Establishment of prediction equations for subcutaneous tissue thickness in two representative intramuscular deltoid injections.

This study clarifies the predicted subcutaneous shoulder depth and investigates the safety of the conventional (three-finger breadth method) and new (axillary method) intramuscular injection methods. The anatomical features of 245 volunteers who received the COVID-19 vaccination via the conventional method were investigated at the injection site (T point) and the hypothetical injection site using the new method (A point) via ultrasonography. The body mass index (BMI) and subcutaneous thickness at the T point (men: r = 0.75; women: r = 0.45) and the A point (men: r = 0.81; women: r = 0.55) were positively correlated. The upper arm circumference and subcutaneous thickness at the T point (r = 0.51) and the A point (r = 0.58) were correlated in women. Formulas to predict subcutaneous thickness using BMI and upper arm circumference were established: predicted subcutaneous thickness at the A point = 0.62 × BMI - 7.7 mm (R2 = 0.66) in men and 0.658 × BMI - 5.5 mm (R2 = 0.31) in women. This study demonstrates safe intramuscular injection sites and their depth.

Principles of glucocorticosteroid administration in patients with COVID-19

Introduction. This article discusses the treatment of coronavirus infection (COVID-19) with glucocorticosteroid drugs (GCS), side effects of drugs and their prevention, transfer from intravenous to intramuscular and then to oral administration, and the development of withdrawal syndrome. The article describes the conditions under which antibiotic therapy is prescribed, as well as the conditions under which the combined use of corticosteroids and antibiotics is necessary. Aim. The aim to analyze the basic principles of corticosteroids prescribing in the treatment of COVID-19: indications for corticosteroids administration, administration regimens and required dosages, side effects of corticosteroids administration. Material and methods. The article uses data from the Interim Guidelines for the Prevention, Diagnosis and Treatment of New Coronavirus Infection (COVID-19), the Federal Clinical Guidelines for the Specialty "Rheumatology", as well as using the literature on basic and clinical endocrinology, cardiology and pharmacology. The work was written using a systems approach, methods of analysis, induction and observation. Results and discussion. Systemic corticosteroids are used in cases of severe and critical course of the disease COVID-19 (confirmation may be an increase in ferritin, procalcitonin, C-reactive protein (CRP), decreased cognitive functions, development of sopor). Their appointment is also justified when the initial course of the disease was not diagnosed as severe, but suddenly the patient's condition deteriorated. The use of antibiotic therapy is advisable when a bacterial infection is attached - (procalcitonin (PCT) > 0.5 ng / ml, purulent sputum, leukocytosis> 12 x 109 / L (in the absence of previous use of glucocorticoids), an increase in band neutrophils of more than 10%). In the presence of chronic infectious diseases in patients with COVID-19 (for example, chronic obstructive pulmonary disease-COPD, chronic pyelonephritis, etc.), antibiotics are prescribed to prevent exacerbations of these diseases. Conclusion. In the course of the study, the authors of the article formulated the following principles of glucocorticoid therapy: drugs should be prescribed according to strict indications;maximum doses are applied in a short course;when the patient's condition is stabilized, it is necessary to reduce the dose in a timely manner and gradually to complete withdrawal to prevent the development of "withdrawal" syndrome, adrenal insufficiency of central genesis, sympathoadrenal crises;during and after treatment, prevention of complications of glucocorticoid therapy (hyperglycemia, hypocalcemia, osteopenia, inflammatory diseases of the urinary system) is recommended;collegial management of patients by infectious diseases and endocrinologists is mandatory.

Safety of COVID-19 vaccine delivery by dentists: An observational cohort study.

Background/purpose: Although many coronavirus disease 2019 (COVID-19) vaccine injections have been administered worldwide, the safety of this practice remains unclear. This study aimed to compare the rates of complications associated with COVID-19 vaccines administered by dentists with those of vaccines administered by nurses. This study aimed to evaluate the safety of a vaccination program delivered by dentists. Materials and methods: This observational cohort study included 537 recipients of the second dose of the Pfizer COVID-19 vaccine, delivered as an intramuscular injection to the upper arm deltoid muscle by dentists or nurses at the study site. Vaccine recipients were divided into two groups according to the vaccination administrator (dentist vs. nurse groups). The rates of complications associated with intramuscular injection technique (numbness in the hand or arm at the time of the injection, vasovagal reflex at the time of the injection, vaccine-related shoulder injury, and prolonged numbness) were examined. Results: A total of 125 vaccine recipients were included (nurse group, n = 84; dentist group, n = 41). The overall incidence rate of complications was lower in the dentist group (2.4%; 1/41) than in the nurse group (8.3%; 7/84). However, this difference was not statistically significant (P = 0.3). Conclusion: This study suggests that the safety of COVID-19 vaccine administration is comparable between dentists and nurses.

