FDA and CDC Reinstate Use of Johnson & Johnson’s Janssen COVID-19 Vaccine Following Comprehensive Safety Review

Recently, following a comprehensive safety review, including two meetings of the CDC’s Advisory Committee on Immunization Practices (ACIP), the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC) announced the lifting of the recommendation to pause the use of the Johnson & Johnson COVID-19 vaccine in the United States, thereby resuming its administration.

Previously, the U.S. FDA and CDC recommended pausing the administration of the adenovirus-vector COVID-19 vaccine Ad26.COV2.S after six cases of rare but severe blood clots were identified among vaccinated individuals. During the pause, medical and scientific teams at the FDA and CDC reviewed available data to assess the risk of thrombosis with thrombocytopenia syndrome (TTS). They also engaged in extensive communication with healthcare providers and clinicians to ensure awareness of the potential for these adverse events, thereby enabling appropriate identification and management.

Following extensive and rigorous safety assessments, the two institutions reached the following conclusion:

·The Ad26.COV2.S Vaccine Should Be Resumed for Use in the United States.

·The U.S. FDA and CDC are confident in the safety and efficacy of this vaccine for preventing COVID-19.

·The FDA has determined that available data demonstrate that the known and potential benefits of the vaccine outweigh its known and potential risks in individuals aged 18 years and older.

·Current data indicate that the incidence of TTS is very low, but the FDA and CDC will remain vigilant and continue to investigate this risk.

Healthcare providers administering vaccines and vaccine recipients or caregivers should consult the latest vaccine prescribing information, as the revised version includes information on the risk of this syndrome, which has occurred in a very small number of individuals receiving this vaccine.

“Safety is our top priority. Based on the FDA and CDC’s review of all available data, in consultation with medical experts, and following the recommendations of the CDC’s Advisory Committee on Immunization Practices (ACIP), we have lifted the pause. We have concluded that the known and potential benefits of this vaccine outweigh its known and potential risks for individuals aged 18 years and older. We are confident that this vaccine will continue to meet our standards for safety, effectiveness, and quality. We recommend that individuals with questions discuss them with their healthcare providers,” said Dr. Janet Woodcock, Acting FDA Commissioner.

References:

[1] FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review. Retrieved April 25, 2021, from https://www.fda.gov/news-events/press-announcements/fda-and-cdc-lift-recommended-pause-johnson-johnson-janssen-covid-19-vaccine-use-following-thorough

Note: This article aims to introduce advances in medical and health research and does not constitute treatment recommendations. For guidance on treatment plans, please consult a qualified healthcare provider at an accredited hospital.

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