INTRODUCTION OF GROUP C MENINGOCOCCAL VACCINE

Transcription

1 INTRODUCTION OF GROUP C MENINGOCOCCAL VACCINE BRIEFING Key Points - about the immunisation programme - about the vaccine Q & A The immunisation campaign (who will get the vaccine/operational issues) The vaccine Research into the vaccine The disease (including epidemiology) Key Points - information materials available for the immunisation campaign - consent for immunisation Background Information - meningococcal infection and meningitis MenCQA.doc 1.

2 KEY POINTS ABOUT THE MENINGITIS C IMMUNISATION PROGRAMME The leaflet MenC vaccine: a new vaccine to protect against meningitis C is available from chemists and GP surgeries and includes information on the new vaccine. The vaccine should be offered to everyone under age 18 by December The vaccine is new and there aren t enough stocks for everyone to have the vaccine straight away so it will be offered to those at most risk first. Everyone under 18 will get an invitation to be immunised in turn. The vaccine will be offered to: from autumn 1999 young people aged 15, 16 and 17 at school babies at 2, 3, 4 and 13 months by GP or community health clinic from January 2000 onwards children up to school entry (5 years of age) by GP or community health clinic children aged 5-14 at school (probably starting in the summer term) Parents do not need to do anything now; babies, pre-school children and school pupils will be called for immunisation when their turn comes. Children under school age (5 years) will be sent an invitation to attend the GP surgery or clinic. Older children will be immunised at school and parents will be given details when this is due to happen. Arrangements will be made locally for children who are not currently attending school and the local immunisation co-ordinator should be able to advise about this. Arrangements will also be made for those aged 16 and 17 who have left school. Parents of school age children, and older pupils, will be given a form to sign to give their consent for the new vaccine to be given. Parents of children under school age should give consent in the same way as for other immunisations. The vaccine will protect against Group C but NOT against Group B meningococcal infection so everyone still needs to be aware of the signs and symptoms of the disease. Signs and symptoms are given in the leaflet MenC vaccine: a new vaccine to protect against meningitis C. MenCQA.doc 2.

3 KEY POINTS ABOUT THE NEW MENINGOCOCCAL C CONJUGATE (MenC) VACCINE Appointments will be scheduled according to supplies of vaccine. Administration the vaccine is given as 0.5ml intramuscular or deep subcutaneous injection. Dosage babies aged 2, 3 and 4 months: one dose with each of the three DTP-Hib and polio immunisations babies 5-11 months: 2 doses one month apart children one year and over and adults: one dose. The contraindications are: being unwell with a fever on the day of the immunisation; a hypersensitivity reaction to a previous dose of one of the vaccine components; and pregnancy. The vaccine may be given to people who are HIV positive in the absence of contraindications. The vaccine uses the same technology as Hib vaccine. The vaccine is new but the constituents are not and have been used for a number of years. The vaccine has an excellent safety profile. Around 25,000 children and adults had been vaccinated with the new vaccine worldwide; in total 60,000 doses of the vaccine had been given before it was licensed. The vaccine is not live. Studies show the vaccine is well tolerated with no serious side effects. Rates of local and systemic reactions are similar to those seen with Hib vaccine. Most common reactions are redness and swelling at the injection site and mild fevers. The vaccine has been given with DTP, Hib, DT, Td and MMR vaccines and studies show MenC vaccine adds very little in the way of systemic reactions. There is no evidence of immunological overload from the addition of the new vaccine to any of the vaccines tested. The vaccine has a black triangle ( ), meaning it is a new vaccine and any suspected adverse reactions associated with it must be reported. People who need meningococcal vaccine for travel purposes should have the A and C vaccine (ACvax or Mengivac A+C). MenCQA.doc 3.

