Materiały źródłowe

• #1 COVID-19: Vaccines – UpToDate

  https://www.uptodate.com/contents/covid-19-vaccines

  COVID-19 vaccines are considered the most promising approach for curbing the coronavirus disease 2019 (COVID-19) pandemic. Several COVID-19 vaccines are available globally. The World Health Organization (WHO) maintains an updated list of vaccine candidates under evaluation and available for administration. […] This topic will cover vaccines for SARS-CoV-2, with a focus on vaccines available in the United States. Other aspects related to the prevention of COVID-19 are discussed in detail elsewhere. […] Although COVID-19 vaccine development has been accelerated, each vaccine that has received emergency use listing by the World Health Organization (WHO; which includes those that have been authorized or approved in the United States) has gone through the standard preclinical and clinical stages of development.

• #2 COVID-19 Vaccine Safety Reporting Systems | Vaccine Safety Systems | CDC

  https://www.cdc.gov/vaccine-safety-systems/monitoring/covid-19.html

  Hundreds of millions of people in the United States have safely received COVID-19 vaccinations. […] COVID-19 vaccines used in the response to the pandemic underwent the most intensive safety monitoring in U.S. history. Safety monitoring used established systems. […] CDC provides timely updates on selected adverse events (any side effect or health problem after vaccination that is concerning to you, even if you are not sure if the vaccine caused the event) reported to VAERS after COVID-19 vaccination. […] After a vaccine is authorized or approved for use, vaccine safety systems monitor adverse events (rare health conditions) and watch for potential safety problems. […] COVID-19 vaccines have undergone the most extensive safety analysis in U.S. history. […] The following system and information sources were developed during the COVID-19 pandemic. They add an additional layer of safety monitoring, giving CDC and FDA the ability to evaluate COVID-19 vaccine safety in real time and make sure COVID-19 vaccines are as safe as possible.

• #3 Overview of U.S. COVID-19 vaccine safety surveillance systems – PubMed

  https://pubmed.ncbi.nlm.nih.gov/38631952/

  The U.S. COVID-19 vaccination program, which commenced in December 2020, has been instrumental in preventing morbidity and mortality from COVID-19 disease. Safety monitoring has been an essential component of the program. The federal government undertook a comprehensive and coordinated approach to implement complementary safety monitoring systems and to communicate findings in a timely and transparent way to healthcare providers, policymakers, and the public. Monitoring involved both well-established and newly developed systems that relied on both spontaneous (passive) and active surveillance methods. […] This report describes the U.S. government’s COVID-19 vaccine safety monitoring systems and programs used by the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, the Department of Defense, the Department of Veterans Affairs, and the Indian Health Service. Using the adverse event of myocarditis following mRNA COVID-19 vaccination as a model, we demonstrate how the multiple, complementary monitoring systems worked to rapidly detect, assess, and verify a vaccine safety signal. In addition, longer-term follow-up was conducted to evaluate the recovery status of myocarditis cases following vaccination. Finally, the process for timely and transparent communication and dissemination of COVID-19 vaccine safety data is described, highlighting the responsiveness and robustness of the U.S. vaccine safety monitoring infrastructure during the national COVID-19 vaccination program.

• #4 COVID-19 Vaccine Safety Surveillance | FDA

  https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/covid-19-vaccine-safety-surveillance

  The Center for Biologics Evaluation and Research (CBER) at the FDA is monitoring the safety of approved and authorized COVID-19 vaccines through both passive and active safety surveillance systems. […] CBER participates actively in ongoing international pharmacovigilance efforts, including those organized by the International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO). […] Passive surveillance is defined as unsolicited reports of adverse events (possible side effects) that are sent to a central database or health authority. […] In the United States, these are received and entered into the Vaccine Adverse Event Reporting System (VAERS), a national vaccine safety surveillance system that is co-managed by FDA and CDC. […] FDA and CDC continually monitor incoming and accumulated VAERS data using various methods, including frequent assessment of report counts and trends, comparisons of current versus historical data, and reporting trends over time, as well as evaluating individual reports, as needed, to identify possible safety concerns associated with vaccines.

• #5 Overview of U.S. COVID-19 vaccine safety surveillance systems – Kaiser Permanente Division of Research

  https://divisionofresearch.kaiserpermanente.org/publications/overview-of-u-s-covid-19-vaccine-safety-surveillance-systems/

  The U.S. COVID-19 vaccination program, which commenced in December 2020, has been instrumental in preventing morbidity and mortality from COVID-19 disease. Safety monitoring has been an essential component of the program. The federal government undertook a comprehensive and coordinated approach to implement complementary safety monitoring systems and to communicate findings in a timely and transparent way to healthcare providers, policymakers, and the public. Monitoring involved both well-established and newly developed systems that relied on both spontaneous (passive) and active surveillance methods. […] This report describes the U.S. governments COVID-19 vaccine safety monitoring systems and programs used by the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, the Department of Defense, the Department of Veterans Affairs, and the Indian Health Service. […] Finally, the process for timely and transparent communication and dissemination of COVID-19 vaccine safety data is described, highlighting the responsiveness and robustness of the U.S. vaccine safety monitoring infrastructure during the national COVID-19 vaccination program.

