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01 // DISEASE X // CASE FILE 001 // PATHOGEN: UNKNOWN

The next pandemic vaccine could reach millions within months.

Its safety has to be watched at the same speed.

Disease X is the WHO's name for the pathogen nobody has met yet. CEPI's 100 Days Mission aims to have a vaccine ready within 100 days of a new pandemic threat being identified. Watching that vaccine's safety depends on data that has to exist before day one.

▮ ASIA-PACIFIC DATA GRID 8 REGIONS 11 DATABASES SOURCE · DUSZYNSKI 2021

02 // WHAT SURVEILLANCE NEEDS

A safety signal is three streams of data meeting in one place.

The survey behind this page asked every database about all three: its vaccine exposure data, its health outcome data, and whether the two can be linked.

01 · EXPOSURE

Who received what, and when

Vaccine, date, dose, batch, brand. Usually held in immunisation registries.

02 · OUTCOME

What happened next

Diagnoses, admissions, deaths recorded afterwards. Held in health records and insurance claims.

03 · LINKAGE

The same person, joined

A shared identifier that matches each vaccination to that person's later health record.

SAFETY SIGNAL

03 // ASIA-PACIFIC DATA GRID

Which databases in the region can already do this?

As COVID-19 vaccines were being introduced, an ISPE-endorsed survey went looking across the Asia-Pacific for databases that could support vaccine-safety surveillance.

“You see, but you do not observe.”
SHERLOCK HOLMES · A SCANDAL IN BOHEMIA, 1891

  1. STAGE 1 · SURVEYED

    19 countries

    37 screening invitations

  2. STAGE 2 · RESPONDED

    11 countries

    20 respondents, 54%

  3. STAGE 3 · COMPLETED

    10 countries

    11 full surveys

  4. STAGE 4 · SUITABLE

    8 regions

    11 databases

  • — Philippines and Vietnam: surveys described spontaneous pharmacovigilance-report databases, not person-level records
  • — Japan: the database lacked systematic immunisation records

11 DATABASES · 8 REGIONS

Follow the clues, or select a flag for its databases.

CASE NOTES

Australia
Registry only. Outcomes by probabilistic linkage.
China
One district. Every setting. One record.
Hong Kong
Two vaccines recorded, none of the childhood schedule — that sits with the Department of Health.
South Korea
Registry holds the vaccines. NHIS holds the outcomes. Join them.
Malaysia
Vaccine and outcome in the same system.
New Zealand
Registry only. Outcomes need linkage.
Thailand
Two regional systems. Outcomes built in.
Taiwan
NIIS holds the vaccines; NHIRD, the outcomes. Linkage joins them.
Japan
Excluded: no systematic immunisation records.
Philippines
Excluded: spontaneous reports only, not person-level.
Vietnam
Excluded: spontaneous reports only, not person-level.

Vaccination and outcomes: in one database, or joined by linkage

Six hold vaccination and outcome records in one place. The other five hold only one side — four are immunisation registries with no outcomes, and Korea's insurance database has outcomes but no vaccination — so each must be linked to another source before the two can be compared. That dependence on linkage is the paper's main obstacle to a regional network.

INTEGRATED

6

vaccine + outcome in one database

  • Yinzhou · China

    Yinzhou Electronic Health Record

    EHR INTEGRATED

  • CDARS · Hong Kong

    Clinical Data Analysis and Reporting System

    EHR INTEGRATED

  • QUEST3+ · Malaysia

    QUEST3+

    EHR INTEGRATED

  • HI · Thailand

    Hospital Information

    EHR INTEGRATED

  • HIMpro · Thailand

    Hospital Information Management professional

    EHR INTEGRATED

  • NHIRD · Taiwan

    National Health Insurance Databases

    CLAIMS INTEGRATED

LINKAGE REQUIRED

5

holds one side; the other must be linked in

  • AIR · Australia

    Australian Immunisation Register

    REGISTRY LINKAGE REQUIRED

  • Registry · South Korea

    Immunization Registry System

    REGISTRY LINKAGE REQUIRED

  • NHIS · South Korea

    National Health Insurance Database, with health screening

    CLAIMS LINKAGE REQUIRED

  • NIR · New Zealand

    National Immunisation Register

    REGISTRY LINKAGE REQUIRED

  • NIIS · Taiwan

    National Immunization Information System

    REGISTRY LINKAGE REQUIRED

Vaccine details each database records

Nine of the eleven record the vaccination date. Fewer record a batch number or a standard ATC code, and the paper found the coding of individual vaccines varied: only influenza vaccine was recorded uniformly across almost all countries.

Date of vaccination 9/11
Country-specific code 8/11
Dose 8/11
Route 7/11
Setting 7/11
Brand 6/11
Batch number 5/11
ATC code 5/11
Manufacturer 5/11
Body site 3/11

SOURCE · DUSZYNSKI 2021, TABLE 3

VIEW AS TABLE
VariableDatabases
Date of vaccination9 of 11
Country-specific code8 of 11
Dose8 of 11
Route7 of 11
Setting7 of 11
Brand6 of 11
Batch number5 of 11
ATC code5 of 11
Manufacturer5 of 11
Body site3 of 11

Where the paper disagrees with itself, this page follows Table 3. The abstract gives brand as 7 of 11, the table 6; the discussion says every database records the vaccination date, the table 9 of 11.

THE DEDUCTION

  1. OBSERVED

    19 countries surveyed. 8 regions had person-level vaccination data.

  2. OBSERVED

    Only 6 of 11 databases hold vaccine and outcome together.

  3. OBSERVED

    In 3 of 8 regions — Australia, South Korea, New Zealand — every database needs linkage.

  4. DEDUCED

    There, outcomes cannot be seen alongside vaccinations until two datasets are joined.

  5. CONCLUSION

    Access to data and reliance on linkage are what stand between the region and a vaccine-safety network.

04 · Why it matters

The region needs its network in place before the next new vaccine.

COVID-19 showed the need for an established Asia-Pacific database network, one that can give population-level evidence on the safety and effectiveness of newly developed vaccines. The paper names what stands in the way.

Vaccines are recorded differently

Coding of individual vaccines varied between databases. Only influenza vaccine was recorded uniformly across almost all countries, and routine childhood vaccines were recorded inconsistently. Hong Kong's CDARS captured two vaccines and none of the childhood schedule, which the Department of Health runs.

Outcomes sit in another database

Australia, Korea, New Zealand and Taiwan keep immunisation registries that need external linkage to reach health outcomes. Korea's insurance database is the reverse: outcomes, but no vaccination.

Access takes time

The time to approval, and the number of approvals needed before data could be released, varied between countries, and that slowed access to the data.

What would close the gap

A common data model, and lessons from vaccine networks already running: PRISM in the United States, and Vac4EU and DARWIN EU in Europe.

Further on this site: Taiwan's COVID-19 vaccination registry and National Immunization Information System on the Taiwan data page, and DARWIN EU among our partner networks.