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3. Overview of U.S. COVID-19 vaccine safety surveillance systems

Author

Gee, Julianne, Shimabukuro, Tom T., Su, John R., Shay, David, Ryan, Margaret, Basavaraju, Sridhar V., Broder, Karen R., Clark, Matthew, Buddy Creech, C., Cunningham, Francesca, Goddard, Kristin, Guy, Harrison, Edwards, Kathryn M., Forshee, Richard, Hamburger, Tanya, Hause, Anne M., Klein, Nicola P., Kracalik, Ian, Lamer, Chris, Loran, David A., McNeil, Michael M., Montgomery, Jay, Moro, Pedro, Myers, Tanya R., Olson, Christine, Oster, Matthew E., Sharma, Andrea J., Schupbach, Ryan, Weintraub, Eric, Whitehead, Brett, and Anderson, Steven

Published
2024
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4. COVID-19 Vaccine Safety Technical (VaST) Work Group: Enhancing vaccine safety monitoring during the pandemic

Author

Markowitz, Lauri E., Hopkins, Robert H., Jr, Broder, Karen R., Lee, Grace M., Edwards, Kathryn M., Daley, Matthew F., Jackson, Lisa A., Nelson, Jennifer C., Riley, Laura E., McNally, Veronica V., Schechter, Robert, Whitley-Williams, Patricia N., Cunningham, Francesca, Clark, Matthew, Ryan, Margaret, Farizo, Karen M., Wong, Hui-Lee, Kelman, Jeffery, Beresnev, Tatiana, Marshall, Valerie, Shay, David K., Gee, Julianne, Woo, Jared, McNeil, Michael M., Su, John R., Shimabukuro, Tom T., Wharton, Melinda, and Keipp Talbot, H.

Published
2024
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5. Early Safety Findings Among Persons Aged [greater than or equal to] 60 Years Who Received a Respiratory Syncytial Virus Vaccine--United States, May 3, 2023-April 14, 2024

Author

Hause, Anne M., Moro, Pedro L., Baggs, James, Zhang, Bicheng, Marquez, Paige, Melgar, Michael, Britton, Amadea, Stroud, Erin, Myers, Tanya R., Rakickas, Jeffrey, Blanc, Phillip G., Welsh, Kerry, Broder, Karen R., Su, John R., and Shay, David K.

Subjects
United States. Food and Drug Administration -- Safety and security measures, Pfizer Inc. -- Safety and security measures, Guillain-Barre syndrome -- Complications and side effects, Vaccination -- Surveys -- Safety and security measures, Respiratory tract diseases -- Complications and side effects, Vaccines -- Complications and side effects, Pharmaceutical industry -- Safety and security measures -- Surveys, Health, Abrysvo (Vaccine) -- Complications and side effects
Abstract

Introduction Respiratory syncytial virus (RSV) infection can cause lower respiratory tract disease, hospitalization, and death in older adults and is responsible for substantial morbidity and mortality among this age group [...]

Published
2024

7. Autopsy Histopathologic Cardiac Findings in 2 Adolescents Following the Second COVID-19 Vaccine Dose

Author

Paddock, Christopher D., Reagan-Steiner, Sarah, Su, John R., Oster, Matthew E., Martines, Roosecelis B., Bhatnagar, Julu, and Shimabukuro, Tom T.

Subjects
Teenagers -- Health aspects, Youth -- Health aspects, Histology, Pathological -- Methods, Health
Abstract

To the Editor.--We read with concern the manuscript by Gill et al (1) that described autopsy findings for 2 adolescents who died after COVID-19 vaccination. The authors correctly stated that [...]

Published
2022

10. Early Safety Findings Among Persons Aged =60 Years Who Received a Respiratory Syncytial Virus Vaccine -- United States, May 3, 2023-April 14, 2024.

Author

Hause, Anne M., Moro, Pedro L., Baggs, James, Bicheng Zhang, Marquez, Paige, Melgar, Michael, Britton, Amadea, Stroud, Erin, Myers, Tanya R., Rakickas, Jeffrey, Blanc, Phillip G., Welsh, Kerry, Broder, Karen R., Su, John R., and Shay, David K.