• #6 Surveillance report on interim COVID-19 vaccination coverage in the EU/EEA, August 2024 – January 2025

  https://www.ecdc.europa.eu/en/publications-data/surveillance-report-interim-covid-19-vaccination-coverage-eueea-august-2024

  This report presents a description of COVID-19 vaccine coverage in the EU/EEA between 1 August 2024 and 17 January 2025, with some variation in dates between countries. […] This report presents an interim description of COVID-19 vaccine coverage in the European Union/ European Economic Area (EU/EEA) between 1 August 2024 and 17 January 2025. More consolidated data are expected in the coming weeks and months. […] During the reporting period, 20/30 EU/EEA countries reported data on COVID-19 vaccination coverage for at least one target group (people aged 60 years and above, people aged 80 years and above, healthcare workers, people with chronic conditions, pregnant women). […] During this period, approximately 13.2 million people aged 60 years and above received one COVID-19 vaccine dose. Of these, approximately 3.9 million people were aged 80 years.

• #7 Surveillance report on interim COVID-19 vaccination coverage in the EU/EEA, August 2024 – January 2025

  https://www.ecdc.europa.eu/en/publications-data/surveillance-report-interim-covid-19-vaccination-coverage-eueea-august-2024

  The median COVID-19 vaccination coverage among people aged 60 years and above was 7.4% (range: 0.152.8%), with high variation among countries. For people aged 80 years and above, the median coverage was 10.8% (range: 0.183.5%), with high variation among countries. […] Among the 20 reporting countries, one country reported a vaccination coverage 50% for the age group 60 years and above, while six countries reported a vaccination coverage 50% for the age group 80 years and above. […] Most of the approximately 15 million COVID-19 vaccine doses administered in the EU/EEA during this period in the overall population were the Pfizer BioNTech Comirnaty JN.1 vaccine (around 10.6 million doses; 70.6% of the total doses administered).

• #8 Coronavirus | Department of Health | Commonwealth of Pennsylvania

  https://www.pa.gov/agencies/health/diseases-conditions/infectious-disease/respiratory-viruses/covid-19.html

  Being unvaccinated or not being up to date on COVID-19 vaccinations also increases your risk of severe COVID-19 outcomes. […] Everyone aged 6 months and older should talk to their doctor about getting vaccinated against serious illness from COVID-19. The updated 2023-2024 COVID-19 vaccines are each preferred equally. […] Vaccines are highly encouraged for people who are moderately or severely immunocompromised.

• #9 Fall Vaccine Frequently Asked Questions (FAQ)

  https://dph.illinois.gov/topics-services/diseases-and-conditions/respiratory-disease/faq/vaccine-faq.html

  The Food and Drug Administration (FDA) has approved, and the Centers for Disease Control and Prevention (CDC) recommends, vaccines for COVID-19, flu, and RSV this fall. […] The updated COVID-19 and flu shots are recommended for everyone over 6 months of age. […] The new COVID-19 shots are designed to target the strains of the virus currently in circulation. They are very effective in preventing severe outcomes, including hospitalization and deaths. […] The vaccines also provide you with protection against long COVID-19. […] There is also evidence that getting the vaccine can help to prevent transmission of the virus even if you get sick by reducing the severity of symptoms like sneezing and coughing. This protects those around you. […] Everyone else should make plans to get vaccinated before the fall and winter respiratory virus season begins.

• #10 COVID-19 Vaccine Safety Surveillance | FDA

  https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/covid-19-vaccine-safety-surveillance

  An example of the work done with passive safety surveillance during the current pandemic has been the evaluation of severe allergic reactions, such as anaphylaxis, and myocarditis or pericarditis as serious types of adverse events following vaccination with COVID-19 vaccines. […] CBER also uses disproportionality analysis, also known as data mining, in its vaccine safety monitoring efforts. […] Active surveillance involves proactively obtaining and rapidly analyzing information occurring in millions of individuals recorded in large healthcare data systems to verify safety signals identified through passive surveillance or to detect additional safety signals that may not have been reported as adverse events to passive surveillance systems. […] In summary, in collaboration and coordination with several different partners, CBER has assembled passive and active surveillance systems that can detect and refine safety findings with the approved and authorized COVID-19 vaccines. […] FDA is conducting intensive monitoring of COVID-19 vaccine safety in the U.S. using a variety of approaches.

• #11 COVID-19 vaccine safety: Report on side effects following immunization – Canada.ca

  https://health-infobase.canada.ca/covid-19/vaccine-safety/

  The information on this page reflects detailed case information data from the Public Health Agency of Canadas Canadian Adverse Events Following Immunization Surveillance System (CAEFISS) and Health Canadas Canada Vigilance program. […] Overall, the rate of serious reports has remained low. […] The higher proportion and rate of adverse event reports for females has been observed in the United States, the United Kingdom, Israel, and other countries. […] Health Canada, PHAC, and provincial and territorial public health authorities will continue to monitor but have not identified this as a safety issue. […] To date, 2 safety signals have been confirmed: Thrombosis with thrombocytopenia syndrome (TTS) and myocarditis/pericarditis. […] Health Canada updated the respective product monographs to include information about these adverse events. Health Canada PHAC will continue to monitor these events.

