1. Vaccination against tuberculosis
Vaccination against tuberculosis is done with the live attenuated vaccine, so-called BCG vaccine. Vaccination is done with one (1) dose of 0.05 ml with the BCG vaccine syringe. The vaccine is given intradermally in the upper arm. Children are vaccinated immediately after birth. Children who for whatever reason were not vaccinated at the maternity hospital should be vaccinated as soon as possible. The effectiveness of the vaccine largely depends on the timing of the vaccine (earlier the better). If the BCG vaccine was not given at the scheduled time with the vaccination calendar, it can be given with other vaccines (simultaneously), up to 12 months old. Regardless of the child's age, their vaccination is done without the PPD test. If the child has proof of having been vaccinated with BCG vaccine, but no cicatrix has formed, that child is considered vaccinated and the dose should not repeated (the child should not be vaccinated again with BCG vaccine).
2. Vaccination against diphtheria
Diphtheria toxoid is combined with tetanus toxoid as diphtheria and tetanus (DT) vaccine or tetanus and diphtheria toxoid (Td) vaccine. Diphtheria toxoid is also combined with both tetanus toxoid and pertussis vaccine such as the DTaP/DTP or Tdap vaccine. Td contains reduced amounts of diphtheria toxoid compared to DT. Children younger than 7 years old should receive the DTaP vaccine or the DT vaccine (in cases where the pertussis vaccine component is contraindicated or when the doctor decides that the pertussis vaccine should not be administered). Persons of 7 years or older should receive the Td vaccine. The vaccine used is the combined vaccine containing DTaP-IPV/Hib - the first 4 doses of vaccines are used in children aged 6 weeks to 4 years old.
Characteristics
Vaccines containing diphtheria toxoid are administered by intramuscular injection. Each dose of vaccine containing diphtheria toxoid contains aluminum as an adjuvant, but not a preservative. DTaP-IPV/Hib, neomycin and polymyxin B as antibiotics.
Vaccination schedule and it`s use
DTaP (diphtheria, tetanus, and pertussis vaccine) is recommended for children aged from 6 weeks to 6 years old. The routine schedule is a primary series of 3 doses at 2, 4, and 6 months of age, a booster dose between 15 and 18 months of age, and another booster dose between 4 and 6 years of age (total of 5 doses). The first 3 doses should be given at intervals of 4 to 8 weeks (minimum 4 weeks). Dose 4 should follow dose 3 by no less than 6 months and should not be administered before 12 months of age.
Dose 4 of DTaP is recommended to be administered at 15 to 18 months of age. Dose 4 can be given as early as 12 months of age if at least 6 months have passed since dose 3 and with the opinion of the vaccine provider, the child dosën`t to return for an additional visit between 15 and 18 months of age.
Children that have received 4 doses before their fourth birthday should receive a fifth dose of DTaP before starting school. The fifth dose is not necessary (but may be given) if dose 4 in the series was given on or after the fourth birthday. Administration of the fifth dose increases antibody levels and may decrease the risk of school-age children passing the disease on to younger siblings who are not fully vaccinated.
If the child has a valid contraindication to the pertussis vaccine, DT should be used to complete the vaccination series. If the child was younger than 12 months when the first dose of DT (such as DTP, DTaP or DT) was administered, the child should receive a total of 4 doses of DT. If the child was 12 months or older at the time of the first dose of DT, 3 doses (with dose 3 given 6 to 12 months after dose 2) will complete the primary DT series. If dose 4 of DTP, DTaP, or DT is administered before the fourth birthday, a fifth dose at 4 to 6 years of age is recommended.
DTaP-IPV/Hib
The DTaP-IPV/Hib vaccine is approved for use as a 4-dose series for children aged 6 weeks to 4 years old. It is given to children aged 2, 4, 6 and 15 to 18 months. The minimum intervals for DTaP-IPV/Hib vaccine are determined by the DTaP component. The first 3 doses should be separated by at least 4 weeks between the doses. Dose 4 should be apart from dose 3 by at least 6 months and should not be administered before 12 months of age. When DTaP-IPV/Hib vaccine is used to provide 4 doses at 2, 4, 6, and between 15 and 18 months of age (based on DTaP and Hib schedules), an additional booster dose with individual standard IPV or DTaP-IPV vaccine should be administered at 4 to 6 years of age. This will result in a 5 dose IPV vaccine series which is acceptable.
Contraindications and precautions to vaccination
As with other vaccines, a history of severe allergic reaction (anaphylaxis) to a vaccine component or after a previous dose is a contraindication for further doses. Moderate or severe acute illness (with or without fever) in a patient is considered as a precaution against vaccination, although persons with a mild illness may be vaccinated. Contraindications for combination vaccines containing DTaP include contraindications for individual component vaccines (eg, IPV, hepatitis B, Hib), but the specific components may vary. Encephalopathy not attributable to another identifiable cause occurring within 7 days after DTaP vaccination, DTP is a contraindication to DTaP vaccination. A progressive or unstable neurological disorder, uncontrollable seizures, or progressive encephalopathy is a precaution against DTaP vaccination. For persons with known or suspected neurological conditions, DTaP vaccination should be delayed until the condition is evaluated, treatment is initiated, and their condition has stabilized. These conditions include the presence of a developing neurologic disorder (eg, uncontrolled epilepsy, infantile spasms, and progressive encephalopathy); a history of seizures that has not been assessed; or a neurologic event occurring between vaccine doses.
Guillain-Barré syndrome within 6 weeks after a previous dose of tetanus toxoid-containing vaccine is a precaution for DTaP, DT, and Td vaccination. History of Arthus-type hypersensitivity reactions after a previous dose of diphtheria toxoid-containing or tetanus toxoid-containing vaccine is a precaution for DTaP, DT, and Td vaccination; vaccination should be postponed until at least 10 years have passed since the last vaccine containing tetanus toxoid.
Vaccine safety
The DTaP vaccine may cause small reactions such as pain, redness, or swelling. Small reactions have been reported in 20% to 40% of children after each of the first 3 doses. Reactions seem to be more frequent after the fourth and/or fifth dose. Mild systemic reactions such as drowsiness, restlessness and low fever may also occur. High fever is reported in 3% to 5% of DTaP recipients. These reactions are self-limited and can be managed with symptomatic treatment with acetaminophen or ibuprofen. Moderate or severe systemic reactions (such as higher fever, febrile convulsions, persistent crying lasting for 3 hours or more, and hypotonic-hyporesponsive episodes) have been reported after DTaP administration, but occur less frequently than in children that received whole-cell DTP. Rates of moderate or severe systemic reactions vary by symptom and vaccine, but usually occur in less than 1 in 10,000 doses.
Vaccine storage and handling
DTaP/DTP, Td vaccines should be stored between 2°C and 8°C.
3. Vaccination against haemophilus influenzae type B
The Hib vaccine is a conjugate vaccine. Conjugation is the process of chemically linking a polysaccharide to a more effective protein carrier. This process changes the polysaccharide from a T-independent to a T-dependent antigen and greatly improves immunogenicity, especially in young children. Three monovalent Hib polysaccharide-protein conjugate vaccines are currently licensed for use. Two Hib-containing combination vaccines are currently licensed for use, DTaP-IPV/Hib and DTaP-IPV-Hib-HepB
Characteristics
Hib vaccines are administered through intramuscular injection. Each dose of Hib vaccine contains aluminum as an adjuvant. Monovalent Hib vaccines do not contain antibiotics or preservatives. The specific ingredients for combination vaccines containing the Hib vaccine can vary.
Vaccination schedule and it`s use
All infants should receive a primary series of Hib conjugate vaccines (monovalent or combination vaccine) starting at 2 months of age. The number of doses in the primary series depends on the type of vaccine used. A primary series requires 3 doses. A booster dose at 12 to 15 months of age is recommended, regardless of which vaccine is used for the primary series. The recommended age for dose 4 of DTaP-IPV/Hib is 15 to 18 months of age, but it can be administered as early as 12 months of age, provided at least 6 months have passed since dose 3.
Routine vaccination program for Haemophilus influenzae type b (Hib)
The recommended interval between doses in the primary series is 8 weeks, with a minimum interval of 4 weeks. At least 8 weeks should separate the booster dose from the previous dose (2 or 3). If DTaP-IPV/Hib is administered for the booster dose, at least 6 months must have elapsed since dose 3. Limited data suggest that Hib conjugate vaccines administered before the infant is 6 weeks old may induce immunological tolerance and reduce response to subsequent Hib vaccine doses. Therefore, Hib vaccines, including combination vaccines containing Hib conjugate vaccine, should never be given to a child younger than 6 weeks old. Unvaccinated children from 7 months or older may not need a full series of 3 or 4 doses. The number of doses a child needs to complete the series depends on the child's current age.