Subjects
RESPIRATORY syncytial virus, GUILLAIN-Barre syndrome, VACCINATION
Abstract

In May 2023, the Food and Drug Administration (FDA) licensed Arexvy and Abrysvo vaccines for prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in adults aged =60 years. In prelicensure trials, Guillain-Barré syndrome (GBS) was identified as a potential safety concern. During August 4, 2023-March 30, 2024, at least 10.6 million adults aged =60 years received a recommended RSV vaccine. During May 3, 2023-April 14, 2024, CDC reviewed data reported after RSV vaccination to V-safe, an active U.S. surveillance system that invites enrolled participants to complete web-based surveys, and reports to the Vaccine Adverse Event Reporting System (VAERS), a passive, voluntary surveillance system that accepts adverse event reports from the public, providers, and manufacturers. Findings from V-safe and VAERS were generally consistent with those from trials. Reporting rates of GBS after RSV vaccination in VAERS (5.0 and 1.5 reports per million doses of Abrysvo and Arexvy vaccine administered, respectively) were higher than estimated expected background rates in a vaccinated population. CDC and FDA are conducting population-based surveillance to assess risks for GBS and other adverse events. Findings from these studies will help guide development of Advisory Committee on Immunization Practices recommendations. [ABSTRACT FROM AUTHOR]

Published
2024
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12. Safety Monitoring of Bivalent COVID-19 mRNA Vaccine Booster Doses Among Children Aged 5-11 Years--United States, October 12-January 1, 2023

Author

Hause, Anne M., Marquez, Paige, Zhang, Bicheng, Su, John R., Myers, Tanya R., Gee, Julianne, Panchanathan, Sarada S., Thompson, Deborah, Shimabukuro, Tom T., and Shay, David K.

Subjects
United States. Food and Drug Administration -- Safety and security measures, Pfizer Inc. -- Safety and security measures, Vaccination -- Health aspects -- Safety and security measures, Messenger RNA -- Safety and security measures -- Health aspects, Vaccines -- Safety and security measures -- Health aspects, Pharmaceutical industry -- Safety and security measures -- Health aspects, Health
Abstract

On October 12, 2022, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) for bivalent (mRNA encoding the spike protein from the SARS-CoV-2 ancestral strain and BA.4/BA.5 Omicron [...]

Published
2023

13. Safety Monitoring of Bivalent COVID-19 mRNA Vaccine Booster Doses Among Persons Aged [greater than or equal to]12 Years--United States, August 31-October 23, 2022

Author

Hause, Anne M., Marquez, Paige, Zhang, Bicheng, Myers, Tanya R., Gee, Julianne, Su, John R., Blanc, Phillip G., Thomas, Alisha, Thompson, Deborah, Shimabukuro, Tom T., and Shay, David K.

Subjects
United States. Food and Drug Administration -- Safety and security measures, Pfizer Inc. -- Safety and security measures, Vaccination -- Health aspects -- Safety and security measures, Messenger RNA -- Safety and security measures -- Health aspects, Adults -- Health aspects -- Safety and security measures, Vaccines -- Safety and security measures -- Health aspects, Health
Abstract

On August 31, 2022, the Food and Drug Administration (FDA) authorized bivalent formulations of BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) COVID-19 vaccines; these vaccines include mRNA encoding the spike protein from [...]

Published
2022

14. COVID-19 mRNA Vaccine Safety Among Children Aged 6 Months-5 Years--United States, June 18, 2022-August 21,2022

Author

Hause, Anne M., Marquez, Paige, Zhang, Bicheng, Myers, Tanya R., Gee, Julianne, Su, John R., Parker, Casey, Thompson, Deborah, Panchanathan, Sarada S., Shimabukuro, Tom T., and Shay, David K.

Subjects
United States. Food and Drug Administration -- Safety and security measures, Pfizer Inc. -- Safety and security measures, Children's furniture -- Safety and security measures, Messenger RNA -- Safety and security measures, Vaccines -- Complications and side effects, Health
Abstract

On June 17, 2022, the Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for mRNA COVID-19 vaccines to include children aged 6 months-4 years for receipt of [...]

Published
2022

15. Safety Monitoring of Pfizer-BioNTech COVID-19 Vaccine Booster Doses Among Children Aged 5-11 Years--United States, May 17-July 31, 2022

Author

Hause, Anne M., Baggs, James, Marquez, Paige, Myers, Tanya R., Su, John R., Hugueley, Brandon, Thompson, Deborah, Gee, Julianne, Shimabukuro, Tom T., and Shay, David K.

Subjects
United States. Food and Drug Administration -- Safety and security measures, Pfizer Inc. -- Safety and security measures, Medical research -- Safety and security measures, Medicine, Experimental -- Safety and security measures, Children's furniture -- Safety and security measures, Vaccination -- Safety and security measures, Vaccines -- Complications and side effects, Pharmaceutical industry -- Safety and security measures, Health, Comirnaty (Vaccine) -- Complications and side effects
Abstract

On May 17, 2022, the Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine to authorize a homologous * booster dose for children [...]

