Safety Monitoring of Pfizer-BioNTech COVID-19 Vaccine Booster Doses Among Children Aged 5-11 Years - United States, May 17-July 31, 2022.

On May 17, 2022, the Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine to authorize a homologous* booster dose for children aged 5-11 years ≥5 months after receipt of the second primary series dose† (1) based on findings from a clinical trial conducted among 401 children aged 5-11 years (2). To further characterize the safety of booster vaccination in this age group, CDC reviewed adverse events and health impact assessments after receipt of a Pfizer-BioNTech third dose reported to v-safe, a voluntary smartphone-based safety surveillance system for adverse events occurring after COVID-19 vaccination, and adverse events reported to the Vaccine Adverse Event Reporting System (VAERS), a passive vaccine safety surveillance system comanaged by CDC and FDA. During May 17-July 31, 2022, approximately 657,302 U.S. children aged 5-11 years received a third Pfizer-BioNTech dose (either a third primary series dose administered to immunocompromised children or a booster dose administered to immunocompetent children)§; 3,249 Pfizer-BioNTech third doses were reported to v-safe for children in this age group. Local and systemic reactions were reported to v-safe after a second dose and a third dose with similar frequency; some reactions (e.g., pain) were reported to be moderate or severe more frequently after a third dose. VAERS received 581 reports of adverse events after receipt of a Pfizer-BioNTech third dose by children aged 5-11 years; 578 (99.5%) reports were considered nonserious, and the most common events reported were vaccine administration errors. Three (0.5%) reports were considered serious; no reports of myocarditis or death were received. Local and systemic reactions were common among children after Pfizer-BioNTech third dose vaccination, but reports of serious adverse events were rare. Initial safety findings are consistent with those of the clinical trial (2).

Safety Monitoring of COVID-19 mRNA Vaccine Second Booster Doses Among Adults Aged ≥50 Years - United States, March 29, 2022-July 10, 2022.

The Advisory Committee on Immunization Practices (ACIP) recommends that all persons aged ≥5 years receive 1 booster dose of a COVID-19 vaccine after completion of their primary series.* On March 29, 2022, the Food and Drug Administration (FDA) authorized a second mRNA booster dose ≥4 months after receipt of a first booster dose for adults aged ≥50 years and persons aged ≥12 years with moderate to severe immunocompromise (1,2). To characterize the safety of a second mRNA booster dose among persons aged ≥50 years, CDC reviewed adverse events and health impact assessments reported to v-safe and the Vaccine Adverse Event Reporting System (VAERS) after receipt of a second mRNA booster dose during March 29-July 10, 2022. V-safe is a voluntary smartphone-based U.S. active surveillance system that monitors adverse events occurring after COVID-19 vaccination. VAERS is a U.S. passive surveillance system for monitoring adverse events after vaccination, managed by CDC and FDA (3). During March 29-July 10, 2022, approximately 16.8 million persons in the United States aged ≥50 years received a fourth dose.† Among 286,380 v-safe registrants aged ≥50 years who reported receiving a second booster of an mRNA vaccine, 86.9% received vaccines from the same manufacturer for all 4 doses (i.e., homologous vaccination). Among registrants who reported homologous vaccination, injection site and systemic reactions were less frequent after the second booster dose than after the first booster dose. VAERS received 8,515 reports of adverse events after second mRNA booster doses among adults aged ≥50 years, including 8,073 (94.8%) nonserious and 442 (5.1%) serious events. CDC recommends that health care providers and patients be advised that local and systemic reactions are expected after a second booster dose, and that serious adverse events are uncommon.

Safety of COVID-19 Vaccination in United States Children Ages 5 to 11 Years.