DTaP-IPV/Hib
The DTaP-IPV/Hib vaccine is used as a 4-dose series for children aged 6 weeks to 4 years old. It is given to babies aged 2, 4, 6 and 15 to 18 months old. The minimum intervals for DTaP-IPV/Hib vaccine is determined by the DTaP component. The first 3 doses should be separated by at least 4 weeks between them. Dose 4 should be separated from dose 3 by at least 6 months and should not be administered before 12 months of age.
Vaccination of special groups and older children
Children younger than 24 months that develop invasive Hib disease should be considered susceptible and should receive the Hib vaccine. Vaccination of these children should be started as soon as possible during the recovery phase of the disease. A full series should be administered as recommended for the child's age. Children aged 12 to 59 months old who are at increased risk for Hib disease, including chemotherapy recipients and those with anatomic and functional asplenia (including sickle cell disease), HIV infection, immunoglobulin deficiency or early complement component deficiency, that received no doses or only 1 dose of Hib vaccine before the age of 12 months should receive 2 additional doses of Hib vaccine, 8 weeks apart. Children that received 2 or more doses of Hib vaccine before age 12 months old should receive 1 additional dose.
If a child younger than 5 years old that is undergoing chemotherapy or radiation treatment has received a dose of Hib vaccine within 14 days of the start of therapy or during therapy, he/she should receive a repeat dose at least 3 months after the end of therapy. Generally, Hib vaccination of persons older than 59 months is not recommended. Most older children are immune to Hib, possibly from asymptomatic infection as infants. However, some older children and adults are at increased risk for invasive Hib disease and can be vaccinated if they were not vaccinated in childhood. A single dose of any Hib-containing vaccine should be given to persons 15 months of age or older undergoing elective splenectomy if they are considered unimmunized. "Unimmunized" means they have not received a primary and booster series or at least 1 dose of Hib vaccine after 14 months of age. If possible, the vaccine should be administered at least 14 days before the procedure. Hib vaccine should be administered to children of 5 years of age and older and adults who have anatomic or functional asplenia if they are considered as unimmunized. Hib vaccine should be given to children and adolescents aged 5 to 18 years if they have HIV and are considered unimmunized. Adults with HIV do not need a dose of Hib vaccine. Hematopoietic stem cell transplant recipients of any age should receive 3 doses of Hib vaccine at least 4 weeks apart, beginning 6 to 12 months after transplantation, regardless of Hib vaccination history.
Immunogenicity and vaccine efficacy
Hib conjugate vaccines are highly immunogenic. More than 95% of infants develop protective levels of antibodies after a primary series. Clinical efficiency has been estimated from 95% to 100%. Invasive Hib disease is uncommon in children that are fully vaccinated. Hib vaccine is also immunogenic in patients at increased risk for invasive disease, such as those with sickle cell disease, leukemia, or those who have had a splenectomy. In persons with HIV infection, immunogenicity varies with the stage of infection and the degree of immunocompromise.
Contraindications and precautions to vaccination
A history of severe allergic reaction (anaphylaxis) to a vaccine component or after a previous dose is a contraindication for further doses. Moderate or severe acute illness with or without fever in a patient is considered a precaution against vaccination, although persons with mild illness may be vaccinated. Hib conjugate vaccines are contraindicated in children younger than 6 weeks of age due to the potential for development of immunological tolerance. Contraindications for combination vaccines containing Hib include contraindications for individual component vaccines, but the specific components may vary.
Vaccine safety
Adverse reactions after Hib conjugate vaccines are not common. Swelling, redness, or pain has been reported in 5% to 30% of recipients and usually resolves within 12 to 24 hours.
Vaccine storage and handling
Hib vaccines should be stored between 2°C and 8°C.
4. Vaccination against viral hepatitis B
Hepatitis B vaccines are available in both pediatric and adult formulations. HBV infection cannot result from the use of the recombinant vaccine as no potentially infectious viral DNA or whole viral particles are produced in the recombinant system. There are also combination vaccines that contain the HepB vaccine.
Characteristics
The recombinant HepB vaccine is produced by introducing a plasmid containing the gene for HBsAg into yeast (Saccharomyces cerevisiae or Hansenula polymorpha) and containing yeast proteins. HepB vaccines are administered by intramuscular injection. Each dose of HepB vaccine contains aluminum as an adjuvant. They are administered as a series of 3 doses in a program of 0, 1, 6 months.
Vaccination schedule and it`s use
Babies and Children
HepB vaccination is recommended for all medically stable infants weighing at least 2000 grams within 24 hours of birth. Only the single-component vaccine should be used for the birth dose and doses administered before 6 weeks of age. The usual schedule is 0, 1 to 2 and 6 to 18 months.
Infants born to mothers that are HBsAg positive should receive birth dose of HepB vaccine and HBIG within 12 hours of birth. HepB vaccine and HBIG should be administered in separate limbs. For infants weighing less than 2000 grams, birth dose should not be counted as part of the vaccine series because of potentially reduced immunogenicity. 3 additional doses of the vaccine should be given (for a total of 4 doses) starting when the baby is 1 month old. Infants whose mothers are HBsAg positive should receive the last dose by 6 months of age, but not before 24 weeks of age. As with infants born to HBsAg-positive mothers, for infants weighing less than 2000 grams the birth dose should not be counted as part of the vaccine series because of potentially reduced immunogenicity; 3 additional doses of the vaccine should be given (a total of 4 doses) starting when the baby is 1 month old.
Premature infants weighing less than 2000 grams have a reduced response to HepB vaccine administered before 1 month of age. However, according to chronological age, 1-month-old preterm infants, regardless of initial birth weight or gestational age are as likely to respond adequately as full-term infants. Preterm, low-birth-weight infants whose mothers are HBsAg-negative can receive the first dose of HepB vaccine at 1 month old. Premature infants discharged before the are 1 month old may receive the HepB vaccine when discharged if they are medically stable and have gained weight consistently, even if they are less than 2000 grams. The third dose of HepB should be administered at least 8 weeks after the second dose and at least 16 weeks after the first dose. The minimum interval between the first and second dose is 4 weeks.
Adolescents
Routine HepB vaccination is recommended for all children and adolescents up to the age of 18. All children who have not previously been vaccinated with the HepB vaccine should be vaccinated.
Adults
The HepB vaccine is recommended for all unvaccinated adults at risk for HBV infection and for all adults seeking protection from HBV infection.
Adults recommended for HepB vaccination include:
Immunogenicity and vaccine efficacy
More than 90% of infants, children and adolescents and more than 90% of healthy adults younger than 40 yeras old develop protective responses after a full series of HepB vaccines. Infants born to mothers that are HBsAg-positive are at high risk of HBV transmission and chronic HBV infection. HepB vaccination and 1 dose of HBIG administered within 24 hours of birth are 85% to 95% effective in preventing chronic HBV infection. HepB vaccine administered alone starting within 24 hours of birth is 70% to 95% effective in preventing perinatal HBV infection. The HepB vaccine is 80% to 100% effective in preventing infection or clinical hepatitis in those who receive the full vaccine series.
Note: Available data indicate that vaccine-induced antibody levels decline over time. However, immune memory remains intact for more than 30 years after immunization, and both adults and children with waning antibody levels are still protected against significant HBV infection (ie, clinical disease, HBsAg antigenemia, or increased significant amounts of liver enzymes). Exposure to HBV results in an anamnestic anti-HBs response that prevents clinically significant HBV infection. Chronic HBV infection has rarely been documented in vaccine responders.
For adults and children with normal immune status, vaccine booster doses are not recommended. Routine serological testing to assess the immune status of vaccinated persons is not recommended. The need for booster doses after longer intervals will continue to be evaluated as additional information becomes available. For dialysis patients who responded to the vaccine, the need for booster doses should be assessed by annual testing of vaccine recipients for antibody levels, and a booster dose should be provided when antibody levels fall below 10 mIU/mL.
Serological testing before vaccination
Vaccination of persons immune to HBV due to current or previous infection or HepB vaccination does not increase the risk of adverse effects. However, in populations that have high rates of prior HBV infection, prevaccination testing may reduce costs by avoiding vaccination of persons who are already immunized. Pre-vaccination testing consists of testing for HBsAg, anti-HBs and anti-HBc. Serological testing should not be a barrier to vaccinating vulnerable persons, especially in populations that are difficult to access. Testing is not a requirement for vaccination and in settings where testing is not feasible, vaccination of recommended persons should continue. The first dose of HepB vaccine should usually be administered immediately after blood collection for serology. Pre-vaccination testing is recommended for household, sexual or needle contacts of HBsAg positive persons, HIV positive persons, persons with elevated ALT/AST of unknown etiology, hemodialysis patients, MSM. Serologic testing is not recommended prior to routine vaccination of infants, children, or adolescents.
Serological testing after vaccination
Testing for immunity after vaccination is not routinely recommended. However, testing is recommended for persons whose subsequent management depends on knowledge of their immune status, including infants born to HBsAg-positive mothers or mothers whose HBsAg status remains unknown, hemodialysis patients, and others who may require ambulatory hemodialysis (eg, predialysis, peritoneal dialysis, and home dialysis), HIV-infected persons, other immunocompromised persons (eg, hematopoietic stem cell transplant recipients or persons who receive chemotherapy), and sexual partners of HBsAg positive persons.