Published
2022

17. Evaluation of association of anti-PEG antibodies with anaphylaxis after mRNA COVID-19 vaccination

Author

Zhou, Zhao-Hua, primary, Cortese, Margaret M., additional, Fang, Jia-Long, additional, Wood, Robert, additional, Hummell, Donna S., additional, Risma, Kimberly A., additional, Norton, Allison E., additional, KuKuruga, Mark, additional, Kirshner, Susan, additional, Rabin, Ronald L., additional, Agarabi, Cyrus, additional, Staat, Mary A., additional, Halasa, Natasha, additional, Ware, Russell E., additional, Stahl, Anna, additional, McMahon, Maureen, additional, Browning, Peter, additional, Maniatis, Panagiotis, additional, Bolcen, Shanna, additional, Edwards, Kathryn M., additional, Su, John R., additional, Dharmarajan, Sai, additional, Forshee, Richard, additional, Broder, Karen R., additional, Anderson, Steven, additional, and Kozlowski, Steven, additional

Published
2023
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18. COVID-19 Vaccine Safety Inquiries to the Centers for Disease Control and Prevention Immunization Safety Office

Author

Miller, Elaine R., primary, Moro, Pedro L., additional, Shimabukuro, Tom T., additional, Carlock, Grace, additional, Davis, Shaeyla, additional, Freeborn, Emma, additional, Roberts, Amy, additional, Gee, Julianne, additional, Taylor, Allan W., additional, Gallego, Ruth, additional, Suragh, Tiffany, additional, and Su, John R., additional

Published
2023
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19. COVID-19 Vaccine Safety First Year Findings in Adolescents

Author

Hesse, Elisabeth M., Hause, Anne, Myers, Tanya, Su, John R., Marquez, Paige, Zhang, Bicheng, Cortese, Margaret, Allen, Andrea Thames, Curtis, Christine R., Maloney, Susan A., Thompson, Deborah, Nair, Narayan, Alimchandani, Meghna, Niu, Manette, Gee, Julianne, Shay, David K., and Shimabukuro, Tom T.

Subjects
Article
Abstract

BACKGROUND/OBJECTIVES: The Food and Drug Administration (FDA) expanded Emergency Use Authorization (EUA) for use of Pfizer-BioNTech (BNT-162b2) COVID-19 vaccine to include people ages 12 years and older on May 10, 2021. Early post-authorization safety data were limited, especially for rare outcomes of concern. We describe adverse events observed during the first full year of the U.S. COVID-19 vaccination program for adolescents ages 12–17 years. METHODS: We conducted descriptive analyses using data from 2 complementary U.S. vaccine safety monitoring systems: v-safe, a voluntary smartphone-based system that monitors reactions and health impacts, and the Vaccine Adverse Event Reporting System (VAERS), the national spontaneous reporting system. We reviewed reports and calculated adverse event reporting rates using vaccine administration data. RESULTS: Among 172,032 adolescents ages 12–17 years enrolled in v-safe, most reported reactions following BNT-162b2 were mild to moderate, most frequently reported on the day after vaccination, and more common after dose 2. VAERS received 20,240 adverse event reports; 91.5% were nonserious. Among adverse events of interest, we verified 39 cases of MIS-C (1.2 cases per million vaccinations), 33 (84.6%) of which had evidence of prior SARS-CoV-2 infection; and 570 cases of myocarditis (17.7 cases per million vaccinations), most of whom (77%) reported symptom resolution at the time of report. CONCLUSIONS: During the first year BNT-162b2 was administered to adolescents ages 12–17 years, most adverse events reported to v-safe and VAERS were mild and appeared self-limited. Rates of myocarditis were lower than earlier reports. No new serious safety concerns were identified.

Published
2023

21. Safety Monitoring of COVID-19 mRNA Vaccine Second Booster Doses Among Adults Aged [greater than or equal to]50 Years--United States, March 29, 2022-July 10, 2022

Author

Hause, Anne M., Baggs, James, Marquez, Paige, Abara, Winston E., Baumblatt, Jane, Blanc, Phillip G., Su, John R., Hugueley, Brandon, Parker, Casey, Myers, Tanya R., Gee, Julianne, Shimabukuro, Tom T., and Shay, David K.

Subjects
United States. Food and Drug Administration -- Safety and security measures, Pfizer Inc. -- Safety and security measures, Messenger RNA -- Safety and security measures, Adults -- Safety and security measures, Vaccines -- Safety and security measures, Pharmaceutical industry -- Safety and security measures, Health
Abstract

The Advisory Committee on Immunization Practices (ACIP) recommends that all persons aged [greater than or equal to]5 years receive 1 booster dose of a COVID-19 vaccine after completion of their [...]