4 THE IMMUNISATION CAMPAIGN WHO WILL GET THE VACCINE? Q: What does the new vaccine protect against? A: The new vaccine will protect against Group C meningococcal disease, a major cause of meningitis and septicaemia in the young. It will NOT protect against Group B infection so parents and health professionals still need to be aware of the signs and symptoms of meningitis and septicaemia. Q: When will the new vaccine be introduced? A: The new vaccine has been licensed. The immunisation programme will begin on 15 November for young people aged 15, 16 and 17 and on 29 November for babies at 2, 3, 4 and 13 months when they come for other primary vaccines. Q: Who will get the vaccine? A: The vaccine will be introduced into the routine immunisation programme at 2, 3 and 4 months and there will be a catch-up campaign offering the vaccine to all children and young people under 18 years old as vaccine becomes available. Q: So who gets the vaccine first? A: There will not be enough vaccine initially to immunise everyone at once. So we will make best use of the vaccine as it comes in. Those most at risk by age will be targeted first, this means: * young people aged 15, 16 and 17 * as part of the routine immunisation programme the vaccine will be made available for infants when they go for their childhood immunisations at 2, 3 and 4 months (DTP/Hib/polio) and when they go for their first dose of MMR at around 13 months. The next phase will be to complete the protection of the under 5s and then the 5-14 year olds. Q: When will the other children get the vaccine? A: This will depend on when more supplies of the vaccine become available. At the moment the timetable looks like this: From 15 November 1999 young people aged 15, 16 and 17 at school From 29 November 1999 babies when they go for their DTP/Hib/polio immunisations at 2, 3 and 4 months and for their first dose of MMR at around 13 months at the surgery/clinic From January children under school age by special appointment at the surgery/clinic From the summer term 2000 children aged 5 to 14 at school MenCQA.doc 4.

5 Q: Weren t babies aged 4 12 months supposed to get the vaccine this autumn? A: Babies in this age group are part of the first phase of the programme, which begins this autumn. The programme is dependent on the supplies of vaccine that are available. The current indications that we have from the manufacturers are that supplies for this age group will be available at the beginning of the new year. Q: Why can t everyone have the vaccine straight away? A: It is a new vaccine and there are no stocks of vaccine for us to use. As soon as vaccine is available from the manufacturers it is being distributed to schools and surgeries for them to use. The immunisation programme allows the children and young people at highest risk to be immunised as quickly as possible. If we had waited until stocks built up for everyone we would not have been able to start this programme until next autumn. And we want to protect the highest risk groups this year before the winter peak in meningitis disease. Q: Why are 15, 16 and 17 year olds getting the vaccine first? A: They are a high risk group for the disease and the highest death rates are in this age group. Q: Adults get meningitis too; shouldn t they get the vaccine at a later date? A: Meningococcal infection represents a very small risk to adults. Because of this blanket immunisation isn t recommended. We expect that one benefit from this widespread campaign will be to reduce the risk from meningococcal Group C to the whole population. Q: Won t people jump the queue and get the vaccine privately? A: No. The vaccine is not available to buy privately. Q: Should it be used as a travel vaccine? A: Meningococcal vaccine remains recommended for people travelling to high risk countries (for example the meningococcal belt of Africa) but the new meningococcal Group C vaccine is not recommended as a travel vaccine. People who need meningococcal vaccine for travel purposes should have polysaccharide vaccine which protects against both Group A and Group C disease (ACvax or Mengivac A+C) because travellers should be protected against Group A disease too. MenCQA.doc 5.

6 OPERATIONAL ISSUES Q: How will children/young people get the vaccine? A: Children under school age: Children under the age of school entry (5 years) will be immunised through their GPs or clinics. Parents will be sent an invitation to attend the surgery or clinic in the same way as for other immunisations. Children over school age: Children over school entry age (5 years) will be immunised through services in their school. Parents and older children will be given details of when immunisation sessions will take place by the school. They will be sent an information leaflet and a form to sign to give their consent for immunisation to take place. Q: What about children and young people who are not attending school? A: Arrangements will be made locally for children who are not currently attending school and the local immunisation co-ordinator should be able to advise about these. Similar arrangement will be made for those under age 18 who have left school. Q: What about offering the vaccine to other group in the future? A: The current programme aims to offer vaccine to everyone under the age of 18 by the end of next year. The Department of Health will look at the role of the vaccine outside the routine immunisation programme once this programme has been achieved. Q: What should parents do now? A: Nothing. Everyone will be invited for immunisation when their turn comes. Parents can find out more about the vaccine in the information leaflet MenC vaccine: a new vaccine to protect against meningitis C which is available from chemists and GP surgeries. Q: Do parents and older children have to agree to an immunisation? A: Nearer the time, parents and older children will be told when the vaccine will be given in each school and they will be given a form to sign to give their consent for the vaccine to be given. Parents of young children being immunised at the surgery/clinic will give their consent in the usual way. Q: Why is most of it being done in schools? A: It is the most efficient way to immunise large groups of children. Q: Won't this be disruptive for schools? A: This is an ambitious immunisation programme and one that will depend upon the cooperation of all those involved. Since schools may be the focus of outbreaks of meningitis C it is in everyone s interests that pupils are protected as effectively as possible. We feel this is a necessary and worthwhile campaign and we want to make the best use of the new vaccine by immunising children as quickly as possible. We hope that the campaign will cause as little disruption as possible. Q: How will schools find out about the plans to run school-based immunisation campaigns locally? A: Each area has an Immunisation Co-ordinator, a doctor appointed by the Health Board with particular responsibility for immunisation. The Co-ordinator has contacted head teachers to discuss arrangements, either directly or through School Health Services, MenCQA.doc 6.