Testing should be performed 1 to 2 months after administration of the final dose of the vaccine series using a method that allows the determination of a protective anti-HBs concentration (greater than or equal to 10 mIU/mL). Persons found to have anti-HBs concentrations greater than or equal to 10 mIU/mL after the primary vaccine series are considered to be immune. Immunocompetent persons have long-term protection and do not need further periodic testing to assess anti-HBs levels. Immunocompromised persons may need annual testing to assess anti-HBs concentrations.
Persons found to have anti-HBs concentrations less than 10 mIU/mL after the primary vaccine series should be revaccinated. Administration of all doses in the second series, according to an appropriate schedule, followed by anti-HB testing 1 to 2 months after the final dose is usually more practical than serologic testing after one or more doses of vaccine (unless when babies born to HBsAg positive mothers are revaccinated). Infants born to HBsAg-positive women should be tested for HBsAg and anti-HB 1 to 2 months after completion of the final dose of the HepB vaccine series, at 9 to 12 months of age. If HBsAg is not present and the anti-HBs antibody is greater than or equal to 10 mIU/mL, children can be considered protected.
Vaccine non-responsivness
Several factors have been associated with non-response to the HepB vaccine. These include vaccine factors (eg, dose, schedule, place of injection) and host factors. People that don`t respond to the first round of HepB vaccine should get a second round of vaccinations. The second series of vaccines should be given at the usual 0, 1, 6 month schedule. Healthcare workers and others for whom postvaccination serological testing is recommended should be retested 1 to 2 months after completing the second series of vaccines. Less than 5% of persons receiving 6 doses of HepB vaccine administered according to the appropriate schedule into the deltoid muscle fail to develop detectable anti-HBs antibodies. One reason for continued non-response to the HepB vaccine is chronic HBV infection. Persons who fail to develop detectable anti-HBs after 6 doses should be tested for HBsAg and anti-HBc
Post-exposure management
Persons who have written proof of a complete series of HepB vaccines and who have not had the post-vaccination test should receive a single booster dose of the vaccine after non-occupational exposure to an HBsAg-positive source. Persons who are in the process of vaccination but have not completed the vaccine series should complete the vaccine series and receive the appropriate dose of HBIG as soon as possible. Studies are limited to the maximum post-exposure interval during which post-exposure prophylaxis is effective, but the interval is unlikely to exceed 7 days for percutaneous exposure and 14 days for sexual exposure. Unvaccinated persons should receive HBIG and a dose of HepB vaccine as soon as possible after exposure (preferably within 24 hours) and complete the HepB vaccine series according to the appropriate schedule. HepB vaccine can be administered simultaneously with HBIG at a separate injection part of the body, i.e., in different limbs.
Contraindications and precautions to vaccination
A history of severe allergic reaction (anaphylaxis) to a vaccine component or after a previous dose is a contraindication for further doses. Moderate or severe acute illness (with or without fever) in a patient is considered a precaution against vaccination, although persons with mild illness may be vaccinated.
The estimated incidence of anaphylaxis among HepB vaccine recipients is 1.1 per million vaccine doses administered. Some HepB vaccine products contain latex, which can cause allergic reactions. Vaccination is not contraindicated in persons with a history of multiple sclerosis, Guillain-Barré syndrome, autoimmune diseases (eg, systemic lupus erythematosus or rheumatoid arthritis), or other chronic diseases. Contraindications to combination vaccines containing the HepB vaccine include contraindications to individual component vaccines (eg DTaP, specific components vary by vaccine.
Vaccination during pregnancy
Pregnancy is not a contraindication for HepB vaccination. Limited data suggest that developing fetuses are not at risk for adverse effects when the HepB vaccine is given to pregnant women. Available vaccines contain non-infectious HBsAg and should not pose a risk of infection to the fetus. Pregnant women that have been identified as being at risk of HBV infection during pregnancy (eg, persons with more than one sexual partner during the previous 6 months, persons who have been evaluated or treated for an STI, or persons who have an HBsAg positive sexual partner ) should be vaccinated.
Vaccine storage and handling
HepB vaccine should be stored between 2°C and 8°C.
5. Vaccination against human papilloma virus
There are three HPV types of vaccines: 9-valent (9vHPV, Gardasil 9), quadrivalent (4vHPV, Gardasil), and a bivalent HPV vaccine (2vHPV, Cervarix). All vaccines prevent infection with high-risk HPV types 16 and 18, the types that cause most cervical and other HPV-attributable cancers. In addition, the 4vHPV and 9vHPV vaccines prevent infections with HPV types 6 and 11, the types that cause anogenital warts.
Orari i vaksinimit dhe përdorimi
HPV vaccination is recommended for females and males at the ages of 9 or 15 years old to prevent HPV infections and HPV-related diseases, including some cancers. HPV vaccination is not recommended for all adults older than 26 years, as the public health benefit of vaccination in this age group is minimal. HPV vaccines are not licensed for use in persons older than 45 years. HPV vaccines are administered as a series of 1-2 or 2-3 doses, depending on age at onset and medical condition (weakened immunity, etc.).
A series of 1 or 2 doses is recommended for people that receive their first valid dose before their 15th birthday (except for people with certain immunocompromising conditions). The second and last dose should be administered 6 to 12 months after the first dose (0, schedule 6-12 months). If dose 2 is administered at least 5 months after the first dose, it can be counted as valid. If dose 2 is administered at a shorter interval, an additional dose should be administered at least 12 weeks after dose 2 and at least 6 to 12 months after dose 1.
There is no maximum interval between doses. If the HPV vaccination schedule is interrupted, the vaccine series does not need to be restarted. Routine HPV vaccination is recommended starting at age 9 for children with a history of sexual abuse or assault. Ideally, the vaccine should be administered before any exposure to HPV through sexual contact. However, people in the routine age group (up to age 26) should be vaccinated, even if they may have been exposed to HPV in the past.
Vaccination will be of less benefit to sexually active persons who are already infected with one or more types of HPV. However, HPV vaccination may provide protection against HPV vaccine types that have not already been acquired. The HPV vaccine should be administered at the same visit as other age-appropriate vaccines.
Vaccination is recommended until the age of 26. Older than this age, shared clinical decision making regarding HPV vaccination is recommended for some adults aged 27 to 45 years who are not adequately vaccinated.
Considerations for shared clinical decision-making regarding HPV vaccination of adults 27 to 45 years of age include:
HPV is a very common sexually transmitted infection. Most HPV infections are transient and asymptomatic and do not cause clinical problems.
Although new HPV infections are most often acquired in adolescence and adulthood, some adults are at risk for acquiring new HPV infections. At any age, having a new sexual partner is a risk factor for getting a new HPV infection.
People who are in a long-term, mutually monogamous sexual partnership are unlikely to get a new HPV infection.
Most sexually active adults have been exposed to some type of HPV, although not necessarily all HPV types targeted by vaccination.
No clinical antibody test can determine whether a person is already immune or still susceptible to any particular type of HPV.
The efficacy of the HPV vaccine is high in persons who have not been exposed to the vaccine type of HPV before vaccination.
Vaccine recipients should always remain seated during the administration of the vaccine, because syncope has sometimes been reported in connection with HPV vaccination, physicians should consider observing recipients for 15 minutes after vaccination.
Immunogenicity and vaccine efficacy
The HPV vaccine is highly immunogenic. More than 98% of recipients develop an antibody response to any HPV type covered within one month of completing the vaccine series. All licensed HPV vaccines are highly effective in preventing persistent infection associated with the type of HPV vaccine. To date, ongoing monitoring has shown that vaccine effectiveness remains above 90%, with no weakening of immunity for at least 10 to 12 years after vaccination.
Contraindications and precautions to vaccination
A history of severe allergic reaction (anaphylaxis) to a vaccine component or after a previous dose is a contraindication for further doses. Moderate or severe acute illness (with or without fever) in a patient is considered a precaution against vaccination, although persons with mild illness may be vaccinated.
Both 4vHPV and 9vHPV are produced using Saccharomyces cerevisiae (baker's yeast) and thus are contraindicated in persons with a history of immediate hypersensitivity to yeast.
Vaccination during pregnancy
HPV vaccines are not recommended for use during pregnancy. If a woman is found to be pregnant after starting the vaccine series, the remainder of the series should be postponed until after the pregnancy. If a dose of vaccine has been administered during pregnancy, no intervention is needed. Pregnancy testing is not necessary before vaccination.
Women that are breastfeeding can receive the HPV vaccine.