Published
2022

22. Safety Monitoring of COVID-19 mRNA Vaccine First Booster Doses Among Persons Aged >12 Years with Presumed Immunocompromise Status--United States, January 12, 2022-March 28, 2022

Author

Hause, Anne M., Baggs, James, Marquez, Paige, Abara, Winston E., Baumblatt, Jane Gwira, Thompson, Deborah, Su, John R., Myers, Tanya R., Gee, Julianne, Shimabukuro, Tom T., and Shay, David K.

Subjects
United States. Food and Drug Administration -- Safety and security measures, Pfizer Inc. -- Safety and security measures, Vaccination -- Safety and security measures, Messenger RNA -- Safety and security measures, Vaccines -- Safety and security measures, Health
Abstract

Persons with moderate to severe immunocompromising conditions are at risk for severe COVID-19, and their immune response to COVID-19 vaccination might not be as robust as the response in persons [...]

Published
2022

23. Vaccine Safety

Author

Su, John R., primary, Duffy, Jonathan, additional, and Shimabukuro, Tom T., additional

Published
2019
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24. List of Contributors

Author

Shimabukuro, Tom T., primary, Duffy, Jonathan, additional, Su, John R., additional, Omer, Saad B., additional, Poland, Caroline M., additional, Gravenstein, Stefan, additional, Cunningham, Anthony L., additional, Heineman, Thomas C., additional, Levin, Myron J., additional, Poland, Gregory A., additional, Ovsyannikova, Inna G., additional, Kennedy, Richard B., additional, Tosh, Pritish K., additional, Loeb, Mark, additional, Harrison, Lee H., additional, Altmann, Daniel M., additional, Whitaker, Jennifer A., additional, Mileno, Maria D., additional, Weber, David J., additional, Pilishvili, Tamara, additional, Nanduri, Srinivas Acharya, additional, Bennett, Nancy M., additional, Chamberlain, Allison T., additional, Saade, Elie A., additional, Canaday, David H., additional, Davidson, H. Edward, additional, Han, Lisa F., additional, Wang, Biao, additional, Sickbert-Bennett, Emily E., additional, Valles, Kenneth, additional, Lau, Colleen, additional, Lonks, John R., additional, Garland, Joseph Metmowlee, additional, Sanchez, Martha C., additional, Nau, Gerard J., additional, and Larkin, Jerome M., additional

Published
2019
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25. Surveillance for multisystem inflammatory syndrome in U.S. children aged 5-11 years who received Pfizer-BioNTech COVID-19 vaccine, November 2021−March 2022

Author

Cortese, Margaret M, primary, Taylor, Allan W, additional, Akinbami, Lara J, additional, Thames-Allen, Andrea, additional, Yousaf, Anna R, additional, Campbell, Angela P, additional, Maloney, Susan A, additional, Harrington, Theresa, additional, Anyalechi, E Gloria, additional, Munshi, Datta, additional, Kamidani, Satoshi, additional, Curtis, C Robinette, additional, McCormick, David W, additional, Staat, Mary A, additional, Edwards, Kathryn M, additional, Creech, C Buddy, additional, Museru, Oidda, additional, Marquez, Paige, additional, Thompson, Deborah, additional, Su, John R, additional, Schlaudecker, Elizabeth P, additional, and Broder, Karen R, additional

Published
2023
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26. Reports of Guillain-Barré Syndrome After COVID-19 Vaccination in the United States

Author

Abara, Winston E., primary, Gee, Julianne, additional, Marquez, Paige, additional, Woo, Jared, additional, Myers, Tanya R., additional, DeSantis, Allison, additional, Baumblatt, Jane A. G., additional, Woo, Emily Jane, additional, Thompson, Deborah, additional, Nair, Narayan, additional, Su, John R., additional, Shimabukuro, Tom T., additional, and Shay, David K., additional

Published
2023
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27. The Advisory Committee on Immunization Practices' Recommendation for Use of Moderna COVID-19 Vaccine in Adults Aged [greater than or equal to]18 Years and Considerations for Extended Intervals for Administration of Primary Series Doses of mRNA COVID-19 Vaccines--United States, February 2022

Author

Wallace, Megan, Moulia, Danielle, Blain, Amy E., Ricketts, Erin K., Minhaj, Faisal S., Link-Gelles, Ruth, Curran, Kathryn G., Hadler, Stephen C., Asif, Amimah, Godfrey, Monica, Hall, Elisha, Fiore, Anthony, Meyer, Sarah, Su, John R., Weintraub, Eric, Oster, Matthew E., Shimabukuro, Tom T., Campos- Outcalt, Doug, Morgan, Rebecca L., Bell, Beth P., Brooks, Oliver, Talbot, H. Keipp, Lee, Grace M., Daley, Matthew F., and Oliver, Sara E.

