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Cluster Of Adverse Events At One California Vaccination Clinic
Triggers Pause In Use Of COVID-19 Vaccination
Vaccinations
Resume After Rapid Investigation
A higher than usual
number of apparently allergic reactions (fewer than 10) to a specific
lot of Moderna COVID-19 vaccine at a single California drive through
vaccination clinic in San Diego in mid-January prompted the California
state epidemiologist Erica Pan to recommend a pause in the use
of that lot. She noted that the action was being taken “out of an
extreme abundance of caution”.
Review Group
The state called upon
the Western States Scientific Safety Review Group as well as allergy
and immunology specialists to review three types of data—the
procedures and staffing at the vaccination site, the distribution of
the vaccine lot in other parts of California and the US, and clinical
and other details about seven individuals who reportedly had adverse
events on January 12 and 13. Reviewers examined signs and symptoms,
time intervals between vaccination and onset, treatments received, and
any histories of allergic or anaphylactic reactions. All seven
patients recovered.
Conclusion
The
advisory group concluded that one or more of the seven affected
persons had angioedema but anaphylaxis was not confirmed. No reason
was uncovered for why these reactions occurred at that site on those
dates. Discussions were held with CDC, FDA, and the manufacturer as
well.
All Clear
In light of the facts
that many other persons had been and were being safely vaccinated with
this lot in other states, and given the severity of the ongoing
pandemic as well as the limited supply of vaccine, the Workgroup
recommended that vaccination with this Moderna lot could continue in
California and other states represented in the Workgroup. The
recommended pause was issued on January 17 and resumption was called
for on January 20.
Final Statement
According to Pan,
there was “no scientific basis to continue the pause.” She added,
“These findings should continue to give Californians confidence that
vaccines are safe and effective, and that the systems put in place to
ensure vaccine safety are rigorous and science-based.”
To read the advisory group’s report,
visit:
https://bit.ly/39r0f29
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