Vaccine safety
The HPV vaccine is generally tolerated well. Safety has been well established by pre-licensure trials and post-licensure monitoring and evaluation. The most common adverse reactions reported during clinical trials of HPV vaccines were reactions at the injection site. In prelicensure clinical trials, local reactions, such as pain, redness, or swelling were reported in 20% to 90% of recipients. High fever during the 15 days after vaccination was reported by 10% to 13% of HPV vaccine recipients. Although rare, anaphylaxis can occur. No other serious adverse events have been significantly associated with any HPV vaccine, based on monitoring by the CDC and FDA. Because syncope has sometimes been reported, vaccine recipients should always remain seated during vaccine administration. Health professionals should consider observing recipients for 15 minutes after vaccination.
Vaccine storage and handling
HPV vaccines should be stored between 2°C and 8°C.
6. Vaccination against measles
The measles vaccine is available as the measles, mumps, and rubella (MMR) vaccine. The MMR vaccines contains live and weakened viruses.
Characteristics
The MMR vaccine is a lyophilized preparation of live measles virus vaccine, an attenuated line of measles virus, derived from the attenuated Edmonston strain of Enders and propagated in chick embryo cell culture; live mumps virus vaccine Jeryl Lynn strain of mumps virus propagated in chicken embryo cell culture; and live rubella virus vaccine, Wistar RA 27/3 strain of live attenuated rubella virus, propagated in diploid human WI-38 lung fibroblasts. Each dose of the MMR vaccine contains neomycin as an antibiotic. Contains no adjuvants or preservatives.
Vaccination schedule and use
The MMR vaccine can be used to implement vaccination recommendations for the prevention of measles, mumps, and rubella. The MMR vaccine is licensed for use in persons 12 months of age and older.
Two doses of MMR vaccine, separated by at least 4 weeks, are recommended in routine vaccination for children aged 12 months or older. Dose 1 of the MMR vaccine should be given at 12 to 15 months of age. Dose 2 is routinely given at ages 4 to 6. All school-entering students should receive 2 doses of the MMR vaccine (with the first dose administered at 12 months of age or older). The 2nd dose of MMR vaccine can be administered as soon as possible, 4 weeks after the 1st dose.
Revaccination
Vaccine containing measles, mumps or rubella virus administered before the age of 12 months (eg depending on the epidemiological situation) should not be counted as part of the 2-dose series. Children vaccinated before 12 months of age should be revaccinated with 2 appropriately spaced doses of MMR vaccine, the first dose administered when the child is between 12 and 15 months of age (12 months if the child lives in an area where the risk of disease is high) and the second dose at least 4 weeks later.
Immunogenicity and vaccine efficacy
Measles antibodies develop in approximately 95% of vaccinated children by 12 months of age. Most people who do not respond to the first dose will respond to the second dose. Studies show that more than 99% of people who receive 2 doses of measles vaccine (with the first dose administered no earlier than their first birthday) develop serological evidence of immunity to measles. Although the antibody titer induced by the vaccine is lower than that after natural disease, both serological and epidemiological evidence indicates that vaccine-induced immunity appears to be long-lasting and possibly lifelong in most people.
Contraindications and precautions to vaccination
A history of severe allergic reaction (anaphylaxis) to a vaccine component or after a previous dose is a contraindication for further doses. Moderate or severe acute illness (with or without fever) in a patient is considered a precaution against vaccination, although persons with mild illness may be vaccinated.
MMR vaccines contain small amounts of neomycin and gelatin.
Severe immune compromise (eg, from hematologic tumors, chemotherapy, congenital immunodeficiency, long-term immunosuppressive therapy, or patients with HIV infection) is a contraindication to MMR vaccination. Patients who have not received chemotherapy for at least 3 months, whose disease remains in remission, and who have restored immunocompetence can receive the MMR vaccine.
People receiving high-dose systemic corticosteroid therapy (2 mg/kg of body weight or more per day or 20 mg or more per day of prednisone) for 14 days to one month should not receive the MMR vaccine. Available data indicate that MMR vaccination has not been associated with severe or unusual adverse reactions in HIV-infected persons who are not severely immunosuppressed, although antibody responses have been variable. The MMR vaccine is recommended for HIV-infected persons 12 months of age or older without evidence of current severe immunosuppression. The MMR vaccine is not recommended for HIV-infected persons with evidence of severe immunosuppression. A history of thrombocytopenic purpura or thrombocytopenia is a precaution for the MMR vaccine. Such persons may be at increased risk of developing clinically significant thrombocytopenia after MMR vaccination. The MMR vaccine cannot be administered to persons allergic to eggs without prior routine skin testing or the use of special protocols.
Special considerations
The effect of administration of antibody-containing blood products (eg, immunoglobulin, whole blood or packed red blood cells, or intravenous immunoglobulin) on the response to MMR vaccine is unknown. Because of possible inhibition of the response to vaccination by passively transferred antibodies, MMR vaccine should also not be administered for 3 to 11 months after receiving antibody-containing blood products. The interval between the antibody-containing blood product and receiving the MMR vaccine is determined by the type of product administered. Antibody-containing products should not be given for 2 weeks after vaccination, unless the benefits outweigh those of the vaccine. In such cases, vaccine recipients should either be revaccinated later at appropriate intervals (from 3 to 11 months) or tested for immunity and revaccinated if seronegative.
Vaccination in pregnancy
Pregnancy is a contraindication for the MMR vaccine. Pregnancy should be avoided for 4 weeks after MMR vaccination. If a pregnant woman inadvertently receives the MMR vaccine, termination of pregnancy is not recommended because the risk to the fetus appears to be extremely low. Instead, for these women individual counseling is recommended.
Vaccine safety
Studies have shown that the MMR vaccine is safe and is well tolerated. Most adverse events reported after MMR vaccination (such as fever and rash) are attributed to the measles component. After MMR vaccination, 5% to 15% of susceptible persons develop a fever of 39.4°C or higher, which usually occurs 7 to 12 days after vaccination and generally lasts 1 or 2 days. Most people with a fever have no other symptoms. The MMR vaccine is associated with a very small risk of febrile seizures—about one case for every 3,000 to 4,000 doses of MMR vaccine administered. Febrile seizures usually occur 6 to 14 days after vaccination and do not appear to be associated with any long-term consequences. Children with a personal or family history of febrile seizures or a family history of epilepsy may be at increased risk for febrile seizures after MMR vaccination. The MMR vaccine may cause a transient rash in approximately 5% of vaccine recipients, usually appearing 7 to 10 days after vaccination. Allergic reactions after administration of the MMR vaccine are rare. Immediate anaphylactic reactions to the MMR vaccine occur in 1.8 to 14.4 cases per million doses.
Arthralgias and other joint symptoms are reported in up to 25% of adult women after MMR vaccination and are associated with the rubella component. Transient lymphadenopathy sometimes occurs after receiving MMR or another rubella-containing vaccine, and parotitis has been reported rarely (less than 1%) after receiving MMR or other mumps-containing vaccines.
Rarely, the MMR vaccine can cause thrombocytopenia within two months of vaccination. The clinical course of these cases is usually transient and benign, although hemorrhage rarely occurs. Based on case reports, the risk of thrombocytopenia associated with MMR vaccine may be higher in persons who have previously had immune thrombocytopenic purpura, especially those who had thrombocytopenic purpura after a previous dose of MMR vaccine. Encephalitis has been documented after measles vaccination in immunocompromised individuals. Numerous studies refute a causal link between autism and the MMR vaccine or between inflammatory bowel disease and the MMR vaccine.
Vaccine storage and handling
For MMR storage and handling specifics, refer to the manufacturer.
7. Vaccination against mumps
The mumps vaccine is available as the measles, mumps, and rubella (MMR) vaccine. MMR vaccines contain live, weakened viruses.
Characteristics
The MMR vaccine is a lyophilized preparation of live measles virus vaccine, an attenuated line of measles virus, derived from the attenuated Edmonston strain of Enders and propagated in chick embryo cell culture; live mumps virus vaccine Jeryl Lynn strain of mumps virus propagated in chicken embryo cell culture; and live rubella virus vaccine, Wistar RA 27/3 strain of live attenuated rubella virus, propagated in diploid human WI-38 lung fibroblasts. MMR vaccines are supplied as a lyophilized (freeze-dried) powder and reconstituted with sterile, preservative-free water and the vaccine contains gelatin. The MMR vaccine is administered by the subcutaneous route. Each dose of the MMR vaccine contains neomycin as an antibiotic. It dosën`t contains adjuvants or preservatives.
Vaccination schedule and it`s use
The MMR vaccine is used to implement vaccination recommendations for the prevention of measles, mumps, and rubella. The MMR vaccine is used for people 12 months and older. Two doses of MMR vaccine, separated by at least 4 weeks, are recommended in routine vaccination for children aged 12 months or older. 1st dose of the MMR vaccine should be given at 12 to 15 months of age. 2nd dose is given in the routine vaccination at 4 to 6 years of age or in first grade. 2nd dose of the MMR vaccine can be given as soon as 4 weeks after 1st dose.