• #12 Kaiser Permanente data key to nation’s COVID-19 vaccine surveillance strategy – Permanente Medicine

  https://permanente.org/kaiser-permanente-data-key-to-nations-covid-19-vaccine-surveillance-strategy/

  The analysis will focus on potential serious adverse health events, as opposed to mild side effects that have been reported with the Pfizer/BioNTech vaccine. […] While the Vaccine Study Center has decades of experience in vaccine evaluation and safety surveillance, the COVID-19 vaccines are unique both in the speed with which they came into use and the national attention focused on their safety, Dr. Klein said. […] The weekly VSD analyses are one part of the federal governments effort to monitor the safety of the new COVID-19 vaccines as they are rolled out into general use. […] The CDC and Food and Drug Administration also maintain the Vaccine Adverse Events Reporting System, a database to which physicians and others can report potential vaccine adverse reactions. […] The 2 agencies said they will also monitor vaccine safety in other ways, such as through the Veterans Affairs and Department of Defense medical systems. […] The CDC also devised the new V-safe mobile app which allows vaccinated people to use their mobile phones to report any reactions to a COVID-19 vaccine.

• #13 COVID-19 Vaccine Safety Reporting Systems | Vaccine Safety Systems | CDC

  https://www.cdc.gov/vaccine-safety-systems/monitoring/covid-19.html

  The V-safe COVID-19 Vaccine Pregnancy Registry: a registry to collect additional health information from v-safe participants who report being pregnant at the time of vaccination or a positive pregnancy test after vaccination. This information helps CDC monitor the safety of COVID-19 vaccines in pregnant women. […] VAERS […] VSD […] CDC’s CISA Project. […] DOD’s Electronic Health Record and Defense Medical Surveillance System: large, linked electronic health records (AHLTA/MHS GENESIS) and administrative data systems for near real-time safety monitoring and research. […] VA Electronic Health Record: a system of electronic health record and administrative data for active surveillance and research. […] CDC monitors the safety of vaccines through four complementary systems.

• #14 Kaiser Permanente data key to nation’s COVID-19 vaccine surveillance strategy – Kaiser Permanente Division of Research

  https://divisionofresearch.kaiserpermanente.org/covid-19-vaccine-surveillance/

  Kaiser Permanentes Vaccine Study Center is leading a key part of the national safety surveillance effort. […] The surveillance involves casting a wide net through electronic patient records, searching for specific potential adverse health effects, such as strokes or anaphylaxis (severe allergic reaction). […] The Vaccine Safety Datalink is the premier system in the United States, and arguably in the world, for active, real-time safety surveillance of vaccines, Klein said. […] Results of the ongoing analyses will be shared within the VSD network, which includes CDC representatives, during its weekly calls. […] The analysis will focus on potential serious adverse health events, as opposed to mild side effects that have been reported with the Pfizer/BioNTech vaccine. […] The weekly VSD analyses are one part of the federal governments effort to monitor the safety of the new COVID-19 vaccines as they are rolled out into general use.

• #15 Collaboration within the global vaccine safety surveillance ecosystem during the COVID-19 pandemic: lessons learnt and key recommendations from the COVAX Vaccine Safety Working Group | BMJ Global Health

  https://gh.bmj.com/content/9/3/e014544

  Vaccine pharmacovigilance, as practised in high-income countries (HICs), is the shared responsibility of national regulatory authorities (NRAs), public health agencies and marketing authorisation holders. […] The limitations of AVSS include its utility only for known, well-defined AESIs and the large resources required to follow samples of large enough size and for long enough periods to study rare AESIs. […] The WHO Global Advisory Committee on Vaccine Safety (GACVS) created a COVID-19 Vaccine Safety Subcommittee that met regularly to assess new safety signals. […] The timely generation of real-world evidence on the safety profile of various COVID-19 vaccines described below was possible due to decades-long investments in creating functional pharmacovigilance systems including passive and active surveillance in several HICs, notably the USA, the UK, the EU, Canada and Australia.

• #16

  https://www.who.int/teams/immunization-vaccines-and-biologicals/immunization-analysis-and-insights/surveillance/covid-19-vaccine-effectiveness-and-impact

  Immunization Analysis and Insights The Immunization Analysis Insights Unit is a data hub and analytics engine for immunization data and performs analytics. The unit supports the work of other technical units within the department of Immunization, Vaccines and Biologicals (IVB) and drives innovation in data quality and use in countries. It also has responsibility for IVBs global work on VPD surveillance and generating data and evidence on the public health and economic impact of vaccines. […] COVID-19 vaccine effectiveness (VE) evaluations are vital to guide policy and strategy because COVID-19 VE evaluations assess how COVID-19 vaccines work in real-life contexts. […] As of end of September 2024, the total number of COVID-19 VE studies is 624 covering 52 countries across the six WHO regions.

• #17 COVID-19: Vaccines – UpToDate

  https://www.uptodate.com/contents/covid-19-vaccines

  Data safety and monitoring committees (DSMCs) composed of independent vaccine experts and study sponsors assess adverse events that are reported in each phase of clinical study and must give approval before a candidate vaccine can advance to the next phase of evaluation. […] Vaccine efficacy in percent is defined as the reduction in disease incidence among those who received vaccine versus those who received the control product.

• #18 Surveillance of COVID-19 in a Vaccinated Population: A Rapid Literature Review | medRxiv

  https://www.medrxiv.org/content/10.1101/2021.11.05.21265763v1

  Objectives With the availability of COVID-19 vaccines, public health focus is shifting to post-vaccination surveillance to identify breakthrough infections in vaccinated populations. Therefore, the objectives of these reviews are to identify scientific evidence and international guidance on surveillance and testing approaches to monitor the presence of the virus in a vaccinated population. […] For population surveillance, the following considerations and limitations were observed: variability in person-to-person testing frequency; lower sensitivity of antigen tests; timing of infections relative to PCR testing can result in missed infections; large studies may fail to identify local variations; and loss of interest in testing by participants in long follow-up studies. […] Seven overarching surveillance methods emerged in the literature. PCR-testing was the most recommended surveillance method, followed by genomic screening, serosurveillance, wastewater surveillance, antigen testing, health record screening, and syndromic surveillance.