7 depending upon the local pattern of service provision. The local Health Board will be able to advise who the Immunisation Co-ordinator is in each area. Q: When will there be a vaccine against Group B disease? A: Work to find a vaccine against meningococcal Group B is much more difficult than for Group C. It is the science rather than the money that makes progress slow although early indicators for Group B are encouraging. The Department is investigating Group B vaccines in collaboration with RIVM (the Dutch national vaccine manufacturer) and funds Group B vaccine dedicated work at CAMR (Centre for Applied Microbiological Research). Q: What about the Cuban Group B vaccine? A: The Cuban vaccine is specific to the one sub-strain of Group B meningococcal infection prevalent in Cuba and has not demonstrated good efficacy in other countries, especially in young children. It is not appropriate for UK needs as it is formulated against the wrong strains of the Group B organism. MenCQA.doc 7.

8 THE VACCINE Q: What kind of vaccine is it? A: The vaccine is made from the sugar coat of the meningococcal organism. The sugar (polysaccharide) is conjugated (glued together) with a protein that makes it effective in children from 2 months of age and leads to immunological memory. This was the way Hib vaccine was developed. Q: Who makes it? A: Wyeth is the first company to have its vaccine licensed and other manufacturers are looking at obtaining licensure. Q: How effective is it? A: The vaccine appears to be very effective. It induces immunity in children from 2 months of age with high levels of antibodies. There is also good evidence of immunological memory, which would mean immunity would be long lasting. Q: How long does immunity last? A: The tests done by Public Health Laboratory Service indicate that the vaccine should produce long lasting immunity as Hib vaccine does. Q: How many doses do children need? A: The recommended schedule for the new meningococcal Group C conjugate vaccine is: babies aged 2, 3 and 4 months: one dose with each DTP-Hib and polio (3 in total) babies 5-11 months: 2 doses one month apart children one year and over and adults: one dose. Q: How was it developed? A: Following the successful development of Hib vaccine, manufacturers have applied similar technology to the development of vaccines against Group C meningococcal infection. Q: It is a new vaccine - how do you know it is safe? A: The manufacturers and the Public Health Laboratory Service have carried out safety tests on the vaccines and they have excellent safety profiles in all ages. As with all new drugs the new vaccines will be closely monitored when they are first used. More than 4,500 children and young people in the UK and over 21,000 children and adults elsewhere have already received these vaccines and they have an excellent safety profile. In total 60,000 doses of the vaccine had been given before it was licensed. Q: Does the vaccine contain human fetal material? A: No Q: Does the vaccine contain thiomersal (a mercury preservative)? A: No Q: Does the vaccine contain human albumen or blood products? A: No MenCQA.doc 8.

9 Q: Does the vaccine contain any bovine products? A: Conjugate MenC vaccine contains some amino acids derived from cow s milk protein. As for all other UK vaccines in current use, we have been assured that this component has been sourced from outside the UK from BSE free countries. Q: Which other countries use this vaccine? A: None at present, we are in a world leading position and will be the first country to benefit from this new vaccine. Q: Aren t our children being used as guinea pigs for this new vaccine? A: No. The vaccine has been properly tested in British children and has shown itself to be safe and effective. It was licensed by the Medicines Control Agency in October Now we have a suitable vaccine, it is important that our children are offered protection against Group C disease as soon as possible. Q: Given the current vaccine supply problems are you sure the vaccine will be available? A: The schedule for the introduction of the new vaccine has been based on the best estimate of vaccine supply. Any changes in this supply will have to be reflected in the way the vaccine is introduced. Q: Can people who have had the polysaccharide vaccine also have the new vaccine? A: Yes. Evidence suggests that people who have had the existing vaccine (the plain polysaccharide A & C vaccine) make good responses to the new vaccine. It is recommended that there be an interval of at least 6 months between having the existing vaccine and the new conjugate vaccine. MenCQA.doc 9.

