Agencies Underscore Confidence in Vaccine’s Safety and Effectiveness Following Data Assessment; Available Data Suggest Potential Blood Clots Are Very Rare Events

Agencies Underscore Confidence in Vaccine’s Safety and Effectiveness Following Data Assessment; Available Data Suggest Potential Blood Clots Are Very Rare Events

The two agencies have determined the following:Use of the Janssen COVID-19 Vaccine should be resumed in the United States. Vaccine safety monitoring will continue and any new information about TTS will be brought to ACIP as needed. We have concluded that the known and potential benefits of the Janssen COVID-19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older. We identified exceptionally rare events – out of millions of doses of the Janssen COVID-19 administered – and we paused to examine them more carefully. Reports of adverse events following vaccination can be made to the Vaccine Adverse Event Reporting Systemexternal icon.

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