• #19 Protocol for COVID-19 vaccine effectiveness multi-country study (VEBIS) using health data registries – Version 3.0

  https://www.ecdc.europa.eu/en/publications-data/protocol-covid-19-vaccine-effectiveness-multi-country-study-vebis-using-health

  This protocol presents an updated common methodology for estimating COVID-19 vaccine effectiveness (VE) using established health data registries in participating European Union (EU) and European Economic Area (EEA) Member States. […] The first objective of the study is to prospectively monitor COVID-19 VE via pooled estimates produced monthly as part of a multi-country network. […] The protocol outlines the agreed methods for VE analyses using national databases, and includes a plan for the pooled analysis of all participating country VE estimates. […] ECDC encourages the conduct of VE studies, using this protocol as a basis, in countries that do not currently plan to participate in ECDC-funded studies.

• #20 Surveillance of COVID-19 vaccine effectiveness: a real-time case–control study in southern Sweden

  https://pmc.ncbi.nlm.nih.gov/articles/PMC8924553/

  The extensive register infrastructure available for coronavirus disease 2019 surveillance in Scania county, Sweden, makes it possible to classify individual cases with respect to hospitalisation and disease severity, stratify on time since last dose and demographic factors, account for prior infection and extract data for population controls automatically. […] The present study aimed to investigate how the Swedish register infrastructure can be used to surveil COVID-19 VE in real time. […] The estimated effectiveness against infection after at least two doses of any of three vaccines was 76% in median, and the weekly estimates varied between 51% and 87% with no evident time trend. […] At least two doses of any of the three vaccines offered high protection against hospitalisation (median effectiveness 87%, range 7094%) and severe disease (median effectiveness 93%, range 6696%), here aggregated monthly due to small numbers.

• #21 Surveillance of COVID-19 vaccine effectiveness: a real-time case–control study in southern Sweden

  https://pmc.ncbi.nlm.nih.gov/articles/PMC8924553/

  Waning effectiveness against hospitalisation was consistently noted 6 months after the last dose, but with substantial fluctuations due to the small numbers. […] Our initial surveillance result presented here show more marked waning VE among persons aged 65 years or over 6 months after the last dose. […] The present investigation demonstrates the strength of combining individual-level population and health care register data to monitor VE in real time.

• #22

  https://www.gov.uk/guidance/monitoring-reports-of-the-effectiveness-of-covid-19-vaccination

  Data on the real-world efficacy of the COVID-19 vaccines. […] The UK Health Security Agency (UKHSA) is monitoring the effectiveness of the COVID-19 vaccines in the real world as set out in the COVID-19 vaccine surveillance strategy and has published reports on the impact of the COVID-19 vaccines on: symptomatic disease, hospitalisation, death, infection (symptomatic or asymptomatic). […] This study estimates the long-term duration of protection of the COVID-19 vaccines against hospitalisation for all adults in England, depending on which vaccine individuals were last eligible to receive. […] This study estimates vaccine effectiveness against hospitalisation of the Sanofi/GSK booster (based on the Beta variant) and the Pfizer Original/BA.4-5 bivalent booster (based on the ancestral and BA.4/5 Omicron sub-lineages), given as part of the spring 2023 vaccination programme, amongst those aged 75 years and older in England.

• #23

  https://www.gov.uk/guidance/monitoring-reports-of-the-effectiveness-of-covid-19-vaccination

  The latest evidence shows that vaccine effectiveness against hospitalisation is similar for the BA.4/5 variants as it is for BA.2. […] This study estimates the effectiveness of booster vaccination with AstraZeneca against symptomatic disease and hospitalisation in individuals who were not able to receive mRNA vaccines in the UK. […] This study reports on vaccine effectiveness against hospitalisation with the Omicron variant in adults aged 75 years and older. […] A study using the SARI watch surveillance system of COVID-19 hospitalisations found high levels of protection against hospitalisation after both a single dose and 2 doses of COVID-19 vaccines. […] A study on deaths with COVID-19 indicates that COVID-19 vaccines offer high levels of protection against mortality. […] The VIVALDI study found evidence that COVID-19 vaccines were associated with a substantially reduced risk of infection in care home residents.

• #24 Surveillance of COVID-19 in a Vaccinated Population: A Rapid Literature Review | medRxiv

  https://www.medrxiv.org/content/10.1101/2021.11.05.21265763v1

  Evidence for post-vaccination COVID-19 surveillance was derived from studies in partially or fully vaccinated populations. Population PCR screening, supplemented by rapid antigen tests, was the most frequently used surveillance method and also the most commonly recommended across jurisdictions. Most recent guidance on COVID-19 surveillance is not specific to vaccinated individuals, or it is in effect but has not yet been updated to reflect that. Therefore, more evidence-informed guidance on testing and surveillance approaches in a vaccinated population that incorporates all testing modalities is required.

