DENMARK S CHILDHOOD VACCINATION PROGRAMME 2013 7th EDITION
Denmark s childhood vaccination programme, 2012 7th edition 2013 by the Danish Health and Medicines Authority. All rights reserved. Danish Health and Medicines Authority Axel Heides Gade 1 DK-2300 Copenhagen S Denmark URL: http://www.sst.dk Translation: David Breuer Keywords: childhood vaccination programme, diphtheria, tetanus, pertussis, polio, meningitis, measles, mumps, rubella, cervical cancer Language: English Version date: 1. juli 2013 Format: pdf Electronic ISBN: 978-87-7104-540-6 Published by the Danish Health and Medicines Authority in collaboration with Rosendahls a/s 2
Contents Introduction... 5 Recommendations of the Danish Health and Medicines Authority... 5 Denmark s childhood vaccination programme... 7 Why should children be vaccinated?... 8 The diseases... 9 Diphtheria... 9 Tetanus... 9 Pertussis (whooping cough)... 10 Poliomyelitis... 11 Meningitis and epiglottitis caused by Haemophilus influenzae type b... 12 Meningitis and other diseases caused by pneumococci... 13 Measles... 13 Mumps... 14 Rubella (German measles)... 15 Cervical cancer... 16 The vaccinations... 18 Questions and answers on vaccination... 19 Side effects... 20 Diphtheria, tetanus, pertussis, polio and Haemophilus influenzae vaccine... 22 3
Pneumococcal vaccine... 24 Measles, mumps and rubella (MMR) vaccine... 25 Diphtheria, tetanus, pertussis and polio booster vaccination... 26 HPV vaccine against cervical cancer... 27 Monitoring the childhood vaccination programme... 29 Further information... 30 4
Introduction The health authorities in all countries recommend that children be vaccinated. Denmark s programme vaccinates children includes 10 diseases. Children adhering to Denmark s vaccination programme are well protected against developing these diseases. Recommendations of the Danish Health and Medicines Authority Since 2009, the Danish Health and Medicines Authority has recommended that children in Denmark be vaccinated against the following diseases: diphtheria; tetanus; pertussis; polio; meningitis and epiglottitis caused by Haemophilus influenzae type b; meningitis and other serious diseases caused by Streptococcus pneumoniae (pneumococci); measles; mumps; rubella; and cervical cancer (only girls are vaccinated). 5
In addition, women who did not receive the MMR (measles, mumps and rubella) vaccination as children may be vaccinated free of charge against rubella. This may take the form of an MMR vaccination. These vaccinations are free of user charges, and parents decide whether to vaccinate their children. General practitioners carry out the vaccination. The following table shows which vaccinations are recommended and when they are administered. 6
Denmark s childhood vaccination programme Age Vaccination Health check-up 5 weeks 3 months Diphtheria, tetanus, pertussis, polio, Hib 1 + PCV-1 5 months Diphtheria, tetanus, pertussis, polio, Hib 2 + PCV-2 12 months Diphtheria, tetanus, pertussis, polio, Hib 3 + PCV-3 15 months Measles, mumps and rubella (MMR) 1 2 years 3 years 4 years MMR 2 5 years Diphtheria, tetanus, pertussis and polio booster vaccination 12 years MMR a 12 years (girls only) Human papillomavirus (3 times) Women 18 years Rubella b Hib: Haemophilus influenza type b vaccine. PCV: pneumococcal conjugate vaccine. a If the child did not previously receive two MMR vaccinations. b May be administered in the form of MMR. 7
Why should children be vaccinated? Vaccination protects children from acquiring diseases that may be serious and cause permanent injury and, in the worst case, death. Some vaccines protect against illnesses that may especially be life-threatening for infants: pertussis, Haemophilus influenza type b meningitis and pneumococcal diseases. Some vaccines protect children against diseases that are so contagious that most children would normally acquire the diseases through the epidemics that would arise every few years in the absence of a vaccination programme. Children normally recover from these diseases in a few weeks, but some children during every epidemic would become severely ill from such diseases as measles, mumps and polio. Some vaccines prevent serious but rare diseases such as tetanus and diphtheria. Children who are not vaccinated will thus not be protected against infections throughout life. They risk acquiring infections at a later age at which the diseases may have more severe effects than in childhood. 8
The diseases Diphtheria Diphtheria is an infectious disease caused by Corynebacterium diphtheriae bacteria. The disease often begins with a fever and a severe throat infection with a thick coating of the throat and swelling of the mucous membranes that can cause asphyxiation. The bacteria can produce a toxin that may spread to other parts of the body. This may create myocarditis (inflammation of the heart muscle) and nervous system disorders. Diphtheria can be fatal even under optimal and modern treatment conditions. Denmark has had few cases of diphtheria in the past 50 years, but there is still a risk of acquiring it outside Denmark. Tetanus Tetanus is caused by Clostridium tetani bacteria. They are especially prevalent in soil and enter the body through such pathways as contaminated wounds. Tetanus cannot be transmitted between people. 9
