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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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