Briefing Note

Serial number:2015/024Date:1st April 2015

Event Vaccine error: Use of Infanrix-IPV instead of Infanrix-IPV+Hib for primary immunisation anduse of Infanrix-IPV+Hib without reconstitution and administration of the Hib component

Notified byImmunisation, Hepatitis and Blood Safety Department, PHE Centre for Infectious Disease Surveillance and Control (CIDSC)

Authorised byDrMary Ramsay

Dr Fu-Meng

ContactDavid Green

Dr Vanessa Saliba

Dr Shamez Ladhani

Incident LeadMary Ramsay

Background and interpretation

Diphtheria, tetanus, pertussis (whooping cough), polio and Haemophilus influenzae (Hib) immunisation programme

In July 2014 Infanrix-IPV+Hib was made available to order alongside Pediacel for primary immunisation against diphtheria, tetanus, pertussis (whooping cough), polio and Haemophilus influenzae (Hib) (DTaP/IPV/Hib) in children aged 2, 3 and 4 months. From September 2014,Infanrix-IPV+Hibbecamethe only vaccine available to order for this programme.It is no longer possible to order Pediacel from the national supply.

In addition,a pre-school booster against diphtheria, tetanus, pertussis and polio (but not Hib) with Infanrix-IPV (DTaP/IPV) or Repevax (dTaP-IPV) is offered to children at 3 years and 4 months of age;although currently Repevax is not available to order form the national supply.

When to immunise / Disease protected against / Vaccine used
2 months / Diphtheria, tetanus, pertussis (whooping cough), polio and Haemophilus influenzae (Hib) / DTaP/IPV/Hib (Pediacel or Infanrix-IPV+Hib)
3 months / Diphtheria, tetanus, pertussis (whooping cough), polio and Haemophilus influenzae (Hib) / DTaP/IPV/Hib (Pediacel or Infanrix-IPV+Hib)
4 months / Diphtheria, tetanus, pertussis (whooping cough), polio and Haemophilus influenzae (Hib) / DTaP/IPV/Hib (Pediacel or Infanrix-IPV+Hib)
Between 12 and 13 months / Haemophilus influenzae (Hib), Meningococcal group C disease (MenC) / Hib/MenC (Menitorix)
3 years 4 months old or soon after / Diphtheria, tetanus, pertussis (whooping cough) and polio / Infanrix-IPV(DTaP/IPV) or Repevax (dTaP-IPV)

Vaccine error

Vaccine errors have been identified involving the use ofInfanrix-IPV+Hib and Infanrix-IPV.Pediacel was presented as a pre-filled syringe containing all the vaccine antigens. However,Infanrix-IPV+Hibcontains the Hib component supplied as a freeze-dried preparation in a separate glass vial that must be reconstituted with the pre-filled syringe containing diphtheria, tetanus, acellular pertussis and inactivated poliomyelitis antigens, prior to administration.

Vaccine errors have been reported involving the use of Infanrix-IPV+Hib for primary immunisation as follows:

•Immunisers have administered Infanrix-IPV (DTaP-IPV, used routinely for the pre-school booster dose), instead of Infanrix-IPV+Hib (DTaP/IPV+Hib)

•Immunisers have used the correct vaccine for primary immunisation i.e. Infanrix-IPV+Hib (DTaP/IPV+Hib), but failed to reconstitute and administer the separate freeze-dried Hib component

Both of these errors result in children missing out on a Hib dose.

Risk to children

The risk of invasive Hib disease in infants (<1 year-olds) is very low because of the excellent population control achieved through the high vaccine coverage in recent years. In the 2014 calendar year, there was only one infant diagnosed with invasive Hib disease across England and Wales. The current immunisation schedule includes a 12-month Hib/MenC (Menitorix) dose which should provide adequate long-term protection against both Hib and MenC even if the child did not receive any Hib vaccine dose in infancy.

Communication

NHS England Patient Safety Team will be cascading an alert with information about this vaccine error to their network of Medication Safety Officers. Awareness will also be raised through the Area Team Bulletin (due 7th April 2015) and the GP bulletin (due in early May).

