vaccination programme to children (2 to16 years of age inclusive)Why vaccinate children?

Extension of the seasonal flu vaccination programme to all children aims to appreciably lower the public health impact of flu by:

•providing direct protection to children thus averting a large number of cases of influenza disease;

•lowering influenza transmission from: – Child to child;– Child to adult;– Child to those in the clinical risk groups of any age

The expected effect of the vaccination of children will then be a reduction in both the morbidity and mortality associated with flu.

Extension of seasonal flu vaccination programme to children (2 to16 years of age inclusive)Cost effectiveness

Studies commissioned by the JCVI 3 suggest that despite the high cost, extending the flu vaccination programme to all children is:

• highly likely to be cost-effective;

•is well below the established cost-effectiveness threshold when indirect protection to the whole population is taken into account, particularly over the longer-term;

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive) - Recent review of burden of influenza in children

• average influenza season: estimated 0.3% to 9.8% of 0-14 year old children present to a GP with influenza; 7

• incidence rates can be markedly higher in the younger age groups;

• influenza associated hospitalisation rates; 8, 9, 10,11,12

- 83-1,038/ 100,000 children 0-59 months old (highest in <6 months)

- 16-210/100,000 children 5-17 years

• children more vulnerable to infection than adults when exposed; 13,14

• children with influenza contribute to the burden of influenza in all age groups because they are more likely to pass on the infection than adults. 15, 14

(Ruf & Knuf, 2013)6

Extension of the seasonal flu programme to children (2 to 16 years of age inclusive) What is the additional evidence to support the offer of

vaccination?• trivalent inactivated vaccine (TIV) shown to be effective in eliciting a

protective antibody response /averting influenza like illness, when a two dose schedule is used for vaccine naïve children; 16,22,24,25

• live attenuated influenza vaccine (LAIV) ~ 50% more effective than TIV in averting laboratory confirmed influenza; 17,18

• meta-anlaysis of six LAIV studies showed median VE of 78% (range: 57-93) in children 6 months to 7 years; 23

• one dose of LAIV provides clinically significant protection against influenza in young influenza vaccine naïve children, with a second dose providing additional protection. Up to 90% of protection are conferred by the first dose; 19,20.

• LAIV is well tolerated in children and adolescents with asthma. 21,26

Extension of seasonal flu vaccinationprogramme to children (2 to 16 years of age inclusive) – types of vaccines

Two main types of vaccine:

• inactivated - by intramuscular injection;• live - by nasal application.

Antibody levels may take 10-14 days to reach protective levels.

Protection lasts for at least one season.

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive)- use of Fluenz®

Fluenz®:

• Generic name: influenza vaccine (live attenuated, nasal);

• Brand name: Fluenz®;

• Marketed by AstraZeneca;

• Licensed from 24 months to less than 18 years of age;

• Nasal Spray (suspension) in a prefilled nasal applicator;

• Supplied as pack containing 10 doses;

• Container dimensions: 117.5 x 115.5 x 36mm;

• Provides greater protection for children than inactivated influenza vaccine.

Live AttenuatedVaccine has been attenuated, or weakened,

so that cannot cause disease.

Also “cold adapted” – can’t replicate at body temperature

Replicates in nose – produces antibodies which then protect against infection

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive)- use of Fluenz®Fluenz® composition:

Active ingredient:A/California/7/2009 (H1N1)pdm09-like virus 107.0±0.5 FFU;A/Texas/50/2012 107.0±0.5 FFU;B/Massachusetts/2/2012-like virus 107.0±0.5 FFU.

Excipients:Sucrose;Dibasic potassium phosphate;Monobasic potassium phosphate;Gelatin (porcine type A);Arginine hydrochloride;Monosodium glutamate monohydrate;Water for injections.

Residues:Egg proteins (e.g. ovalbumin);Gentamicin.

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive) - use of Fluenz®

Fluenz® presentation:

• Prefilled nasal applicator-ready to use, no reconstitution or dilution required;

• Nasal spray (suspension);

• Each applicator contains 0.2ml.

• Colourless to pale yellow, clear to opalescent. Small white particles may be present

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive) – use of Fluenz®

Storage of Fluenz®:

Fluenz® must be stored in accordance with manufacturer’s instructions:• Store between +2°C and +8°C; • Store in original packaging:• Protect from light.

Using FluenzMay be taken out of fridge, for maximum 12 hours not above 25C.If not used should then be disposed ofWhilst may make running school clinics easier need to take care to avoid wastage.

