Investigating the safety of the NHS childhood vaccination program

Summary of Post-Marketing Surveillance of Tetravalent Diphtheria-Tetanus-Acellular Pertussis and Inactivated Poliovirus (DTaP-IPV) Vaccine in South Korea (2009-2015):

Introduction:

• TETRAXIM™ (Sanofi), a combined DTaP-IPV vaccine, licensed in South Korea since 2009, was evaluated for safety in real-world clinical practice among infants and children (2, 4 Summary of Post-Marketing Surveillance of Tetravalent Diphtheria-Tetanus-Acellular Pertussis and Inactivated Poliovirus (DTaP-IPV) Vaccine in South Korea (2009-2015):

Introduction:

• TETRAXIM™ (Sanofi), a combined DTaP-IPV vaccine, licensed in South Korea since 2009, was evaluated for safety in real-world clinical practice among infants and children (2, 4 Summary of Post-Marketing Surveillance of Tetravalent Diphtheria-Tetanus-Acellular Pertussis and Inactivated Poliovirus (DTaP-IPV) Vaccine in South Korea (2009-2015):

• Introduction:

  • TETRAXIM™ (Sanofi), a combined DTaP-IPV vaccine, has been licensed in South Korea since August 31, 2009, for active immunization against tetanus, diph Summary of Post-Marketing Surveillance of Tetravalent Diphtheria-Tetanus-Acellular Pertussis and Inactivated Poliovirus (DTaP-IPV) Vaccine in South Korea (2009-2015):

Safety Assessment and Adverse Events (AEs):

• Unexpected Adverse Drug Reactions (ADRs): Defined as ADRs not listed in the local product label's AE section.
• **Serious Adverse Events (SAEs Summary of Post-Marketing Surveillance of Tetravalent Diphtheria-Tetanus-Acellular Pertussis and Inactivated Poliovirus (DTaP-IPV) Vaccine in South Korea (2009-2015):

Demographic and Baseline Characteristics:

• 602 participants received the primary vaccination series; 45 received the school-entry booster dose.

• Exclusion criteria: failure to follow up (n = 12) and off-label vaccine usage (n = Summary of Post-Marketing Surveillance of Tetravalent Diphtheria-Tetanus-Acellular Pertussis and Inactivated Poliovirus (DTaP-IPV) Vaccine in South Korea (2009-2015):

• Unexpected Adverse Events (AEs):

  • Among 268 reported AEs, 212 were unexpected and observed in 152 participants (23.5%).
  • Common unexpected AEs included bronchitis (11.8%), upper Summary of Post-Marketing Surveillance of Tetravalent Diphtheria-Tetanus-Acellular Pertussis and Inactivated Poliovirus (DTaP-IPV) Vaccine in South Korea (2009-2015):

Discussion:

• Objective: The PMS study aimed to evaluate the safety of the DTaP-IPV vaccine in South Korea for participants aged 2-6 months (primary series) and 4-6 years (booster dose).
• Summary of Post-Marketing Surveillance of Tetravalent Diphtheria-Tetanus-Acellular Pertussis and Inactivated Poliovirus (DTaP-IPV) Vaccine in South Korea (2009-2015):

Incidence of Adverse Reactions:

• Injection Site Reactions:
  • Tenderness, erythema, and swelling occurred in 27.0–36.9% of DTaP-IPV recipients, 11. Summary of Post-Marketing Surveillance of Tetravalent Diphtheria-Tetanus-Acellular Pertussis and Inactivated Poliovirus (DTaP-IPV) Vaccine in South Korea (2009-2015):

Study Conduct and Ethical Compliance:

• The study adhered to the Declaration of Helsinki guidelines and MFDS Notification No. 2009-46.
• Informed consent was obtained from all participants or their legal representatives.

Data Availability:

• Data ### Summary of Pertussis Prevalence and Vaccine Studies:

• Pertussis Prevalence Studies in Korea:

  • Studies have examined the prevalence of pertussis among Korean adolescents and adults with persistent cough, using PCR-based methods to identify infections.
  • Sustained vaccination coverage was observed during the COVID-19 pandemic in Korea.