Immunogenicity and safety of BNT162b2 mRNA vaccine in Chinese adults: A phase 2 randomised clinical trial.

Background: BNT162b2, an mRNA vaccine against COVID-19, is being utilised worldwide, but immunogenicity and safety data in Chinese individuals are limited. Methods: This phase 2, randomised, double-blind, placebo-controlled trial included healthy or medically stable individuals aged 18-85 years enrolled at two clinical sites in China. Participants were stratified by age (≤55 or >55 years) and randomly assigned (3:1) by an independent randomisation professional to receive two doses of intramuscular BNT162b2 30 µg or placebo, administered 21 days apart. Study participants, study personnel, investigators, statisticians, and the sponsor's study management team were blinded to treatment assignment. Primary immunogenicity endpoints were the geometric mean titers (GMTs) of neutralising antibodies to live severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and seroconversion rates (SCR) 1 month after the second dose. Safety assessments included reactogenicity within 14 days of vaccination, adverse events (AEs), and clinical laboratory parameters. Randomised participants who received at least one dose were included in the efficacy and safety analyses on a complete case basis (incomplete/missing data not imputed). Results up to 6 months after the second dose are reported. Findings: Overall, 959 participants (all of Han ethnicity) who were recruited between December 5th, 2020 and January 9th, 2021 received at least one injection (BNT162b2, n=720; placebo, n=239). At 1 month after the second dose, the 50% neutralising antibody GMT was 294.4 (95% CI; 281.1-308.4) in the BNT162b2 group and 5.0 (95% CI; 5.0-5.0) in the placebo group. SCRs were 99.7% (95% CI; 99.0%-100.0%) and 0% (95% CI; 0.0%-1.5%), respectively (p<0.0001 vs placebo). Although the GMT of neutralising antibodies in the BNT162b2 group was greatly reduced at 6 months after the second dose, the SCR still remained at 58.8%. BNT162b2-elicited sera neutralised SARS-CoV-2 variants of concern. T-cell responses were detected in 58/73 (79.5%) BNT162b2 recipients. Reactogenicity was mild or moderate in severity and resolved within a few days after onset. Unsolicited AEs were uncommon at 1 month following vaccine administration, and there were no vaccine-related serious AEs at 1 month or 6 months after the second dose. Interpretation: BNT162b2 vaccination induced a robust immune response with acceptable tolerability in Han Chinese adults. However, follow-up duration was relatively short and COVID-19 rates were not assessed. Safety data collection is continuing until 12 months after the second dose. Funding: BioNTech - sponsored the trial. Shanghai Fosun Pharmaceutical Development Inc. (Fosun Pharma) - conducted the trial, funded medical writing. ClinicalTrialsgov registration number: NCT04649021. Trial status: Completed.

An Optical Guidance Method for Robotic Intramuscular Injection System

Intramuscular (IM) injection is mainly performed manually at present. Large-scale COVID-19 vaccination has exposed various problems of manual IM injection. In addition, the clinical success rate of manual IM injection is also unsatisfactory. Using robotic intramuscular injection system (RIMIS) is expected to realize automated vaccination and improve the success rate of IM injection. The existing robotic needle insertion system based on image guidance is not a practical option for IM injection because of the time-consuming medical imaging process. In this paper, an optical guidance method for RIMIS is proposed, which uses near-infrared optical tracking system and retro-reflective patch to achieve rapid acquisition of surface normal vector. A closed loop formed by six coordinate systems is used to realize the accurate control of the injection angle and depth. Experimental results show that the RIMIS based on the proposed method can complete the simulated IM injection operation without image guidance and possess accurate control of the injection angle and depth. © 2022 IEEE.

The effect of needle length and skin to deltoid muscle distance in adults receiving an mRNA COVID-19 vaccine.