• #25

  https://www.who.int/teams/immunization-vaccines-and-biologicals/immunization-analysis-and-insights/surveillance/covid-19-vaccine-effectiveness-and-impact

  The Strategic Advisory Group of Experts on Immunization (SAGE)s Working Group on COVID-19 Vaccines has published WHO SAGE roadmap on uses of COVID-19 vaccines in the context of OMICRON and substantial population immunity that lists questions that need to be answered in order to assist SAGE in formulating policy recommendations for consideration by WHO regarding the use of COVID-19 vaccines. […] WHO guidance on conducting COVID-19 VE evaluations.

• #26 Collaboration within the global vaccine safety surveillance ecosystem during the COVID-19 pandemic: lessons learnt and key recommendations from the COVAX Vaccine Safety Working Group | BMJ Global Health

  https://gh.bmj.com/content/9/3/e014544

  This analysis describes the successes, challenges and opportunities to improve global vaccine safety surveillance as observed by the Vaccine Safety Working Group from its role as a platform of exchange for stakeholders responsible for monitoring the safety of vaccines distributed through the COVAX mechanism. […] The global pharmacovigilance infrastructure therefore needed to ensure quick detection and effective management of any emergent safety signals. […] The aim of this analysis is to provide a description of the basic elements of vaccine safety surveillance systems and the reinforcements implemented to address the challenges of safety surveillance during the global immunisation campaign, to assess how well they have functioned, to describe specific challenges faced by vaccine developers, and to provide recommendations for an improved and robust response for vaccine safety surveillance for the next pandemic.

• #27 Collaboration within the global vaccine safety surveillance ecosystem during the COVID-19 pandemic: lessons learnt and key recommendations from the COVAX Vaccine Safety Working Group | BMJ Global Health

  https://gh.bmj.com/content/9/3/e014544

  Reporting into passive surveillance systems has been unprecedented; in its final safety update on 8 December 2022, EMA reported that it had received over 1.6million reports for all COVID-19 vaccines it had licensed for use. […] The pandemic has served as a catalyst for surveillance system strengthening in LMICs. […] Despite the above progress in systems strengthening in LMICs, the generation of evidence of safety from these regions remains limited, and the consequences of the lack of local safety data for the COVID-19 vaccines in the LMIC context have been described from Zimbabwe. […] A landscape survey and literature review to map AVSS activities globally and to identify vaccine safety evidence gaps was commissioned by the VSWG and executed by International Vaccine Access Center of Johns Hopkins University.

• #28 Collaboration within the global vaccine safety surveillance ecosystem during the COVID-19 pandemic: lessons learnt and key recommendations from the COVAX Vaccine Safety Working Group | BMJ Global Health

  https://gh.bmj.com/content/9/3/e014544

  Vaccine developers from HICs have communicated the solutions they found during the pandemic and have made recommendations for improving the generation of real-world evidence of safety. […] In the absence of mature and robust pharmacovigilance and quality management systems, it is difficult for vaccine developers and manufacturers to perform vaccine safety surveillance and implement RMPs according to international standards. […] Implementation of these recommendations will require collaboration and coordination between stakeholders within the global vaccine safety ecosystem.

• #29 Optimizing safety surveillance for COVID-19 vaccines | Nature Reviews Immunology

  https://www.nature.com/articles/s41577-020-0372-8

  Evolution of the current infrastructure for surveillance of vaccine safety will be essential to meet our commitments to the public in the deployment of a vaccine (or vaccines) to COVID-19. […] Public confidence in vaccination programmes is therefore at high risk if the systems for monitoring vaccine safety do not perform optimally. Improved coordination and the incorporation of new methodologies and technologies into current vaccine safety systems will be crucial if we are to meet our obligations to safeguard from potential harms caused by vaccination. The COVID-19 pandemic could be the catalyst that propels vaccine safety surveillance into the twenty-first century. […] Monitoring of vaccine safety after licensure relies upon a combination of passive and active surveillance. […] To ensure the safety of COVID-19 vaccines, global cooperation in a robust system for the timely detection and elucidation of any safety signals will be crucial. Real-time global data exchange is essential as the pooling of reports of AEFIs into larger databases will allow for the earlier detection of safety signals. […] If and when a vaccine safety concern is identified, a commitment by regulatory authorities to determine how and why an AEFI, however rare, occurred is essential both to further our knowledge of the immune system and to ensure public trust in immunization programmes.

• #30 National surveillance data analysis of COVID-19 vaccine uptake in England by women of reproductive age | Nature Communications

  https://www.nature.com/articles/s41467-023-36125-8

  Women of reproductive age are a group of particular concern with regards to vaccine uptake, related to their unique considerations of menstruation, fertility, and pregnancy. […] Here we show that among women of reproductive age, older age, White ethnicity and being in the least-deprived index of multiple deprivation are each independently associated with higher vaccine uptake, for first and second doses; however, ethnicity exerts the strongest influence (and IMD the weakest). […] Concerns have been expressed on social media about potentially negative impacts of COVID-19 vaccines on reproductive function (male or female), as well as menstrual irregularities. […] As only about half of pregnancies in the UK are planned, regardless of pregnancy intent, it is important to acknowledge that being unvaccinated leaves women of reproductive age vulnerable to the higher risks of SARS-CoV-2 infection during pregnancy, which itself is associated with complications that include maternal mortality, severe COVID-19 illness, pre-eclampsia, preterm birth, obstetric intervention, perinatal mortality, and neonatal unit admission.