Vaccination of adults
All adults can receive 2 doses of the MMR vaccine if they have no other acceptable proof of immunity to measles, mumps and rubella
Revaccination
Vaccine containing measles, mumps, or rubella virus administered before age 12 months should not count as part of the 2-dose series. Children vaccinated before the age of 12 months should be revaccinated with 2 appropriately spaced doses of MMR vaccine.
Immunogenicity and vaccine efficacy
Approximately 94% of single-dose recipients develop measurable mumps antibodies. The seroconversion rate is similar for the single-antigen mumps vaccine, the MMR vaccine. Post-licensure studies determined that the effectiveness of the single-dose mumps or MMR vaccine was 78% and the effectiveness of the two-dose mumps vaccine was 88%.
Contraindications and precautions to vaccination
A history of severe allergic reaction (anaphylaxis) to a vaccine component or after a previous dose is a contraindication for further doses. Moderate or severe acute illness (with or without fever) in a patient is considered a precaution against vaccination, although persons with mild illness may be vaccinated.
Severe immune compromise is a contraindication to MMR vaccination. Patients that haven`t received chemotherapy for at least 3 months, whose disease remains in remission, and who have restored immunocompetence can receive the MMR vaccine.
People receiving high-dose systemic corticosteroid therapy (2 mg/kg of body weight or more per day or 20 mg or more per day of prednisone) for 14 days to one month should not receive the MMR vaccine. MMR should not be administered for at least 1 month after discontinuation of high-dose systemic corticosteroid therapy.
Available data indicate that MMR vaccination has not been associated with severe or unusual adverse reactions in HIV-infected persons who are not severely immunosuppressed, although antibody responses have been variable. The MMR vaccine is recommended for HIV-infected persons 12 months of age or older without evidence of current severe immunosuppression. The MMR vaccine is not recommended for HIV-infected persons with evidence of severe immunosuppression.
A history of thrombocytopenia is a precaution for the MMR vaccine. Such persons may be at increased risk of developing clinically significant thrombocytopenia after MMR vaccination. MMR vaccine cannot be administered to persons allergic to eggs without prior routine skin testing or the use of special protocols.
Special considerations
The effect of administration of antibody-containing blood products on the response to MMR vaccine (eg, immunoglobulin, whole blood or packed red blood cells, or intravenous immunoglobulin) is unknown. Because of possible inhibition of the response to vaccination by passively transferred antibodies, MMR vaccine should not be administered for 3 to 11 months after receiving antibody-containing blood products. The interval between the antibody-containing blood product and receiving the MMR vaccine is determined by the type of product administered. Antibody-containing products should not be given for 2 weeks after vaccination, unless the benefits outweigh those of the vaccine. In such cases, vaccine recipients should either be revaccinated later at appropriate intervals (from 3 to 11 months) or tested for immunity and revaccinated if seronegative.
Vaccination in pregnancy
Pregnancy is a contraindication for the MMR vaccine. Pregnancy should be avoided for 4 weeks after MMR vaccination. If a pregnant woman inadvertently receives the MMR vaccine, termination of pregnancy is not recommended because the risk to the fetus appears to be extremely low. Instead, for these women individual counseling is recommended.
Vaccine safety
Studies have shown that MMR vaccines are safe and well tolerated. The experts determined that the evidence supports a causal relationship between MMR vaccination and anaphylaxis, febrile convulsions, thrombocytopenic purpura, transient arthralgia, and corporal encephalitis involving measles in persons with demonstrated immunodeficiency.
Most of the side effects reported after MMR vaccination (such as fever and rash) are attributed to the measles component. After MMR vaccination, 5% to 15% of susceptible persons develop a fever of 39.4°C or higher, which usually occurs 7 to 12 days after vaccination and generally lasts 1 or 2 days. Most people with a fever have no other symptoms. The MMR vaccine is associated with a very small risk of febrile seizures; approximately one case for every 3000 to 4000 doses of MMR vaccine administered. Febrile seizures usually occur 6 to 14 days after vaccination and do not appear to be associated with any long-term consequences. Children with a personal or family history of febrile seizures or a family history of epilepsy may be at increased risk for febrile seizures after MMR vaccination. Allergic reactions after administration of the MMR vaccine are rare. Immediate anaphylactic reactions to the MMR vaccine occur in 1.8 to 14.4 cases per million doses. Rarely, the MMR vaccine can cause thrombocytopenia within two months of vaccination. The clinical course of these cases is usually transient and benign, although hemorrhage rarely occurs. Based on case reports, the risk of thrombocytopenia associated with the MMR vaccine may be higher in persons who have previously had immune thrombocytopenia, especially those who had thrombocytopenic purpura after a previous dose of the MMR vaccine.
Multiple studies refute a causal link between autism and the MMR vaccine.
Vaccine storage and handling
For MMR storage and handling specifics, refer to the manufacturer.
8. Vaccination against whooping cough
The acellular pertussis vaccine is combined with tetanus toxoid and diphtheria toxoid as DTaP. DTaP contains the same components of whooping cough. Children younger than 7 years should receive the DTaP vaccine or the DT vaccine (in cases where the pertussis vaccine component is contraindicated or when the doctor decides that the pertussis vaccine should not be administered). People 7 years of age or older should receive the Td vaccine or vaccine even if they have not completed a DTaP or DT series. Combination vaccines are available and contain the DTaP vaccine. DTaP-IPV/Hib is licensed for the first 4 doses of the component vaccines in children aged 6 weeks to 4 years.
Characteristics
Whooping cough vaccines are administered by intramuscular injection. Each dose of pertussis vaccine contains aluminum as an adjuvant, but not a preservative. DTaP-IPV/Hib, contain neomycin and polymyxin B.
Vaccination schedule and it`s use
DTaP (diphtheria, tetanus, and pertussis vaccine) is recommended for children ages 6 weeks to 6 years old. Routine vaccination is the primary series of 3 doses at 2, 4, and 6 months of age, a booster dose between 15 and 18 months of age, and another booster dose between 4 and 6 years of age (total of 5 doses). The first 3 doses should be given at intervals of 4 to 8 weeks (minimum 4 weeks). Dose 4 should follow dose 3 by no less than 6 months and should not be administered before 12 months of age.
DTaP dose 4 is recommended to be administered at 15 to 18 months of age. Dose 4 can be given from the age of 12 months if at least 6 months have passed since dose 3.
Children that have received 4 doses before their fourth birthday should receive a fifth dose of DTaP before starting school. The fifth dose is not necessary (but may be given) if dose 4 in the series was given on or after the fourth birthday.
If a child has a contraindication to pertussis vaccine, DT should be used to complete the vaccination series. If the child was younger than 12 months when the first dose of DT (such as DTP, DTaP or DT) was administered, the child should receive a total of 4 doses of DT. If the child was 12 months or older at the time of the first dose of DT, 3 doses (with dose 3 given 6 to 12 months after dose 2) will complete the primary DT series. If dose 4 of DTP, DTaP, or DT is administered before the fourth birthday, the fifth dose at 4 to 6 years of age is recommended.
DTaP-IPV/Hib
The DTaP-IPV/Hib vaccine is approved for use as a 4-dose series for children aged 6 weeks to 4 years. It is given to babies aged 2, 4, 6 and 15 to 18 months. The minimum intervals for DTaP-IPV/Hib vaccine are determined by the DTaP component. The first 3 doses should be separated by at least 4 weeks between doses. Dose 4 should be separated from dose 3 by at least 6 months and should not be administered before 12 months of age. When DTaP-IPV/Hib vaccine is used to provide 4 doses at 2, 4, 6 and between 15 and 18 months of age (based on DTaP and Hib schedules).
Immunogenicity and efficacy of the vaccine
The efficacy of the DTaP vaccine ranges from 80% to 85%.
Contraindications and precautions to vaccination
A history of severe allergic reaction (anaphylaxis) to a vaccine component or after a previous dose is a contraindication for further doses. Acute moderate or severe illness (with or without fever) is considered a precaution against vaccination, although persons with mild illness may be vaccinated.
Contraindications for combination vaccines containing DTaP include contraindications for individual component vaccines. Encephalopathy not attributable to another identifiable cause occurring within 7 days after DTaP vaccination, DTP is a contraindication to DTaP vaccination.
Progressive neurological disorder, uncontrolled seizures, or progressive encephalopathy are precautions for DTaP vaccination. For persons with known or suspected neurological conditions, DTaP vaccination should be delayed until the condition is evaluated, treatment is initiated, and the condition is stabilized. These conditions include the presence of a developing neurologic disorder (eg, uncontrolled epilepsy, infantile spasms, and progressive encephalopathy); history of seizures not evaluated; or a neurologic event occurring between vaccine doses.
Guillain-Barré syndrome within 6 weeks after a previous dose of tetanus toxoid-containing vaccine is a precaution for DTaP, DT, and Td vaccination.
History of Arthus-type hypersensitivity reactions after a previous dose of diphtheria toxoid-containing or tetanus toxoid-containing vaccine is a precaution for DTaP, DT, and Td vaccination; vaccination should be postponed until at least 10 years have passed since the last vaccine containing tetanus toxoid.