The bacteria produce a toxin that enters the nervous system and leads to muscle stiffness and cramping. In the worst cases, people with tetanus cannot breathe. Infants previously acquired tetanus through contamination of the navel. Most cases are now among unvaccinated older people; there are very few cases, although some people die from it. Pertussis (whooping cough) Pertussis is caused by Bordetella pertussis bacteria, which are transmitted through airborne droplets from the respiratory tract, often expelled by coughing or sneezing. The bacteria are transmitted very easily. Pertussis can be life-threatening for infants. Pertussis initially resembles a normal cold but develops within 1 2 weeks into very violent and prolonged coughing fits. The coughs come in rapid succession and prevent the child from breathing. Then when the child breathes in, this produces make a heaving, whooping sound. The child coughs up thick phlegm and may vomit during an attack. The attacks are very exhausting, and infants do not have the strength to cough up the thick phlegm. 10
Mild cases among older children or adults may resemble a cold or throat infection. Infants are often infected by older siblings, and people with colds or coughs should therefore stay away from unvaccinated infants. Physicians may administer prophylactic antibiotics to infants exposed to pertussis. Poliomyelitis Polio is caused by poliovirus, which is very contagious. Polio has different manifestations. Most people have no symptoms, but some people have mild fever and headache for a few days. A small minority have symptoms in the nervous system that include severe paralysis. The paralysis may affect a few muscle groups or be so extensive that the respiratory muscles are paralysed. Some people are paralysed permanently, and others recover. Polio can be fatal. Polio has not been reported in Denmark since 1976, but there have been large outbreaks recently in eastern Europe and central Asia (including Kazakhstan, the Russian Federation and Turkmenistan) with up to 500 people infected and 30 dying. Wild poliovirus is still present in Afghanistan, Nigeria and Pakistan. 11
The widespread campaigns for polio vaccination led by the World Health Organization are assumed to be able to eradicate polio. Meningitis and epiglottitis caused by Haemophilus influenzae type b Haemophilus influenzae type b are bacteria that may cause serious diseases such as meningitis and epiglottitis, especially among young children. Children with meningitis have high fever and are acutely ill. They may be drowsy, and respiration may be affected. Meningitis and epiglottitis can be fatal. Permanent complications of Haemophilus influenzae type b infections include impaired hearing and brain damage. Before the vaccination for Haemophilus influenzae type b was added to Denmark s childhood vaccination programme in 1993, an average of about 2 children died annually from Haemophilus influenzae type b disease. This has been nearly eradicated in Denmark but might return if vaccination is discontinued. 12
Note that the Haemophilus influenzae type b vaccination does not protect against the types of meningitis caused by other bacteria or viruses. Meningitis and other diseases caused by pneumococci Pneumococci (Streptococcus pneumoniae) are bacteria, and there are many strains. Infection with pneumococci often causes acute middle-ear or sinus infections or pneumonia. Pneumococci cause the most severe illness when they enter the bloodstream and cause septicaemia and/ or meningitis. Severe pneumococcal diseases may cause permanent disabilities such as impaired hearing and brain damage and occasionally death. Young children, older people and people with reduced immune functioning are especially vulnerable to pneumococcal diseases. The risk of severe pneumococcal disease declines substantially towards the age of 2 years, and children older than 4 years have a very small risk of acquiring severe pneumococcal diseases. Before the vaccination was added to the childhood vaccination programme, Denmark had about 20 annual cases of meningitis and about 50 13
other severe cases of pneumococcal diseases among children younger than 2 years. Measles Measles is caused by morbillivirus, a very contagious virus. Measles usually begins with high fever and a cold, with a red, blotchy rash. There are often comorbid diseases such as middle-ear infection and pneumonia. There may occasionally be complications such as encephalitis, which can cause permanent brain damage, deafness and death. Before Denmark added the MMR vaccination to the childhood vaccination programme in 1987, nearly all children acquired measles. Measles has been rare in Denmark for many years, but Denmark had an outbreak in January 2011 in connection with a large outbreak in Europe that was the largest in 15 years. The epidemic in Europe caused several hundred otherwise healthy children to die. Mumps Mumps is caused by the mumps virus, which is less contagious than the measles virus. 14
