Meningococcal disease group C vaccination.

REMEMBER: this vaccine will only prevent 1/3 of all cases of meningococcal disease.

You must remain alert for the disease, as most cases are due to the group B strain of the disease, which CANNOT BE PREVENTED by vaccination.

Revised: July 16, 2003.

I don’t guarantee that everything on this page is correct, although it was all written in good faith. If you think I’ve got anything wrong, please email me. The page has been put together quickly, so as to disseminate information while it is still useful. I have not, therefore, checked it with colleagues, and take full and sole responsibility for the views expressed, and for any errors in the information contained.

A shorter page of information that was current at the time is also avilable.

Peter English.

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STOP PRESS

December 2000

The campaign is now complete. The vaccine has now been included into the routine baby jabs, and may be given to anybody who was aged 0-17 on 1st September 1999 (i.e. anybody born after31 August 1982. It may also be given to anybody entering higher education (at least half time) for the first time (although most of these people will already have received the vaccine, and do not need a further dose). GPs may claim an item of service fee for immunising people in the above categories.

27/7/2000

DoH have informed vaccination coordinators that all students starting higher education for the first time, and who have not already had the MCC vaccine, should have the vaccine, from their GP, before they start at school college or university. They should receive information about this with their UCAS papers confirming their place at college or university. Further information to GPs is due to follow in "mid August".

Students from overseas may be unable to obtain this vaccine: they should seek vaccination with MACP vaccine before they start (if they will not be arriving in the UK before the start of term).

The same letter also announced that the North American Vaccines product, NeisVac-C (TM) had received its Market Authorisation (product approvale), and is now available. It will be distributed for use in the schools campaign. It, like the Chiron product, is not licensed for use in babies under 1 year of age.

4/4/2000

Letter from David Salisbury: GPs can now get an item of service payment (B rate) for vaccinating young people who were aged 15-17 on 1 September 1999.

14/2/2000

Letter received from David Salisbury giving details of timing of campaign.

Chiron is expected to receive a product license in time for the vaccine to be delivered in March 2000. A large delivery is expected by 8th March, and a second, slightly larger delivery on 20th - subject, of course, to licensing. I believe that they already have large stocks of vaccine, which has passed its batch-testing.

Introduction

This campaign was originally planned for autumn 2000. As soon as it became apparent (in July 1999) that the conjugate vaccine would be available this year instead of next, the CMO announcement of the campaign was made. This information was also carried in cmo9902 and in CDR Weekly Volume 9, No  30 (23/7/99). Surrey Communicable Disease Control Service issued a press release about this on 21 July 1999.

Since then, Freshers have been immunised with the older AC polysaccharide vaccine.

The new conjugate vaccine is to be offered to all children and young people who were aged under 18 on 1st September 1999. This is being done as quickly as the vaccination production and licensing will allow, starting with those most at risk from meningococcal group C disease. See below for details.

School students in school years 11-13 (5th and 6th formers in old money), and most young people who were 15-17 years old on 1 September 1999 have already been offered the new conjugate vaccine.

This page contains information I have gleaned from various sources. I shall try to keep it up-to-date. A previous version of this page includes a lot of information about the earlier - and now completed stages of the campaign. A summary version about the campaign in Surrey is also available.

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Vaccine availability.

Conjugate vaccine

Three companies will be providing vaccine: Wyeth, Chiron, and North American Vaccines. Wyeth’s vaccines start in USA, and their manufacture is completed in Switzerland (at a "finishing school"? ;-) ). Similarly, Chiron’s vaccines are manufactured in USA and Italy. NAV complete the process in the USA. The three companies will enter the market sequentially.

The first manufacturer's vaccine (Meningitec, from Wyeth) was licensed on Friday 15 October 1999, and has been being delivered promptly to schedule. Details of planned deliveries are available via Farillon's web site (if you have a user name and password - available to Farillon's customers, and to trust and district immunisation coordinators).

Chiron received its product license in time for the vaccine to be delivered in March 2000. It is not licensed for use in babies under 1 year of age.

The North American Vaccines product, NeisVac-C (TM)   received its Market Authorisation (product approval), and became available, in July/August 2000. It will be distributed for use in the schools campaign. It, like the Chiron product, is not licensed for use in babies under 1 year of age.

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Mixing vaccines

The group C conjugate vaccines, when available, can (if necessary) be used interchangeably – so a course started with one vaccine can be continued with another.

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MENINGOCOCCAL GROUP C VACCINATION CAMPAIGN.

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The programme – school age children.

