Surveillance of COVID-19 vaccine safety among elderly persons aged 65 years and older

BackgroundMonitoring safety outcomes following COVID-19 vaccination is critical for understanding vaccine safety especially when used in key populations such as elderly persons age 65 years and older who can benefit greatly from vaccination. We present new findings from a nationally representative early warning system that may expand the safety knowledge base to further public trust and inform decision making on vaccine safety by government agencies, healthcare providers, interested stakeholders, and the public. MethodsWe evaluated 14 outcomes of interest following COVID-19 vaccination using the US Centers for Medicare & Medicaid Services (CMS) data covering 30,712,101 elderly persons. The CMS data from December 11, 2020 through Jan 15, 2022 included 17,411,342 COVID-19 vaccinees who received a total of 34,639,937 doses. We conducted weekly sequential testing and generated rate ratios (RR) of observed outcome rates compared to historical (or expected) rates prior to COVID-19 vaccination. FindingsFour outcomes met the threshold for a statistical signal following Pfizer-BioNTech vaccination including pulmonary embolism (PE; RR=1.54), acute myocardial infarction (AMI; RR=1.42), disseminated intravascular coagulation (DIC; RR=1.91), and immune thrombocytopenia (ITP; RR=1.44). After further evaluation, only the RR for PE still met the statistical threshold for a signal; however, the RRs for AMI, DIC, and ITP no longer did. No statistical signals were identified following vaccination with either the Moderna or Janssen vaccines. InterpretationThis early warning system is the first to identify temporal associations for PE, AMI, DIC, and ITP following Pfizer-BioNTech vaccination in the elderly. Because an early warning system does not prove that the vaccines cause these outcomes, more robust epidemiologic studies with adjustment for confounding factors, including age and nursing home residency, are underway to further evaluate these signals. FDA strongly believes the potential benefits of COVID-19 vaccination outweigh the potential risks of COVID-19 infection.

SARS-CoV-2 Seroprevalence Survey Among District Residents Presenting for Serologic Testing at Three Community Based Test Sites in Washington, DC, July to August, 2020

BackgroundThe District of Columbia (DC), a major metropolitan area, continues to see community transmission of SARS-CoV-2. While serologic testing does not indicate current SARS-CoV-2 infection, it can indicate prior infection and help inform local policy and health guidance. The DC Department of Health (DC Health) conducted a community-based survey to estimate DCs SARS-CoV-2 seroprevalence and identify seropositivity-associated factors. MethodsA mixed-methods cross-sectional serology survey was conducted among a convenience sample of DC residents during July 27-August 21, 2020. Free serology testing was offered at three public test sites. Participants completed an electronic questionnaire on household and demographic characteristics, COVID-like illness (CLI) since January 1, 2020, comorbidities, and SARS-CoV-2 exposures. Univariate and bivariate analyses were conducted to describe the sample population and assess factors associated with seropositivity. ResultsAmong a sample of 671 participants, 51 individuals were seropositive, yielding an estimated seroprevalence of 7.6%. More than half (56.9%) of the seropositive participants reported no prior CLI; nearly half (47.1%) had no prior SARS-CoV-2 testing. Race/ethnicity, prior SARS-CoV-2 testing, prior CLI, employment status, and contact with confirmed COVID-19 cases were associated with seropositivity (P<0.05). Among those reporting prior CLI, loss of taste or smell, duration of CLI, fewer days between CLI and serology test, or prior viral test were associated with seropositivity (P[≤]0.006). ConclusionsThese findings indicate many seropositive individuals reported no symptoms consistent with CLI since January or any prior SARS-CoV-2 testing. This underscores the potential for cases to go undetected in the community and suggests wider-spread transmission than previously reported in DC. What is already known on this subject?Traditional case-based detection and syndromic surveillance efforts might not identify mildly symptomatic or asymptomatic SARS-CoV-2 infections. This is particularly true among people in the general population who do not have increased risk of severe illness or might not be tested otherwise. Consequently, the true population prevalence of prior SARS-CoV-2 infections might not be known. What this study adds?A community-based seroprevalence survey conducted in Washington, DC, during July 27-August 21, 2020 estimated that 7.6% of the convenience sample had antibodies to SARS-CoV-2, indicating prior infection. At the time of this survey, most of the participants reported that they had not been previously infected with or tested for SARS-CoV-2. These findings highlight both the value of serologic surveillance in complementing other surveillance methods, and the importance of continued prevention and mitigation measures, such as maintaining physical distances of at least 6 feet, avoiding crowds and poorly ventilated spaces, practicing frequent hand hygiene, and wearing face masks properly and consistently around people who do not live with you.

SARS CoV-2 Seroprevalence among First Responders in the District of Columbia, May-July 2020

First responders are at increased risk of occupational exposure to SARS-CoV-2 while providing frontline support to communities during the COVID-19 pandemic. In the District of Columbia (DC), first responders were among the first people exposed to and infected with SARS-CoV-2, with over 200 first responders diagnosed with COVID-19 by May 15, 2020. From June - July 2020, DC Health conducted a serologic survey to estimate SARS-CoV-2 seroprevalence and assess risk factors and occupational exposures among a convenience sample of first responders in DC. Of the 310 first responders tested, 3.5% (n = 11) had anti-SARS-CoV-2 antibodies. Seropositivity varied by occupation, with 4.8% (3/62) of firefighters; 3.6% (8/220) of police officers; and no paramedics (0/10) or administration and support staff (0/18) testing positive. Type and consistency of personal protective equipment (PPE) use also varied: all paramedics (n=10) reported wearing a N95 respirator all or most of the time, compared to 83.3% of firefighters, 38.8% of police officers, and 23.5% of administration and support staff (p<0.001). All paramedics reported wearing gloves all or most of the time, compared to 80.0% of firefighters, 27.8% of administration and support staff, and 24.3% of police (p<0.001). The relatively low seroprevalence among first responders highlights the benefits of continuous training on and reinforcement of the proper use of PPE while performing job duties to mitigate potential transmission within and between first responders and the community. SummaryUnderstanding occupational exposure to and infection with SARS-CoV-2 among first responders is important for workforce planning and emergency preparedness and response. Seroprevalence among first responders (3.5%; 11/310) who participated in a survey conducted by the District of Columbia Department of Health (DC Health) from May 28 - July 15 was 48% lower than reported in the DC community (6.7%; 876/12990). The lower prevalence of SARS-CoV-2 among first responders highlights the importance of continuous training on and reinforcement of the proper use of personal protective equipment (PPE). Proper use of PPE is a critical mitigation strategy to reduce transmission among and between first responders and the community.