In addition PHE are working with the MHRA and the vaccine manufacturer (GSK) to improve the labelling of both Infanrix-IPV-Hib and Infanrix-IPV.

A national reactive media line has been prepared and shared with regional PHE communications for localising if necessary.

Implications and recommendations for PHE Centres and Health Protection Teams (HPTs)

PHECentres and HPTs may be asked for advice in the local investigation and response to Infanrix-IPV+Hib errors. The clinical advice for the management of children who have missed out on one or more Hib primary doses is summarised below and can be found in full here:

What actions should be taken if the immuniser administers Infanrix-IPVOR forgets to reconstitute the Hib component of the vaccine and only gives the Infanrix®-IPV component ofInfanrix-IPV+Hibin the pre-filled syringe?

  • If the error occurs at two months, give Menitorix® vaccine at the same visit (or as soon as possible after error realised) and then give MenC as per the schedule at three months (at least one month after the Menitorix® dose).
  • If the error occurs at three months and MenC vaccine has not yet been given at visit, give Menitorix®. The infant will still need a MenC vaccine at four months because Menitorix® contains a lower MenC antigen dose compared with the single antigen MenC vaccines.
  • If the error occurs at three months and MenC vaccine has already been given at visit before the error is realised, give a dose of Menitorix® in addition to the vaccines already given. The child requires early protection against Hib and the additional MenC antigen in the Menitorix® vaccine will not be harmful.
  • If the error occurs at four months, give Menitorix® at the same visit (or as soon as possible after error realised).

If the error is picked up retrospectively (or, for example, identified from a look back exercise), the following action should be taken:

  • Children aged >4 months to <12 months who have two recorded doses of Hib - give the 12-month Menitorix dose on time
  • Children aged >4 months to <12 months who have only one or no recorded doses of Hib - give Menitorix at the time that the error is identified and give the 12-month Menitorix dose on time (with an interval of at least 1 month between the doses)
  • Children aged >12 months – children over the age of 12 months and less than 10 years old require only one dose Hib (i.e. one dose of Menitorix). Therefore, if they have received their 12-month booster, then no additional action needs to be taken

Although PHE is aware of some children who may have received Infanrix-IPV+Hib, as a pre-school booster, instead of the recommended Infanrix-IPV, this is not a clinical safety issue. From a supply viewpoint, however, efforts should be made to use the correct vaccine.

All vaccine errorsshould be reported to the local SIT. It is important to establish if the error was a one-off occurrence or a systematic error that might require a look back exercise.

Implications and recommendations for Screening and Immunisation Teams (SITs)

SITs may see an increase in the reporting of Infanrix-IPV+Hibvaccine errors and incidents.All reported incidents should be investigated as per routine protocols and undergo a local risk assessment by the SIT. In particular, it is important to establish if the error was a one-off occurrence or a systematic error that may possibly affect a larger number of children.

When isolated errors are identified clinical advice can be sought from the HPT. Health professionals can also be referred to this guidance which outlines management of children who have missed out on one or more doses.

If a local risk assessment and investigation reveals that a systematic error has occurred, for example, in a particular practice or other provider, a look-back exercise should be undertaken to establish the number of children affected and exact details of the error. An incident management team should be established with clinicaladvice obtained from the local HPT.

The local response to incidents identified has to be proportionate to the risk of Hib disease in infants prior to their 12 month Hib/MenC (Menitorix) booster dose, which is likely to be very low even if they have only received one dose of Hib in infancy. These infants should mount an adequate long-term response to their 12 month Hib/MenC booster.

Lessons learned from the investigation of local incidents should be disseminated widely among local health professionals and immunisation providers to minimise the risk of future errors occurring.

Implications and recommendations for local authorities

None

References/ Sources of information

  1. Use of Infanrix®-IPV+Hib in the infant schedule, information for Healthcare Professionals.V3, Public Health England, August 2014.
  1. Use of Infanrix®-IPV+Hib in the infant schedule, information for Healthcare Professionals, PowerPoint presentation.

PHE Briefing Note Issued