Local community trusts (school health services) will be offering the vaccine to all school age children. This applies to both state schools, and independents schools.

Please note that UK primary schools run from year 1 (aged 5 on 1st September at the start of the school year) through to year 6 (aged 10 on 1st September at the start of the school year).  UK secondary schools run from year 7 (aged 11 on 1st September at the start of the school year) through to year 13 (aged 17 on 1st September at the start of the school year). Years 7 to 11 used to be called 1st to fourth forms in many schools, and years 12 and 13 were the sixth forms. Some private schools - and possibly state schools in some areas  - overlap the primary and secondary stages.

We hope to have offered MCC vaccine to most school students as follows:

1 Subject to licensing of Chiron vaccine - now received.
2 Subject to availability of licensed vaccine

Arrangements are being made for those students who miss vaccination at school, and for young people who were aged 15-17 on 1^st September 1999, but are not at school or college, to be offered the vaccine. These arrangements will be announced to GPs, through the press, and in East Surrey Health Authority’s magazine, Care Spectrum. Click here for more details.

Consent forms will usually be sent out by the schools. Young people aged 16 years or more should usually complete and sign the "Self-consent" form (the blue side of the form). For younger children a parent (or whoever has parental responsibility) should usually complete and sign the "Parental consent" form (the pink side of the form).

(Younger children who are old enough to fully understand the issues may sign the self-consent forms, but it will be simpler if the parental consent form is signed and completed.)

The programme – other children and young people.

Phase I of the programme will start in November 1999.

Children aged below 5 months

Since 29 November 1999, children aged below 5 months have been offered three doses of the vaccine. This can/should be given when they have their DTP/Hib/Polio. Additional appointments will be necessary for those who have already had one dose of the other vaccines. These doses should be given in primary care, and there will be an item of service payment for this.

Repeat doses should be given at least 4 weeks after the previous dose.

Click here for detailed information on the number of doses each child should have.

Children aged 13 months

Children aged 13 months should be given a single dose of the vaccine "to be offered when they are called up for MMR vaccine". These doses should be given in primary care, and there will be an item of service payment for this.

Click here for detailed information on the number of doses each child should have.

Children aged below 2 who have not already been offered the vaccine

A catch-up programme started in January 2000 to offer the vaccine to all children under 2 who did not receive the vaccine with their MMR or baby jabs. This programme is being run in the same way as the routine childhood vaccination programmes. This will be done through primary care, and an item of service fee will be payable.

Click here for detailed information on the number of doses each child should have.

Children aged below 5 who have not already been offered the vaccine

A catch-up programme started on 10 April 2000 to offer the vaccine to all children under 5 who have not previously been offered the vaccine. This programme is due to run over 3-4 months, and will be run in the same way as the routine childhood vaccination programmes. This will be done through primary care, and an item of service fee will be payable.

Those who were 5 on 1/9/99 (i.e. those whose date of birth is on or before 31/8/1994) should be done in school, those who born after on that date should be offered the vaccine in primary care.

A Department of Health letter reads:

"We are now in a position to be assured of enough vaccine to roll out the catch-up programme for children under 5 years of age. From week commencing 10 April 2000, Farillon will start to issue extra vaccine for this purpose, in addition to the quantities needed to cover primary immunisations due at 2, 3, and 4 months of age. Any GP who has completed the immunising of the under 2s and has surplus vaccine in hand can move immediately to starting the catch-up of their under 5s"

I've had quite a few calls from practices who have surplus vaccine (why? - poor uptake, failure to offer it, or supplied more than they needed - I can't answer these questions yet) - and who want to know if they can use the vaccine on other age groups, so this is extremely helpful.

The letter is accompanied by a revised version of the "Meningitis C: reduce the risk" booklet. I think the changes are all on page 6, and on the back cover (although I suspect I may have seen a version with the old page 6, and the new back cover - but perhaps I was getting muddled. Confusingly the front cover is identical). The back cover has a list of other language versions, available via http://www.immunisation.org.uk (no phone number or address given). Page 6 lists side effects, and there are some changes that have been made in the light of experience since the start of the campaign.

The letter confirms that:

The letter also points out that it is important, when reporting adverse reactions to state which brand is used, as well as which batch number, now that more than one brand will be circulating.

Click here for detailed information on the number of doses each child should have.

Those entering higher education for the first time

Since August 2000, all students starting higher education for the first time, and who have not already had the MCC vaccine, should have the vaccine, from their GP, before they start at school college or university. They should receive information about this with their UCAS papers confirming their place at college or university. Further information to GPs is/was due to follow in "mid August".