• #31 Safety of COVID-19 Vaccines among People with History of Allergy: A European Active Surveillance Study

  https://www.mdpi.com/2076-393X/12/9/1059

  Safety of COVID-19 Vaccines among People with History of Allergy: A European Active Surveillance Study […] The aim of this study was to assess and compare the safety profile of different doses and brands of COVID-19 vaccines in subjects with a history of allergy vs. those without a history of allergy. […] The EMA funded the “COVID Vaccine Monitor” (CVM), a comprehensive multi-country project (EUPAS42504). The CVM is a large-scale cohort event monitoring study that aims to collect self-reported outcomes from vaccinees regarding the safety of all EMA-authorized COVID-19 vaccines from the general population and special cohorts, including individuals with a history of allergy, from eleven European countries. […] In particular, although serious adverse allergic reaction occurred rarely, concerns regarding the safety of COVID-19 vaccination in people with a prior history of allergies have been raised.

• #32 National surveillance data analysis of COVID-19 vaccine uptake in England by women of reproductive age | Nature Communications

  https://www.nature.com/articles/s41467-023-36125-8

  Yet, no negative effect of COVID-19 vaccination before or in pregnancy has been demonstrated, for the mother or child and vaccination is strongly recommended by the Royal College of Obstetricians and Gynaecologists (RCOG), Royal College of Midwives (RCM), and the UK Teratology Information Service (UKTIS). […] Nevertheless, as of 3 November 2022 vaccine surveillance report in England, only 73% of women giving birth by June 2022 had received at least one vaccination, with 22% having done so prior to pregnancy. […] Here, we have used national vaccination data to evaluate uptake in England by women of reproductive age, to better understand barriers to vaccine acceptance in this population and inform responses to future pandemics. […] Our multivariable Poisson modelling revealed that age, ethnicity, and IMD were each independently associated with any vaccine uptake, with the effect strongest for certain ethnicities and weakest for IMD.

• #33 COVID-19 Vaccines Not Linked to Miscarriage < Yale School of Medicine

  https://medicine.yale.edu/news-article/covid-19-vaccines-not-linked-to-miscarriage/

  There is no association between the COVID-19 vaccine and miscarriage, a new Obstetrics and Gynecology study confirms. […] The team hopes their findings will help improve COVID-19 vaccination rates among women who are pregnant or are planning to become pregnant, a group that may be hesitant due to mistrust that the vaccine is safe for them and the fetus. […] Whenever any vaccine becomes available, researchers conduct post-marketing surveillance, in which they continue to monitor its safety in the general population following clinical trials. This ongoing monitoring is important for identifying any rare side effects and better understanding a vaccines safety and efficacy in a broader population. […] These studies have confirmed that the vaccine is safe for pregnant women. This surveillance has found, for instance, that the COVID-19 vaccines have no association with stillbirths and that vaccinated women are more likely to have healthier pregnancies.

• #34 COVID-19 Vaccines Not Linked to Miscarriage < Yale School of Medicine

  https://medicine.yale.edu/news-article/covid-19-vaccines-not-linked-to-miscarriage/

  There was no association between being vaccinated and having a miscarriage, the researchers found. Furthermore, the number of vaccine doses, type of vaccine (Moderna, Pfizer, etc.), and the timing of the vaccination were not linked to miscarriage. […] This is a rigorously conducted study that continues to show that the COVID-19 vaccines are safe during pregnancy, says Sheth. For women who are early in pregnancy or those who are thinking about getting pregnant, given the risks of COVID-19 disease, they should feel encouraged to go ahead and get vaccinated if they are not already.

• #35 Postmarketing active surveillance of myocarditis and pericarditis following vaccination with COVID-19 mRNA vaccines in persons aged 12 to 39 years in Italy: A multi-database, self-controlled case series study | PLOS Medicine

  https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1004056

  Myocarditis and pericarditis following the Coronavirus Disease 2019 (COVID-19) mRNA vaccines administration have been reported, but their frequency is still uncertain in the younger population. This study investigated the association between Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) mRNA vaccines, BNT162b2, and mRNA-1273 and myocarditis/pericarditis in the population of vaccinated persons aged 12 to 39 years in Italy. […] We conducted a self-controlled case series study (SCCS) using national data on COVID-19 vaccination linked to emergency care/hospital discharge databases. The outcome was the first diagnosis of myocarditis/pericarditis between 27 December 2020 and 30 September 2021. […] This population-based study of about 3 millions of residents in Italy suggested that mRNA vaccines were associated with myocarditis/pericarditis in the population younger than 40 years. According to our results, increased risk of myocarditis/pericarditis was associated with the second dose of BNT162b2 and both doses of mRNA-1273.

• #36 Safety of COVID-19 Vaccines among People with History of Allergy: A European Active Surveillance Study

  https://www.mdpi.com/2076-393X/12/9/1059

  The results showed that people with a history of allergies, asthma, and anaphylaxis were more likely to experience allergic reactions compared to those with no such medical history. […] However, in this study, information on the COVID-19 vaccine dose, other previous vaccinations, and a history of allergic reaction following previous COVID-19 vaccine doses was not assessed. […] To date, no observational studies evaluating the comparative safety of all European Medicines Agency (EMA)-authorized COVID-19 vaccines across different brands and doses specifically in individuals with a history of allergy have been published. […] The findings from this study highlighted an overall favorable safety profile of COVID-19 vaccines in people with a history of allergy. […] However, individual responses can vary and careful monitoring is recommended regardless of the type of vaccine used. […] In general, the use of any drug or vaccine may carry the risk of severe allergic reactions, although the benefits of vaccination typically outweigh these potential risks, as demonstrated with the COVID-19 vaccines.

