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First Month of COVID-19 Vaccine Safety Monitoring - United States, December 14, 2020-January 13, 2021.
MMWR Morb Mortal Wkly Rep. 2021 Feb 26; 70(8):283-288.MM

Abstract

Two coronavirus disease 2019 (COVID-19) vaccines are currently authorized for use in the United States. The Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine on December 11, 2020, and for the Moderna COVID-19 vaccine on December 18, 2020; each is administered as a 2-dose series. The Advisory Committee on Immunization Practices issued interim recommendations for Pfizer-BioNTech and Moderna COVID-19 vaccines on December 12, 2020 (1), and December 19, 2020 (2), respectively; initial doses were recommended for health care personnel and long-term care facility (LTCF) residents (3). Safety monitoring for these vaccines has been the most intense and comprehensive in U.S. history, using the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting system, and v-safe,* an active surveillance system, during the initial implementation phases of the COVID-19 national vaccination program (4). CDC conducted descriptive analyses of safety data from the first month of vaccination (December 14, 2020-January 13, 2021). During this period, 13,794,904 vaccine doses were administered, and VAERS received and processed† 6,994 reports of adverse events after vaccination, including 6,354 (90.8%) that were classified as nonserious and 640 (9.2%) as serious.§ The symptoms most frequently reported to VAERS were headache (22.4%), fatigue (16.5%), and dizziness (16.5%). A total of 113 deaths were reported to VAERS, including 78 (65%) among LTCF residents; available information from death certificates, autopsy reports, medical records, and clinical descriptions from VAERS reports and health care providers did not suggest any causal relationship between COVID-19 vaccination and death. Rare cases of anaphylaxis after receipt of both vaccines were reported (4.5 reported cases per million doses administered). Among persons who received Pfizer-BioNTech vaccine, reactions reported to the v-safe system were more frequent after receipt of the second dose than after the first. The initial postauthorization safety profiles of the two COVID-19 vaccines in current use did not indicate evidence of unexpected serious adverse events. These data provide reassurance and helpful information regarding what health care providers and vaccine recipients might expect after vaccination.

Authors

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Pub Type(s)

Journal Article

Language

eng

PubMed ID

33630816

Citation

Gee, Julianne, et al. "First Month of COVID-19 Vaccine Safety Monitoring - United States, December 14, 2020-January 13, 2021." MMWR. Morbidity and Mortality Weekly Report, vol. 70, no. 8, 2021, pp. 283-288.
Gee J, Marquez P, Su J, et al. First Month of COVID-19 Vaccine Safety Monitoring - United States, December 14, 2020-January 13, 2021. MMWR Morb Mortal Wkly Rep. 2021;70(8):283-288.
Gee, J., Marquez, P., Su, J., Calvert, G. M., Liu, R., Myers, T., Nair, N., Martin, S., Clark, T., Markowitz, L., Lindsey, N., Zhang, B., Licata, C., Jazwa, A., Sotir, M., & Shimabukuro, T. (2021). First Month of COVID-19 Vaccine Safety Monitoring - United States, December 14, 2020-January 13, 2021. MMWR. Morbidity and Mortality Weekly Report, 70(8), 283-288. https://doi.org/10.15585/mmwr.mm7008e3
Gee J, et al. First Month of COVID-19 Vaccine Safety Monitoring - United States, December 14, 2020-January 13, 2021. MMWR Morb Mortal Wkly Rep. 2021 Feb 26;70(8):283-288. PubMed PMID: 33630816.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - First Month of COVID-19 Vaccine Safety Monitoring - United States, December 14, 2020-January 13, 2021. AU - Gee,Julianne, AU - Marquez,Paige, AU - Su,John, AU - Calvert,Geoffrey M, AU - Liu,Ruiling, AU - Myers,Tanya, AU - Nair,Narayan, AU - Martin,Stacey, AU - Clark,Thomas, AU - Markowitz,Lauri, AU - Lindsey,Nicole, AU - Zhang,Bicheng, AU - Licata,Charles, AU - Jazwa,Amelia, AU - Sotir,Mark, AU - Shimabukuro,Tom, Y1 - 2021/02/26/ PY - 2021/2/25/entrez PY - 2021/2/26/pubmed PY - 2021/2/27/medline SP - 283 EP - 288 JF - MMWR. Morbidity and mortality weekly report JO - MMWR Morb Mortal Wkly Rep VL - 70 IS - 8 N2 - Two coronavirus disease 2019 (COVID-19) vaccines are currently authorized for use in the United States. The Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine on December 11, 2020, and for the Moderna COVID-19 vaccine on December 18, 2020; each is administered as a 2-dose series. The Advisory Committee on Immunization Practices issued interim recommendations for Pfizer-BioNTech and Moderna COVID-19 vaccines on December 12, 2020 (1), and December 19, 2020 (2), respectively; initial doses were recommended for health care personnel and long-term care facility (LTCF) residents (3). Safety monitoring for these vaccines has been the most intense and comprehensive in U.S. history, using the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting system, and v-safe,* an active surveillance system, during the initial implementation phases of the COVID-19 national vaccination program (4). CDC conducted descriptive analyses of safety data from the first month of vaccination (December 14, 2020-January 13, 2021). During this period, 13,794,904 vaccine doses were administered, and VAERS received and processed† 6,994 reports of adverse events after vaccination, including 6,354 (90.8%) that were classified as nonserious and 640 (9.2%) as serious.§ The symptoms most frequently reported to VAERS were headache (22.4%), fatigue (16.5%), and dizziness (16.5%). A total of 113 deaths were reported to VAERS, including 78 (65%) among LTCF residents; available information from death certificates, autopsy reports, medical records, and clinical descriptions from VAERS reports and health care providers did not suggest any causal relationship between COVID-19 vaccination and death. Rare cases of anaphylaxis after receipt of both vaccines were reported (4.5 reported cases per million doses administered). Among persons who received Pfizer-BioNTech vaccine, reactions reported to the v-safe system were more frequent after receipt of the second dose than after the first. The initial postauthorization safety profiles of the two COVID-19 vaccines in current use did not indicate evidence of unexpected serious adverse events. These data provide reassurance and helpful information regarding what health care providers and vaccine recipients might expect after vaccination. SN - 1545-861X UR - https://www.unboundmedicine.com/medline/citation/33630816/First_Month_of_COVID_19_Vaccine_Safety_Monitoring___United_States_December_14_2020_January_13_2021_ L2 - https://doi.org/10.15585/mmwr.mm7008e3 DB - PRIME DP - Unbound Medicine ER -