Students from overseas may be unable to obtain this vaccine: they should seek vaccination with MACP vaccine before they start (if they will not be arriving in the UK before the start of term).

Those entering higher education (e.g. university) for the first time in autumn 1999 were offered "plain" (MACP) vaccine (not conjugate – the existing AC polysaccharide vaccination). The risk to students is greatest in the first weeks of their first term. One expert suggested to me that only students who live in halls of residents at particular universities really need vaccination; but all students are being offered vaccination because of the outcry that would be inevitable if/when a case were to arise. By autumn 2000, the vast majority of new students will already have been vaccinated.

Interestingly, US guidelines have since been changed to recommend vaccination (with polysaccharide vaccine), "especially for college freshmen ... in dormitories".

At present the Department of Health has not announced any plans for the autumn 2000 student intake but, as far as I am aware, the statement of fees and allowances has not been revoked and will permit GPs to claim an IoS fee for vaccinating people entering higher education for the first time in the same way as last year.

Adverse reactions to meningococcal group C conjugate vaccines

Meningococcal group C conjugate vaccines have undergone extensive safety testing.

The Chiron vaccine is not licensed for use in infants (babies under the age of one year). The multi-dose formulation from Chiron - which is only used in school vaccination sessions - has been associated with a considerable number of non-serious reactions such as sore arm and headache. This has been attributed to the preservative used. It is not associated any more serious reactions than other vaccines.

The media picked up on this on 12 June 2000, with an alarming, front-page article in the Daily Express. In response the Deputy Chief Medical Officer sent this letter via the CMO's urgent communication channels.

Giving other vaccines with this meningococcal group C conjugate vaccines

The new meningococcal group C conjugate vaccines have been extensively tested both alone, and in combination with other vaccines. Nevertheless, there may be some problems with certain combinations as described below. (The guidance is from CDSC.)

Vaccines contatining diphtheria or tetanus antigens.

The Wyeth and Chiron vaccines are conjugated with diphtheria protein, and the NAV vaccine - if it ever gets marketed in the UK - is conjugated with tetanus toxoid.

Any combination of vaccines may be given simultaneously - and that, in practice, this can mean within 2-3 days. If other vaccines containing the same antigen are to be given subequently, this should be delayed, wherever possible, for at least one month.

Giving the group C conjugate vaccine (MCCV) after the polysaccharide A&C vaccine (MACPV).

MACP may still be required for travel purposes, or following exposure to group A meningococcus.

If these cannot be given simultaneously - and that, in practice, this can mean within 2-3 days, MCCV administration should be delayed for an interval of at least two weeks. Recent administration of MACP may, theoretically, interfere with the response to MCCV, so that a booster dose may be required later.Age specific guidance follows.

Children under 2 years of age: give MCCV when scheduled (but at least two weeks after MACPV).Offer booster MCCV six months later.

Children aged 2 or more, and less than 5 years: delay MCCV until 6 months after MACPV, unless recommended because of contact with a case of group C disease. In the latter case, give MCCV when advised by Surrey Communicable Disease Control Service or local CCDC. Offer booster MCCV six months later.

Children aged 5 years or more and adults: elay MCCV until 6 months after MACPV.

Giving the polysaccharide A&C vaccine (MACPV) after the group C conjugate vaccine (MCCV).

Delay until at least 2 weeks, if possible.

Information leaflets and consent forms.

Leaflets and consent forms have already being sent to Child Health Computer Systems. They go to GPs and schools in the week commencing 18 October; and to colleges of further education in the week commencing 25 October. The HEA is writing to head teachers and Directors of Education to warn them about this; and to advise them to await advice from co-ordinators before starting distribution. They will be asked not to distribute the leaflets before 28 October, when an advertising campaign will begin in the media.

Information leaflets

A leaflet, "Reduce the risk: your guide to the new meningitis vaccine", has been produced by the Health Education Authority (HEA). Leaflets and consent forms have already being sent to Child Health Computer Systems. They go to GPs and schools in the week commencing 18 October; and to colleges of further education in the week commencing 25 October.

The leaflet will be posted in *.pdf format on the by the HEA, presumably on their immunisation website (which rather begs the question of why more of their leaflets can't be downloaded in that format... or maybe they can, but I can't find them).

Another leaflet is being sent to people who are due to start at university or college of higher education.

Consent forms

As stated above, these will be sent out with the information leaflets.

Usual consent arrangements will apply. Parents will generally (GIllick rules apply) sign for children under 16; those 16+ will generally sign their own consent forms.  (No guidance on this is included on the consent form, or the "Reduce the risk: your guide to the new meningitis vaccine" leaflet.)

