For the latest news on COVID-19, visit  https://www.aappublications.org/news/2020/01/28/coronavirus.

Federal health officials will be using a new smartphone-based tool to track whether
people receiving COVID-19 vaccines are experiencing any adverse reactions.

The Vaccine Safety Assessment for Essential Workers (V-SAFE) will run alongside more
traditional surveillance systems to monitor the safety of the vaccines that could
begin to roll out later this month.

“Especially for these vaccines, we are going to hold ourselves to exceedingly high
standards for safety monitoring after a vaccine is authorized and when it goes out
more broadly,” Nancy Messonnier, M.D., director of the Centers for Disease Control
and Prevention’s (CDC’s) COVID-19 Vaccine Planning Unit, told the agency’s vaccine
committee this week.

Pfizer and Moderna, which have applied to the Food and Drug Administration (FDA) for
emergency use authorization of their vaccines, have said they have had no serious
safety concerns during their clinical trials. Some participants have reported systemic
reactions like fatigue, headaches and myalgia as their immune system responds to the
vaccine.

The FDA’s Vaccines and Related Biological Products Advisory Committee and the CDC’s
Advisory Committee on Immunization Practices (ACIP) will be reviewing in-depth phase
three clinical trial data in the coming weeks as they determine whether the vaccines
are safe and effective. ACIP recommends that once a vaccine is approved, the first doses go to health care workers and residents of long-term care facilities.

Everyone who gets vaccinated will be encouraged to register for the V-SAFE tool. They
will receive text messages with links to surveys on a daily basis for the first week,
then weekly until six weeks.

Anyone who reports a clinically important event — missing work, being unable to do
normal daily activities or receiving medical care — will get a follow-up phone call
and a report may be filed in the Vaccine Adverse Event Reporting System (VAERS), according
to Tom Shimabukuro, M.D., M.P.H., M.B.A., a member of the CDC’s COVID-19 Vaccine Task
Force.

VAERS, a long-running system managed by the CDC and FDA, is a national database covering
the entire population. It will be one of the main sources monitoring the safety of
COVID-19 vaccines, especially in the early months of vaccination.

 Dr. Shimabukuro told ACIP this week that experts will review VAERS reports classified
as serious, which include death, life-threatening illness, hospitalization, permanent
disability, congenital anomaly or birth defects. Deaths reports will be processed
in a day, serious reports in three days and non-serious reports in five days.

Multidisciplinary CDC teams will review clusters of clinically serious events reported
in VAERS. The CDC’s Clinical Immunization Safety Assessment Project will perform clinical
case reviews, and an ACIP subgroup will review and evaluate COVID-19 safety data.

Additional safety monitoring systems also will be collecting data from electronic
health records, medical claims, specific health care organizations and specific populations
like the military.

“I want to reassure the ACIP, our public health and health care providers, and the
public that we have the systems in place to collect safety data,” Dr. Shimabukuro
said. “We have validated methods to rapidly analyze the data. We have processes in
place to respond to safety signals when we detect them, and we have trusted partners
we will depend on when we implement the vaccination program.”

He called on physicians to talk through safety concerns with patients and encourage
those who get vaccinated to sign up for V-SAFE and report adverse events to VAERS.

Copyright © 2020 American Academy of Pediatrics



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