Subjects
United States. Food and Drug Administration, United States. Department of Health and Human Services, Pfizer Inc., Messenger RNA -- Usage -- Health aspects, Adults -- Health aspects -- Usage, Vaccines -- Usage, Pharmaceutical industry -- Health aspects -- Usage, Health
Abstract

The mRNA-1273 (Moderna) COVID-19 vaccine is a lipid nanoparticle-encapsulated, nucleoside-modified mRNA vaccine encoding the stabilized prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. During December 2020, the vaccine [...]

Published
2022

28. Safety Monitoring of COVID-19 Vaccine Booster Doses Among Persons Aged 12-17 Years--United States, December 9, 2021-February 20, 2022

Author

Hause, Anne M., Baggs, James, Marquez, Paige, Abara, Winston E., Olubajo, Babatunde, Myers, Tanya R., Su, John R., Thompson, Deborah, Gee, Julianne, Shimabukuro, Tom T., and Shay, David K.

Subjects
United States. Food and Drug Administration -- Safety and security measures, Pfizer Inc. -- Safety and security measures, Vaccines -- Safety and security measures -- Reports, Pharmaceutical industry -- Reports -- Safety and security measures, Health, Comirnaty (Vaccine) -- Reports
Abstract

On March 1, 2022, this report was posted as an MMWR Early Release on the MMWR website (https://www.cdc.gov/mmwr). As of February 20, 2022, only BNT162b2 (PfizerBioNTech) COVID-19 vaccine has been [...]

Published
2022

29. Safety Monitoring of COVID-19 Vaccine Booster Doses Among Adults--United States, September 22, 2021-February 6, 2022

Author

Hause, Anne M., Baggs, James, Marquez, Paige, Myers, Tanya R., Su, John R., Blanc, Phillip G., Baumblatt, Jane A. Gwira, Woo, Emily Jane, Gee, Julianne, Shimabukuro, Tom T., and Shay, David K.

Subjects
United States. Food and Drug Administration -- Safety and security measures, Pfizer Inc. -- Safety and security measures, Adults -- Reports -- Safety and security measures, Vaccines -- Safety and security measures -- Reports, Pharmaceutical industry -- Reports -- Safety and security measures, Health
Abstract

On February 11, 2022, this report was posted as an MMWR Early Release on the MMWR website (https://www.cdc.gov/mmwr). During September 22, 2021-February 6, 2022, approximately 82.6 million U.S. residents aged [...]

Published
2022

31. Safety Monitoring of Bivalent COVID-19 mRNA Vaccine Booster Doses Among Persons Aged ≥12 Years — United States, August 31–October 23, 2022

Author

Hause, Anne M., primary, Marquez, Paige, additional, Zhang, Bicheng, additional, Myers, Tanya R., additional, Gee, Julianne, additional, Su, John R., additional, Blanc, Phillip G., additional, Thomas, Alisha, additional, Thompson, Deborah, additional, Shimabukuro, Tom T., additional, and Shay, David K., additional

Published
2022
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32. Outcomes at least 90 days since onset of myocarditis after mRNA COVID-19 vaccination in adolescents and young adults in the USA: a follow-up surveillance study

Author

Kracalik, Ian, primary, Oster, Matthew E, additional, Broder, Karen R, additional, Cortese, Margaret M, additional, Glover, Maleeka, additional, Shields, Karen, additional, Creech, C Buddy, additional, Romanson, Brittney, additional, Novosad, Shannon, additional, Soslow, Jonathan, additional, Walter, Emmanuel B, additional, Marquez, Paige, additional, Dendy, Jeffrey M, additional, Woo, Jared, additional, Valderrama, Amy L, additional, Ramirez-Cardenas, Alejandra, additional, Assefa, Agape, additional, Campbell, M Jay, additional, Su, John R, additional, Magill, Shelley S, additional, Shay, David K, additional, Shimabukuro, Tom T, additional, Basavaraju, Sridhar V, additional, Campbell, Paula, additional, Anugwom, Chidera, additional, Arvelo Jefferson, Colenda, additional, Badger, Kimberly, additional, Bafford, Nastocia, additional, Barnes, Chandra, additional, Boles, Stephanie, additional, Collins, Emory, additional, Desai, Mitesh, additional, Dulski, Theresa, additional, Dyleski, Barbara, additional, Edwards, Kathryn, additional, Feyereisen, Melanie, additional, Gonsahn, Stephanie, additional, Gregory, Tchernavia, additional, Gunta, Jyothi, additional, Jacobs Slifka, Kara, additional, Kabore, Charlotte, additional, Kapella, Bryan K., additional, Karol, Susan, additional, Kennebrew, Kalah, additional, Kluisza, Nancy, additional, Lang, Sean, additional, Lanier Gholston, Labretta, additional, Law, Marcella, additional, Lehman, Jennifer, additional, Mazurek, Jacek M., additional, McGruder, Henraya, additional, McNamara, Kiara, additional, Moore, Maria-Luisa, additional, Moro, Pedro, additional, Moroney, John F., additional, Museru, Oidda, additional, Nale, Cassandra, additional, Neiman, Andi, additional, Newsome, Kim, additional, Odom, Erika, additional, Pantazides, Brooke, additional, Patel, Suchita, additional, Rao, Agam, additional, Reynolds, Laura, additional, Robinson, Sonya, additional, Ruberg, Frederick L., additional, Schaeffer, Tammy, additional, Solanky, Dipesh, additional, Sperling, Laurence, additional, Stanley, Toscha, additional, Sullivan, Regina, additional, Taylor, Allan, additional, Thomas, Kimberly, additional, Thompson, Shayle, additional, Tola, Jigsa, additional, Tran, Cuc H., additional, Wiersma, Steven, additional, and Works, Kimberly, additional

