A few days ago, after a comprehensive safety review, including two meetings of the CDC Immunization Practice Advisory Committee, the US FDA and the US Centers for Disease Control and Prevention (CDC) announced that they would cancel the recommendation to suspend the use of Johnson & Johnson's new crown vaccine in the United States and resume the vaccine.
Previously, due to the discovery of 6 rare and severe thrombosis patients in the population after the adenovirus new crown vaccine Ad26.
S, the US FDA and CDC recommended to suspend the vaccination of this vaccine.
During the suspension, the FDA and CDC medical and scientific teams reviewed existing data and assessed the risk of thrombo-thrombocytopenia syndrome (TTS).
And extensive communication with medical staff and clinicians to ensure that they are aware of the possibility of these adverse events so that they can be properly identified and managed.
The two organizations came to the following conclusions after extensive and rigorous security assessments:
S vaccine should be resumed in the United States.
· The US FDA and CDC have confidence in the safety and effectiveness of this vaccine to prevent COVID-19.
· The FDA has determined that existing data show that the known and potential benefits of the vaccine in individuals 18 years of age and older outweigh the known and potential risks.
· Existing data indicate that the probability of TTS is very low, but the FDA and CDC will remain vigilant and continue to investigate the risk.
Vaccinated health care providers and vaccinators or caregivers should consult the latest vaccine leaflet.
The revised version incorporates information about the risk of the syndrome, which occurred in a very small number of people who received the vaccine.
"Safety is our top priority.
According to the review of all existing data by the US FDA and CDC, and in consultation with medical experts, according to the recommendations of the CDC Immunization Practice Advisory Committee, we lifted the suspension.
We have concluded that , The known and potential benefits of this vaccine in individuals 18 years of age and older exceed its known and potential risks.
We are confident that the vaccine will continue to meet our safety, effectiveness, and quality standards.
We recommend those in doubt People have discussions with their health care providers.
” Acting FDA Commissioner Dr.
Janet Woodcock said.
 FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review.
Retrieved April 25, 2021, from /fda-and-cdc-lift-recommended-pause-johnson-johnson-janssen-covid-19-vaccine-use-following-thorough
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