BACKGROUND: The mRNA COVID vaccines are only licensed for intramuscular injection but it is unclear whether successful intramuscular administration is required for immunogenicity. METHODS: In this observational study, eligible adults receiving their first ComirnatyTM/BNT162b2 dose had their skin to deltoid muscle distance (SDMD) measured by ultrasound. The relationship between SDMD and height, weight, body mass index, and arm circumference was assessed. Three needle length groups were identified: 'clearly sufficient' (needle exceeding SDMD by >5 mm), 'probably sufficient' (needle exceeding SDMD by ≤ 5 mm), and 'insufficient' (needle length ≤ SDMD). Baseline and follow-up finger prick blood samples were collected and the primary outcome variable was mean spike antibody levels in the three needle length groups. RESULTS: Participants (n = 402) had a mean age of 34.7 years, BMI 29.1 kg/m2, arm circumference 37.5 cm, and SDMD 13.3 mm. The SDMD was >25 mm in 23/402 (5.7%) and >20 mm in 61/402 (15.2%) participants. Both arm circumference (≥40 cm) and BMI (≥33 kg/m2) were able to identify those with a SDMD of >25 mm, the length of a standard injection needle, with a sensitivity of 100% and specificities of 71.2 and 79.9%, respectively. Of 249/402 (62%) participants with paired blood samples, there was no significant difference in spike antibody titres between needle length groups. The mean (SD) spike BAU/mL was 464.5 (677.1) in 'clearly sufficient needle length' (n = 217) compared with 506.4 (265.1) in 'probably sufficient' (n = 21, p = 0.09), and 489.4 (452.3) in 'insufficient needle length' (n = 11, p = 0.65). CONCLUSIONS: A 25 mm needle length is likely to be inadequate to ensure vaccine deposition within the deltoid muscle in a small proportion of adults. Vaccine-induced spike antibody titres were comparable in those vaccinated with a needle of sufficient versus insufficient length suggesting deltoid muscle deposition may not be required for an adequate antibody response to mRNA vaccines.

Appropriate Needle Length Determined by Ultrasonic Echography for Intramuscular Injection in Japanese Elderly over 50 Years.

Adjuvanted vaccines are administered through intramuscular injection. To perform appropriate injection using an appropriate needle in different age groups or different daily living activities, we investigated the depth from the skin surface to muscle fascia and bone in the deltoid muscle area in 156 elderly aged ≥ 50 years by ultrasonic echography. Subjects consisted of 50 healthy elderly aged 50-64 years, 50 subjects aged 65-74 years, and 56 subjects aged ≥ 75 years (20 outpatients, 18 who needed nursing care, and 18 bedridden in a nursing home). The mean depth ± 1.0 SD from the skin surface to muscle fascia was 7.52 ± 2.13 mm for subjects aged ≥ 75 years, being shorter than 9.16 ± 3.02 mm in those aged 50-64years (p < 0.01). The depth from the skin surface to bone was 22.54 ± 3.85 mm for subjects aged ≥ 75 years and 25.41 ± 4.24 mm for those aged 65-74 years, significantly shorter than those aged 50-64 years (p < 0.01), depending on the reduced muscle volume. The subcutaneous volume length was greater in females (8.29 ± 2.63 mm) than in males (5.62 ± 2.80 mm) aged 50-64 years (p < 0.01). A similar result was obtained in those aged 65-74 years, but there was no difference in the muscle volume length. Our study found that a five-eighths of an inch (16 mm) needle was an appropriate length for average-sized elderly aged ≥ 50 years, but it should be longer for those with large body sizes.

Physical Characteristics of Injection Site Pain After COVID-19 mRNA BNT162b2 Vaccination.

BACKGROUND: BNT162b2, an mRNA COVID-19 vaccine, was launched in many countries as an intramuscular vaccination for COVID-19 infection. Few studies have assessed the physical indications of pain at the immunization site. This study aimed to characterize pain at the injection site and investigate morphological attributes using ultrasound. METHODS: Forty-three of 211 healthcare workers who received a second dose of BNT162b2 between February 2021 and March 2021 were enrolled in the study. The mean age of the subjects was 40 years. We evaluated patients' pain at the injection site using the Numerical Rating Pain Scale (NRPS). We also assessed the thickness of the deltoid muscle fascia at the injection site by ultrasound. Bayesian robust correlation was employed to explore the relationship between the pain intensity scores and ultrasound measurements. RESULTS: All eligible subjects complained of pain at the injection site. A median pain onset of 8 hours post-vaccination and a median peak intensity score of 4 were reported. Onset of relief occurred after 2 days. Ultrasound images demonstrated a 2.5-fold increase in fascia thickness at the injection site without intramuscular echogenicity change in all subjects. A correlation was established between the NRPS score and the non-injection-to-injection-side ratio of fascia thickness at the injection site (rho = 0.66). CONCLUSION: A sore arm was the most prevalent side effect of BNT162b2 vaccination and could be attributed to temporal fasciitis.

Effectiveness of and immune responses to SARS-CoV-2 mRNA vaccines and their mechanisms. (Special Issue: COVID-19 and historical pandemics part 2.)

