Vaccine最新文献

As the worldwide COVID-19 pandemic unfolded, the clinical and public health community raced to understand SARS-CoV-2 infection and develop life-saving vaccines. Pregnant persons were disproportionately impacted, experiencing more severe illness and adverse pregnancy outcomes. And yet, when COVID-19 vaccines became available in late 2020, safety and efficacy data were not available to inform their use during pregnancy because pregnant persons were excluded from pre-authorization clinical trials. Concerns about vaccine safety during pregnancy and misinformation linking vaccination and infertility circulated widely, creating a lack of vaccine confidence. Many pregnant people initially chose not to get vaccinated, and while vaccination rates rose after safety and effectiveness data became available, COVID-19 vaccine acceptance was suboptimal and varied across racial and ethnic distribution of the pregnant population. The COVID-19 pandemic experience provided valuable insights that can inform current and future approaches to maternal vaccination against.

During December 2020 through May 2023, the Centers for Disease Control and Prevention's (CDC) Immunization Services Division supported and executed the largest vaccine distribution effort in U.S. history, delivering nearly one billion doses of COVID-19 vaccine to vaccine providers in all 50 states, District of Columbia, Puerto Rico, Virgin Islands, Guam, Federated States of Micronesia, American Samoa, Marshall Islands, Northern Mariana Islands, and Palau. While existing infrastructure, ordering, and distribution mechanisms were in place from the Vaccines for Children Program (VFC) and experience had been gained during the 2009 H1N1 pandemic and incorporated into influenza vaccination pandemic planning, the scale and complexity of the national mobilization against a novel coronavirus resulted in many previously unforeseen challenges, particularly related to transporting and storing the majority of the U.S. COVID-19 vaccine at frozen and ultra-cold temperatures. This article describes the infrastructure supporting the distribution of U.S. government-purchased COVID-19 vaccines that was in place pre-pandemic, and the infrastructure, processes, and communications efforts developed to support the heightened demands of the COVID-19 vaccination program, and describes lessons learned.

During the COVID-19 pandemic, candidate COVID-19 vaccines were being developed for potential use in the United States on an unprecedented, accelerated schedule. It was anticipated that once available, under U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) or FDA approval, COVID-19 vaccines would be broadly used and potentially administered to millions of individuals in a short period of time. Intensive monitoring in the post-EUA/licensure period would be necessary for timely detection and assessment of potential safety concerns. To address this, the Centers for Disease Control and Prevention (CDC) convened an Advisory Committee on Immunization Practices (ACIP) work group focused solely on COVID-19 vaccine safety, consisting of independent vaccine safety experts and representatives from federal agencies - the ACIP COVID-19 Vaccine Safety Technical Work Group (VaST). This report provides an overview of the organization and activities of VaST, summarizes data reviewed as part of the comprehensive effort to monitor vaccine safety during the COVID-19 pandemic, and highlights selected actions taken by CDC, ACIP, and FDA in response to accumulating post-authorization safety data. VaST convened regular meetings over the course of 29 months, from November 2020 through April 2023; through March 2023 FDA issued EUAs for six COVID-19 vaccines from four different manufacturers and subsequently licensed two of these COVID-19 vaccines. The independent vaccine safety experts collaborated with federal agencies to ensure timely assessment of vaccine safety data during this time. VaST worked closely with the ACIP COVID-19 Vaccines Work Group; that work group used safety data and VaST's assessments for benefit-risk assessments and guidance for COVID-19 vaccination policy. Safety topics reviewed by VaST included those identified in safety monitoring systems and other topics of scientific or public interest. VaST provided guidance to CDC's COVID-19 vaccine safety monitoring efforts, provided a forum for review of data from several U.S. government vaccine safety systems, and assured that a diverse group of scientists and clinicians, external to the federal government, promptly reviewed vaccine safety data. In the event of a future pandemic or other biological public health emergency, the VaST model could be used to strengthen vaccine safety monitoring, enhance public confidence, and increase transparency through incorporation of independent, non-government safety experts into the monitoring process, and through strong collaboration among federal and other partners.

This manuscript is being submitted as a Commentary; Abstract not applicable.