• #37 COVID-19 2023 Update – Ending of the Public Health Emergency

  https://portal.ct.gov/dph/communications/health-topics/covid-19-2023-update—ending-of-the-public-health-emergency

  DPH issued its last COVID-19 report for the 2022-23 respiratory viral disease season on the Open Data Portal on June 1, 2023. […] COVID-19 public data reporting will resume on Oct. 5, 2023, and continue through the winter months, as part of DPHs respiratory surveillance reporting program. This new COVID-19 report will include data that are relevant to current COVID-19 disease activity and trends and integrate COVID-19 with viral respiratory surveillance reporting, including influenza.

• #38 Respiratory Disease Data – Epidemiology

  https://www.vdh.virginia.gov/epidemiology/respiratory-diseases-in-virginia/data/

  Monitoring the number of deaths with COVID-19, flu, or RSV listed on the death certificate helps monitor the impact of severe illness and outcomes from respiratory viruses. […] Lab data helps us see trends for which viruses are circulating. […] Monitoring a variety of data sources, including emergency department and urgent care visits, reported outbreaks, and laboratory results. […] Staying up to date on recommended vaccinations reduces the risk of illness from respiratory viruses and of serious outcomes from respiratory viruses. Everyone 6 months of age and older is recommended to receive an updated COVID-19 and flu vaccine. […] The updated mRNA COVID-19 vaccines with 2024-2025 formula were granted emergency use authorization by FDA on August 22, 2024. […] The updated protein-based COVID-19 vaccine with 2024-2025 formula was granted emergency use authorization by FDA on August 30, 2024.

• #39 COVID-19 Data | Vermont Department of Health

  https://www.healthvermont.gov/disease-control/covid-19/covid-19-data

  COVID-19 Vaccine COVID-19 Data Preventing COVID-19 COVID-19 Testing COVID-19 Symptoms Treatment COVID-19 Guidance for Health Care Professionals COVID-19 Therapeutics Long Term Care and Group Living Settings […] Note (2/19/2025): As of Feb. 19, the Health Departments COVID-19 surveillance report will no longer include information about cases and deaths, as data reporting transitions to a format similar to other respiratory viruses like the flu. […] The department continues to monitor the impact of COVID-19 in Vermont using the most meaningful data, including emergency department visits, wastewater data and outbreaks. […] Vermont COVID-19 and flu vaccination data reported to the Vermont Immunization Registry is now available in an interactive dashboard. This vaccination information is more detailed than CDCs state-level data and allows us to look at differences in vaccination rates by county, race, ethnicity, age and gender. It also includes how many Vermonters received a COVID-19 and Flu vaccine on the same day. […] COVID-19 Vaccine Effectiveness Analysis (Feb. 2022) […] COVID-19 in Long Term Care Facilities (Jul. 2021)

• #40 Surveillance For Adverse Events After COVID-19 mRNA Vaccination – PHERN

  https://phern.communitycommons.org/cc_resource/surveillance-for-adverse-events-after-covid-19-mrna-vaccination/

  Disease surveillance helps us detect disease cases, understand burden of disease and risk factors, provide the basis for timely and informed decision-making, guide control measures, and monitor impacts. […] Since the onset of COVID-19, surveillance efforts have worked to provide real-time tracking and forecast data, despite challenges with diagnostic capacity, case reporting, insufficient contact tracing, and fragmented data systems. […] COVID-19 has highlighted the need to invest in modern data systems, expand and skill up the workforce, and ensure data reporting and interpretation retain high ethical and epidemiological standards.

• #41 North Carolina Respiratory Virus Summary Dashboard | NC COVID-19

  https://covid19.ncdhhs.gov/dashboard

  This dashboard includes summary information about COVID-19 wastewater monitoring. […] NCDHHS is testing samples of wastewater from select treatments plants across the state to look for COVID-19. This metric helps us understand spread of COVID-19 at the community level. […] Research suggests that the virus that causes COVID-19 can appear in wastewater 4-6 days before the first cases are identified and can serve as an early warning indicator before changes are seen in other metrics.

• #42

  https://link.springer.com/article/10.1007/s10654-020-00671-y

  Vaccine hesitancy remains a barrier to full population inoculation against highly infectious diseases. Coincident with the rapid developments of COVID-19 vaccines globally, concerns about the safety of such a vaccine could contribute to vaccine hesitancy. […] Our results indicate that healthcare staff involved in the care of COVID-19 positive patients, and individuals considering themselves at risk of disease, were more likely to self-report acquiescence to COVID-19 vaccination if and when available. In contrast, parents, nurses, and medical workers not caring for SARS-CoV-2 positive patients expressed higher levels of vaccine hesitancy. Interventional educational campaigns targeted towards populations at risk of vaccine hesitancy are therefore urgently needed to combat misinformation and avoid low inoculation rates.

• #43 The pandemic’s role in shaping parents’ attitudes toward vaccines | News | University of Michigan School of Public Health | Vaccines | COVID-19 Pandemic | Childhood Vaccination |

  https://sph.umich.edu/news/2024posts/the-pandemics-role-in-shaping-parents-attitude-toward-vaccines.html

  The COVID-19 pandemic influenced parents attitudes and feelings toward vaccinating their children, according to a recent study conducted by University of Michigan School of Public Health researchers. […] In November 2023, the Centers for Disease Control and Prevention released a report which found that nationwide vaccination coverage for kindergarteners was below pre-pandemic levels. Public health officials attributed the decrease in vaccination rates in this population to doubts about COVID-19 vaccines. […] We hypothesized that, with the rollout of the COVID-19 vaccine, some parents would have become more hesitant toward other pediatric vaccines. […] Belief that vaccines are less effective was also more common among parents who lived in areas with low COVID-19 vaccination coverage. Overall, this hints at growing polarization of attitudes toward vaccination.