Vaccine safety
The DTaP vaccine may cause local reactions, such as pain, redness, or swelling. Reactions have been reported in 20% to 40% of children after each of the first 3 doses. Reactions seem to be more frequent after the fourth and/or fifth dose. Mild systemic reactions such as drowsiness, restlessness and low fever may also occur. Temperature of 39°C or higher is reported in 3% to 5% of DTaP recipients. These reactions are self-limited and can be managed with symptomatic treatment. Moderate or severe systemic reactions (such as higher fever, febrile convulsions, persistent crying lasting 3 hours or more, and hypotonic-hyporesponsive episodes) have been reported after DTaP administration, but occur more rarely than in children who received whole-cell DTP. The rates of these moderate or severe systemic reactions vary by symptom and vaccine, but usually occur in less than 1 in 10,000 doses.
Vaccine storage and handling
DTaP vaccines should be stored between 2°C and 8°C.
9. Vaccination against Streptococcus pneumoniae
Characteristics of the pneumococcal conjugate vaccine
PCV13 contains 13 serotypes of S. pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) conjugated to a nontoxic variant of diphtheria toxin known as CRM197. PCV13 is administered by intramuscular injection. Each dose of PCV13 contains aluminum phosphate as an excipient. It does not contain antibiotics or preservatives.
Characteristics of polysaccharide vaccine against pneumococcus
PPSV23 consists of purified preparations of pneumococcal capsular polysaccharides from 23 species of pneumococci. Serotypes are: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, and 23F. PPSV23 is administered either by intramuscular or subcutaneous injection. Each dose of PPSV23 contains phenol as a preservative. It doesn`t contains adjuvants or antibiotics.
Vaccination schedule and it`s use
All children aged 2 to 59 months in routine vaccination should receive PCV13 and all adults aged 65 years and older should receive PPSV23. In addition, people aged 2 years and older with certain health conditions should receive PCV13 and PPSV23, or only PPSV23. PPSV23 is not recommended for children younger than 2 years old. Children and adults that have a medical condition for which the PCV13 vaccine is indicated should receive PCV13 first, followed by PPSV23 at least 8 weeks later. Adults aged 65 and over that have no condition for which PCV13 is indicated can discuss with their doctor and decide whether to take PCV13 (shared clinical decision making). If the decision to take PCV13 was made based on shared clinical decision making, it should be given at least 1 year before PPSV23.
Children from 2 to 23 months old
Children should receive a primary series of 2 doses of PCV13 at age 2, 4 and dose 3 (booster) at age 12 to 15 months as routine vaccination. 1st dose can be administered as early as 6 weeks old. For doses given before the first birthday, the minimum interval between doses is 4 weeks; doses given at 12 months of age or older should be separated by at least 8 weeks. PCV13 can be administered at the same time as other vaccines in the regular schedule.
Unvaccinated children 7 months and older do not need the full series of three doses. The number of doses depends on the current age of the child and the age at which the first dose of PCV13 was administered. If the child's current age is between 7 and 11 months old, the recommended series is 2 doses at least 4 weeks apart and a booster dose at 12 to 15 months of age. If the vaccination series begins at 7 to 11 months of age and the next dose is administered after the first birthday, the next dose should be administered 8 weeks later. If the child's current age is 12 to 23 months, the recommended series is 2 doses at least 8 weeks apart.
Healthy children from 24 to 59 months
Healthy children aged from 24 to 59 months old should receive 1st dose of PCV13 if the child is unvaccinated or has received an incomplete program. Routine use of PCV13 is not recommended for healthy children aged 5 years and older.
Children aged 24 to 71 months, with certain medical conditions
Children aged 24 to 71 months with certain conditions should receive 2 doses of PCV13 separated by 8 weeks if they are unvaccinated or have received an incomplete schedule of less than 3 doses. Children with any incomplete 3-dose schedule should receive 1st dose of PCV13 at least 8 weeks after the last dose.
These children should receive a dose of PPSV23 at least 8 weeks after the final dose of PCV13. Additionally, if they are immunocompromised or have functional or anatomical asplenia, they should receive a second dose of PPSV23 five years after the first dose.
Children and adolescents aged 6 to 18 years, with certain medical conditions
Unvaccinated children and adolescents aged 6 to 18 years with certain medical conditions should receive PCV13 and PPSV23. A single dose of PCV13 should be given followed by a dose of PPSV23 at least 8 weeks later. A second dose of PPSV23 is recommended 5 years after the first dose of PPSV23 for children with anatomic or functional asplenia, or other immunocompromising conditions.
If the full three-dose series of PCV13 has been given, no additional doses are needed. If PCV13 has not been given and two doses of PPSV23 have already been given, a dose of PCV13 should be given at least 8 weeks after the last dose of PPSV23. PCV13 can also be given between two doses of PPSV23.
Some children and adolescents in this age group with certain conditions need to receive only one dose of PPSV23 if they have not already received it.
Adults from 19 to 64 years of age, with certain chronic or immunocompromising conditions
Routine use of PCV13 or PPSV23 is not recommended for healthy adults aged 19 to 64 years. Unvaccinated persons aged from 19 to 64 years with certain chronic conditions should get a dose of PPSV23 if they haven't got it already. Unvaccinated persons aged 19 years and older with certain immunocompromising conditions should receive a single dose of PCV13 followed by a dose of PPSV23 at least 8 weeks later. If a dose of PPSV23 was given first, PCV13 should be administered at least 1 year later. A second dose of PPSV23 is recommended 5 years after the first dose of PPSV23 for adults with anatomic or functional asplenia or other immunocompromising conditions.
Adults 65 years or older
A single dose of PPSV23 is recommended for all adults aged 65 years and older, regardless of previous history of pneumococcal vaccination. If any dose of PPSV23 was given before age of 65, a single, final dose of PPSV23 should be given at age 65 or at least 5 years after the last dose of PPSV23. If PPSV23 was administered at age 65 or later, no additional doses are needed.
Immunogenicity and vaccine efficacy
Pneumococcal polysaccharide vaccine
More than 80% of healthy adults who receive PPSV23 develop antibodies against the serotypes included in the vaccine, usually within 2 to 3 weeks after vaccination. Elevated antibody levels after vaccination persist for at least 5 years in healthy adults, but decline more rapidly in persons with certain preexisting diseases.
Pneumococcal conjugate vaccine
According to scientific evidence, PCV13 was shown to reduce invasive disease caused by vaccine serotypes by 97%.
Contraindications and precautions to vaccination
As with other vaccines, a history of severe allergic reaction (anaphylaxis) to a vaccine component or after a previous dose is a contraindication for further doses. Acute moderate or severe illness (with or without fever) is considered a precaution against vaccination, although persons with mild illness may be vaccinated.
Vaccine safety
Studies support the safety of PCV13 and PPSV23 in children and adults.
Pneumococcal conjugate vaccine
According to the studies, the commonly reported side reactions are local reactions (pain, tenderness, swelling and erythema), decreased appetite, fatigue, headache, muscle pain, nervousness and fever.
Vaccination in pregnancy
PCV13 and PPSV23 vaccine is not recommended during pregnancy.
Vaccine storage and handling
PCV13 and PPSV23 should be kept at refrigerator temperature between 2°C and 8°C.
10. Vaccination against Poliovirus
bOPV is a live attenuated (weakened) poliovirus vaccine that contains only poliovirus types 1 and 3. Available in multi-dose vials. It is very sensitive to heat and must be kept frozen during long-term storage. After thawing, it can be kept at a temperatures between +2 °C and +8 °C for a maximum of six months or it can be refrozen again.
IPV is an inactivated poliovirus vaccine available as a stand-alone product or in combination with diphtheria, tetanus, pertussis, hepatitis B and/or Hib. It is stable outside the cold chain but should be stored between +2 °C and +8 °C. It should not be frozen. Supplied in vials of one, five or ten doses.
OPV is given orally and IPV is injected intramuscularly in a dose of 0.5 ml.
Both bOPV and IPV vaccines are extremely safe. IPV is one of the safest vaccines that are routinely used. No serious post-vaccination adverse effects have been associated with it. Mild side effects include redness in injection site in less than 1% of vaccinees, swelling in 3-11%, and pain in 14-29%.
There are also combined vaccines containing IPV, DTaP-IPV/Hib and DTaP-IPV-Hib-HepB etc.
Characteristics
The IPV vaccine is administered either by subcutaneous or intramuscular injection. Each dose of IPV vaccine contains the antibiotics neomycin, streptomycin and polymyxin B, as well as the preservative 2-phenoxyethanol. It doesn`t contain adjuvants. The specific ingredients for the combination vaccines that contain the IPV vaccine vary.