Published
2022
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33. Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine: Updated Interim Recommendations from the Advisory Committee on Immunization Practices--United States, December 2021

Author

Oliver, Sara E., Wallace, Megan, See, Isaac, Mbaeyi, Sarah, Godfrey, Monica, Hadler, Stephen C., Jatlaoui, Tara C., Twentyman, Evelyn, Hughes, Michelle M., Rao, Agam K., Flore, Anthony, Su, John R., Broder, Karen R., Shimabukuro, Tom, Lale, Allison, Shay, David K., Markowitz, Lauri E., Wharton, Melinda, Bell, Beth P., Brooks, Oliver, McNally, Veronica, Lee, Grace M., Talbot, H. Keipp, and Daley, Matthew F.

Subjects
United States. Food and Drug Administration, Johnson & Johnson, Vaccination -- Usage, Vaccines -- Usage, Pharmaceutical industry -- Usage, Health
Abstract

On February 27, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the adenovirus-vectored COVID-19 vaccine (Janssen Biotech, Inc., a Janssen Pharmaceutical company, Johnson & [...]

Published
2022

34. COVID-19 Vaccine Safety in Children Aged 5-11 Years--United States, November 3-December 19, 2021

Author

Hause, Anne M., Baggs, James, Marquez, Paige, Myers, Tanya R., Gee, Julianne, Su, John R., Zhang, Bicheng, Thompson, Deborah, Shimabukuro, Tom T., and Shay, David K.

Subjects
United States. Food and Drug Administration -- Safety and security measures, Pfizer Inc. -- Safety and security measures, Vaccination -- Safety and security measures, RNA -- Safety and security measures, Vaccines -- Complications and side effects, Pharmaceutical industry -- Safety and security measures, Health, Comirnaty (Vaccine) -- Complications and side effects
Abstract

On October 29, 2021, the Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for Pfizer-BioNTech COVID-19 (BNT162b2) mRNA vaccine to expand its use to children aged 5-11 [...]

Published
2021

36. Use of COVID-19 Vaccines After Reports of Adverse Events Among Adult Recipients of Janssen (Johnson & Johnson) and mRNA COVID-19 Vaccines (Pfizer-BioNTech and Moderna): Update from the Advisory Committee on Immunization Practices--United States, July 2021

Author

Rosenblum, Hannah G., Hadler, Stephen C., Moulia, Danielle, Shimabukuro, Tom T., Su, John R., Tepper, Naomi K., Ess, Kevin C., Woo, Emily Jane, Mba-Jonas, Adamma, Alimchandani, Meghna, Nair, Narayan, Klein, Nicola P., Hanson, Kayla E., Markowitz, Lauri E., Wharton, Melinda, McNally, Veronica V., Romero, Jose R., Talbot, H. Keipp, Lee, Grace M., Daley, Matthew F., Mbaeyi, Sarah A., and Oliver, Sara E.

Subjects
United States. Food and Drug Administration, Johnson & Johnson, Pfizer Inc., Messenger RNA -- Usage, Adults -- Usage, Vaccines -- Usage -- Complications and side effects, Pharmaceutical industry -- Usage, Health
Abstract

On August 10, 2021, this report was posted as an MMWR Early Release on the MMWR website (https://www.cdc.gov/mmwr). In December 2020, the Food and Drug Administration (FDA) issued Emergency Use [...]