• #44 The pandemic’s role in shaping parents’ attitudes toward vaccines | News | University of Michigan School of Public Health | Vaccines | COVID-19 Pandemic | Childhood Vaccination |

  https://sph.umich.edu/news/2024posts/the-pandemics-role-in-shaping-parents-attitude-toward-vaccines.html

  Related, we found that peoples experiences during the pandemic affected their beliefs about childhood vaccines. For instance, parents who had a severe case of COVID-19 themselves thought childhood vaccines as a whole were less effective. […] Negative attitudes toward one vaccine could generalize to negative attitudes toward vaccines in general. […] There is more and more research being conducted on how to increase vaccine uptake in diverse populations—this includes experiments on the use of text messaging, increasing convenience of vaccination, and communication strategies like motivational interviewing. […] However, we do already know that one of the largest predictors of vaccination is a strong recommendation from a trusted health care provider. […] What we are realizing is that there are a lot of complexities to vaccine hesitancy. Having a positive, or even neutral, experience getting vaccinated could build momentum toward greater openness to getting vaccinated.

• #45 Health Alert on mRNA COVID-19 Vaccine Safety | Florida Department of Health

  https://www.floridahealth.gov/newsroom/2023/02/20230215-updated-health-alert.pr.html

  A second study, Sun CLF et al, Sci Rep. 2022, found increased acute cardiac arrests and other acute cardiac events following mRNA COVID-19 vaccination. […] Additionally, Dag Berild J et al, JAMA Netw Open. 2022, assessed the risk of thromboembolic and thrombocytopenic events related to COVID-19 vaccines and found preliminary evidence of increased risk of both coronary disease and cardiovascular disease. […] While the CDC has identified safety signals for stroke among individuals 65 and older following the bivalent booster administration, there is a need for additional assessments and research regarding safety of all mRNA COVID-19 vaccines. […] To support transparency, the State of Florida reminds health care providers to accurately communicate the risks and benefits of all clinical interventions to their patients, including those associated with the COVID-19 vaccine as additional risks continue to be identified and disclosed to the public.

• #46 Health Alert on mRNA COVID-19 Vaccine Safety | Florida Department of Health

  https://www.floridahealth.gov/newsroom/2023/02/20230215-updated-health-alert.pr.html

  The State Surgeon General is notifying the health care sector and public of a substantial increase in Vaccine Adverse Event Reporting System (VAERS) reports from Florida after the COVID-19 vaccine rollout. […] In Florida alone, there was a 1,700% increase in VAERS reports after the release of the COVID-19 vaccine, compared to an increase of 400% in overall vaccine administration for the same time period. […] The reporting of life-threatening conditions increased over 4,400%. This is a novel increase and was not seen during the 2009 H1N1 vaccination campaign. There is a need for additional unbiased research to better understand the COVID-19 vaccines’ short- and long-term effects. […] The findings in Florida are consistent with various studies that continue to uncover such risks. […] According to a study, Fraiman J et al, Vaccine. 2022, mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events, including coagulation disorders, acute cardiac injuries, Bells palsy, and encephalitis.

• #47 RFK Jr. Misleads About Safety of COVID-19 Vaccine in Children – FactCheck.org

  https://www.factcheck.org/2025/05/rfk-jr-misleads-about-safety-of-covid-19-vaccine-in-children/

  Three years of vaccine safety monitoring data shows that the COVID-19 vaccines are safe in children. As the CDC explains, children may experience some mild and temporary side effects, as is expected after any vaccination. But adverse reactions are rare and the benefits of COVID-19 vaccination outweigh the known risks of COVID-19 and possible severe complications. […] Myocarditis and pericarditis were identified as rare serious side effects of the COVID-19 vaccines, as weve reported. But over time, that risk has appeared to decline. […] In terms of the vaccine itself having profound risk, the risks of adverse events from vaccination for children are characterized in numerous studies, and has not been shown to be greater than the risk of COVID-19 infection in children, he told us in an email.

• #48 RFK Jr. Misleads About Safety of COVID-19 Vaccine in Children – FactCheck.org

  https://www.factcheck.org/2025/05/rfk-jr-misleads-about-safety-of-covid-19-vaccine-in-children/

  In recent interviews, Health and Human Services Secretary Robert F. Kennedy Jr. has minimized the risk COVID-19 poses to kids and exaggerated the risk of the vaccine, incorrectly claiming that the shot poses a profound risk to children. While serious side effects can occur, they are rare, and have not been shown to outweigh the benefits of the vaccine in protecting against COVID-19. […] The vaccines are very safe in kids, he told us in a phone interview, referring to the COVID-19 shots. […] Myocarditis and pericarditis, the inflammation of the heart muscle and the outer lining of the heart, were identified early-on as rare side effects of some COVID-19 vaccines. The risk of these side effects is highest for adolescent and young adult males after a second dose, but is still very low. For younger children, the risk is so low it is sometimes not detectable in vaccine safety surveillance systems. According to CDC data, no increased risk has been observed for any age group since the 2022-2023 season.

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