This virus causes inflammation and swelling of the salivary glands and mild fever and general malaise. Between 1% and 10% of the people who acquire mumps experience mild meningitis. Some children become deaf in one ear after having mumps. Mumps may infect boys testicles (orchitis) during or after puberty. This can reduce the quantity of sperm they produce, either temporarily or permanently. Rubella (German measles) Rubella is a disease caused by rubellavirus that is mild among children. Among children, the disease often begins with coldlike symptoms and mild fever. After about 24 hours, the lymph nodes in the neck get sore and swollen and a rash may emerge. The rash is blotchy and reddish and declines after a few days. Rubella may also occur without any rash or completely without symptoms. Vaccination against rubella is mainly given to prevent children from transmitting the virus to pregnant women. A pregnant woman who has rubella in the first 15
half of pregnancy risks giving birth to a child with congenital deformities such as eye abnormalities, impaired hearing, brain or damage or heart disease. Many other viral diseases resemble rubella, so an adult woman cannot determine whether she has had rubella. All children are therefore offered MMR vaccination, which includes rubella vaccine. The women who turn 18 years without having received MMR vaccine are offered rubella vaccination free of charge. This may be offered as MMR vaccination. Cervical cancer Cervical cancer is caused by certain strains of human papillomavirus (HPV). This is transmitted through sexual contact and can occasionally cause other types of cancer. HPV is very common, especially among young people. Many people do not have symptoms, and the infection clears up spontaneously for most people. Nevertheless, some people continue to carry the virus, and this may result in cellular changes that may cause cancer many years later. 16
Vaccination protects against the two strains of HPV that cause most cases of cervical cancer. The vaccine is estimated to protect against 70% of cases of cervical cancer. Since HPV vaccination does not protect against all cases of cervical cancer, all women are invited to be screened for any cellular changes in the cervix from the time they turn 23 years. This screening programme will be able to find and treat the preliminary stages of disease before they develop into cancer. Other types of HPV may cause anogenital warts (located on or near the sex organs). These are harmless but annoying. Read more at www.sst.dk (in Danish). 17
The vaccinations The table below shows when each vaccination was added to Denmark s childhood vaccination programme. YEAR ADDED TO THE CHILDHOOD VACCINATION PROGRAMME Diphtheria 1943 Tetanus 1949 Polio 1955 Pertussis 1961 Measles, mumps, rubella (MMR) 1987 Haemophilus influenzae type b 1993 Pneumococcal diseases 2007 Cervical cancer (HPV) 2009* * October 1, 2008 for girls born in 1993, 1994 and 1995. The vaccinations that have been administered for many years have resulted in the diseases nearly being eradicated or at least affecting very few children or adults. A vaccination programme only succeeds if nearly all the target group is vaccinated because otherwise the diseases continue to spread. When the authorities decide which vaccinations to recommend, they assess whether each infectious 18
disease is serious enough that vaccination should be recommended for all children, whether the vaccine is safe and whether it can be fit into the existing vaccination programme. Questions and answers on vaccination How do vaccines work? Vaccines can be either inactivated (killed) vaccines, which include components of the killed but virulent viruses or bacteria, or live vaccines, comprising viruses or bacteria in a live but attenuated form. Vaccination causes the child s immune system to create antibodies that protect against the microbes that cause illness in the same way as if the child had acquired the disease. When the child later encounters this virus or bacterium, the body remembers this and the antibodies fight the microbes. The child has become immune. Can several vaccines be administered simultaneously? Efforts are made to inject children as few times as possible. Trials with vaccines have shown that vaccination against several diseases can be carried out simultaneously so that children get fewer injections. 19
Where are the vaccines injected? The location of the injection differs for each type of vaccine, but young children are normally vaccinated in the thigh and older children in the shoulder. Should ill children be vaccinated? Children who are ill, such as running a fever, are not normally vaccinated. Nevertheless, children who have a mild cold can be vaccinated. If a vaccination is postponed, the vaccination series does not have to be started over. Side effects Vaccines generally have few side effects, and the side effects are much rarer and less serious than the conditions resulting from the diseases. During a vaccination series, most children will have a mild reaction at some point, with such symptoms as swelling at the vaccination site, brief fever or a rash. These side effects are expected. About 360,000 vaccinations are administered to children annually in Denmark, and about 200 cases of side effects are reported each year. Most are local swelling at the injection site, rash or fever. 20