• Vaccination Coverage and Comparative Studies:

  • Comparative studies have estimated the coverage of national immunization program vaccines versus non-NIP vaccines Summary of Antibody Persistence and Immunogenicity Studies:

1. Antibody Persistence and Booster Immunogenicity:
   • Studies focused on the persistence of antibodies against diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenzae type b (Hib) in children aged 5-6 years after receiving a primary vaccination and a first booster with a pentavalent combined acellular pertussis vaccine.
   • Evaluations

The PGD (Patient Group Direction) document for the administration of the diphtheria, tetanus, acellular pertussis, and inactivated poliomyelitis vaccine (dTaP/IPV) targets individuals aged 3 years 4 months to under 10 years. It adheres to the national immunisation program in England. Developed by the UK Health Security Agency (UKHSA), the PGD ensures that the vaccine is administered by registered healthcare practitioners and must be authorised by The current chunk of text outlines the availability of the UKHSA Immunisation PGD templates for authorisation and the process for addressing concerns or inquiries regarding the PGD. It includes a detailed change history of the dTaP/IPV PGD, highlighting routine reviews and amendments made over various versions to ensure clarity, consistency, and alignment with updated guidelines and organizational changes. The development of this PGD has involved several health professionals, including a lead pharmacist, consultant epidemiologist, and nurse consultant, and ### Key Points and Arguments Extracted:

1. Expert Panel Involvement:

   • The PGD (Patient Group Direction) for the dTaP/IPV vaccine has been developed with input from a diverse panel of health professionals, including consultants in communicable disease control, epidemiologists, pharmacists, paramedics, nurse consultants, and medicines optimisation pharmacists.

2. Organisational Authorisations:

   • The PGD is not legally valid without relevant organisational authorisation.

   • Key Points and Arguments Extracted:

3. Professional Qualifications and Registration:

   • The PGD mandates that practitioners administering the dTaP/IPV vaccine must be registered professionals with specific bodies, including:
     • Nurses and midwives registered with the Nursing and Midwifery Council (NMC)
     • Pharmacists registered with the General Pharmaceutical Council (GPhC)
     • Paramedics and physiotherapists registered with the Health and Care Professions Council (HCPC)

Key Points and Arguments Extracted:

1. Consent and Exclusion Criteria:

   • Valid consent or best-interests decision must be obtained in accordance with the Mental Capacity Act 2005.
   • Exclusions include individuals with a history of confirmed anaphylactic reactions to previous doses of vaccines containing diphtheria, tetanus, pertussis, or poliomyelitis, or to any components of the vaccine.

2. Acute Illness and Immunisation:

Key Points and Arguments Extracted:

1. Exclusion and Referral Criteria:

   • Individuals with a history of confirmed anaphylactic reactions to previous doses of the vaccine or any component should be referred to a clinician for specialist advice.
   • If primary immunisation is incomplete, priming doses of DTaP/IPV/Hib/HepB should be provided.
   • Postponement due to acute severe febrile illness requires advising on when the individual can be vaccinated and arranging ### Key Points and Arguments Extracted:

2. Administration Guidelines for Individuals with Bleeding Disorders:

   • Vaccines normally given intramuscularly should follow the recommendations in the ‘Green Book’ Chapter 4 or the product’s SPC (Summary of Product Characteristics).

3. Vaccine Appearance and Handling:

   • The vaccine should appear as a uniform cloudy, white suspension and must be shaken well before administration.
   • It should not be used if discoloured or containing foreign ### Key Points and Arguments Extracted:

4. Quantity and Administration:

   • Single 0.5ml dose per administration for the dTaP/IPV vaccine.
   • Other recommended vaccines for primary immunisation and subsequent boosters to complete immunisation per national recommendations.

5. Supply and Storage:

   • Vaccines for the national immunisation program can be ordered via ImmForm and are provided free of charge.
   • Store vaccines at +2°C to +8°C, ### Key Points and Arguments Extracted from the Current Chunk:

6. Immunisation Status Verification:

   • Individuals should have their immunisation status checked to ensure they are up to date with the recommended UK immunisation programs.

7. Vaccine Dosage Specificity:

   • The dTaP/IPV (Repevax® or Boostrix®-IPV) vaccine contains lower doses of pertussis and diphtheria antigens compared to DTaP/IP ### Key Points and Arguments Extracted from the Current Chunk:

8. Guideline References:

   • The PGD references multiple authoritative sources and guidelines, including:
     • Summary of Product Characteristics for Boostrix®-IPV.
     • Guidelines for the vaccination of individuals with uncertain or incomplete immunisation status.
     • Public health control and management guidelines for diphtheria, pertussis, polio, and tetanus.
     • Health Technical Memorandum 07-01: