COVID-19 Vaccination in Home Health and Hospice: Barriers to Vaccination and Results From a Home Vaccination Program

Little is known about vaccination rates in home health and hospice populations. Results draw upon two separate data sources from The Visiting Nurse Association Health Group (VNAHG). Among VNAHG patients surveyed between February 2 and March 1, 202, 24% had received at least one COVID-19 vaccine. Among vaccinated patients, roughly one quarter did not travel to get the vaccine (received inpatient vaccination). They mostly traveled by car (88%), and 70% received help from a family member. Of patients who had not received a vaccine (76%), 81% were pursuing or planning to pursue obtaining a vaccine. Additionally, of those not pursuing a vaccine, 30% indicated it was because they could not get to a vaccine site. 44% of patients in the VNAHG “in home” vaccination pilot were bedbound, and 100% of patients had ambulation difficulties that make it impossible for them to leave home. All (100%) had a health care provider(s) recommended they get the vaccine. Only 38% have internet access. A quarter tried to call to schedule a vaccine, but only one was able to speak to someone. 40% of the patients attempted to get a COVID-19 vaccine prior to enrollment in the program. Most patients (81%) did not have someone available to assist with their transportation to get vaccinated, and most indicated difficulty securing an appointment. Many indicated severe traveling difficulties (requiring oxygen, needing ambulance transport). These findings highlight the high barriers for homebound patients, and the need and value of clinicians traveling to provide in-home vaccines.

Assessing unused residual Pfizer-BioNTech Covid-19 vaccine: a community observational study

Summary: Worldwide morbidity and mortality associated with Covid-19 are severe and ongoing. The Pfizer-BioNTech vaccine is said to be up to 95% effective against severe disease or death. We were able to demonstrate that an additional 9.8% of COVID-19 vaccine doses could theoretically be given if the residual vaccine within the reconstituted Pfizer vials after six doses are extracted were used. This could be achieved by aseptically combining this excess vaccine from multiple vials to achieve full 0.3ml doses. Methods: An observational study was conducted in April, 2021, at a mass vaccine site run by a community volunteer organization on Bainbridge Island, Washington. We measured the amount of Pfizer-BioNTech COVID-19 vaccine that was left in 172 vials after six doses had been withdrawn per Centers for Disease Control (CDC) protocol. Results: A total of 30.68 ml of leftover vaccine was measured and discarded as medical waste. 1,036 doses were given from these vials. An extra 102 doses theoretically could have been given using the residual vaccine in the vials. This would have resulted in 9.8% additional doses of COVID-19 vaccine without requiring new vials. Conclusion: The ability to combine solution from reconstituted Pfizer vaccine vials to minimize waste and obtain additional doses of vaccine could result in an increase in the number of individuals that could be vaccinated worldwide without additional cost. Further studies to validate our findings are warranted. Clinical trials to study the feasibility, safety and efficacy of protocols using this excess vaccine should be considered.

Multisystem inflammatory syndrome in an adult following the SARS-CoV-2 vaccine (MIS-V)

SARS-CoV-2 vaccine roll-out has been successful in the UK and other parts of the world; however, there are increasing concerns about adverse events. A 44-year-old woman presented to a UK hospital with left upper arm pain at the vaccine site a couple of days after receiving the Pfizer-BioNTech mRNA vaccine, which progressed to fever, diarrhoea and abdominal pain over the next few days. She had an erythematous rash on the chest with subcutaneous oedema. Her C reactive protein was 539 mg/L, white cell count of 17×109/L (1.8–7.5), troponin-T of 1013 ng/L and creatine kinase of 572 u/L. She developed an unprovoked pulmonary embolism with acute kidney injury. After administration of intravenous methylprednisolone, the muscle oedema, skin rashes and acute kidney injury resolved. Although multisystem inflammatory syndrome (MIS) is described in children (MIS-C) and adults (MIS-A) following SARS-CoV-2 infection, we highlight the first reported MIS-V case after the SARS-CoV-2 vaccine.

COMPARISON OF THE SIDE EFFECTS OF THE VARIOUS COVID-19 VACCINES

Purpose: In this paper, we will analyze the side effects of the 4 popular Covid-19 vaccines (Moderna, Pzer, Johnson & Johnson, AstraZeneca) and compare the population groups involved in each vaccine trial. With the availability of these 4 different vaccines, people are trying to understand the differences in the side effect prole of each vaccine. We have attempted to collect data from the different publicly reported sites which include information about the various trials for each vaccine and pull all the numbers in one place to help the readers compare for themselves. Method: We collected data relating to the side effects of each vaccine from the Fact Sheet for Health Care Providers EUA published by the FDA for each vaccine as well as data from the Phase 1-2a trial of the AstraZeneca vaccine published by the Lancet. https://www.fda.gov/media/144637/download https://www.fda.gov/media/144413/download https://www.fda.gov/media/146304/download https://www.thelancet.com/action/showPdf?pii=S0140-6736%2820%2932661-1 Results: The common side effects after the vaccines such as headache, fatigue, nausea, pain, swelling at vaccine site, fever was compared between different vaccine groups as well as between various age subgroups in each vaccine group. Then we focused on the rare side effects associated with each vaccine such as Bell's Palsy with Pzer and Moderna vaccines and thromboembolic events with J&J vaccine and transverse myelitis in the Astra Zeneca vaccine. The side effect rate in each vaccine and placebo group is included in the data. Conclusion:In effect all vaccines are found safe with incidence of the rare and serious adverse events being extremely low and, in some cases, extremely difcult to say whether the adverse event could actually be attributed to the vaccine or to chance given the actual incidence of the disease in the general population.

Final report and long-term outcomes: Phase I trial of a HER2 intracellular plasmid-based vaccine in HER2+ advanced stage breast cancer.

2619 Background: Vaccination with the intracellular domain (ICD) of HER2 in pre-clinical models is both immunogenic and protective against the development of mammary tumors. This study (NCT00436254) was designed to examine the safety and optimal immunogenic dose of a DNA-based vaccine encoding the HER2 ICD in subjects with HER2+ breast cancer. Methods: Sixty-six patients with stage III or IV HER2 + breast cancer in remission or with stable bone only disease were enrolled into three vaccine arms: 1 (10mcg dose of plasmid), 2 (100mcg) and 3 (500mcg). Vaccines were administered i.d. monthly for three immunizations. Endpoints included safety and optimal dose. HER2 specific IFN-gamma immune responses were evaluated and DNA persistence at the vaccine site was assessed. Toxicity and clinical outcomes were followed for 10 years. Results: The majority of vaccine-related toxicity was grade 1 (89%) and grade 2 (11%) and was not significantly different between the three dose arms. All Arms developed HER2 ICD immunity after vaccination, however, patients in Arm 2 and Arm 3 had significantly better immune responses (of higher magnitude and at most time points) than patients in Arm 1 (p=0.003 and p<0.001, respectively) after adjusting for baseline factors. At 60 weeks, the number of patients who maintained the greatest fold-difference in HER2 ICD immune responses from their baseline was highest in Arm 2 (73%) when compared to Arm 1 (47%) and Arm 3 (45%). Associations between ICD responses and plasmid DNA persistence at the vaccine site were estimated via linear regression models. HER ICD immunity after the end of immunizations, relative to baseline, was significantly lower in patients with DNA persistence at week 16 compared to those without persistence (p=0.02). Patients at the highest dose demonstrated the greatest incidence of plasmid persistence (92%) as compared to 33% in Arm 1 and 10% in Arm 2. The median time of follow-up was 118.6 months (Arm 1), 99.7 months (Arm 2), and 73.5 months (Arm 3). The median OS and PFS has not been reached in any Arm and did not differ with respect to treatment arm (Log-rank p-value 0.36 for OS, and 0.63 for PFS). However, we observed a separation of Kaplan-Meier curves for OS from about 40 months and curves for PFS from about 30 months, and the separation maintained until the end of the study for Arm 2 versus Arm 1 and Arm 3. One patient in Arm 2 developed lymphocytic colitis 2.2 years from enrollment deemed possibly related to vaccination. Conclusions: An intermediate dose (100mcg) of vaccine was immunogenic and associated with persistence of immunity at 60 weeks. A randomized phase II trial of the HER2 ICD plasmid-based vaccine in the neoadjuvant setting is in development. Clinical trial information: NCT00436254.