In October 2020, the CDC's Vaccinate with Confidence strategy specific to COVID-19 vaccines rollout was published. Adapted from an existing vaccine confidence framework for childhood immunization, the Vaccinate with Confidence strategy for COVID-19 aimed to improve vaccine confidence, demand, and uptake of COVID-19 vaccines in the US. The objectives for COVID-19 were to 1. build trust, 2. empower healthcare personnel, and 3. engage communities and individuals. This strategy was implemented through a dedicated unit, the Vaccine Confidence and Demand (VCD) team, which collected behavioral insights; developed and disseminated toolkits and best practices in collaboration with partners; and collaborated with health departments and community-based organizations to engage communities and individuals in behavioral interventions to strengthen vaccine demand and increase COVID-19 vaccine uptake. The VCD team collected and used social and behavioral data through establishing the Insights Unit, implementing rapid community assessments, and conducting national surveys. To strengthen capacity at state and local levels, the VCD utilized "Bootcamps," a rapid training of trainers on vaccine confidence and demand, "Confidence Consults", where local leaders could request tailored advice to address local vaccine confidence challenges from subject matter experts, and utilized surge staffing to embed "Vaccine Demand Strategists" in state and local public health agencies. In addition, collaborations with Prevention Research Centers, the Institute of Museum and Library Services, and the American Psychological Association furthered work in behavioral science, community engagement, and health equity. The VCD team operationalized CDC's COVID-19 Vaccine with Confidence strategy through behavioral insights, capacity building opportunities, and collaborations to improve COVID-19 vaccine confidence, demand, and uptake in the US. The inclusion of applied behavioral science approaches were a critical component of the COVID-19 vaccination program and provides lessons learned for how behavioral science can be integrated in future emergency responses.

During the COVID-19 vaccination rollout from March 2021- December 2022, the Centers for Disease Control and Prevention funded 110 primary and 1051 subrecipient partners at the national, state, local, and community-based level to improve COVID-19 vaccination access, confidence, demand, delivery, and equity in the United States. The partners implemented evidence-based strategies among racial and ethnic minority populations, rural populations, older adults, people with disabilities, people with chronic illness, people experiencing homelessness, and other groups disproportionately impacted by COVID-19. CDC also expanded existing partnerships with healthcare professional societies and other core public health partners, as well as developed innovative partnerships with organizations new to vaccination, including museums and libraries. Partners brought COVID-19 vaccine education into farm fields, local fairs, churches, community centers, barber and beauty shops, and, when possible, partnered with local healthcare providers to administer COVID-19 vaccines. Inclusive, hyper-localized outreach through partnerships with community-based organizations, faith-based organizations, vaccination providers, and local health departments was critical to increasing COVID-19 vaccine access and building a broad network of trusted messengers that promoted vaccine confidence. Data from monthly and quarterly REDCap reports and monthly partner calls showed that through these partnerships, more than 295,000 community-level spokespersons were trained as trusted messengers and more than 2.1 million COVID-19 vaccinations were administered at new or existing vaccination sites. More than 535,035 healthcare personnel were reached through outreach strategies. Quality improvement interventions were implemented in healthcare systems, long-term care settings, and community health centers resulting in changes to the clinical workflow to incorporate COVID-19 vaccine assessments, recommendations, and administration or referrals into routine office visits. Funded partners' activities improved COVID-19 vaccine access and addressed community concerns among racial and ethnic minority groups, as well as among people with barriers to vaccination due to chronic illness or disability, older age, lower income, or other factors.

From December 2020 through March 2023, the COVID-19 vaccination efforts in long-term care (LTC) settings, identified many gaps and opportunities to improve public health capacity to support vaccine distribution, education, and documentation of COVID-19 vaccines administered to LTC residents and staff. Partner engagement at the local, state, and federal levels helped establish pathways for dissemination of information, improve access and delivery of vaccines, and expand reporting of vaccine administration data to monitor the impact of COVID-19 vaccination in LTC settings. Sustaining the improvements to the vaccine infrastructure in LTC settings that were created or enhanced during the COVID-19 vaccination efforts is critical for the protection of residents and staff against COVID-19 and other vaccine preventable respiratory outbreaks in the future.

This article has been withdrawn at the request of the Editor-in-Chief due to serious concerns regarding the scientific soundness of the article. Review by the Editor-in-Chief and evaluation by outside experts, confirmed that the methodology is seriously flawed, and the claims that the article makes are unjustified. As an international peer-reviewed journal we believe it is our duty to withdraw the article from further circulation, and to notify the community of this issue. The full Elsevier Policy on Article Withdrawal can be found at http://www.elsevier.com/locate/withdrawalpolicy.