Content
Available Vaccines
Pertussis
In this chapter:
- Vaccines
- Vaccines Available in Malaysia
- Mode of Administrations
- Co-administration with Other Vaccines
- Contraindications and Adverse Effects
- Target Group in Malaysia
- Implications for Healthcare Workers (HCWs)
- Additonal Doses of Tdap for the General Population
- Evidence for Effectiveness
- Recommendations for Vaccination for Pertussis, Tetanus, and Diphtheria
Introduction
Pertussis also known as whooping cough, is an upper respiratory tract infection caused by Bordetella pertussis. Transmission is via direct contact with respiratory secretion or by aerosolised droplets from the infected persons. Its classical presentation is characterised by paroxysmal cough with inspiratory whoop. However, adolescents and adults who are infected experience a milder form of the symptoms due to the presence of varying degrees of immunity acquired from childhood vaccination or past infection. Adults can suffer from a chronic cough for weeks or months and often are misdiagnosed for bronchitis or other respiratory infections.
In recent years, there has been an epidemiological shift towards higher incidences of pertussis among adolescents and adults due to waning immunity. Epidemiologic data indicate that adults who are family members, particularly parents are the most important source of pertussis to susceptible children. In more than 50% of primary cases, parents are the presumed source of infection.
In Malaysia, the incidence of pertussis was less than 0.1 per 100,000 population in the 1990s and early 2000s. In the mid-2000s, a higher incidence in pertussis was attributed to an actual increase in the burden of disease which were also reflected in the improvement in the detection of the organism by molecular diagnosis, increased health care personnel and public awareness of pertussis, and better reporting of cases. In recent years (2014-2017), the cases continued to escalate with incidence rates ranged between 0.94-3.08 per 100,000 population and mortality rates between 0.01-0.04 per 100,000 population.
The last pertussis booster vaccine under the Malaysian National Immunisation Programme is given at 18 months of age. It is therefore expected that immunity would have diminished during adolescence; hence adults are once again susceptible to pertussis and may become potential reservoirs.
Vaccines
- Pertussis vaccine is available as an acellular formulation in combination with diphtheria, tetanus and other antigens.
- Tdap is the adult formulation of tetanus, diphtheria and acellular pertussis containing vaccine. Tdap contains substantially lesser amounts of diphtheria toxoid and pertussis antigens than the child formulation (DTaP).
- Other combinations available include DTaP-HepB-Hib-IPV and DTaP-Hib-IPV which are mainly used in childhood immunisation.
- There are a number of acellular pertussis containing vaccines that contain two or more purified components of Bordetella pertussis depending on the manufacturer. The components are pertussis toxin (PT), filamentous haemagglutinin (FHA), pertactin (PRN) and fimbrial (FIM) antigens.
Note:
Upper-case letters in the above abbreviations denote full-strength doses tetanus (T) toxoids. Lower-case “d” and “p” denote reduced doses of diphtheria and pertussis. The “a” in Tdap stands for “acellular”, meaning that the pertussis component contains only a part of the pertussis organism.