Equity Impacts of Dollar Store Vaccine Distribution

We use geospatial data to examine the unprecedented national program currentlyunderway in the United States to distribute and administer vaccines against COVID-19. We quantify the impact of the proposed federal partnership with the companyDollar General to serve as vaccination sites and compare vaccine access with DollarGeneral to the current Federal Retail Pharmacy Partnership Program. Although dollarstores have been viewed with skepticism and controversy in the policy sector, we showthat, relative to the locations of the current federal program, Dollar General stores aredisproportionately likely to be located in Census tracts with high social vulnerability;using these stores as vaccination sites would greatly decrease the distance to vaccinesfor both low-income and minority households. We consider a hypothetical alternativepartnership with Dollar Tree and show that adding these stores to the vaccinationprogram would be similarly valuable, but impact different geographic areas than theDollar General partnership. Adding Dollar General to the current pharmacy partnersgreatly surpasses the goal set by the Biden administration of having 90% of the popu-lation within 5 miles of a vaccine site. We discuss the potential benefits of leveragingthese partnerships for other vaccinations, including against influenza.

Lymphangiogenesis-inducing vaccines elicit potent and long-lasting T cell immunity against melanomas

In melanoma, the induction of lymphatic growth (lymphangiogenesis) has long been correlated with metastasis and poor prognosis, but we recently showed it can synergistically enhance cancer immunotherapy and boost T cell immunity. Here, we develop a translational approach for exploiting this “lymphangiogenic potentiation” of immunotherapy in a cancer vaccine using lethally irradiated tumor cells overexpressing vascular endothelial growth factor C (VEGF-C) and topical adjuvants. Our “VEGFC vax” induced extensive local lymphangiogenesis and promoted stronger T cell activation in both the intradermal vaccine site and draining lymph nodes, resulting in higher frequencies of antigen-specific T cells present systemically than control vaccines. In mouse melanoma models, VEGFC vax elicited potent tumor-specific T cell immunity and provided effective tumor control and long-term immunological memory. Together, these data introduce the potential of lymphangiogenesis induction as a novel immunotherapeutic strategy to consider in cancer vaccine design.

COVID Arm: Delayed Hypersensitivity Reactions to SARS-CoV-2 Vaccines Misdiagnosed as Cellulitis

The term “COVID arm” has been coined to describe a harmless delayed hypersensitivity reaction occurring approximately a week after administration of the novel SARS-CoV-2 mRNA vaccine. It appears as a red, warm, pruritic, indurated, or swollen area in the vicinity of the vaccine site. These reactions, especially if accompanied by systemic symptoms, have been mistaken for cellulitis. We report 3 cases of COVID arm, 2 of which were mistaken for cellulitis. Distinguishing features of COVID arm from cellulitis include pruritus as a common finding, occurrence approximately a week after vaccination, a lack of progression of symptoms, rapid response to topical steroids, and/or spontaneous resolution usually over 4 to 5 days. Practice Points: • Patients receiving SARS-CoV-2 vaccines may experience delayed hypersensitivity reactions characterized by erythema, swelling, and itching occurring near the vaccination site (COVID arm), approximately a week after vaccination. • Clinicians can distinguish SARS-CoV-2 vaccine reactions from cellulitis by the time of onset (approximately a week vs 5 days), by the lack of progression of symptoms, and resolution over 4 to 5 days. • Severe cases of COVID arm may be treated with topical steroids.

The Adaptation of a Clinic-Adjacent Parking Garage for Drive-In COVID-19 Vaccination

Purpose: The distribution and vaccination of COVID-19 vaccines to billions of people worldwide will likely be one of the biggest public health undertakings in history. There has been a large focus on identifying processes to safely, efficiently, and effectively vaccinate large populations. We aimed to describe the development and operationalization of a drive-in COVID-19 vaccine site in a parking garage adjacent to outpatient clinics at University of Florida (UF) Health Physicians and how it was informed by the roll-out of SARS-CoV-2 testing and administration of respiratory vaccinations. Design/Methodology/Approach: A technical description and analysis of a drive-in COVID-19 vaccine site. Findings: We incrementally increased the number of vaccines performed per day from 300 in the first 2 weeks to 700 an additional 2 weeks later. By the end of January, we completed nearly 14 000 vaccinations. At this capacity, we estimate the site could performed 5000 vaccinations per week. Practical Implications: This manuscript provides step-by-step guidance how to develop, operationalize, and implement a sustainable drive-in COVID-19 vaccination site. Originality/Value: To our knowledge, this is the first description of a drive-in approach to COVID-19 vaccination. Our findings can help inform other health entities as they develop or expand vaccination efforts that may serve as a template for other sites to adapt.