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

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

doi:10.15585/mmwr.mm7107e1

Cited by 67 publications

(57 citation statements)

References 4 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Reports to v-safe after receipt of a booster dose in an adolescent were generally similar to those previously described for persons aged ≥18 years who received a homologous booster dose of Pfizer-BioNTech vaccine ( 6 , 7 ); however, reactions among adolescents were reported to v-safe with equal or slightly higher frequency after receipt of a booster dose than after dose 2. Reactions reported after both dose 2 and booster dose vaccination were mostly mild to moderate in severity.…”

Section: Discussionsupporting

confidence: 74%

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

Hause¹,

Baggs²,

Marquez³

et al. 2022

MMWR Morb. Mortal. Wkly. Rep.

Self Cite

View full text Add to dashboard Cite

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 (Pfizer-BioNTech) COVID-19 vaccine has been authorized for use in persons aged 12-17 years in the United States (1). The Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for Pfizer-BioNTech vaccine on December 9, 2021, to authorize a homologous* booster dose for persons aged 16-17 years ≥6 months after receipt of dose 2 (1). On January 3, 2022, authorization was expanded to include persons aged 12-15 years, and for all persons aged ≥12 years, the interval between dose 2 and booster dose was shortened to ≥5 months (1). To characterize the safety of Pfizer-BioNTech booster doses among persons aged 12-17 years (adolescents), CDC reviewed adverse events and health impact assessments during the week after receipt of a homologous Pfizer-BioNTech booster dose reported to v-safe, a voluntary smartphone-based safety surveillance system for adverse events after COVID-19 vaccination, and adverse events reported to the Vaccine Adverse Event Reporting System (VAERS), a passive vaccine safety surveillance system managed by CDC and FDA. During December 9, 2021-February 20, 2022, approximately 2.8 million U.S. adolescents received a Pfizer-BioNTech booster dose. † During this period, receipt of 3,418 Pfizer-BioNTech booster doses were reported to v-safe for adolescents. Reactions were reported to v-safe with equal or slightly higher frequency after receipt of a booster dose than after dose 2, were primarily mild to moderate in severity, and were most frequently reported the day after vaccination. VAERS received 914 reports of adverse events after Pfizer-BioNTech booster dose vaccination of adolescents; 837 (91.6%) were nonserious and 77 (8.4%) were serious. Health care providers, parents, and adolescents should be advised that local and systemic reactions are expected among adolescents after homologous Pfizer-BioNTech booster vaccination, and that serious adverse events are rare.V-safe is a voluntary, smartphone-based U.S. active safety surveillance system established to monitor adverse events after COVID-19 vaccination (https://vsafe.cdc.gov/en/). The v-safe platform allows current registrants to report receipt of a booster dose of COVID-19 vaccine and new registrants to * Homologous refers to a booster dose of the same product administered for the primary series. † https://covid.cdc.gov/covid-data-tracker/#vaccination-demographic

show abstract

Section: Discussionsupporting

confidence: 74%

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

Hause¹,

Baggs²,

Marquez³

et al. 2022

MMWR Morb. Mortal. Wkly. Rep.

Self Cite

View full text Add to dashboard Cite

show abstract

“…5 A study by Georgi Bogdanov et al showed similar results, with injection-site reactions amongst the most frequent adverse events, which were mostly mild, usually self-limited and without serious consequences. 6 Although aetiology of delayed local reactions due to the Covishield vaccine is unclear, a delayed-type hypersensitivity reaction to the excipient polysorbate 80 might be the potential aetiology, similar to that seen in the study by Georgi Bogdanov et al 6 Serious adverse events did not occur in any vaccine. Limitations include incomplete follow-up, delayed injection site reactions that needed long-term follow-ups and data were entered at one point of time only.…”

Section: Cutaneous Adverse Effects Of the Available Covid-19 Vaccines...mentioning

confidence: 65%

Cutaneous adverse effects of the available COVID‐19 vaccines in India: a questionnaire‐based study

Bawane¹,

Kataria²,

Mohite³

et al. 2022

Acad Dermatol Venereol

View full text Add to dashboard Cite

“…When considering the safety of heterologous and booster vaccines, one study that assessed the safety and reactogenicity of heterologous primary vaccination with mRNA, adenovirus vector, and protein based vaccines showed no safety concerns 82. Another study that examined the safety of booster doses in adults also showed fewer local and systemic reactions after a homologous mRNA booster than after a two dose homologous regimen 83…”

Section: Discussionmentioning

confidence: 99%

Effectiveness of heterologous and homologous covid-19 vaccine regimens: living systematic review with network meta-analysis

Cheung

2022

BMJ

View full text Add to dashboard Cite

Objective To evaluate the effectiveness of heterologous and homologous covid-19 vaccine regimens with and without boosting in preventing covid-19 related infection, hospital admission, and death. Design Living systematic review and network meta-analysis. Data sources World Health Organization covid-19 databases, including 38 sources of published studies and preprints. Study selection Randomised controlled trials, cohort studies, and case-control studies. Methods 38 WHO covid-19 databases were searched on a weekly basis from 8 March 2022. Studies that assessed the effectiveness of heterologous and homologous covid-19 vaccine regimens with or without a booster were identified. Studies were eligible when they reported the number of documented, symptomatic, severe covid-19 infections, covid-19 related hospital admissions, or covid-19 related deaths among populations that were vaccinated and unvaccinated. The primary measure was vaccine effectiveness calculated as 1−odds ratio. Secondary measures were surface under the cumulative ranking curve (SUCRA) scores and the relative effects for pairwise comparisons. The risk of bias was evaluated by using the risk of bias in non-randomised studies of interventions (ROBINS-I) tool for all cohort and case-control studies. The Cochrane risk of bias tool (version 2; ROB-2) was used to assess randomised controlled trials. Results The first round of the analysis comprised 53 studies. 24 combinations of covid-19 vaccine regimens were identified, of which a three dose mRNA regimen was found to be the most effective against asymptomatic and symptomatic covid-19 infections (vaccine effectiveness 96%, 95% credible interval 72% to 99%). Heterologous boosting using two dose adenovirus vector vaccines with one mRNA vaccine has a satisfactory vaccine effectiveness of 88% (59% to 97%). A homologous two dose mRNA regimen has a vaccine effectiveness of 99% (79% to 100%) in the prevention of severe covid-19 infections. Three dose mRNA is the most effective in reducing covid-19 related hospital admission (95%, 90% to 97%). The vaccine effectiveness against death in people who received three doses of mRNA vaccine remains uncertain owing to confounders. In the subgroup analyses, a three dose regimen is similarly effective in all age groups, even in the older population (≥65 years). A three dose mRNA regimen works comparably well in patients who are immunocompromised and those who are non-immunocompromised. Homologous and heterologous three dose regimens are effective in preventing infection by covid-19 variants (alpha, delta, and omicron). Conclusion An mRNA booster is recommended to supplement any primary vaccine course. Heterologous and homologous three dose regimens work comparably well in preventing covid-19 infections, even against different variants. The effectiveness of three dose vaccine regimens against covid-19 related death remains uncertain. Systematic review registration This review was not registered. The protocol is included in the supplementary document. Readers’ note This article is a living systematic review that will be updated to reflect emerging evidence. Updates may occur for up to two years from the date of original publication.

show abstract

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

Cited by 67 publications

References 4 publications

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

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

Cutaneous adverse effects of the available COVID‐19 vaccines in India: a questionnaire‐based study

Effectiveness of heterologous and homologous covid-19 vaccine regimens: living systematic review with network meta-analysis

Contact Info

Product

Resources

About