Research and analysis

HPR volume 18 issue 3: news (14 March and 2&4 April 2024)

Updated 20 December 2024

Outbreak of Burkholderia cepacia complex associated with carbomer-containing lubricating eye products in the United Kingdom, 2023 to 2024

The UK Health Security Agency (UKHSA) has been working with key stakeholders and partners, including the NHS and the Medicines and Healthcare products Regulatory Agency (MHRA), to investigate an outbreak of Burkholderia cepacia complex (specifically Burkholderia cenocepacia ST 2147 and Burkholderia cepacia ST 840) associated with carbomer-containing lubricating eye products used for dry eyes.

Burkholderia cepacia complex (Bcc) is a group of Gram-negative bacteria that are widely found within the environment and are naturally resistant to many antibiotics. Bcc very rarely cause infection but can cause severe infections in people with weakened immune systems and those living with cystic fibrosis.

As of 21 March 2024, there were 52 confirmed and 6 probable cases associated with this outbreak (see figure below). Cases were identified from across the UK and had specimen dates from January 2023 to February 2024. Thirty cases were male (52%). Cases were aged 0 to 91 years, with a median age of 59 years. Forty-one cases (71%) were hospital inpatients, 38 of these (66% of all cases) were in critical-care settings.

Twenty-five cases (43%) were considered to have clinically significant infections attributable to Bcc (that is: where Bcc was thought to have caused infection by the clinical team and/or the patient received antibiotics to cover potential Bcc infection). Of these, 11 cases had eye infections/presentations (including 6 corneal ulcers, 3 conjunctivitis, 1 deep tissue infection and 1 unspecified). Nine cases had respiratory tract infections, including 8 ventilator associated pneumonias (VAP). Four cases had bacteraemias (1 case additionally had VAP). Two cases were in individuals with cystic fibrosis (CF); 1 was treated for infection, though presence of Bcc in individuals with CF is considered clinically important regardless of infection. Bcc infection was considered to have contributed to the death of one case.  

Testing of products, submitted by hospitals with cases, conducted at UKHSA Food Water and Environment (FWE) laboratories identified contaminated carbomer-containing lubricating eye products as the source of this outbreak. B. cenocepacia ST2147 and B. cepacia ST 840 were recovered from products produced by a single manufacturer.

Based on the investigation findings, the manufacturer undertook a voluntary product recall of three products, issuing a Field Safety Notice on 22 November 2023. MHRA issued an accompanying Device Safety Information (DSI) on 24 November 2023 with advice to health professionals, patients and customers. A National Patient Safety Alert was issued on 7 December 2023. The DSI and National Patient Safety Alert included recommendations to avoid the use of carbomer-containing eye products in individuals with cystic fibrosis, patients being cared for in critical care settings, the severely immunocompromised and patients awaiting lung transplantation.

Distribution of confirmed and probable cases with specimen dates between January 2023 and February 2024, by week of specimen date (n = 58), showing dates of key interventions

The outbreak peaked in October to November 2023. Since January 2024 there has been a marked reduction in the number of new cases occurring. Follow up of new cases identified after the interventions described above has not demonstrated evidence of exposures to non-recalled products.

MHRA has now received sufficient assurance from manufacturers and suppliers to conclude that products available on the UK market are safe to use and free of contamination.

As of 21 March 2024, UKHSA, MHRA and the Incident Management Team are satisfied that the risk associated with this outbreak has reduced such that there is no longer need to avoid use of carbomer-containing lubricating eye products. Therefore, the recommendation to avoid use of all carbomer-containing eye products in individuals with cystic fibrosis, patients being cared for in critical care settings, the severely immunocompromised and patients awaiting lung transplantation has been stepped down. Other recommendations within the National Patient Safety Alert remain (that is: to note the product recall and follow the Field Safety Notice instructions, and to submit relevant Bcc isolates to the UKHSA AMRHAI reference laboratory). An amendment to the Central Alerting System (CAS) page has been made to indicate this.

UKHSA will continue to follow up new cases and keep vigilance for emergent clusters of Burkholderia cepacia complex.

UKHSA would like to thank colleagues for their help and support in this investigation, particularly: clinical and IPC teams from affected NHS Trusts; MHRA; the Department of Health and Social Care; UK Four Nations colleagues; NHS Supply Chain; NHS England; the Royal College of Ophthalmologists; UK Cystic Fibrosis Medication Association and Cystic Fibrosis Trust; and all other individuals involved in the Incident Management Team and in supporting investigations.

References

1. Gutiérrez Santana JC, Coria Jiménez VR (2024). ‘Burkholderia cepacia complex in cystic fibrosis: critical gaps in diagnosis and therapy’. Annals of Medicine: volume 56, issue 1.

2. Baldwin A, Mahenthiralingam E, Vandamme P, Govan JR, Waine DJ and other (2007). ‘Environmental Burkholderia cepacia complex isolates in human infections’. Emerging Infectious Diseases: volume 13, issue 3, pages 458 to 461.

Shingles vaccine uptake (England): Interim report on uptake of the new Shingrix vaccination programme in England

The aim of the routine shingles (herpes zoster) vaccination programme is to prevent severe morbidity from shingles in groups at the highest risk.

A routine shingles vaccination programme began in England on 1 September 2013 (1) offering a single-dose of Zostavax shingles vaccine to all 70 year olds, together with a catch-up programme for older cohorts. Adults became eligible at 70 years old and remained eligible until their 80th birthday.

From September 2021, a new shingles recombinant sub-unit vaccine (Shingrix) was added to the programme to increase protection against shingles (herpes zoster) amongst eligible cohorts unable to have the live Zostavax shingles vaccine due to immunosuppression or/and contraindication.

From September 2023, these two programmes ceased, being replaced with a new programme offering 2 doses of Shingrix vaccine to:

• all severely immunosuppressed individuals (eligibility as defined in the Green Book Shingles chapter 28a) from 50 years of age
• immunocompetent individuals turning 65 and 70 years of age

Immunocompetent individuals will remain eligible for the Shingrix vaccine until their 80th birthday and vaccines will be offered in a phased implementation over a 10-year period. Full details on eligibility and the phased programme are available on the UKHSA webpages.

Preliminary data has been collected assessing vaccine uptake amongst the routine immunocompetent 65 and 70 year olds offered their first dose of Shingrix since 1 September 2023. This data is from a subset of GP practices, representing 39.9% of all GP’s in England.

Uptake is as follows:

• among adults who turned 65 years of age between 1 September 2023 and 30 November 2023, uptake of dose 1 of Shingrix was 25.1% as of 6 March 2024
• among adults who turned 70 years of age between 1 September 2023 and 30 November 2023, uptake of dose 1 of Shingrix was 34.2 % as of 6 March 2024

This data is provisional and subject to revision. Further vaccine uptake and coverage figures among both immunocompetent and immunosuppressed patients individuals eligible for shingles vaccination, including data stratified by NHS Commissioning region and integrated care board will be published later this year.

Reference

1. HPA (2013). Herpes zoster (shingles) vaccination programme to protect the elderly’. Health Protection Report: volume 7, issue 35.

Infection reports

Group A streptococcal infections: fourth update on seasonal activity in England, 2023 to 2024

Travel-associated infections in England, Wales and Northern Ireland: 2023

Vaccine coverage reports

Prenatal pertussis vaccination coverage in England from October to December 2023

Quarterly vaccination coverage statistics for children aged up to 5 years in the UK (COVER programme): October to December 2023

Pneumococcal polysaccharide vaccine (PPV): coverage report, England, April 2022 to March 2023