30 Sep Preliminary CDC Data Finds Side Effects from COVID Booster Similar to Second Shot
MedicalResearch.com Interview with:
Anne Hause PhD
Centers for Disease Control and Prevention
MedicalResearch.com: What is the background for this study?
Response: On August 12, 2021, the Food and Drug Administration (FDA) amended Emergency Use Authorizations (EUA) for the Pfizer-BioNTech and Moderna COVID-19 vaccines to authorize administration of an additional dose following completion of a primary vaccination series to eligible persons with moderate to severe immunocompromise.
MedicalResearch.com: What are the main findings?
Response: Preliminary data on the safety of an additional dose of mRNA COVID-19 vaccine found that side effects, which are expected with vaccination, were similar to those from second vaccine doses, and were mostly mild, moderate, and short-lived.
The most commonly reported side effects included arm pain at the shot location, fatigue, and headache. These initial findings indicate no unexpected patterns following an additional dose of COVID-19 vaccine.
MedicalResearch.com: What should readers take away from your report?
Response: As of September 19, 2021, approximately 2.21 million persons have received additional doses of COVID-19 vaccines. During August 12–September 19, 2021, no unexpected patterns of adverse events were found among more than 21,935 registrants who received an additional dose of COVID-19 vaccine. Most reported local and systemic reactions were mild to moderate, transient, and most frequently reported the day following vaccination. Most registrants who received an additional dose reported a primary mRNA vaccination series followed by third dose from the same manufacturer.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: CDC and FDA continue to monitor COVID-19 vaccine safety, including the safety of additional doses of COVID-19 vaccine, through various surveillance systems. These data are used to guide vaccine recommendations and protect public health. One of the surveillance systems CDC is using is v-safe, a smartphone-based safety surveillance tool that uses text messaging and web surveys to give personalized health check-ins after you receive a COVID-19 vaccine.
CDC will continue to monitor the safety of additional doses of COVID-19 vaccine. Additional data on adverse reactions associated with different combinations of vaccines and of time since completion of primary series will be important to guide public health recommendations.
MedicalResearch.com: Is there anything else you would like to add?
Response: The findings in this report are subject to at least four limitations.
First, enrollment in v-safe is voluntary and likely not representative of the immunized U.S. population. Second, during this study period additional dose recommendations were limited to immunocompromised persons who completed a primary series of mRNA COVID-19 vaccine; however, v-safe does not include specific information about immune status. Additional dose recipients likely include persons with and without immunocompromise. Third, a causal relationship between a vaccine and clinically serious adverse event reported following vaccination cannot be established with v-safe. Finally, insufficient data were available to determine patterns of adverse events after receipt of an additional dose from a manufacturer different from the primary series or for the Janssen vaccine.
Self WH, Tenforde MW, Rhoads JP, et al. Comparative Effectiveness of Moderna, Pfizer-BioNTech, and Janssen (Johnson & Johnson) Vaccines in Preventing COVID-19 Hospitalizations Among Adults Without Immunocompromising Conditions — United States, March–August 2021. MMWR Morb Mortal Wkly Rep 2021;70:1337–1343. DOI: http://dx.doi.org/10.15585/mmwr.mm7038e1external icon.
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