National Center for Emerging and Zoonotic Infectious Diseases

Update: v-safe after vaccination health checker

Advisory Committee on Immunization Practices (ACIP) meeting

April 19, 2023

Tom T. Shimabukuro, MD, MPH, MBA

Director, Immunization Safety Office

Division of Healthcare Quality Promotion 

Centers for Disease Control and Prevention (CDC)
Topics

▪ Overview of v-safe

▪ Contributions of v-safe to the COVID-19 response

▪ Historical and current participation in v-safe

▪ Planning for the wind-down of the current system and 

development of next version of v-safe

▪ Continued safety monitoring of COVID-19 vaccines

2
Overview of v-safe for COVID-19 vaccines

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▪ Implemented December 2020

▪ Designed to collect near-real time data by direct outreach to 

COVID-19 vaccine recipients

• Initially conceived to rapidly collect basic safety data (local and 

systemic reactogenicity, health impacts) at the onset of the COVID-19 

vaccination program to provide early data while other systems, such 

as VAERS and the Vaccine Safety Datalink, were accruing data

• Identified vaccinated pregnant persons for possible enrollment in the 

COVID-19 Vaccine Pregnancy Registry

• Was useful in rapidly collecting early safety data when authorizations 

and recommendations expanded to other age and risk groups (e.g., 

additional doses for immunocompromised persons)

• Was quickly adapted to capture simultaneous administration of other 

non-COVID vaccines (e.g., flu vaccine)

▪ Designed, built, and supported in collaboration with Oracle 

Health Services under a donation agreement with HHS
Overview of v-safe for COVID-19 vaccines (continued)

4

▪ Enrollment by self-registration on smartphone with any 

dependents added to guardian’s account

▪ Survey completion prompted by text message reminders for 

“health check-ins”

▪ Call follow-up to all participants who report a medically 

attended event

▪ Robust participation in its first year 

• 9.3 million participants / 131 million health surveys completed

▪ Total participation to date

• 10.1 million participants / 151 million health surveys completed
Key contributions of v-safe to COVID-19 vaccine safety

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*V-safe identifies pregnant people for enrollment in Vaccine Pregnancy Registry | CDC

▪ V-safe has been particularly effective in characterizing the basic safety of COVID-19 vaccines during 

early vaccine introduction and following new authorizations and recommendations

▪ V-safe successfully accomplished its mission and worked as intended
Participation in v-safe for COVID-19 vaccines

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0

10,000,000

20,000,000

30,000,000

40,000,000

50,000,000

60,000,000

70,000,000

80,000,000

90,000,000

100,000,000

0

500,000

1,000,000

1,500,000

2,000,000

2,500,000

Dec-20

Jan-21

Feb-21

Mar-21

Apr-21

May-21

Jun-21

Jul-21

Aug-21

Sep-21

Oct-21

Nov-21

Dec-21

Jan-22

Feb-22

Mar-22

Apr-22

May-22

Jun-22

Jul-22

Aug-22

Sep-22

Oct-22

Nov-22

Dec-22

Jan-23

Feb-23

Mar-23

New v-safe registrants by month

New Active Registrants Doses COVID-19 Vaccine Administered in United States

Active registrants defined as those completing at least one survey by April 9, 2023

Doses COVID-19 vaccine administered sourced from COVID Data Tracker

Registrants Doses
Next steps for v-safe

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▪ Timing for final registration and completing surveys will be announced soon

▪ Follow up will continue on reports of medically attended health events

▪ Next generation v-safe is under development

• Plans to collect data on new vaccines

• Will allow greater flexibility for surveys and use CDC IT infrastructure

• Designed to permit longer-term support for collecting data rapidly from a large 

number of vaccine recipients
CDC vaccine safety monitoring for COVID-19 vaccines

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▪ Safety monitoring and assessment of COVID-19 vaccines will continue in:

• Vaccine Adverse Events Reporting System (VAERS) 

VAERS | Vaccine Safety | CDC, Vaccine Adverse Event Reporting System (VAERS) (hhs.gov)

• Vaccine Safety Datalink (VSD) 

Vaccine Safety Datalink (VSD) | VSD | Monitoring | Ensuring Safety | Vaccine Safety | CDC

• Clinical Immunization Safety Assessment (CISA) Project 

Clinical Immunization Safety Assessment (CISA) Project | CISA | Monitoring | Ensuring Safety | Vaccine Safety | CDC
CDC vaccine safety monitoring

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▪ Strong, complementary systems are in place―both new and established 

VAERS VSD CISA Project v-safe

Full list of U.S. COVID-19 vaccine safety monitoring systems

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety.html

Vaccine Adverse Event Reporting System (VAERS), Vaccine Safety Datalink (VSD), Clinical Immunization Safety Assessment (CISA)
Acknowledgements

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▪ CDC Immunization Safety Office

• V-safe Team

▪ COVID-19 Vaccine Task Force Data Monitoring and Reporting Group

▪ CDC NCEZID and DHQP Communications Teams

▪ Oracle Health Services

▪ Participants in v-safe
For more information, contact CDC

1-800-CDC-INFO (232-4636)

TTY: 1-888-232-6348 www.cdc.gov

The findings and conclusions in this report are those of the authors and do not necessarily represent the 

official position of the Centers for Disease Control and Prevention.

Photo credit: James Gathany

(https://phil.cdc.gov/Details.

aspx?pid=8876)