Check expiry dates regularly:• Fluenz® has an expiry date 18 weeks after manufacture – this is much shorter than

inactivated flu vaccines.

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive) – use of Fluenz®

Fluenz® dosage and schedule

• A single dose is 0.2ml (administered as 0.1ml per nostril);

• A single dose for all children not in clinical at risk group.

Children aged less than nine years who are in clinical at risk groups who have not received influenza vaccine before should receive two doses of Fluenz® with the second dose at least four weeks after the first.

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive)Administration of Fluenz®

• Fluenz® is different from other influenza vaccine, it is a live nasal vaccine and must not be injected;

• Fluenz® can be administered at the same time as other vaccines including live vaccines;

• If not given at same time as another live vaccine normally leave 4 week gap – but do not delay Fluenz because of this – more important to give protection before start of flu season;

• Patient should breathe normally - no need to actively inhale or sniff;

• No need to repeat either half of dose if patient sneezes, blows their nose or their nose drips following administration.

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive)Administration of Fluenz®

The vaccine may only be administered:

• Against a prescription written manually or electronically by a registered medical practitioner or other authorised prescriber:

o Against a Patient Specific Direction;

o Against a Patient Group Direction.

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive)Administration of Fluenz®

Video clip showing administration

Click on the following link to access the video clip( to be inserted) showing how to administer Fluenz ® vaccine

Extension of seasonal flu vaccination programme to

children (2 to 16 years of age inclusive)- the use of Fluenz®

Infection control issues:• There are no specific infection control precautions required

when administering Fluenz®;• Routine hand hygiene procedures should be performed before

and after each child contact.

Disposal of clinical waste:• Empty Fluenz® vaccines should be disposed of in accordance

with local procedures for disposal of clinical waste.

Extension of seasonal flu vaccination programme to children ( 2 to 16 years of age inclusive)- use of Fluenz®

Contraindications• Age under 2 years;

• Age 18 years or above – routine programme will be up to and including 16 but “at risk” is up to and including 17;

• Confirmed anaphylactic reaction to a previous dose of influenza vaccine;

• Confirmed anaphylactic reaction to any component of the vaccine;

• including gentamicin and gelatin;

• Allergy to egg – use injected vaccine with low ovalbumin content.

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive) - use of Fluenz®Contraindications (cont’d)• Severe immunosuppression due to conditions or

immunosuppressive therapy: Acute and chronic leukaemias; Lymphoma; HIV positive patient not on highly active antiretroviral therapy; Cellular immune deficiencies; High dose steroids.

• Individuals receiving salicylate therapy ;

• Individuals with severe asthma (BTS/SIGN step 4 or above);

• Active wheezing at the time of vaccination;

• Known to be pregnant.

• Injected vaccine should be actively considered for the above.

• Acute severe febrile illness:o defer until recovered.

• Heavy nasal congestion or severe rhinitis;o defer until resolved or consider inactivated influenza vaccine.

Please note: Minor illnesses without fever or systemic upset are not valid reasons to postpone vaccination.

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive)- Administration of Fluenz®

Precautions

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive)- Administration of Fluenz® Precautions

Precautions Cont’d:

• Use with antiviral agents against flu;

• Fluenz® should not be administered at the same time;

• Fluenz® should not be administered within 48 hours of cessation of treatment with flu antiviral agents;

• Administration of flu antiviral agents within two weeks of administration of Fluenz® may adversely affect the effectiveness of the vaccine.

• Potential for transmission of live attenuated virus to very severely immunocompromised contacts (e.g. bone marrow transplant patients requiring isolation);

• Risk is for one to two weeks following vaccination;

• Where close contact is likely or unavoidable (e.g. household members) consider inactivated flu vaccine.

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive)- Administration of Fluenz®

Risk of transmission

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive)- use of inactivated flu vaccineIn many cases where Fluenz cannot be given, an injected

inactivated vaccine should be considered.

This includes both “at risk” and “healthy” children.

“At risk” examples: immunosuppression, severe asthma, wheezing at time of immunisation, pregnancy or salicylate therapy

“Healthy” example: egg allergy

Very few children cannot have any vaccine.

Presentation:• Inactivated flu vaccines are supplied as prefilled syringes;

• Must be shaken well before they are administered.

Storage:• Store between +2°C and +8°C, in original packaging, protected from

light.