Children who have been vaccinated may also become irritable or drowsy, sleep poorly, vomit or have diarrhoea and reduced appetite. Less frequent side effects include febrile seizures and a few more serious side effects. Physicians are required to notify the Danish Health and Medicines Agency of any severe or unexpected side effects. A legislative amendment adopted on 1 July 2003 enables patients and their family members to register side effects on a form available at pharmacies or at www.meldenbivirkning.dk (for English, click on the British flag after you arrive at the page). Both pharmacies and the website provide guidance on how to fill out the form. If the vaccination is associated with permanent injury, this should also be reported to the Danish Patient Insurance Association, and compensation may be awarded. Note that young children occasionally acquire infections or other diseases during the period when the vaccination is administered. Parents must therefore always assess whether a child who seems ill with such symptoms as high fever in the days after vaccination should be taken to a physician to determine whether the cause is vaccination or illness. 21
Where is more information available on vaccines? The physician who administers the vaccination can inform the parents about the effects and any side effects of the vaccines. In addition, many parents will have discussed the vaccinations with a public health nurse by this time. Diphtheria, tetanus, pertussis, polio and Haemophilus influenzae type b vaccine The vaccine used against diphtheria, tetanus, pertussis, polio and Haemophilus influenzae is administered to children three times: at 3, 5 and 12 months. The vaccine comprises completely detoxified components of the toxoids of the bacteria that cause diphtheria, tetanus and pertussis and inactivated poliovirus and components of the inactivated Haemophilus influenza type b bacteria. The type of pertussis vaccine introduced in Denmark in 1997 causes many fewer side effects than the type previously used. For how long is the vaccine effective? The three vaccinations effectively protect against diphtheria, tetanus, pertussis and polio until children reach 5 6 years of age. 22
Children should receive a booster vaccination at 5 years of age against diphtheria, tetanus, pertussis and polio and will then be protected against diphtheria and tetanus for a further 10 years. The period of effective protection against pertussis is probably the same. Protection against polio after this booster vaccination is considered to be lifelong. Three vaccinations against Haemophilus influenza type b are assumed to completely protect children, and they do not need booster vaccinations. What are the side effects of diphtheria, tetanus, pertussis, polio and Haemophilus influenzae type b vaccine? The most frequent side effects are reddening and tenderness at the vaccination site. A few children also have fever and general malaise for the first few days after vaccination. Some children with fever will have febrile seizures, especially children who tend to get these. Each year a couple of cases of prolonged crying are reported; these were especially frequent after vaccination with the previous pertussis vaccine, which contained whole inactivated pertussis bacteria. The cause of this reaction is not known, but after the prolonged crying the children recovered. 23
More than 180,000 children per year are vaccinated in Denmark with the diphtheria, tetanus, pertussis, polio and Haemophilus influenzae type b vaccine, and the coverage is very high. Pneumococcal vaccine Pneumococcal vaccine contains cell components of 13 strains of pneumococci that cause about 75% of the cases of serious pneumococcal disease among children 6 24 months old in Denmark. The vaccine also prevents a few of the cases of pneumonia and middle-ear infection among children. The pneumococcal vaccine used for children younger than 2 years is administered three times at 3, 5 and 12 months, at the same times as the diphtheria, tetanus, pertussis, polio and Haemophilus influenzae type b vaccination. The injection sites should be different. Note that pneumococcal vaccine does not protect against all types of pneumococci but against most of the strains that cause serious illness among young children. Vaccinated children thus still have a slight risk of developing meningitis from pneumococci. 24
For how long is the vaccination effective? The vaccine is effective until the child reaches 4 years, and after that the risk of severe pneumococcal disease is very low. A booster vaccination is only recommended for children with special diseases. What are the side effects? Up to half of all children have fever exceeding 38 C after vaccination. A few percent exceed 39.5 C and may therefore have febrile seizures. More than one third are tender and swollen at the vaccination site. Hypersensitivity reactions are rarely reported. Measles, mumps and rubella (MMR) vaccine MMR vaccine is administered at 15 months and 4 years of age. Children who were not vaccinated twice previously are vaccinated at 12 years. The vaccine comprises live attenuated virus, which may produce a mild infection. The vaccine has been used in Denmark since 1987, and more than 100,000 children receive MMR vaccination annually in Denmark. Since the proportion of children in Denmark not being vaccinated has exceeded 10 15% for the past several years, minor epidemics of these three diseases may emerge. 25