Published
2021

37. COVID-19 Vaccine Safety in Adolescents Aged 12-17 Years--United States, December 14, 2020-July 16, 2021

Author

Hause, Anne M., Gee, Julianne, Baggs, James, Abara, Winston E., Marquez, Paige, Thompson, Deborah, Su, John R., Licata, Charles, Rosenblum, Hannah G., Myers, Tanya R., Shimabukuro, Tom T., and Shay, David K.

Subjects
United States. Food and Drug Administration -- Safety and security measures, Pfizer Inc. -- Safety and security measures, Teenagers -- Safety and security measures, Youth -- Safety and security measures, RNA -- Safety and security measures, Vaccines -- Safety and security measures, Pharmaceutical industry -- Safety and security measures, Health
Abstract

On July 30, 2021, this report was posted as an MMWR Early Release on the MMWR website (https://www.cdc.gov/mmwr). As of July 30, 2021, among the three COVID-19 vaccines authorized for [...]

Published
2021

42. Use of mRNA COVID-19 Vaccine After Reports of Myocarditis Among Vaccine Recipients: Update from the Advisory Committee on Immunization Practices--United States, June 2021

Author

Gargano, Julia W., Wallace, Megan, Hadler, Stephen C., Langley, Gayle, Su, John R., Oster, Matthew E., Broder, Karen R., Gee, Julianne, Weintraub, Eric, Shimabukuro, Tom, Scobie, Heather M., Moulia, Danielle, Markowitz, Lauri E., Wharton, Melinda, McNally, Veronica V., Romero, Jose R., Talbot, H. Keipp, Lee, Grace M., Daley, Matthew F., and Oliver, Sara E.

Subjects
United States. Food and Drug Administration, Pfizer Inc., Messenger RNA -- Usage, Vaccines -- Usage, Pharmaceutical industry -- Usage, Health
Abstract

On July 6, 2021 this report was posted as an MMWR Early Release on the MMWR website (https://www.cdc.gov/mmwr). In December 2020, the Food and Drug Administration (FDA) issued Emergency Use [...]

Published
2021

43. Safety Monitoring of the Janssen (Johnson & Johnson) COVID-19 Vaccine--United States, March-April 2021

Author

Shay, David K., Gee, Julianne, Su, John R., Myers, Tanya R., Marquez, Paige, Liu, Ruiling, Zhang, Bicheng, Licata, Charles, Clark, Thomas A., and Shimabukuro, Tom T.

Subjects
United States. Food and Drug Administration -- Safety and security measures, Johnson & Johnson -- Safety and security measures, Vaccines -- Safety and security measures -- Reports, Pharmaceutical industry -- Safety and security measures -- Reports, Health
Abstract

On April 30, 2021, this report was posted as an MMWR Early Release on the MMWR website (https://www.cdc.gov/mmwr). On February 27, 2021, the Food and Drug Administration (FDA) issued an [...]

Published
2021

44. Surveillance for Multisystem Inflammatory Syndrome in US Children Aged 5–11 Years Who Received Pfizer-BioNTech COVID-19 Vaccine, November 2021 through March 2022.

Author

Cortese, Margaret M, Taylor, Allan W, Akinbami, Lara J, Thames-Allen, Andrea, Yousaf, Anna R, Campbell, Angela P, Maloney, Susan A, Harrington, Theresa A, Anyalechi, E Gloria, Munshi, Datta, Kamidani, Satoshi, Curtis, C Robinette, McCormick, David W, Staat, Mary A, Edwards, Kathryn M, Creech, C Buddy, Museru, Oidda, Marquez, Paige, Thompson, Deborah, and Su, John R

Subjects
MULTISYSTEM inflammatory syndrome in children, SARS-CoV-2, COVID-19 vaccines, COVID-19, CORONAVIRUS diseases
Abstract

Multisystem inflammatory syndrome in children (MIS-C) is a complication of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection; in the United States, reporting of MIS-C after coronavirus disease 2019 (COVID-19) vaccination is required for vaccine safety monitoring. Pfizer-BioNTech COVID-19 vaccine was authorized for children aged 5−11 years on 29 October 2021. Covering a period when approximately 7 million children received vaccine, surveillance for MIS-C ≤ 90 days postvaccination using passive systems identified 58 children with MIS-C and laboratory evidence of past/recent SARS-CoV-2 infection, and 4 without evidence. During a period with extensive SARS-CoV-2 circulation, MIS-C illness in children after COVID-19 vaccination who lacked evidence of SARS-CoV-2 infection was rare (<1 per million vaccinated children). [ABSTRACT FROM AUTHOR]

Published
2023
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45. Safety Monitoring of COVID-19 mRNA Vaccine Second Booster Doses Among Adults Aged ≥50 Years — United States, March 29, 2022–July 10, 2022