10 RESEARCH INTO THE VACCINE Q: It is a new vaccine how do you know it is safe? A: The manufacturers and the Public Health Laboratory Service have carried out extensive safety tests on the vaccine and it has an excellent safety profiles in all ages. There are no new ingredients in the vaccine. It is made with the sugar coat of the meningitis germ that is used in the current vaccine, which has been linked to the same proteins that are put in Hib vaccines. The ingredients have been given to millions of children worldwide in the current meningitis vaccine or in Hib vaccines. This experience adds to the confidence we have in the safety of these new meningitis vaccines. Q: What studies have been done? A: In addition to the usual safety and effectiveness studies manufacturers are required to do, there have been a number of other studies carried out. There have been a number of coordinated studies in the UK carried out by PHLS in infants, toddlers, school children and students specifically designed to study the vaccines performance in UK children. These studies have shown the vaccine to be safe and effective. Some of these studies have looked at the possibility of an interaction between these vaccines and DTP, Hib, DT, Td and MMR vaccines. Q: How many children have had the vaccine? A: The vaccine has already been given to around 4,500 babies, children and young adults in the UK. Altogether around 8,500 doses have been given with follow up after each dose by study nurses. Over 21,000 children and adults have been vaccinated in other countries (US, Canada, Holland). No serious side effects of the vaccine have been found. Q: Where have the results been published? A: Studies have been published in journals and have been presented at scientific conferences. Q: What long term studies have been carried out? A: Infants first received the vaccine in the UK in 1994 and these children are still being followed up. No adverse effects of the vaccine have been seen. Q: Is it safe to give babies yet another vaccine as part of the routine programme? A: Yes. There is no evidence that vaccines overload a child s immune system. American researchers have looked at the number of hospital visits in the week after multiple simultaneous vaccination compared with the number of hospital visits after a single oral polio vaccine. The authors found no increase in hospital visits after immunising against up to 8 diseases at one visit. Q: Can the vaccine be given at the same time as the childhood vaccines? A: The results of the studies have shown that it can safely be given at the same time as Hib/DTP, MMR and the pre-school booster and the school leavers immunisation. These studies showed the vaccine to be safe and effective and showed that the meningococcal Group C vaccine did not have an effect on the other vaccines. Q: What about other vaccines? A: There are no studies to date on hepatitis B or BCG vaccine being administered at the same time, although there is no reason to suspect an interaction and meningococcal C conjugate vaccine has been given within a month of BCG with no adverse effects. There is MenCQA.doc 10.

11 also no concern about giving meningococcal C conjugate vaccine either at the same time as, or shortly before or after, influenza vaccine (which is an inactivated vaccine) or any of the travel vaccines. Q: What are the side effects of the vaccine? A: The results of the studies showed that all the vaccines were well tolerated with no serious side effects. Rates of local and systemic reactions are similar to those seen with Hib vaccine. Most common reactions are redness and swelling at injection site and mild fevers, in particular: Babies: some redness and swelling where the injection is given. Toddlers (over 12 months): some redness and swelling where the injection is given; one in four toddlers may have disturbed sleep and one in 20 toddlers may have a mild fever. Pre-school children: about one in 20 may have swelling where the injection is given and about one in 50 may have a mild temperature within a few days of vaccination. Older children and young people: about one in four may have redness or swelling where the injection is given; about one in 50 may have a mild temperature and about one in 100 may have a very sore arm from the injection which may last a day or so. Q: Can a child get meningitis or septicaemia from the vaccine? A: No. The new vaccine is not live and cannot give anyone meningitis or septicaemia. MenCQA.doc 11.

12 THE DISEASE (INCLUDING EPIDEMIOLOGY) Q: What is the pattern of disease in this country? A: Meningococcal meningitis/septicaemia is the commonest cause of death in children aged 1-5 years, and the commonest infectious cause of death in children and young people up to 20 years. Two strains account for almost all cases of meningococcal disease in the UK - Group B and Group C. The proportion of Group C cases has risen over recent years to around 50%. There have also been shifts with more cases in the later teenage group, in whom the fatalities are highest. Q: Does the new vaccine mean that children won t get meningitis any more? A: No. It is important to remember that this vaccine only protects against Group C disease and not Group B, so awareness of the signs and symptoms of meningococcal disease remains vital. Q: Does the vaccine protect against septicaemia (blood poisoning)? A: The vaccine will protect against septicaemia caused by Group C strains but not disease caused by Group B. Q: How many cases of/deaths from meningococcal disease are there each year? A: The latest annual estimate (1998) is 160 cases of Group C disease in Scotland and 10 deaths. Q: Which ages are currently at greatest risk from the disease? A: The highest risk group for meningococcal disease is the under 1s, with those aged 1-5 following closely. The next highest risk group is young people aged years. The highest death rates are in 15, 16 and 17 year olds. Q: Doesn t this campaign put the children who have to wait for the vaccine at greater risk? A: Based on our experience with Hib vaccine we expect the population to benefit eventually from herd immunity. This means that as more children are immunised the transmission of disease is reduced and so the risk is lower for all. With the supplies available to us, we cannot immunise everyone straight away, so we have had to make priorities. MenCQA.doc 12.