For how long is the vaccination effective? When children receive two vaccinations they are considered to be protected for life. The body can remember that it has encountered a virus and has created antibodies that protect the body against the microorganisms. What are the side effects? Since the vaccine comprises live attenuated virus, children may develop mild symptoms similar to the disease 1 2 weeks after vaccination. Most side effects include fever, a cold or rashes, but the children are not contagious. Children who have previously had febrile seizures may benefit from medicine prescribed by a physician if they have fever after vaccination. Meningitis arises in very rare cases after vaccination. Diphtheria, tetanus, pertussis and polio booster vaccination This vaccine has the same cell components as the diphtheria, tetanus, pertussis, polio and Haemophilus influenzae type b vaccine but with reduced concentration for diphtheria and pertussis. Children receive a booster vaccination against diphtheria and tetanus at 5 years of age to ensure long- 26
term protection against both diseases. This protects the children for an additional 10 years. Protection against pertussis probably lasts the same amount of time. Protection against polio is considered lifelong. A booster vaccination against pertussis was added to Denmark s childhood vaccination programme on 1 September 2003. In addition to protecting the children themselves against pertussis, the pertussis booster vaccination reduces transmission to infants who have not been vaccinated against pertussis. The booster vaccination against polio for children 5 years of age was added to the childhood vaccination programme on 1 July 2004. What are the side effects? There is occasionally local swelling at the vaccination site. HPV vaccine against cervical cancer HPV vaccine is only given to girls as part of Denmark s childhood vaccination programme. It protects against the two types of HPV that cause 70% of all cases of cervical cancer and protects against several other types of cancer of the reproductive organs. Further, it protects against the two types of HPV 27
that cause 90% of the cases of anogenital warts. The HPV vaccine comprises small virus-like particles. It is prophylactic and should be administered before the girls are infected with the virus against which the vaccine protects. Girls are therefore vaccinated at 12 years of age before sexual initiation. The vaccine is administered three times, with about 2 months between the first and second vaccinations and at least 4 months between the second and third vaccinations. The vaccination is free of charge for girls 12 14 years old. For how long is the vaccination effective? The vaccine is assumed to be effective for a long time. Nevertheless, this is a new vaccine, so this is not known with certainty. Booster vaccinations may be necessary after a few years. What are the side effects? Many of the people vaccinated are tender, reddened and swollen at the vaccination site. Some have mild fever. In rare cases, the vaccine causes hypersensitivity reactions. Read more at www.sst.dk (Danish only). 28
Monitoring the childhood vaccination programme The childhood vaccination programme is continually monitored to determine whether it is functioning as intended. The numbers of cases of the diseases against which children have been vaccinated are registered. Further, the numbers of vaccinations administered by physicians and the numbers and types of side effects reported are recorded. The programme can be changed if necessary. Denmark s childhood vaccination programme functions well, and the diseases against which children are protected are therefore very rare in Denmark. Nevertheless, this is no reason to stop vaccinating. In addition to the continued risk of transmission in Denmark, children living in Denmark also risk being infected when travelling outside Denmark and risk bringing the microbes to Denmark. 29
Further information www.sst.dk/en Danish Health and Medicines Authority The Authority provides information on infectious diseases generally and on vaccination programmes. See Infectious diseases. For product information on medicines and side effects, see www.dkma.dk. www.ssi.dk Statens Serum Institut Statens Serum Institut provides information on the childhood vaccination programme, the individual diseases and vaccines. www.euro.who.int World Health Organization (WHO) Regional Office for Europe Click on What we do Health topics Vaccines and immunization. The WHO Regional Office for Europe provides information on WHO s objectives for childhood vaccination programmes and vaccination statistics in the WHO European Region. WHO has many publications on vaccines and immunization. 30
Published by the Danish Health and Medicines Authority in collaboration with Rosendahls-Schultz Grafisk a/s www.sst.dk 1, Axel Heides Gade DK-2300 Copenhagen S Tel.: +45 72 22 74 00 E-mail: sst@sst.dk