Age restrictions:• Some flu vaccines (inactivated) are restricted to use in particular age

groups. Practitioners must be familiar with and refer to the summary of product characteristics for the particular brand when administering vaccines. All CENTRALLY supplied vaccines in NI, apart from the egg free vaccine, are suitable for all ages from 6 months upwards.

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive)- use of inactivated flu vaccine

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive)- use of inactivated flu vaccineContraindications, precautions and adverse reactions

Contraindications:• Confirmed anaphylactic reaction to a previous dose of influenza vaccine;

• Confirmed anaphylactic reaction to any component of the vaccine;

• Confirmed anaphylactic reaction to egg proteins.

Precautions:• Acute severe febrile illness defer until recovered.

Adverse Reactions:• Pain, swelling, redness at injection site;

• Low grade fever, malaise, shivering, fatigue, headache, muscle pain and joint pain.

Influenza Vaccination for Winter 2013/2014

Children aged two or three

years who are not in a

clinical risk group*

Children and adults in clinical risk groups:

Chronic respiratory disease Chronic heart diseaseChronic liver diseaseChronic kidney diseaseChronic neurological diseaseDiabetesImmunosuppressionAll pregnant women (at any stage of pregnancy)See Table 19.5 for additional

All people aged 65

and over**

Other***Health & social care workersPeople in long-stay residential care homes or other long-stay facilitiesCarersHousehold contacts of immunocompromised patients

Children aged 6 months to less than 18 years

One dose of inactivated influenza vaccine§

Can they receive Fluenz®? †

If never received influenza vaccine before and aged 6

months to less than9 years of age, give second dose at least

4 weeks later

One dose of inactivated

influenza vaccine§

No

Yes

No

One dose of Fluenz® influenza

vaccine

Yes

If never received influenza vaccine before and two years

to less than 9 years of age, give second dose of Fluenz® at

least 4 weeks later

Can they receive

Fluenz®? †

One dose of Fluenz®influenza vaccine

No

Yes

Egg Anaphylaxis Patients with confirmed ANAPHYLAXIS to

egg or egg allergy and uncontrolled asthma (BTS SIGN 4 or above)

Adults – give egg free vaccine – Optaflu – in primary care

Children – Optaflu not licensed for use – refer to paediatric unit for vaccination as day case in controlled conditions.

Egg allergy Other egg allergic patients (adults and children)

– vaccinate as normal with low ovalbumin vaccine

The main centrally purchased vaccines in NI are low ovalbumin

Do NOT use Optaflu for these patients – limited supplies

Supply of Optaflu to practices will be closely monitored and controlled.

Manufacturer Name of

Product

Vaccine Type Route of

administration

Age Suitable for Egg

Allergy Patients

Sanofi Pasteur MSD Inactivated

Influenza

Vaccine

Inactivated Intramuscular

injection

From 6 months Yes

GlaxoSmithKline UK

Ltd

Fluarix® Inactivated Intramuscular

injection

From 6 months Yes

AstraZeneca UK Ltd Fluenz® Live Attenuated

 

Nasal spray From 24

months to less

than 18 yrs of

age

No

Novartis Vaccines Optaflu® Inactivated Intramuscular

injection

From 18 yrs Reserve for egg

anaphylactic

patients

One or Two doses?Healthy children of any age receiving Fluenz require

only 1 dose even if never vaccinated before i.e. new group being added only need 1 dose if getting Fluenz

Healthy children who need injected vaccine, are being vaccinated for the first time and are under 9 years old require 2 doses

“At risk” children, being vaccinated for the first time and under 9 years old require 2 doses, whichever vaccine they receive.

Extension of seasonal flu vaccination programme to children ( 2 to 16 years of age inclusive)- Data Collection

• Very important to closely monitor uptake from start;

• Weekly collection of total number of doses given to 2&3 year olds from each practice;

• Weekly collection of uptake for P6 children in schools;

• Will allow early action to be taken if uptake is significantly different from that predicted;

• End of season vaccination uptake data will be provided in a more detailed analysis.

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive)- Reporting suspected adverse reactions

Yellow card scheme:

• Voluntary reporting system for suspected adverse reaction to medicines/vaccines;

• Success depends on early, complete and accurate reporting;• Report even if uncertain about whether vaccine caused condition

• http://mhra.gov.uk/yellowcard;

• See chapter 8 of Green Book for details.

