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Safety Monitoring of an Additional Dose of COVID-19 Vaccine - United States, August 12-September 19, 2021.
MMWR Morb Mortal Wkly Rep. 2021 Oct 01; 70(39):1379-1384.MM

Abstract

On August 12, 2021, the Food and Drug Administration (FDA) amended Emergency Use Authorizations (EUAs) for the Pfizer-BioNTech and Moderna COVID-19 vaccines to authorize administration of an additional dose after completion of a primary vaccination series to eligible persons with moderate to severe immunocompromising conditions (1,2). On September 22, 2021, FDA authorized an additional dose of Pfizer-BioNTech vaccine ≥6 months after completion of the primary series among persons aged ≥65 years, at high risk for severe COVID-19, or whose occupational or institutional exposure puts them at high risk for COVID-19 (1). Results from a phase 3 clinical trial conducted by Pfizer-BioNTech that included 306 persons aged 18-55 years showed that adverse reactions after receipt of a third dose administered 5-8 months after completion of a 2-dose primary mRNA vaccination series were similar to those reported after receipt of dose 2; these adverse reactions included mild to moderate injection site and systemic reactions (3). CDC developed v-safe, a voluntary, smartphone-based safety surveillance system, to provide information on adverse reactions after COVID-19 vaccination. Coincident with authorization of an additional dose for persons with immunocompromising conditions, the v-safe platform was updated to allow registrants to enter information about additional doses of COVID-19 vaccine received. During August 12-September 19, 2021, a total of 22,191 v-safe registrants reported receipt of an additional dose of COVID-19 vaccine. Most (97.6%) reported a primary 2-dose mRNA vaccination series followed by a third dose of the same vaccine. Among those who completed a health check-in survey for all 3 doses (12,591; 58.1%), 79.4% and 74.1% reported local or systemic reactions, respectively, after dose 3, compared with 77.6% and 76.5% who reported local or systemic reactions, respectively, after dose 2. These initial findings indicate no unexpected patterns of adverse reactions after an additional dose of COVID-19 vaccine; most of these adverse reactions were mild or moderate. CDC will continue to monitor vaccine safety, including the safety of additional doses of COVID-19 vaccine, and provide data to guide vaccine recommendations and protect public health.

Authors+Show Affiliations

CDC COVID-19 Response Team.CDC COVID-19 Response Team.CDC COVID-19 Response Team.CDC COVID-19 Response Team.CDC COVID-19 Response Team.CDC COVID-19 Response Team.CDC COVID-19 Response Team.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

34591835

Citation

Hause, Anne M., et al. "Safety Monitoring of an Additional Dose of COVID-19 Vaccine - United States, August 12-September 19, 2021." MMWR. Morbidity and Mortality Weekly Report, vol. 70, no. 39, 2021, pp. 1379-1384.
Hause AM, Baggs J, Gee J, et al. Safety Monitoring of an Additional Dose of COVID-19 Vaccine - United States, August 12-September 19, 2021. MMWR Morb Mortal Wkly Rep. 2021;70(39):1379-1384.
Hause, A. M., Baggs, J., Gee, J., Marquez, P., Myers, T. R., Shimabukuro, T. T., & Shay, D. K. (2021). Safety Monitoring of an Additional Dose of COVID-19 Vaccine - United States, August 12-September 19, 2021. MMWR. Morbidity and Mortality Weekly Report, 70(39), 1379-1384. https://doi.org/10.15585/mmwr.mm7039e4
Hause AM, et al. Safety Monitoring of an Additional Dose of COVID-19 Vaccine - United States, August 12-September 19, 2021. MMWR Morb Mortal Wkly Rep. 2021 Oct 1;70(39):1379-1384. PubMed PMID: 34591835.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety Monitoring of an Additional Dose of COVID-19 Vaccine - United States, August 12-September 19, 2021. AU - Hause,Anne M, AU - Baggs,James, AU - Gee,Julianne, AU - Marquez,Paige, AU - Myers,Tanya R, AU - Shimabukuro,Tom T, AU - Shay,David K, Y1 - 2021/10/01/ PY - 2021/9/30/entrez PY - 2021/10/1/pubmed PY - 2021/10/2/medline SP - 1379 EP - 1384 JF - MMWR. Morbidity and mortality weekly report JO - MMWR Morb Mortal Wkly Rep VL - 70 IS - 39 N2 - On August 12, 2021, the Food and Drug Administration (FDA) amended Emergency Use Authorizations (EUAs) for the Pfizer-BioNTech and Moderna COVID-19 vaccines to authorize administration of an additional dose after completion of a primary vaccination series to eligible persons with moderate to severe immunocompromising conditions (1,2). On September 22, 2021, FDA authorized an additional dose of Pfizer-BioNTech vaccine ≥6 months after completion of the primary series among persons aged ≥65 years, at high risk for severe COVID-19, or whose occupational or institutional exposure puts them at high risk for COVID-19 (1). Results from a phase 3 clinical trial conducted by Pfizer-BioNTech that included 306 persons aged 18-55 years showed that adverse reactions after receipt of a third dose administered 5-8 months after completion of a 2-dose primary mRNA vaccination series were similar to those reported after receipt of dose 2; these adverse reactions included mild to moderate injection site and systemic reactions (3). CDC developed v-safe, a voluntary, smartphone-based safety surveillance system, to provide information on adverse reactions after COVID-19 vaccination. Coincident with authorization of an additional dose for persons with immunocompromising conditions, the v-safe platform was updated to allow registrants to enter information about additional doses of COVID-19 vaccine received. During August 12-September 19, 2021, a total of 22,191 v-safe registrants reported receipt of an additional dose of COVID-19 vaccine. Most (97.6%) reported a primary 2-dose mRNA vaccination series followed by a third dose of the same vaccine. Among those who completed a health check-in survey for all 3 doses (12,591; 58.1%), 79.4% and 74.1% reported local or systemic reactions, respectively, after dose 3, compared with 77.6% and 76.5% who reported local or systemic reactions, respectively, after dose 2. These initial findings indicate no unexpected patterns of adverse reactions after an additional dose of COVID-19 vaccine; most of these adverse reactions were mild or moderate. CDC will continue to monitor vaccine safety, including the safety of additional doses of COVID-19 vaccine, and provide data to guide vaccine recommendations and protect public health. SN - 1545-861X UR - https://www.unboundmedicine.com/medline/citation/34591835/Safety_Monitoring_of_an_Additional_Dose_of_COVID_19_Vaccine___United_States_August_12_September_19_2021_ L2 - https://doi.org/10.15585/mmwr.mm7039e4 DB - PRIME DP - Unbound Medicine ER -