Safety Monitoring of an Additional Dose of COVID-19 Vaccine — United States, August 12–September 19, 2021

Details

• Journal Article:
  Morbidity and Mortality Weekly Report (MMWR)
• Personal Author:
  Hause, Anne M. ; Baggs, James ; Gee, Julianne ; Marquez, Paige ; Myers, Tanya R. ; Shimabukuro, Tom T. ; Shay, David K.
• Description:
  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.
• Subjects:
  Adolescent Adult Adverse Drug Reaction Reporting Systems Aged Aged, 80 And Over Child Child, Preschool CoronaVirus Infections COVID-19 COVID-19 Vaccines Drug-Related Side Effects And Adverse Reactions Female Humans Infant Infant, Newborn Male Middle Aged Product Surveillance, Postmarketing Vaccines, Synthetic Young Adult

  More +
• Source:
  MMWR Morbidity Mortal Weekly Rep. 70(39):1379-1384
• Series:
  Weekly Report: Morbidity and Mortality Weekly Report (MMWR)
• DOI:
  http://dx.doi.org/10.15585/mmwr.mm7039e4
• ISSN:
  0149-2195 (print) ; 1545-861X (digital)
• Pubmed ID:
  34591835
• Pubmed Central ID:
  PMC8486391
• Document Type:
  Journal Article
• Place as Subject:
  United States
• Pages in Document:
  6 pdf pages
• Volume:
  70
• Issue:
  39
• Collection(s):
  Morbidity and Mortality Weekly Report (MMWR)
• Main Document Checksum:
  urn:sha-512:97f724e38173278c61ad1133b4327ffdbec331ef1e544dc780d4c610f137593e8df0c7d14393d6b8dbe79d7cfee5feabb0ee5afc210ce39b7c8e795371beccd1
• Download URL:
  https://stacks.cdc.gov/view/cdc/110735/cdc_110735_DS1.pdf
• File Type:
  [PDF - 146.62 KB ]