Guidance

[Withdrawn] Reporting to the enhanced surveillance of COVID-19 cases in vaccinated individuals

Updated 11 November 2021

This guidance was withdrawn on

The enhanced surveillance of cases in vaccinated individuals has now ended. Thank you to all individuals who took part in this study.

Applies to England

The UK Health Security Agency (UKHSA, formerly Public Health England) Immunisation Department is conducting enhanced surveillance of cases of infection in vaccinated individuals in England, in order to confirm infection, identify risk factors and outcomes, and monitor phenotypic and genetic characteristics of SARS-CoV-2 isolates and to compare these cases to those in unvaccinated individuals. Individuals will mainly be identified by active follow up of a sample of cases identified by linkage between community testing and vaccination data.

Clinicians who are seeing hospitalised patients face to face are also encouraged to report any confirmed cases in individuals who have received a booster dose if they tested positive within the preceding 7 days. This provides an opportunity to get early and complete samples from these cases. This surveillance applies to England only.

Criteria for reporting

The following cases should be reported:

Individuals with a SARS-CoV-2 PCR positive sample with symptom onset date at least 7 days after their booster dose of vaccine (this includes any cases who develop symptoms after a booster dose of vaccine).

If the case was asymptomatic, test date should be used in place of symptom onset date.

Vaccinated individuals who test positive using a lateral flow device should be confirmed using PCR.

In order that optimum samples are received, reporting is only requested if the case tested positive within the preceding 7 days. This passive reporting is an opportunity to collect acute samples and clinicians are not required to report retrospective cases.

Reporting cases

Cases can be reported using the online form.

Minimum sample set

Samples should be sent to the national reference laboratory for confirmatory testing, sequencing and serology.

The following samples are requested from the reporting clinician.

On identification of the case or as soon as possible afterwards:

  • one nose and throat swab
  • one serum sample

Twenty-eight days after the first sample set:

  • a second serum sample

If the patient is likely to have been discharged within 28 days, please indicate this on the reporting form and UKHSA can arrange for a phlebotomist to take the 28 day serum sample at the patient’s home. A kit will be sent beforehand to the patient’s home containing the appropriate sample materials.

Reporting is only requested if patients are seen face to face and clinicians do not need to recall community cases in vaccinated individuals for additional samples if they are not in hospital.

Samples should be taken within 7 days of the first positive test.

Sample transfer

Samples should be sent by category B transport with the E59 sample submission form to:

Virus Reference Department
UKHSA Colindale
61 Colindale Avenue
London
NW9 5EQ

Further details on packaging and transport requirements are available.

Reporting of results

Results will be reported to the requesting clinician. Please note it is essential that the correct E59 submission form with the ECOVACC code is used to allow reporting of results. PCR results will be reported in real-time and serology results within approximately 8 weeks.

Follow-up

If the patient is likely to have been discharged within 28 days, please indicate this on the reporting form and UKHSA can arrange for a phlebotomist to take the 28 day serum sample at the patient’s home.

SIREN study participants

Please note that SARS-CoV-2 Immunity and REinfection EvaluatioN (SIREN) study participants are exempted from this enhanced surveillance as they will be investigated within the SIREN study.

If you are aware of a new infection in a vaccinated SIREN participant then you do not need to report this case through this route. Please report any such cases in SIREN participants directly to the SIREN study team siren@phe.gov.uk

Collection of patient data

Surveillance of COVID-19 testing and vaccination is undertaken under Regulation 3 of The Health Service (Control of Patient Information) Regulations 2002 to collect confidential patient information under Sections 3(i) (a) to (c), 3(i)(d) (i) and (ii) and 3(3).

Further information

If you would like more information about this surveillance please contact PHE.vaccines@nhs.net