Vaccines Available in Malaysia
- Adacel® (Tdap; tetanus-diphtheria-acellular pertussis)
Sanofi Pasteur (M) Sdn Bhd/Sanofi Pasteur Limited, Canada - Adacel® Polio (Tdap-IPV; tetanus-diphtheria-acellular pertussis-inactivated polio)
Sanofi Aventis (M) Sdn Bhd/Sanofi Pasteur, France - Boostrix® (Tdap; tetanus-diphtheria-acellular pertussis)
GlaxoSmithKline Pharmaceuticals (M) Sdn Bhd/GlaxoSmithKline Biologicals S.A., Belgium - Boostrix-Polio® (Tdap-IPV; tetanus-diphtheria-acellular pertussis-inactivated polio)
GlaxoSmithKline Pharmaceuticals (M) Sdn Bhd/GlaxoSmithKline Biologicals S.A., Belgium - Infanrix Hexa® (DTaP; diphtheria-tetanus-acellular pertussis-inactivated polio-Hib-Hep B)
GlaxoSmithKline Pharmaceutical Sdn Bhd/GlaxoSmithKline Biologicals S.A., Belgium - Infanrix-IPV+Hib® (DTaP; diphtheria-tetanus-acellular pertussis-inactivated polio-Hib)
GlaxoSmithKline Pharmaceutical Sdn Bhd/GlaxoSmithKline Biologicals S.A., Belgium - Infanrix-IPV® (DTaP; diphtheria-tetanus-acellular pertussis-inactivated polio)
GlaxoSmithKline Pharmaceutical Sdn Bhd/GlaxoSmithKline Biologicals S.A., Belgium - DTP (DTP; tetanus-diphtheria-acellular pertussis)
Propharm (M) Sdn Bhd/FT Bio Farma, Indonesia - Pentaxim® (DTaP; diphtheria-tetanus-acellular pertussis-inactivated polio/Hib)
Sanofi-Aventis (M) Sdn Bhd/Sanofi Pasteur, France - Hexaxim® (DTaP; diphtheria-tetanus-acellular pertussis-inactivated polio-Hib-Hep B)
Sanofi-Aventis (M) Sdn Bhd/Sanofi Pasteur, France - SII Diphtheria and Tetanus Vaccine Adsorbed (Paediatric) – 10 and 20 doses) (TD; tetanus-diphtheria)
SM Pharmaceuticals Sdn Bhd/Serum Institute of India - SII Diphtheria, Tetanus and Pertussis Vaccine Adsorbed- 10 and 20 doses) (DTaP; diphtheria-tetanus-acellular pertussis)
SM Pharmaceuticals Sdn Bhd/Serum Institute of India
Mode of Administration
The dose of pertussis-containing vaccines is 0.5mL to be given by IM injection.
Co-administration with Other Vaccines
Several vaccines can be given together as long as there are no contraindications for individual agents. There are no contraindications to simultaneous administration of live attenuated vaccines with inactivated or toxoid vaccines. Do not mix tetanus toxoid with other vaccines in the same syringe unless approved for mixing by manufacturer.
Contraindications and Adverse Effects
- The only absolute contraindications to acellular pertussis containing vaccines are anaphylaxis, following a previous dose and anaphylaxis following any vaccine component.
- The reduced antigen content of the adult formulations of Tdap vaccines are safe and well tolerated in adults. The incidence of fever is low. Booster doses of Tdap given within 10 years are also safe and well tolerated in adults and limb swelling reactions following booster doses rarely occur.
- Adverse effects include pain, tenderness, localised erythema and oedema at the injection site have been reported. Fever, headache, lethargy and myalgia are rare.
- To date, the most frequently reported adverse events of pertussis containing vaccines in children received by the National Adverse Drug Reactions Monitoring Centre (NPRA) include injection site reactions such as injection site erythema, fever and rash. Cases of febrile seizure and convulsions had also been reported in children.
Target Group in Malaysia
- Adults aged ≥ 19 years who have not been immunised with Tdap or for whom vaccine status is unknown.
- Pregnant women. The optimal timing for the vaccine administration is between 27 and 36 weeks gestation to maximise the maternal antibody response and passive antibody transfer to the infant. Maternal anti-pertussis antibodies are short-lived. Thus, Tdap vaccination in one pregnancy will not provide sufficiently high levels of antibodies to protect the newborn during subsequent pregnancies. Thus, it is recommended Tdap be given at every pregnancy regardless of previous receipt of Tdap.
- Adolescents and adults (e.g., parents, siblings, grandparents) who have or anticipate having close contact with an infant aged <12 months.
- Staff working in early childhood education and care (kindergarten and nursery).
Implications for Healthcare Workers (HCWs)
- A dose of Tdap is recommended to be given to all HCWs, as soon as feasible, if they have not received Tdap previously. Vaccinating HCWs with Tdap will protect them against pertussis and is expected to reduce transmission to patients and other HCWs. Tdap boosters are recommended every 10 years thereafter.
Additional Doses of Tdap for the General Population
- Tdap is licensed for use as a single dose for active booster immunisation; Boostrix® and Adacel® are approved for use in persons aged 4 years and above.
- Tdap is not licensed for multiple administrations nor is it recommended for multiple administrations, with the exception of the recommendation that pregnant women receive a dose of Tdap during each pregnancy.