They state that the person signing the form has "read and understood" the "Reduce the risk: your guide to the new meningitis vaccine" leaflet.

Slides and speaking notes

Any immunisation co-ordinator who wants copies of slides/speaking notes prepared by dh can have them sent to them by email, by sending the following details to Mrs Monica Francis, Area 714, Department of Health, Wellington House, 135-155 Waterloo Road, LONDON SE1 8UG (fax 0171 972 4182): their name, email address, region, HA/NHS Trust, and phone number. Please also indicate if you would like Microsoft PowerPoint 95 or version Microsoft PowerPoint 97. (Viewers allowing these presentations to be viewed if you do not have Microsoft PowerPoint are free and easy to obtain via the world wide web, e.g. from UMIST or from here.)

I have received a copy of these notes in PowerPoint 97 format. I did ask the dh if they would agree to my posting them on this web-site, so that they could be downloaded from here. dh was concerned, however, that people who did not have a good understanding of the subject might misunderstand the notes, and that, for the general public, could raise more questions than they answer, and thus generate more calls to GPs and the dh. They were also concerned that people might edit the originals, and pass these versions off as the original... Having been politely asked not to post them, I'd better not, or they won't send me stuff in the future!

Payments

Item of service payments for GPs

A letter from David Salisbury to GPs, dated 2nd September 1999, clarifies the item of service arrangements.  It has since been confirmed in Health Service Circular,  HSC 1999/215 "The new meningococcal C vaccine: amendment to the statement of fees and allowances, GP pay; arrangements and accountability arrangements", dated 24/9/99, which can be obtained via the DoH "Circulars On the INternet" site. The letter stated:

Subsequent communications have clarified that GPs who jumped the gun, and vaccinated freshers before 2nd September, or before the issuing of the circular referred to, will be paid.

A letter of 4/4/2000 stated that, as of that date, GPs can also claim a (rate B) item of service payment for vaccinating young people who were 15-17 on 1/1/99, and have not yet received the MCC vaccine.

Funding for children of school age.

Many community NHS trusts are running on bare minimum staff, and are just able to tick over with the routine work: there will be no spare staff to implement the campaign.

The DoH will provide the vaccine (with luck more reliably than it has done so far - see vaccine availability). DS' letter says that HAs will receive £1 per child aged 5 to 17, based on mid-1999 population. Funding "for 15-17 year olds will be released shortly; funding for children aged 5 to 14 will be released during next financial year." (If the campaign won't happen until the summer term, this timing seems reasonable.)

A further letter from Nick Adkin at DoH includes figures for each HA. East and West Surrey HAs will receive £15,000 and £26,000 respectively in the first instance, based on the number 15 - 17 year-olds in the HA mid-1999 population estimates.

The amounts will be insufficient, however. Our (Surrey) community trusts have stated that it will cost them £3 per head. Even if this is a negotiating stance, the HA is likely to have to contribute funds.

Black triangle issues.

Concern has been expressed that newly licensed drugs will all have "black triangles", and that this will mean - in addition to greater effort being put into identifying possible adverse reactions - that only doctors will be able to give the injections. This is based partly on statements in the Crown Report (which, as far as I know, is not available on the web - for shame).

The CMO letter PL/CMO/99/4; PL/CNO/99/8; PL/CPHO/99/3 (available on the web at www.doh.gov.uk/cmo/cmo2.htm or at www.doh.gov.uk/coinh.htm) states:

"It is recommended that a doctor should direct that meningococcal C conjugate vaccine should be  administered to the groups of named children due to receive the vaccine by signing the group lists. The doctor should direct that the administration should be undertaken under a Group Protocol. The content of a Group Protocol should be consistent with the recommendations referred to in HSC 1998/051."

Forum for further questions and discussion.

There appeared to be many people who still had questions to ask and points to make at the end of the V&I coordinators' meeting. Further discussion of this campaign will take place on the this page, and at the vaccination and immunisation co-ordinators' and practitioners' email list.

Surveillance of group C meningococcal disease after introducing the new vaccine

It will be essential to monitor adverse events, vaccine failures, changes in the epidemiology (prevalence of carriage of different groups of meninogoccus, incidence, morbidity, mortality caused by meningococcus overall, and by group...).

Adverse events will be monitored by CSM etc. in the normal way.