Key message - Extension of the seasonal flu programme to children (2 to 16 years of age inclusive)

• In 2012 the Joint Committee on Vaccination and Immunisation (JCVI) recommended that the seasonal influenza programme should be extended to all children aged 2 to 16 years of age inclusive, the phased introduction of this will begin in 2013;

• From 1st October 2013 the seasonal flu vaccination programme will be extended to all two and three year old children via primary care, and to P6 children in school via school health service;

• This extension to the flu vaccination programme is designed to reduce the impact of seasonal flu on children and reduce transmission of flu within the community;

• Registered healthcare practitioners have a key role in promoting increased uptake of flu vaccination in children through increasing awareness.

Extension of the seasonal flu programme to children (2 to 16 years of age inclusive)

Resources

• Green Book available at: http://www.dh.gov.uk/greenbook• Patient Group Directions• Leaflets for 2&3 year olds and for P6s• Q&A briefing• Publications will be available at: http://www.publichealth.hscni.net/• CMO letters available at:

http://www.dhsspsni.gov.uk/index/phealth/professional/cmo_communications.htm

Extension of seasonal flu vaccination programme to children (2 to 16 years of age inclusive)References

1. JVCI minutes. 2013. http://media.dh.gov.uk/network/261/files/2012/07/JCVI-minutes-13-June-2012-revised.pdf

[last accessed 11th July 2013].2. CMO letter- to be added when available3.Pitman R.J., Nagy L.D. and Sculpher M.J. (2013) Cost-effectiveness of childhood influenza vaccination

in England and Wales: Results from a dynamic transmission model. Vaccine 31(6):927-42http://www.ncbi.nlm.nih.gov/pubmed/23246550

4. Rhorer et al. (2009) Efficacy of live attenuated influenza vaccine in children: a meta-analysis of nine randomized clinical trials. Vaccine. 27, 1101-1110.

5 Jefferson et al. (2012) Vaccines for preventing influenza in healthy children. Cochrane database of Systematic Reviews. Issue 8, Art. No. CD004879

6. Ruf B.R., Knuf M. (2013) The burden of seasonal and pandemic influenza in infants and children. European Journal of Pediatrics. 2013 May 10. [Epub ahead of print]

References (continued)

7. Paget W.J., Balderston C., Casas I., Donker G., Edelman L., Fleming D., Larrauri A., Meijer A., Puzelli S., Rizzo C., Simonsen L., EPIA collaborators (2010) Assessing the burden of paediatric influenza in Europe: the European Paediatric Influenza Analysis (EPIA) project. European Journal of Pediatrics 169(8):997-1008

8. Izurieta H.S., Thompson W.W., Kramarz P., Shay D.K., Davis R.L., DeStefano F., Black S., Shinefield H., Fukuda K. (2000) Influenza and the rates of hospitalisation for respiratory disease amongst infants and young children. N Engl J Med 342(4):232-239

9. Mullooly J.P., Barker W.H. (1982) Impact of type A influenza on children: a retrospective study. Am J Public Health 72(9): 1008-1016

10. Neuzil K.M., Mellen B.G., Wright P.F., Mitchel E.F. Jr, Griffin M.R. (2000) The effect of influenza on hospitalisations, outpatient visits and courses of antibiotics in children. N Engl J Med 342(4):225-231

11. Poehling K.A., Edwards K.M., Weinberg G.A., Szilagyi P., Staat M.A., Iwane M.K., Bridges C.B., Grijalva C.G., Zhu Y., Bernstein D.I., Herrera G., Erdman D., Hall C.B., Seither R., Griffin M.R., Network NVS (2006) The underrecognised burden of influenza in young children. N Engl J Med 355(1):31-40

12. Weigl J.A., Puppe W., Schmitt H.J. (2002) The incidence of influenza-associated hospitalisations in children in Germany. Epidemiol Infect 129(3):525-533

13. Hayden F.G., Belshe R., Villanueva C, Lanno R., Hughes C., Small I., Dutkowski R., Ward P., Carr J. (2004) Management of influenza in households: a prospective, randomised comparison of oseltamivir treatment with or without postexposure prophylaxis. J Infect Dis 189(3):440-449

14.Viboud C., Boelle P-Y, Cauchemez S., Lavenu A., Valleron A.J., Flahault A., Carrat F. (2004) Risk factors of influenza transmission in households Br J Gen Pract 54(506):684-689