Following the online publication of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) genome in January 2020, two lipid nanoparticle-encapsulated mRNA vaccines, BNT162b2 and mRNA-1273, were rapidly developed and are now being used worldwide to prevent coronavirus disease 2019 (COVID-19). The mRNA of both vaccines encodes the full-length spike protein of SARS-CoV-2, which binds to the host cell receptor angiotensin-converting enzyme 2 and is believed to mediate virus entry into cells. After intramuscular injection of the vaccine, the spike protein is produced in the cells. Both humoral and cellular immune responses to the spike protein are elicited for protection against COVID-19. The efficacy of the two mRNA vaccines against COVID-19 with wild-type SARS-CoV-2 is more than 90% and is slightly decreased with the Delta variant, which is currently the predominant variant in many countries. In this review, the effectiveness of and immune responses to COVID-19 mRNA vaccines and their mechanisms are summarized and discussed. Potential waning immunity and an additional dose of COVID-19 mRNA vaccines are also discussed.

COVID-19 vaccination clinics: meeting clinical hours and improving nursing students' skills.

Background: As 2020 drew to an end and the country was looking forward to 2021, the University of Texas Medical Branch School of Nursing was presented with the challenge of administrating large quantities of COVID-19 vaccines. As the vaccines became more readily available, staff skilled in intramuscular injections (IM) were needed at multiple locations to administer the vaccinations. Method: The school of nursing faculty recognized this as an opportunity for nursing students to gain clinical experience by substituting one virtual clinical day with one day at the in-person vaccine clinic. A comprehensive implementation plan was developed in collaboration with leadership from across the health system. Results: The students were able to increase confidence in IM injection skills while helping the community by administering life-saving doses of vaccine to patients and Galveston county residents. Conclusions: Vaccination clinic participation proved to be a worthwhile experience for the nursing students and faculty.

Implications of obesity for drug administration and absorption from subcutaneous and intramuscular injections: A primer.

PURPOSE: To discuss the potential implications of obesity for drug administration and absorption from subcutaneous (SC) and intramuscular (IM) injection sites. SUMMARY: The SC and IM routes are useful for the parenteral administration of medications to optimize pharmacokinetic properties such as time to onset and duration of effect, for cost considerations, or for ease of administration, such as when intravenous access is unavailable. The choice of SC or IM injection depends on the specific medication, with SC administration preferred for products such as insulin where a slower and more sustained response is desirable, while IM administration is usually preferred for products such as vaccines where more rapid absorption leads to a more rapid antibody response. Obesity has the potential to influence the rate and extent of absorption, as well as adverse effects, of medications administered by the SC or IM route through changes in SC tissue composition and depth or by inadvertent administration of IM medications into SC tissue because of improper needle length. Potential adverse effects associated with IM or SC injections in addition to pain, bruising, and hematoma formation include sciatic nerve injury, particularly with IM injection in the upper outer quadrant of the buttock; bone contusion or rarely osteonecrosis if the IM injection is excessively deep; and granulomas, fat necrosis, and calcification with SC injection. CONCLUSION: Issues related to medication absorption in obese patients are likely to become more prominent in the future with increasing approvals of a wide range of biotherapeutic agents administered by SC injection. Studies should be directed toward these and other agents to assist with dosing decisions in this challenging population.

Comparison of in-vial exhaust method versus conventional exhaust method in the injection of COVID-19 vaccine

Objective: The objective of the study was to compare the application effects of in-vial exhaust method and conventional exhaust method in the process of coronavirus disease 2019 vaccine injection. Materials and Methods: Using convenient sampling method, 102 vaccines were selected as experiment group during the process of vaccine injection, and the in-vial exhaust method was used. One hundred and five vaccines were selected as the control group and the conventional exhaust method was adopted. The incidence of vaccine solution spillage and exhausting time in the two groups during exhaust were observed. Results: The incidence of solution spillage in the experiment group was lower than that in the control group (0 vs. 6.67%, P < 0.05). The exhausting time of the experiment group was shorter than that of the control group ([15.12 ± 4.43] s vs. [22.74 ± 6.53] s, P < 0.05). Conclusion: Implementing the in-vial exhaust method in the vaccine injection can effectively reduce the incidence of solution spillage, reduce nucleic acid contamination, and ensure that the vaccine is injected at the prescribed dose. Moreover, the operation is simple and easy, which improves the nurse's vaccination efficiency, and has a higher promotion and application value. © 2021 Journal of Integrative Nursing ;Published by Wolters Kluwer - Medknow.

COVID-19 Vaccination: An Overview and Education Tool for Nuclear Medicine Technologists.

Some nuclear medicine technologists may be called on to administer COVID-19 vaccines, but many may have never administered a vaccine. This article summarizes COVID-19 vaccination procedures and provides links to additional information, training, and self-assessment.