Vaccination schedule and it`s use
DTaP-IPV/Hib
The DTaP-IPV/Hib vaccine is used as a 4-dose series for children aged 6 weeks to 4 years old. It is given to babies aged 2, 4, 6 and 15 to 18 months old. The minimum intervals for DTaP-IPV/Hib vaccine are determined by the DTaP component. The first 3 doses should be separated by at least 4 weeks between them. Dose 4 should be separated from dose 3 by at least 6 months and should not be administered before 12 months of age. When DTaP-IPV/Hib vaccine is used to provide 4 doses at ages 2, 4, 6, and between 15 and 18 months (based on DTaP and Hib schedules), an additional booster dose with bOPV should be administered at ages 4 to 6 years old. This will result in a series of 5 doses, which is considered acceptable.
Polio vaccination of adults
When an adult at increased risk of exposure to poliomyelitis has never received poliomyelitis vaccine or has no written documentation of poliomyelitis vaccination, primary immunization with IPV is recommended. The recommended schedule is 2 doses separated by 1 to 2 months, and a third dose administered 6 to 12 months after the second dose. The minimum interval between dose 2 and 3 is 6 months.
Immunogenicity and vaccine efficacy
The IPV vaccine is very effective in producing immunity to poliovirus and protection against paralytic poliomyelitis. 90% or more of vaccine recipients develop protective antibodies to all three types of poliovirus after 2 doses, and at least 99% are immune after 3 doses.
Contraindications and precautions to vaccination
As with other vaccines, a history of a severe allergic reaction (anaphylaxis) to a vaccine component or after a previous dose is a contraindication to further doses. Acute moderate or severe illness (with or without fever) is considered a precaution against vaccination, although persons with mild illness may be vaccinated.
Pregnancy
Pregnancy is a precaution against IPV/bOPV vaccination. Although no adverse effects of the IPV vaccine on pregnant women or their fetuses have been documented, vaccination of pregnant women should theoreticaly be avoided. However, if a pregnant woman is at increased risk for infection and requires immediate protection against poliomyelitis, the IPV vaccine can be administered in accordance with the recommended schedule for adults.
Vaccine safety
Local reactions are mild and transient.
Vaccine storage and handling
The IPV vaccine should be stored at a temperature between 2°C and 8°C.
11. Vaccination against Rotavirus
Two live, oral rotavirus vaccines are currently licensed for use, the RV5 (RotaTeq) and RV1 (Rotarix) vaccines.
Characteristics
The RV5 vaccine contains approximately 2 x 106 infectious units of each of five recombinant strains developed from human and bovine rotavirus strains. The RV1 vaccine contains a live, attenuated human rotavirus strain 89-12 (type G1P1A8ç). Each dose contains at least 106 mean cell culture infectious units of virus. RV1 and RV5 vaccines are administered orally. RV5 and RV1 vaccines do not contain adjuvants, antibiotics or preservatives. The oral applicator of the RV1 vaccine contains latex rubber.
Vaccination schedule and it`s use
Rotavirus vaccine is routinely recommended for infants. The vaccine should be administered orally as a series of two doses (at 2 and 4 months of age) for the RV1 vaccine or three doses (at 2, 4 and 6 months of age) for the RV5 vaccine. The vaccination series for both vaccines can start as early as 6 weeks of age. The minimum interval between doses is 4 weeks.
According to the recommendations, the maximum age for the first dose of any vaccine is 15 weeks. The minimum interval between doses of both rotavirus vaccines is 4 weeks. The maximum age for each dose of either rotavirus vaccine is 32 weeks. No rotavirus vaccine should be administered to infants older than 32 weeks.
Rotavirus vaccine should be given at the same visit/simultaneous with other recommended vaccines.
Infants documented to have had rotavirus gastroenteritis before receiving the full course of rotavirus vaccination should begin or complete the 2- or 3-dose series following age recommendations, as initial infection may provide only partial protection against subsequent rotavirus disease.
Immunogenicity and vaccine efficacy
According to evidence, the efficacy of the 2-dose series against severe rotavirus gastroenteritis up to 1 year of age was 96%. Both vaccines have demonstrated broad effectiveness across all rotavirus genotypes. The duration of immunity from the rotavirus vaccine is not precisely known, although good efficacy has been demonstrated during the first 2 to 3 years of life.
Contraindications and precautions to vaccination
A history of severe allergic reaction (anaphylaxis) to a vaccine component or after a previous dose is a contraindication for further doses. Acute moderate or severe illness (with or without fever) is considered a precaution against vaccination, although persons with mild illness may be vaccinated.
There is Latex rubber in the oral applicator of the RV1 vaccine, so infants with severe latex allergies should not receive the RV1 vaccine. The RV5 vaccine dosing tube is latex-free. Some experts prefer that infants with spina bifida or bladder exstrophy, who are at high risk for latex allergy, receive the RV5 vaccine instead of the RV1 vaccine to minimize latex exposure in these children.
In children with known or suspected immunodeficiency, an immunologist or infectious disease specialist should be consulted before the rotavirus vaccine is administered. Children that are immunocompromised due to congenital immunodeficiency or hematopoietic stem cell transplantation sometimes experience severe, prolonged, and even fatal wild-type rotavirus gastroenteritis.
Studies of currently licensed vaccines have revealed an increased risk of intussusception after administration of rotavirus vaccine. As a result, a history of intussusception is a contraindication to rotavirus vaccination.
Infants living in households with pregnant women should be vaccinated according to the routine schedule. Because most women of childbearing age have pre-existing immunity to rotavirus, the risk of infection from the attenuated vaccine virus is considered to be very low. It is prudent that all family members use measures to avoid contact with the vaccinated baby's feces, such as good hand washing after diaper changes.
Rotavirus vaccine should generally be delayed in infants with acute, moderate, or severe gastroenteritis or other acute illness until the condition improves. However, infants with mild acute gastroenteritis or other mild acute illness may be vaccinated, especially if a delay in vaccination will delay the first dose of vaccine beyond 15 weeks of age.
Vaccine safety
Clinical trials (more than 60,000 infants each) of the RV5 and RV1 vaccine evaluated the occurrence of intussusception after vaccination. No increased risk of intussusception was observed for either of these vaccines. The risk appears to be mostly during the first week after the first or second dose, but may last up to 21 days after the first dose. Parents and health care providers should be aware of the low-level increase in risk of intussusception after rotavirus vaccine so that infants with possible intussusception can be promptly evaluated.
Vaccine storage and handling
Rotavirus vaccine should be stored between 2°C and 8°C.
12. Vaccination against Rubella
The rubella vaccine is available as the measles, mumps, and rubella (MMR) vaccine. The MMR vaccine contains live, weakened viruses.
Characteristics
The MMR vaccine is the lyophilized preparation of the live measles virus vaccine, an attenuated strain of the measles virus. The vaccine is supplied as a lyophilized (freeze-dried) powder and reconstituted with sterile water, without preservatives and containing gelatin. Administered subcutaneously. Each dose of the MMR vaccine contains neomycin. Doesn`t contains adjuvants or preservatives.
Vaccination schedule and it`s use
The MMR vaccine is used in persons 12 months and older. Two doses of the MMR vaccine, separated by at least 4 weeks, are routinely recommended for children 12 months of age or older. 1st dose of the MMR vaccine should be given at 12 to 15 months of age. 2 dose is routinely given at ages 4 to 6 or in first grade. 2 dose of MMR vaccine can be given as soon as 4 weeks after 1st dose.
Revaccination
Vaccine containing measles, mumps, or rubella virus administered before age 12 months should not count as part of the 2-dose series. Children vaccinated before the age of 12 months should be revaccinated with 2 appropriately spaced doses of MMR vaccine.
Immunogenicity and vaccine efficacy
At least 95% of vaccinated persons aged 12 months or older develop serological evidence of immunity to rubella after a single dose, and more than 90% have protection against clinical rubella for at least 15 years.
Contraindications and precautions to vaccination
A history of severe allergic reaction (anaphylaxis) to a vaccine component or after a previous dose is a contraindication for further doses. Acute moderate or severe illness (with or without fever) is considered a precaution against vaccination, although persons with mild illness may be vaccinated.
MMR vaccines contain small amounts of neomycin and gelatin. People with an alpha-gal allergy may want to consult their doctor before receiving a vaccine containing gelatin.
MMR vaccination is contraindicated in persons with severely compromised immunity. Patients who have not received chemotherapy for at least 3 months, whose disease remains in remission, and who have restored immunocompetence can receive the MMR vaccine.
Persons receiving high-dose systemic corticosteroid therapy (2 mg/kg of body weight or more per day or 20 mg or more per day of prednisone) for 14 days or more should not receive the MMR vaccine because of concern about vaccine safety. MMRs should not be administered for at least 1 month after discontinuation of high-dose systemic corticosteroid therapy. Although people taking high doses of systemic corticosteroids every day or on alternate days for less than 14 days can generally receive MMR immediately after stopping treatment, some experts prefer to wait up to 2 weeks after stopping therapy.