Author

Hause, Anne M., primary, Baggs, James, additional, Marquez, Paige, additional, Abara, Winston E., additional, Baumblatt, Jane, additional, Blanc, Phillip G., additional, Su, John R., additional, Hugueley, Brandon, additional, Parker, Casey, additional, Myers, Tanya R., additional, Gee, Julianne, additional, Shimabukuro, Tom T., additional, and Shay, David K., additional

Published
2022
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46. Safety Monitoring of COVID-19 mRNA Vaccine First Booster Doses Among Persons Aged ≥12 Years with Presumed Immunocompromise Status — United States, January 12, 2022–March 28, 2022

Author

Hause, Anne M., primary, Baggs, James, additional, Marquez, Paige, additional, Abara, Winston E., additional, Baumblatt, Jane Gwira, additional, Thompson, Deborah, additional, Su, John R., additional, Myers, Tanya R., additional, Gee, Julianne, additional, Shimabukuro, Tom T., additional, and Shay, David K., additional

Published
2022
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47. Safety of COVID-19 Vaccination in United States Children Ages 5 to 11 Years

Author

Hause, Anne M., primary, Shay, David K., additional, Klein, Nicola P., additional, Abara, Winston E., additional, Baggs, James, additional, Cortese, Margaret M., additional, Fireman, Bruce, additional, Gee, Julianne, additional, Glanz, Jason M., additional, Goddard, Kristin, additional, Hanson, Kayla E., additional, Hugueley, Brandon, additional, Kenigsberg, Tat’Yana, additional, Kharbanda, Elyse O., additional, Lewin, Bruno, additional, Lewis, Ned, additional, Marquez, Paige, additional, Myers, Tanya, additional, Naleway, Allison, additional, Nelson, Jennifer C., additional, Su, John R., additional, Thompson, Deborah, additional, Olubajo, Babatunde, additional, Oster, Matthew E., additional, Weintraub, Eric S., additional, Williams, Joshua T.B., additional, Yousaf, Anna R., additional, Zerbo, Ousseny, additional, Zhang, Bicheng, additional, and Shimabukuro, Tom T., additional

Published
2022
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48. Reported cases of multisystem inflammatory syndrome in children aged 12–20 years in the USA who received a COVID-19 vaccine, December, 2020, through August, 2021: a surveillance investigation

Author

Yousaf, Anna R, primary, Cortese, Margaret M, additional, Taylor, Allan W, additional, Broder, Karen R, additional, Oster, Matthew E, additional, Wong, Joshua M, additional, Guh, Alice Y, additional, McCormick, David W, additional, Kamidani, Satoshi, additional, Schlaudecker, Elizabeth P, additional, Edwards, Kathryn M, additional, Creech, C Buddy, additional, Staat, Mary A, additional, Belay, Ermias D, additional, Marquez, Paige, additional, Su, John R, additional, Salzman, Mark B, additional, Thompson, Deborah, additional, Campbell, Angela P, additional, Museru, Oidda, additional, Howard, Leigh M., additional, Parise, Monica, additional, Openshaw, John J., additional, LeMarchand, Chloe, additional, Finn, Lauren E., additional, Kim, Moon, additional, Raman, Kiran V., additional, Komatsu, Kenneth K., additional, Spiker, Bryce L., additional, Burkholder, Cole P., additional, Lang, Sean M., additional, and Soslow, Jonathan H., additional

Published
2022
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50. Updated Recommendations from the Advisory Committee on Immunization Practices for Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine After Reports of Thrombosis with Thrombocytopenia Syndrome Among Vaccine Recipients--United States, April 2021

Author

MacNeil, Jessica R., Su, John R., Broder, Karen R., Guh, Alice Y., Gargano, Julia W., Wallace, Megan, Hadler, Stephen C., Scobie, Heather M., Blain, Amy E., Moulia, Danielle, Daley, Matthew F., McNally, Veronica V., Romero, Jose R., Talbot, H. Keipp, Lee, Grace M., Bell, Beth P., and Oliver, Sara E.

Subjects
United States. Food and Drug Administration -- Reports, United States. Department of Health and Human Services -- Reports, Johnson & Johnson -- Reports, Blood clot -- Complications and side effects, Thrombosis -- Complications and side effects, Medical colleges -- Usage -- Reports, Vaccines -- Usage -- Complications and side effects, Pharmaceutical industry -- Reports -- Usage, Health
Abstract

On April27, 2021, this report was posted as an MMWR Early Release on the MMWR website (https://www.cdc.gov/mmwr). On February 27, 2021, the Food and Drug Administration (FDA) issued an Emergency [...]

Published
2021

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