- If a dose of Tdap is administered to a person who has previously received Tdap, this dose should count as the next booster dose of tetanus toxoid–containing vaccine.
Evidence for Effectiveness
An anamnestic response can be induced with the administration of a booster dose of Tdap, which is the adult formulation. A randomised trial in adults reported a point estimate of 92% efficacy against culture/nucleic acid test-positive disease within 2.5 years of vaccination, with a 3 component monovalent pertussis vaccine. A long term follow-up of adults vaccinated with Tdap vaccine has shown a rapid decline in levels of pertussis antibodies, within the first 2 years after vaccination, with a continued steady decline up to 10 years after vaccination, although antibody levels remained above baseline. The rate of decline in clinical protection is unknown, but protection against clinical disease, is likely to persist for up to 10 years and is immunogenic in the elderly.
Recommendations for Vaccination for Pertussis, Tetanus, and Diphtheria
- Primary vaccination in adults: Three doses of vaccine are required with an interval of 4-6 weeks between the 1st and 2nd doses, and 6-12 months between the 2nd and 3rd doses. Tdap can be used for the 1st dose with Td vaccine for the subsequent doses.
- Booster vaccination: Persons aged ≥19 years who previously have not received a dose of Tdap should receive a single dose of Tdap. To ensure continued protection against tetanus and diphtheria, booster doses of Td should be administered every 10 years throughout life.
- Do NOT administer DTaP to adolescents and adults as the higher doses of the diphtheria and pertussis components may result in greater adverse effects.
References
- Bisgard, K. M., Pascual, F. B., Ehresmann, K. R., et al. (2004). Infant pertussis: who was the source? Pediatr Infect Dis J, 23, 985-9
- Booy, R., Van der Meeren, O., Ng, S. P., et al. (2010). A decennial booster dose of reduced antigen content diphtheria, tetanus, acellular pertussis vaccine (Boostrix™) is immunogenic and well tolerated in adults. Vaccine, 29, 45-50
- Centers for Disease Control and Prevention (CDC) (2018). Advisory Committee on Immunization Practices (ACIP). Prevention of Pertussis, Tetanus, and Diphtheria with Vaccines in the United States. MMWR, 67(2), 1-44. https://www.cdc.gov/mmwr/volumes/67/rr/rr6702a1.htm
- Centers for Disease Control and Prevention (CDC). (2011). Advisory Committee on Immunisation Practices (ACIP). Immunisation of Health-Care Personnel. MMWR, 60(RR07), 1-45. https://www.cdc.gov/mmwr/pdf/rr/rr6007.pdf
- Güriş, D., Strebel P.M., Bardenheier, B., et al. (1999). Changing epidemiology of pertussis in the United States: Increasing reported incidence among adolescents and adults, 1990–1996. Clin Infect Dis, 28, 1230-7
- Healy, C. M., Rench, M. A., Baker, C. J. (2013). Importance of timing of maternal Tdap immunization and protection of young infants. Clin Infect Dis, 56, 539–44
- Malaysian National Centre of Adverse Drug Reactions database. https://npra.gov.my
- Ministry of Health Malaysia. (2019). National Pharmaceutical Regulatory Agency (NPRA). Senarai Produk Vaksin Berdaftar Dengan Pihak Berkuasa Kawalan Dadah
- Ministry of Health of Malaysia (MOH). (2014-2018). Health facts: Incidence rate and mortality rate of communicable diseases. https://www.moh.gov.my/index.php/pages/view/58
- Van Damme, P., McIntyre, P., Grimprel, E., et al. (2011). Immunogenicity of the reduced-antigen-content Tdap vaccine (Boostrix®) in adults 55 years of age and over: A sub-analysis of four trials. Vaccine, 29, 5932-9
- Ward, J. I., Cherry, J.D., Chang, S. J, et al. (2005). Efficacy of an acellular pertussis vaccine among adolescents and adults. New Engl J Med, 353, 1555-63
- Wendelboe, A.M., Njamkepo, E., Bourillon, A., et al. (2007). Transmission of Bordetella pertussis to young infants. Pediatr Infect Dis J, 26, 293-9