Available data indicate that MMR vaccination has not been associated with severe or unusual adverse reactions in HIV-infected persons who are not severely immunosuppressed, although antibody responses have been variable. MMR vaccine is recommended for HIV-infected persons 12 months of age or older without evidence of severe immunosuppression. MMR vaccine is not recommended for HIV-infected persons with evidence of severe immunosuppression.
Thrombocytopenic purpura or thrombocytopenia are precautions for the MMR vaccine.
The MMR vaccine cannot be administered to persons allergic to eggs without prior routine skin testing or the use of special protocols.
Special considerations
The effects of administration of antibody-containing blood products (eg, immunoglobulin, whole blood or packed red blood cells, or intravenous immunoglobulin) on the response to MMR vaccine is unknown. Because of possible inhibition of the response to vaccination by passively transferred antibodies, MMR vaccine should not be administered for 3 to 11 months after receiving antibody-containing blood products. The interval between the antibody-containing blood product and receiving the MMR vaccine is determined by the type of product administered. Antibody-containing products should not be given for 2 weeks after vaccination, unless the benefits outweigh those of the vaccine. In such cases, vaccine recipients should either be revaccinated later at appropriate intervals (from 3 to 11 months) or tested for immunity and revaccinated if seronegative.
Vaccination during pregnancy
Pregnancy is a contraindication for the MMR vaccine. Pregnancy should be avoided for 4 weeks after MMR vaccination. If a pregnant woman inadvertently receives the MMR vaccine, termination of pregnancy is not recommended because the risk to the fetus appears to be extremely low. Instead, individual counseling is recommended for these women.
Vaccine safety
Studies have shown that MMR vaccines are safe and well tolerated. Most side effects after MMR vaccination (such as fever and rash) are attributed to the measles component. After MMR vaccination, 5% to 15% of susceptible persons develop a fever of (39.4°C) or higher, which usually occurs 7 to 12 days after vaccination and generally lasts 1 or 2 days. Most people with a fever have no other symptoms. Children with a personal or family history of febrile seizures or a family history of epilepsy may be at increased risk for febrile seizure after MMR vaccination. Allergic reactions after administration of the MMR vaccine are rare. Immediate anaphylactic reactions to the MMR vaccine occur in 1.8 to 14.4 cases per million doses. Arthralgias and other joint symptoms are reported in up to 25% of adult women after the MMR vaccine and are associated with the rubella component. Transient lymphadenopathy sometimes occurs after receiving MMR or another rubella-containing vaccine, and mumps has been reported rarely (less than 1%) after receiving MMR or other mumps-containing vaccines.
Rarely, the MMR vaccine can cause thrombocytopenia within two months of vaccination. The clinical course of these cases is usually transient and benign, although hemorrhage rarely occurs. Based on case reports, the risk of thrombocytopenia associated with MMR vaccine may be higher in persons who have previously had immune thrombocytopenic purpura, especially those who had thrombocytopenic purpura after a previous dose of MMR vaccine.
Vaccine storage and handling
For MMR storage and handling specifics, refer to the manufacturer.
13. Vaccination against tetanus
Tetanus toxoid is combined with diphtheria toxoid as diphtheria and tetanus toxoid (DT) vaccine or tetanus and diphtheria toxoid (Td) vaccine. Tetanus toxoid is also combined with both diphtheria toxoid and pertussis vaccine as the DTaP/DTP vaccine. Td contains reduced amounts of diphtheria toxoid compared to DT and DTaP/DTP. Children younger than 7 years old should receive the DTaP/DTP vaccine or the DT vaccine (in cases where the pertussis vaccine component is contraindicated or when the doctor decides that the pertussis vaccine should not be administered). Persons aged 7 years or older should receive the Td vaccine even if they have not completed a DTaP or DT series. DTP vaccines are combined diphtheria and tetanus toxoids and whole-cell pertussis vaccine. There are also combination vaccines that contain the DTaP vaccine. DTaP-IPV/Hib is licensed for the first 4 doses of component vaccines in children aged 6 weeks to 4 years. DTaP-IPV-Hib-HepB is licensed for use in children 6 weeks to 4 years of age.
Characteristics
Vaccines containing tetanus toxoid are administered by intramuscular injection. Each dose of tetanus toxoid vaccines contains aluminum as an adjuvant, but not as a preservative.
Vaccination schedule and it`s use
DTaP (diphtheria, tetanus, and pertussis vaccine) is recommended for children ages 6 weeks to 6 years old. Routine vaccination with primary series of 3 doses at 2, 4 and 6 months of age, a booster dose between 15 and 18 months of age and another booster dose between 4 and 6 years of age (5 doses in total). The first 3 doses should be given at intervals of 4 to 8 weeks (minimum 4 weeks). Dose 4 should follow dose 3 by no less than 6 months and should not be administered before 12 months of age. DTaP dose 4 is recommended to be administered at 15 to 18 months of age. Dose 4 may be given as early as 12 months of age if at least 6 months have passed since dose 3. The fifth dose is not necessary (but may be given) if dose 4 in the series was given on or after the fourth birthday.
If a child has a contraindication to pertussis vaccine, DT should be used to complete the vaccination series. If the child was younger than 12 months when the first dose of DT (such as DTP, DTaP or DT) was administered, the child should receive a total of 4 doses of DT. If the child was 12 months or older at the time of the first dose of DT, 3 doses (with dose 3 given 6 to 12 months after dose 2) will complete the primary DT series. If dose 4 of DTP, DTaP, or DT is administered before the fourth birthday, the fifth dose at 4 to 6 years of age is recommended.
DTaP-IPV/Hib (Pentacel)
The DTaP-IPV/Hib vaccine is approved for use as a 4-dose series for children aged 6 weeks to 4 years old. It is given to babies aged 2, 4, 6 and 15 to 18 months. The minimum intervals for DTaP-IPV/Hib vaccine are determined by the DTaP component. The first 3 doses should be separated by at least 4 weeks between doses. Dose 4 should be separated from dose 3 by at least 6 months and should not be administered before 12 months of age.
Td is approved for use in persons 7 years of age and older. All adolescents and adults must have received a primary series of at least 3 documented doses of vaccines containing tetanus and diphtheria toxoid (ie, DTaP, DTP, DT, or Td) during their lifetime. The person without such documentation must receive a series of 3 doses of vaccines containing tetanus and diphtheria.
Vaccination during pregnancy
Pregnant women who have completed the childhood immunization program and were last vaccinated more than 10 years ago should receive a booster dose of vaccine containing tetanus toxoid to prevent neonatal tetanus. If more than 1 dose is needed, Td can be used. The primary series of 3 doses should be completed at the recommended intervals.
Immunogenicity and vaccine efficacy
Antitoxin levels decrease over time. Up to 10 years after the last dose, most people have antitoxin levels that only approach the minimal protective level. As a result, routine boosters are recommended every 10 years. In a small percentage of individuals, antitoxin levels fall below the minimum protective level before 10 years have passed. To ensure adequate protective levels of antitoxin, persons who have a wound that is not clean and small should receive a tetanus booster if more than 5 years have passed since their last dose.
Contraindications and precautions to vaccination
A history of a severe allergic reaction (anaphylaxis) to a vaccine component or after a previous dose is a contraindication for further doses. Acute moderate or severe illness (with or without fever) is considered a precaution against vaccination, although persons with mild illness may be vaccinated. If moderate to severe acute illness accompanies a wound that is neither clean nor minor, the risk of withholding tetanus toxoid vaccine outweighs the risk of administering tetanus toxoid vaccine, so the vaccine should be given as part of wound management.
Contraindications for combination vaccines containing DTaP include contraindications for individual component vaccines (eg, IPV, hepatitis B, Hib), but the specific components may vary. Guillain-Barré syndrome within 6 weeks after a previous dose of tetanus toxoid-containing vaccine is a precaution for DTaP, Tdap, DT, and Td vaccination. History of Arthus-type hypersensitivity reactions after a previous dose of diphtheria toxoid-containing or tetanus toxoid-containing vaccine is a precaution for DTaP, DT, and Td vaccination; vaccination should be postponed until at least 10 years have passed since the last vaccine containing tetanus toxoid.
Vaccine safety
The DTaP vaccine may cause mild reactions, such as pain, redness, or swelling. Reactions have been reported in 20% to 40% of children after each of the first 3 doses. Local reactions seem to be more frequent after the fourth and/or fifth dose. Mild systemic reactions such as drowsiness, restlessness and low fever may also occur. Temperature of 39°C or higher is reported in 3% to 5% of DTaP recipients. These reactions are self-limited and can be managed with symptomatic treatment with acetaminophen or ibuprofen. Moderate or severe systemic reactions (such as temperature of 40°C or higher, febrile convulsions, persistent crying lasting 3 hours or more, and hypotonic-hyporesponsive episodes) have been reported after administration of DTaP. DTaP, but occur less frequently than in children who received whole-cell DTP. Rates of moderate or severe systemic reactions vary by symptom and vaccine, but usually occur in less than 1 in 10,000 doses. DTaP/DTP and Td vaccines should be stored between 2°C and 8°C.