Vaccine failures The other issues

Details of how possible vaccine failures will be investigated have been published in "Surveillance of impact of meningococcal serogroup C conjugate vaccination programme in England and Wales and protocol for investigation of vaccine failures: Joint document from the Public Health Laboratory Service and the Institute of Child Health, London".  I've not read this carefully, with a copy of existing guidance next to me, but it will require additional specimens to be taken.

Official sources of information.

The Deparment of health have a web site on the vaccination campaign. This has been updated since the beginning of November, and contains a lot of useful information and links.

"Key pharmaceutical/technical issues" information for pharmacists and others can be found in "questions and answers" format at the DoH web site.

Some other material - including the HEA leaflet "Meningitis C: reduce the risk" - will be posted (some of it in *.pdf format) at the HEA immunisation website (also here). The Reduce the Risk has now been translated into (on 1/12/99) 14 other languages, and the translated versions can be downloaded from this site.

Department of health circulars can be viewed at www.doh.gov.uk/cmo/cmo2.htm, and CMO letters can be viewed at  www.doh.gov.uk/coinh.htm. The CMO letter in response to alarmist media reports of adverse reactions can be seen here.

Details of planned deliveries are available via Farillon's web site (if you have a user name and password - available to Farillon's customers, and to trust and district immunisation coordinators).

A 4-week media campaign started on 8 November 1999.

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Chiron's vaccine

I have been told by one of our community pharmacists, that the Chiron vaccine that they have had delivered has a use-by date of 1/8/2000 - i.e. a very short shelf-life.

In the absence of official information on this, on the internet, I have emailed Chiron and received the following information.

Shelf Life:

Menjugate has a shelf-life of 18 months (single and multi-dose formulations)

Reconstituted shelf-life of the single-dose product : The manufacturer recommends that the product be used immediately

Reconstituted shelf-life of the multidose product: Use within 4 hours of reconstitution. Other in-use storage times and conditions are the responsibility of the user. The two components of the product may have different expiry dates. The outer carton bears the earlier of the two dates and this date must be respected. The carton and ALL its components should be discsrded on reaching this outer carton expiry date.

Special Precautions for Storage:

Store between +2°C to 8°C. Do not freeze. Protect from light.

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Surrey's responses.

Surrey's district immunisation coordinators are both members of the Surrey Communicable Disease Control Service.

We held a planning meeting with key players in Surrey on 10th September to pass on what we learned at the the national immunisation co-ordinators' meeting, which took place on 25th August 1999. We will be meeting again on 1 October to share further information.

15/9/99.

We have had a few calls from GPs and freshers. One recurrent problem seems to be supply of vaccine. Freshers turn up wanting immunisation NOW. GPs have to order the vaccine for those students they know about, but not as contingency. I think I shall advise practices to keep a few doses in reserve for freshers who turn up out of the blue, ordering them as travel vaccine if need be. (See also Vaccine availability: polysaccharide vaccine.)

We do not, according to the lists sent with the 31/8/99 DH letter, have any Young Offenders Institutions (where we would need to arrange vaccination of the students) or prisons with mother and baby units (where we would need to arrange vaccination of the babies).

28/9/99.

We called DoH yesterday to ask how the £9M allegedly put aside to pay for this campaign will be divided up.  They did not know (or would not admit it if they did). Will call them again on 30th.

29/9/99.

Discussed how to do the "mop-up" of chool-age children (5-17 inclusive) who, for whatever reason, do not attend school, college, or YOI; or who miss out on the vaccine at school. Our initial thought is that it would be simplest to direct them all to their GPs - if GPs are prepared to cooperate. Presumably we will have to pay them a sum equivalent to the item of service fee for students/pre-school students.

Royal Holloway College report that a high proportion (80% approx) of new students - who have already started - were vaccinated before arrival. Quite a lot of those that weren't had declined vaccination for a variety of reasons - but could have had it. This is good news. Well done those GPs! It's a shame that polysaccharide vaccine does not provide herd immunity. (Apparently it is effective in preventing invasive disease, but not in preventing nasopharyngeal carrieage. Allegedly. Or is this a myth?)

30/9/99

Second joint planning meeting of district immunisation committees.

Week starting 18/10/99

Further meeting of planning team. Press release planned.

5/11/99

Meetings planned [and subsequently held] in Frimley and Epsom (the two HA HQs) with schools with 6th forms [or equivalent].

13/1/2000

The programme for vaccinating young people in years 11-13 at school (or equivalent - see above) is now largely complete.

Arrangements are being made to "mop-up" those who missed their vaccination - click here for details.

The programme for vaccinating pre-school children in primary care is now under way. 

Peter M B English
Revised: July 16, 2003.