COVID-19 vaccine monitoring

VAC4EU and its members were key partners of the ACCESS project. VAC4EU and its members are currently monitoring COVID-19 vaccines through the Early-Covid-Vaccine-Monitor project that is also funded by EMA.

The Early-Covid-Vaccine-Monitor project will monitor COVID-19 vaccines in 8 countries using two complementary methodologies:

• A prospective cohort event monitoring, vaccinated persons will be included and monitored through apps/internet. Incidence rates of suspected adverse drug reactions will be calculated.

• A retrospective cohort study, monitoring the incidence rates of ACCESS adverse events of special interest and COVID-19 prior to vaccination, and post vaccination.

The project is focused on monitoring of incidence and not signal detection nor signal evaluation.

ACCESS was a project funded by EMA to prepare a European infrastructure to monitor COVID-19 vaccines. The project started May 2020 and ends February 15, 2021

ACCESS delivered the following deliverables which have gone through EMA and stakeholder review:

1. List of Adverse events of special interest

A list of 37 events of interest with definitions, ICD-9, ICD-10, READ, ICPC and SNOMED codes, for which we need to be prepared. The list of AESI & definitions & codes is available (AESI lock point August 2020)

2. Background rates of AESI

• • Protocol background rates of AESI Background rates of AESI protocol (EUPAS 37273)

  • Results of background rate calculations (https://vac4eu.org/covid-19-tool/)

3. Template protocols for different types of studies to be adapted for full implementation to local situation

Signal detection based on cohort event monitoring

• • Cohort event monitoring to assess safety of COVID-19 vaccines using patient reported events, a protocol template from the ACCESS project

Rapid assessment of new safety signals based on electronic health record data (EHR)

1. • Rapid assessment of COVID-19 vaccines safety concerns through electronic health records: a protocol template from the ACCESS project

Safety signal evaluation studies (EHR or hospital based)

1. • Safety evaluation of COVID-19 vaccines through electronic health records: a protocol template from the ACCESS project

   • Safety Protocol for Hospital Case–Based Monitoring of Specific Adverse Events Following COVID-19 Vaccines: A Protocol Template from the ACCESS project

Effectiveness studies (EHR or hospital based)

1. • Protocol for COVID-19 vaccine effectiveness studies (test-negative design studies): a protocol from the ACCESS project

   • Assessment of effectiveness of COVID-19 vaccines through electronic health record: a protocol template from the ACCESS project

Coverage study (EHR/registry based)

• • Estimation of COVID-19 vaccine coverage using registers and EHR: a protocol template from the ACCESS project

4. Feasibility assessment of countries to participate in studies

• • Final report with feasibility assessment

How have these products been reviewed?

• ACCESS deliverables have been discussed with an advisory committee that was installed by EMA, which had members from the PRAC, CHMP, EMA & ECDC. Comments were received and incorporated with rebuttal documents.

• Subsequently protocols (except 3a and 3g) went for an external stakeholder consultation that was organized by EMA where possible comments from stakeholders were included. This review was conducted for all protocols, except for the cohort event monitoring and coverage protocols.

• VAC4EU organized monthly scientific webinars to discuss different aspects of the ACCESS work which were open to the public. All webinars are publicly available from the VAC4EU website.

Who will implement the ACCESS protocols?

Protocols and products from ACCESS may be used by vaccine manufacturers or public entities (e.g. ECDC, EMA, EC).

Opportunities for implementation of COVID-19 vaccine monitoring studies

Implementation of any of the studies can be facilitated through VAC4EU taking 5 steps

1. Study requesters (public or vaccine manufacturers) can contact the VAC4EU secretariat secretariat@vac4eu.org with a request for proposal (RFP)

2. VAC4EU secretariat will share the RFP with the member organizations and inquire about interest to participate, roles, capacities, desired responsibilities. A coordinating center will be agreed. Choices are made based on interest, excellence, experience, price and fairness.

3. The VAC4EU secretariat will respond to the study requester and facilitate negotiations.

4. Once the coordinating center is mutually agreed and the participating organizations, the coordinating center will contract with the study requester and subcontract participating organizations.

5. VAC4EU secretariat will provide the study team access to infrastructure (tools, templates, procedures for collaboration).

Are you interested to become part of VAC4EU and participate in studies?

• European public health and research organizations can become a member organization of VAC4EU by writing to secretariat@vac4eu.org and complying to membership rules. This will entitle organization to use VAC4EU services and participation in studies.

• Individuals can join the scientific community (please sign up on vac4eu website)