BACKGROUND AND OBJECTIVES: Limited postauthorization safety data for the Pfizer-BioNTech coronavirus disease 2019 vaccination among children ages 5 to 11 years are available, particularly for the adverse event myocarditis, which has been detected in adolescents and young adults. We describe adverse events observed during the first 4 months of the United States coronavirus disease 2019 vaccination program in this age group. METHODS: We analyzed data from 3 United States safety monitoring systems: v-safe, a voluntary smartphone-based system that monitors reactions and health effects; the Vaccine Adverse Events Reporting System (VAERS), the national spontaneous reporting system comanaged by the Centers for Disease Control and Prevention and Food and Drug Administration; and the Vaccine Safety Datalink, an active surveillance system that monitors electronic health records for prespecified events, including myocarditis. RESULTS: Among 48 795 children ages 5 to 11 years enrolled in v-safe, most reported reactions were mild-to-moderate, most frequently reported the day after vaccination, and were more common after dose 2. VAERS received 7578 adverse event reports; 97% were nonserious. On review of 194 serious VAERS reports, 15 myocarditis cases were verified; 8 occurred in boys after dose 2 (reporting rate 2.2 per million doses). In the Vaccine Safety Datalink, no safety signals were detected in weekly sequential monitoring after administration of 726 820 doses. CONCLUSIONS: Safety findings for Pfizer-BioNTech vaccine from 3 United States monitoring systems in children ages 5 to 11 years show that most reported adverse events were mild and no safety signals were observed in active surveillance. VAERS reporting rates of myocarditis after dose 2 in this age group were substantially lower than those observed among adolescents ages 12 to 15 years.

Predictors of Dual E-Cigarette and Cigarette Use.

OBJECTIVE: To compare prevalence of e-cigarette and cigarette use and to determine predictors of dual use. DESIGN, SETTING, AND PARTICIPANTS: Using a countywide random digit dial telephone health survey conducted during January 2018 to March 2019, we analyzed data from a random sample of 6966 adults. Bivariate analyses described vaping, cigarette use, and sociodemographics. A multivariable logistic regression model examined dual use. RESULTS: Young adults 18 to 24 years of age had the highest prevalence of e-cigarette-only use (11.5%), the second-highest prevalence of dual use (3.9%), and the lowest prevalence of cigarette-only use (5.8%). Males were more likely than females to use e-cigarettes (5.1% vs 2.7%), traditional cigarettes (11.1% vs 6.9%), or be dual users (3.6% vs 1.1%). Of those who used e-cigarettes or both, approximately half had also used marijuana in the past 30 days. CONCLUSIONS: E-cigarette use among young adults is concerning because it could lead to eventual dual use of e-cigarettes and traditional cigarettes.

Baseline HIV drug-resistance testing: 12 US jurisdictions, 2014-2019.

OBJECTIVE: To understand recent patterns in reported baseline HIV drug-resistance testing over time in the United States. DESIGN: Data from the National HIV Surveillance System for persons who were aged at least 13 years at the time of HIV diagnosis during 2014-2019 and resided in one of 12 US jurisdictions with high levels of reporting in 2014 and 2015. METHODS: Among persons included in the analysis, we calculated the total proportion of HIV diagnoses occurring during 2014-2019 with a reported baseline sequence by year of diagnosis and sequence type. A baseline sequence was defined as any protease/ reverse transcriptase (PR/RT) or integrase sequence generated from a specimen collected 90 days or less after diagnosis. RESULTS: During 2014-2019, reported levels of baseline PR/RT (with or without integrase) testing varied by year from 46.9% to 51.8% without any clear pattern over time. PR/RT with integrase testing increased (8.3-19.4%) and integrase-only testing remained low (1.9-1.3%). CONCLUSION: While reported levels of baseline PR/RT (with or without integrase) testing have remained sufficiently high for the purposes of molecular cluster detection, higher levels would strengthen jurisdictions' and the Centers for Disease Control and Prevention's ability to monitor trends in HIV drug-resistance and detect and respond to HIV molecular clusters. Efforts to increase levels of reported baseline testing likely need to address both gaps in testing as well as reporting.