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Pfizer concerned at UK Government’s decision to implement a reduced schedule for the childhood pneumococcal immunisation programme

18/04/19

The childhood pneumococcal immunisation programme is a UK success story.  Since its introduction as a 2+1 dosing schedule in 2006, overall levels of invasive pneumococcal disease, which causes diseases such as meningitis, sepsis and pneumonia, have fallen significantly in the UK, especially in children.1 However, following advice from the Joint Committee on Vaccination and Immunisation based on modelling1 and a small immunogenicity study in 213 infants,2 the UK Government has decided to drop one of the primary doses and implement a 1+1 dosing schedule.

We do not support this decision because we believe that the implementation of a reduced schedule at this time will have a negative impact on the protection offered by our vaccine. Making such a change would be inconsistent with the approved dosing schedule described in the summary of product characteristics and could potentially pose a significant individual and public health risk.

Pneumococcal disease can affect a person of any age but is most common in infants and older adults.3 The introduction of the pneumococcal conjugate vaccine into the childhood immunisation programme in the UK has resulted in reduced pneumococcal disease among both vaccinated and unvaccinated people through a combination of direct and indirect protection.4,5 This includes a reduction in community-acquired pneumonia in adults.6

Nevertheless, independent research indicates that serotypes included in the vaccine continue to circulate with some of them on the rise in people over 65, for example 19A and 19F.4,7-10 Modelling undertaken by Pfizer and published in the peer reviewed medical journal Epidemiology & Infection in July 2018, suggests that removing one of the primary doses would result in more cases of invasive and non-invasive disease that will affect not just the infant population but also older ages, especially the elderly.11 We believe that the risk, including between 241 and 743 avoidable deaths over five years,11 currently far outweighs any benefits such as simplifying the vaccination schedule.

The impact on the schedule could also have more wide-ranging consequences. For instance, it could place an increased and unnecessary burden on the health service, adding further pressure to both GPs and hospitals.11 In addition, it could potentially exacerbate Antimicrobial Resistance (AMR), which we know is a key priority for the Government, since vaccines are typically administered to prevent infections from happening in the first place.

Given the significant uncertainty associated with implementing a 1+1 dosing schedule at this time and the likely negative impact on individual and public health, we worked with the Government prior to a final decision being made to try and ensure that the current infant pneumococcal immunisation schedule was maintained. We now urge the Government to reconsider its decision, taking into account all available data, and to ensure that the success of the pneumococcal immunisation programme continues with the established 2+1 schedule.

Pfizer is committed to working with the Government to find a solution that works for all stakeholders and, most importantly, that safeguards the health of the population.

 

References

  1. Joint Committee on Vaccination and Immunisation. Draft meeting minutes. October 2017.  Available at: https://app.box.com/s/iddfb4ppwkmtjusir2tc. [Last accessed April 2019]
  2. Goldblatt D, et al. Pneumococcal conjugate vaccine 13 delivered as one primary and one booster dose (1 + 1) compared with two primary doses and a booster (2 + 1) in UK infants: a multicentre, parallel group randomised controlled trial. Lancet Infectious Diseases. 2018; 18: 171–79
  3. Trotter C, Wright P, Andrews N et al. Epidemiology of invasive pneumococcal disease in the pre-conjugate vaccine era: England and Wales, 1996 – 2006. Journal of Infection. 2010; 60, 200e208
  4. Ladhani SN, et al. Rapid increase in non-vaccine serotypes causing invasive pneumococcal disease in England and Wales, 2000-17: a prospective national observational cohort study. The Lancet Infectious Diseases. 2018
  5. Waight PA, et al. Effect of the 13-valent pneumococcal conjugate vaccine on invasive pneumococcal disease in England and Wales 4 years after its introduction: an observational cohort study. The Lancet Infectious Diseases. 2018; 15:535–543
  6. Rodrigo C, et al. Impact of infant 13-valent pneumococcal conjugate Vaccine on serotypes in adult pneumonia. European Respiratory Journal. 2015; 45:1632–1641
  7. Kent A, Makwana A, Sheppard CL, Collins S, Fry NK, Heath PT, Ramsay M, Ladhani SN. Invasive pneumococcal disease in UK children <1 year of age in the post–13-valent pneumococcal conjugate vaccine era: What are the risks now? Clinical Infectious Diseases. October 2018.
  8. Makwana A, et al. Characteristics of children with invasive pneumococcal disease after the introduction of the 13-valent pneumococcal conjugate vaccine in England and Wales, 2010-2016. Pediatric Infectious Disease Journal. 2018; 37(7): 697-70
  9. Adler H, et al. Pneumococcal colonization in healthy adult research participants in the conjugate vaccine era, United Kingdom, 2010-2017. Journal of Infectious Diseases. 2019
  10. Kandasamy R, et al. Sero-prevalence of antibodies to PCV13 serotypes in PCV vaccinated UK children: evidence for ongoing circulation of serotypes 3 and 19A. ESPID 2017
  11. Wasserman M, Lucas A, Jones D, Wilson M, Hilton B, Vyse A, Farkouh R. Dynamic transmission modelling to address infant pneumococcal conjugate vaccine schedule modifications in the UK. Epidemiology and Infection. July 2018; 146(14): 1797-1806

 

PP-VAC-GBR-1191 / April 2019