15. Neuzil K.M., Hohlbein C., Zhu Y. (2002) Illness among schoolchildren during influenza season: effect on school absenteism, parental absenteism and secondary illness in families. Arch Pediatr Adolesc Med 156(10):986-991

(References continued)16. Allison MA Daley MF, Crane LA et al. (2006) Influenza vaccine effectiveness in healthy 6 to 21 month-old

children during the 2003--2004 season. J Pediatr 149: 755-62.17. Ashkenazi S, Vertruyen A, Aristegui J et al. (2006) Superior relative efficacy of live attenuated influenza vaccine

compared with inactivated influenza vaccine in young children with recurrent respiratory tract infections. Pediatr Infect Dis J 25(10): 870-9. http://www.ncbi.nlm.nih.gov/sites/entrez/17006279

18. Belshe RB, Edwards KM, Vesikari T et al. (2007) Live attenuated versus inactivated influenza vaccine in infants and young children. N Engl J Med 356(7): 685-96. http://www.ncbi.nlm.nih.gov/sites/entrez/17301299

19. Block S L, Toback SL, Yi T et al. (2009) Efficacy of a single dose of live attenuated influenza vaccine in previously unvaccinated children: a post hoc analysis of three studies of children aged 2 to 6 years. Clin Ther. 31, 2140-7.

20. Bracco Neto H, Farhat CK, Tregnaghi MW, et al. (2009) Efficacy and safety of 1 and 2 doses of live attenuated influenza vaccine in vaccine-naive children. Pediatr Infect Dis J. 28, 365-71.

21. Fleming DM, Crovari P, Wahn U et al. (2006) Comparison of the efficacy and safety of live attenuated cold-adapted influenza vaccine, trivalent, with trivalent inactivated influenza virus vaccine in children and adolescents with asthma. Pediatr Infect Dis J 25(10): 860-9. http://www.ncbi.nlm.nih.gov/sites/entrez/17006278

22. Neuzil KM, Jackson LA, Nelson J et al. (2006) Immunogenicity and reactogenicity of 1 versus 2 doses of trivalent inactivated influenza vaccine in vaccine-naive 5-8-year-old children. J Infect Dis 194(8): 1032-9. http://www.ncbi.nlm.nih.gov/sites/entrez/16991077

References continued

23. Osterholm, M. T., Kelley, N. S., Sommer, A., and Belongia, E. A. (2012) Efficacy and effectiveness of influenza vaccines: a systematic review and meta-analysis. Lancet Infect Dis. 12. 12(1. 1), 36-44

24. Ritzwoller DP, Bridges CB, Shetterly S et al. (2005) Effectiveness of the 2003-- 2004 influenza vaccine among children 6 months to 8 years of age, with 1 vs 2 doses. Pediatrics 116: 153-9.

25. Shuler CM, Iwamoto M, Bridges CB, et al. (2007) Vaccine effectiveness against medically attended, laboratory-confirmed influenza among children aged 6 to 59 months, 2003-2004. Pediatrics 119: e587-95.

26. Wright PF, Thompson J, Vaughn WK et al. (1977) Trials of influenza A/New Jersey/76 virus vaccine in normal children: an overview of age-related antigenicity and reactogenicity. J Infect Dis 136 (suppl): S731–41.

Disclaimer

We very gratefully acknowledge the assistance of Scottish

colleagues in sharing draft materials with us and for all their hard

work in preparing them. However we take full responsibility for

using them and the following disclaimed should be noted:

These ‘draft’ training resources have been prepared with reference to the version of Public

Health England’s “Immunisation against infectious disease: the green book’ available at the time

of publication. The resources have been made available at this time, to allow the training to

commence in line with the requirements of and at the request of the Scottish Immunisation

Service Delivery Group, the Scottish Immunisation Coordinating Group and other UK partners.

It should be noted that whilst every effort has been made to ensure the accuracy of this training

material and information at the time of publication, additions, updates, alterations and changes to

the “Green Book” are likely to occur between the time of publication and the time the user views

the training material.

NHS Education for Scotland (NES) advises users to verify the accuracy and completeness of the

information before any future use of the materials or committing to any related course of action.

Under no circumstances will NES be liable for damages arising from use of this information or

training material.

Meningococcal C Vaccine.

Key MessageThe changes will make the overall Meningococcal serogroup C conjugate immunisation programme more effective and offer greater protection by extending routine protection to adolescents and young adults.

 

Aims of resource• To raise awareness of current Meningococcal

serogroup C epidemiology and the impact of the vaccination programme to date

• To support healthcare professionals (HCPs) involved in discussing MenC vaccination with parents and young persons by offering evidence based information

• To increase awareness of the changes among HCPs to ensure a smooth and effective transition to the new schedule

What is Meningococcal serogroup C disease?

• Meningococcal disease occurs as a result of an invasive bacterial infection caused by Neisseria meningitidis

• Transmission is by aerosol, droplets or direct contact with nasopharyngeal secretions and usually requires frequent or prolonged close contact

• Incubation period 2 – 7 days• Meningococcal infection most commonly presents as either meningitis

or septicaemia, or a combination of both• Meningococcal C is one of 12 serogroups of Neisseria meningitidis • In the UK serogroups B & Y are currently the most common, less

common include C & W

Clinical presentation of Meningococcal infection

Neck stiffness & muscle pain

Babies and toddlers Children and young adults

Fever with poor peripheral perfusion Fever with poor peripheral perfusion

Poor feeding, refusing food or vomiting Vomiting

Tense, bulging fontanelle and photophobia Severe headache and photophobia

Fretful, unusual cry, moaning or rapid breathing

Confusion and irritability

Neck stiffness Neck stiffness and muscle pain

Pale blotchy complexion & or non blanching rash

Pale blotchy complexion &/or non blanching rash

Drowsy & loss of consciousness Drowsy & loss of consciousness

Symptoms can appear in any order, some may not appear at all.

The meningococcal rash•The rash starts as a cluster of pinprick blood spots under the skin, spreading to form bruises. It can appear anywhere on the body.

•It can be distinguished from other rashes by the fact that it does not fade when pressed under the bottom of a glass (THE TUMBLER TEST).

•A febrile illness and rash that does not fade under pressure is a sign of meningococcal septicaemia.

The ‘tumbler’ test picture courtesy of Meningitis Research Foundation

http://www.meningitis.org/symptoms

Meningococcal disease,potential complications

• Overall mortality in the UK has reduced from 10% in 2005/6 to 5% in 2010/11

• Mortality higher in cases with septicaemia than those with meningitis alone

• Most common long term effects: – - Skin scarring - Seizures– - Limb amputation - Brain Damage– - Hearing loss

Background to MenC vaccination programme

• In 1999 children and adolescents under the age of 18 years were offered MenC vaccine over a two-year period

• January 2002 the campaign extended to include all adults under 25 years

• Following the campaign the number of cases fell by over 90% in all age groups immunised

Impact of MenC vaccination programme

Number of laboratory confirmed serogroup C cases in England and Wales, 1998-2010. Source: Public Health England, Infectious Disease Epidemiological Data

http://www.hpa.org.uk/webw/HPAweb&HPAwebStandard/HPAweb_C/1234859709051?p=1201094595391

Reduction in capsular group C carriage following introduction of meningococcal serogroup C conjugate vaccines

Slide courtesy of Prof Ray Borrow

Meningococcal disease cases by group and epidemiological year in England and Wales

Source: Public Health England, Meningococcal Reference Unit, Invasive meningococcal infections laboratory reports, England and Wales, as at 14/09/2012

Risk Factors• Age

– Highest incidence in children under five years, peak incidence in those under one year of age. A second peak in incidence is noted in young people aged 15-19 years of age

• Season– Seasonal variation, peak levels in winter, declining to low levels by

late summer• Social

– Living in closed or semi – closed communities:– university halls of residence – military barracks

• Smoking– Exposure to tobacco smoke increases the risk

What are the changes to the UK schedule for MenC vaccination

© Leah Millinship

Infants

New starters at

university/fresher students

Adolescents

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Revised MenC vaccination schedule

Age Dose3 months (12 weeks)

1 dose - MenC vaccineNeisVac-C®, Menjugate Kit® only

Just after 1st birthday 1 dose Hib/MenC vaccineMenitorix®

From 14-15 years 1 dose MenC vaccineAny MenC vaccine**

New starters at university/freshers *

1 dose MenC vaccineAny MenC vaccine **

*Temporary catch up for new starters entering university setting under 25 years

** Any MenC vaccine can be given, Meningitec advised to help balance vaccine stocks

Why is there a change to the MenC vaccination schedule?• One dose MenC vaccine is now considered to offer sufficient

direct protection to infants with the 12m booster • Individual protection in young children wanes • A booster dose for adolescents will provide longer-term

protection and maintain herd protection to help protect infants and younger children  

• To protect freshers (temporary catch up for new starters at university setting under 25 years coomencing in 2014) because of an increased risk of disease and sub-optimal protection from vaccination under 10 years

When will the change to the schedule be implemented?

Infant • Child Health systems will stop inviting infants for MenC

vaccination at 16 weeks from 1st June 2013• One dose in infancy has been shown to provide

sufficient protection until booster at 12/13 months• The infant will still be called for other primary

immunisations at 8, 12 and 16 weeks • Hib/MenC booster with MMR & PCV13 is still given just

after 1st birthday.• Rotavirus vaccination starts July 1st 2013

When will the change to the schedule

be implemented?AdolescentBegin in academic year starting September 2013

An adolescent booster dose of MenC vaccine to be given at same time as the Td/IPV teenage booster vaccine

HPV and MMR vaccines can be given at same time

Delivered through school based delivery model

When will the change be implemented?

New starters at university/freshers, • From summer 2014• A time limited catch-up programme offering vaccine to freshers

entering university• Defined as new starters at university under 25 years i.e 24 years

and 364 days• Ideally provided by own GP at least 2 weeks before starting

university• Information provided with offer of university place• Those that have received a Men C vaccine over the age of 10

years will not require the booster dose

Which vaccines are recommended?

Age Primary/Booster Product

3 months (12 weeks)

Primary MenCNeisVac-C® or Menjugate Kit®only

12-13 months Booster Hib/MenC Vaccine Menitorix®

From 14-15 years Booster MenC VaccineAll can be given

New starters at university /freshers

Booster MenC VaccineAll can be given

Supply issues may dictate use of Meningitec® for teenagers and freshers

Vaccine products

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© Docsimon

Primary under 1 year

USE THE CORRECT VACCINE

Primary under 1 year

X Primary under 1 year

©Baxter

Meningitec® is less immunogenic, as a single dose in infancy than other vaccines

Different schedules for MenC vaccines

Summary of Product Characteristics (SPC) for MenC conjugate vaccines state that two doses should be given two months apart in those under 1 year of age

This is superseded by the Green Book recommendation to give a single dose of NeisVac-C® or Menjugate Kit® MenC vaccine in infancy

Consideration should be given as to whether a quadrivalent meningococcal vaccine should be used if protection is required for travel

Contraindications and precautions

Contraindications

Confirmed anaphylactic reaction to a previous dose of the vaccine

Confirmed anaphylactic reaction to any constituent of the vaccine, including meningococcal polysaccharide, diphtheria toxoid or the CRM197 carrier protein or tetanus toxoid

Precautions

Acute febrile illness (defer until recovered)

Unstable/evolving neurological conditions

Adverse events • Pain, tenderness, swelling or redness at the

injection site and mild fever• Infants and toddlers: crying, irritability,

drowsiness, impaired sleep, reduced eating, diarrhoea and vomiting

• Older children and adults: headaches, myalgia and drowsiness

• Neurological reactions such as dizziness, febrile/afebrile seizures, faints, numbness and hypotonia are very rare

Reporting Adverse EventsYellow card scheme• Voluntary reporting system for suspected adverse

reaction to medicines/vaccines• Serious adverse events in adults or all suspected

adverse reactions in children that may be attributable to the vaccine should be reported to the Medicines and Healthcare Products Regulatory Agency (MHRA) using the yellow card system

• http://yellowcard.mhra.gov.uk/• Chapter 8 of Green Book

for details © MHRA

Supplies• Meningitis C conjugate:

– Menjugate® – manufactured by Novartis Vaccines – NeisVac-C® – manufactured by Baxter Healthcare – Meningitec® – manufactured by Pfizer  

• Supplies should be obtained in line with routine ordering for childhood vaccines

•

Monitoring uptake

• Vaccination against MenC should be recorded in the GP, patient and child health computer records as routine

• Immunisation uptake data will be collected using the Child Health Information System for the infant and teenage doses

Resources

• Green Book https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/195250/Green_Book_Chapter_22_v2_2A.PDF

• Patient group direction (PGD)• Chief Medical Officer (CMO) Letter• http://www.dhsspsni.gov.uk/hss-md-12-2013.pdf• Leaflets/posters/factsheets/ – will be available at:• http://www.publichealth.hscni.net/publications

Key Message

The changes will make the overall Meningococcal serogroup C conjugate immunisation programme more effective and offer greater protection by extending routine protection to adolescents and young adults