13 INFORMATION MATERIALS AVAILABLE FOR THE IMMUNISATION CAMPAIGN There will be a publicity campaign to accompany the introduction of the new vaccine. Public information: there is a NHS parent information leaflet MenC vaccine: a new vaccine to protect against meningitis C. The leaflet is available from chemists and GP surgeries and includes information on the new vaccine and its side effects. Information for professionals: The Health Education Board for Scotland (HEBS) has produced information on the new vaccine for teachers and for health professionals. The chapter on meningococcal disease from Immunisation against Infectious Disease has been revised and sent to health care professionals. Leaflets, posters and consent forms have been sent to schools and GP surgeries. Information on the programme and the information materials can be found on the SHOW website: and the HEBS website: MenCQA.doc 13.

14 CONSENT FOR IMMUNISATION Consent forms for parents and for young people have been supplied by HEBS in conjunction with the Health Department, along with the leaflet MenC vaccine: a new vaccine to protect against meningitis C to schools and GP surgeries. The leaflet gives relevant information on the new vaccine and on meningococcal disease to allow parents and older children to give informed consent. A consent form should be signed by parents or guardians for children aged under 16. People aged 16 and over should sign their own consent forms. Situations where consent is refused or where a parent and child have conflicting views will need to be resolved on an individual basis, and should be resolved in discussion with the parent/guardian and the child. Children under school age will be offered the immunisation through their GPs and consent from parents/guardians will be obtained in the usual way as for other routine childhood vaccine. A parental consent form suitable for use for children under school age is available from HEBS, should the GP wish to use it. MenCQA.doc 14.

15 BACKGROUND Meningococcal infection - bull points Meningococcal disease can present as septicaemia (more rapid onset, worse outcome) or meningitis, or both together. Winter meningococcal season starts before Christmas and usually peaks in mid January. Meningococcal season is often exacerbated if it occurs at the same time as the influenza season. Two main strains of meningococci Group B and Group C. Group B strains usually account for 60% of infections. Group C strains have increased in recent years (reason unknown) and cause more clusters of cases, often affecting teenagers. Highest death rates in yr olds. No vaccine available or imminent for prevention of Group B major biological hurdles to overcome. Cuban vaccine is not appropriate for UK needs (formulated against the wrong strains of Group B organisms), but DH collaborating with Dutch national vaccine manufacturers to develop and evaluate vaccines that would be appropriate. MenCQA.doc 15.

16 MENINGOCOCCAL MENINGITIS MENINGITIS: Inflammation of the meninges (the lining of the brain). TYPES: Bacterial - more severe, outcome can be fatal or leave permanent consequences. Meningococcal meningitis (including septicaemia/blood poisoning) - now commonest. Peak incidence in the under ones but second smaller peak in late teenagers. Onset can be very rapid and non-specific. Usually two thirds of cases are Group B, one third Group C. This has changed recently with Group C responsible for 50% of cases last year. About 10% of the population, and about 25% of young adults, may be symptomless carriers of meningococci at any one time. Risk factors are active and passive smoking and damp environments. Pneumococcal meningitis - less common, affects the very young, the elderly and immunocompromised, but has the highest case fatality rate. Accounts for deaths a year in the UK. Hib (haemophilus influenzae type b) - used to be the most common cause of bacterial infection in the under fives. Very rare in fives and above. Virtually eliminated by Hib vaccine introduced in Oct Viral - less severe, used to be mostly due to measles and mumps, but these are now largely prevented by immunisation. THE SYMPTOMS: The very early signs of meningitis can be rather vague and vary slightly between age groups. The disease rapidly progresses from a flu-like illness to, for young children - fever, irritability, restlessness, a high-pitched cry, vomiting and refusing feeds. In older people a severe headache, dislike of bright lights, drowsiness or confusion and stiffness of the neck are signs to look out for. In all cases, red or purple spots that do not fade under pressure can indicate the very serious condition, septicaemia (blood poisoning). If not treated rapidly, infection can quickly progress to shock, collapse, coma and death. ADVICE FOR PARENTS WORRIED ABOUT MENINGITIS: Meningococcal infections are relatively rare but can be very serious. If a parent is worried that their child is ill with meningitis or septicaemia, they should consult their family doctor without delay. Parents should be aware of the signs and symptoms of meningitis and septicaemia. MenCQA.doc 16.