Lymphatic osteopathic manipulative treatment reduces duration of deltoid soreness after Pfizer/BioNTech COVID-19 vaccine

Pfizer-BioNTech BNT162b2 is one of the three U.S. Food and Drug Administration (FDA)-approved vaccines for the prevention of COVID-19. Its most common side effect, injection site pain, occurs because of locally recruited inflammatory mediators and is mitigated by the lymphatic system. Side effects may discourage individuals from receiving vaccines; therefore, reducing the duration of injection site pain can promote vaccination compliance. Osteopathic manipulative treatments (OMT) can directly affect the physiology underlying muscle soreness; however, there is currently no literature that supports the use of OMT in this scenario. In this case report, an otherwise healthy male presented with acute left deltoid soreness after receiving the Pfizer COVID-19 vaccine. The pain began 5 h prior to the visit. Three hours after being treated with lymphatic OMT, the severity of the pain was significantly reduced and was alleviated 8h after onset in comparison to the median duration of 24–48 h. He received his second dose 3 weeks later. This case report can provide future studies with the groundwork for further investigating the role of OMT in treating postvaccination muscle soreness, which can improve patient satisfaction and potentially promote vaccination compliance.

Adverse events following immunization with Covi-shield tm vaccine: a descriptive cross-sectional study at a tertiary center, Nepal

Introduction: As the COVID-19 pandemic continues to unfold, rapid global efforts to develop and test vaccines against SARS-CoV-2 have started. Adverse events after immunization are a common issue seen in many vaccines. This study aims at finding the adverse events following the first dose of CovishieldTM vaccine administered to the staffs at two health institutions in Kathmandu. Methods: This was a descriptive cross sectional study conducted among the staffs at National Public Health Laboratory and Sukraraj Tropical and Infectious Disease Hospital, Kathmandu between February to April, 2021. It included 162 participants who had taken the first dose of CovishieldTM vaccine. Ethical approval was taken from Nepal Health Research Council. Statistical Package for the Social Sciences were used for analysis. Results: Various adverse events were seen in 139 (85.8%) participants which were all minor events. None of the participants developed serious adverse events. Very common adverse events experienced were Injection site pain 116 (71.6%), myalgia 76 (46.9%), chills 68 (42%), headache 65 (40.1%), fever 54 (33.3%), dizziness 43 (26.5%) and nausea 20 (12.4%). Similarly, the range of time period from onset to recovery of adverse event was different for different adverse reactions. Conclusions: The adverse events following first dose of CovishieldTM vaccine were all minor reactions with commonest being injection site pain followed by myalgia, chills, headache and fever.

Reactogenicity of COVID-19 vaccine in hemodialysis patients: a single-center retrospective study

Introduction Some hemodialysis patients are reluctant to COVID-19 for the development of adverse events (AEs). The aim of this study was to verify the safety of mRNA-1273 vaccine in hemodialysis patients. Methods We conducted a retrospective analysis of in-center hemodialysis patients who underwent mRNA-1273 vaccine from March 1st to April 30th, 2021. All AEs occurring after the first and the second doses were collected and classified as local or systemic. Results Overall, 126 patients on chronic maintenance dialysis were vaccinated with two doses of mRNA-1273 vaccine. Mean age was 68 (IQR, 54,7-76) years and 53.6% of patients were aged ≥ 65 years. During the observational period of 68 (IQR, 66-70) days, AEs occurred in 57.9% and 61.9% of patients after the first dose and second dose, respectively. The most common AEs were: injection-site pain (61.9%), erythema (4.8%), itching (4.8%), swelling (16.7%), axillary swelling/tenderness (2.4%), fever (17.5%) headache (7.9%), fatigue (23.8%), myalgia (17.5%), arthralgia (12.7%), dyspnoea (2.4%); nausea/ vomiting (7.1%), diarrhoea (5.6%), shivers (4%) and vertigo (1.6%). The rates of local AEs were similar after the first and second doses (P=0.8), whereas systemic AEs occurred more frequently after the second dose (P=0.001). Fever (P=0.03), fatigue (P=0.02) and nausea/vomiting (P=0.03) were significantly more frequent after the second dose of vaccine. There were no age-related differences in the rate of AEs. Overall, vaccine-related AEs in hemodialysis patients seem lower than in the general population. Conclusion RNA-1273 vaccine is associated with the development of transient AEs after the first (57.9%) and second dose (61.9%) in patients on chronic maintenance dialysis. Systemic AEs were more common after the second dose. Overall, all AEs lasted for a few days, without any apparent sequelae.

1045. Safety of the Synthetic Saponin Adjuvant TQL1055: Preliminary Results from a First-in-humans Trial

Background Saponin adjuvants reliably enhance immune response to a variety of antigens, but their use is hindered by dose-limiting toxicities and supply constraints. TQL1055 is a semi-synthetic analog of the natural saponin adjuvant QS-21, rationally modified to improve tolerability and enable large-scale manufacturing. We previously showed that the combination of acellular pertussis vaccine (aP) and TQL1055 was well-tolerated and increased anti-pertussis toxin (PT) antibody responses in mice and rabbits, with a no observed adverse effect level (NOAEL) > 2000 mcg/dose. Methods Here we report interim results from a Phase 1 first-in-humans dose-escalation study of TQL1055. Healthy adults 18 to 50 years of age were sequentially enrolled into 6 groups (n=12/group) and randomized 10:2 to receive one intramuscular dose of aP + TQL1055 or aP alone on Day 1. TQL1055 dose increased by group from 25 to 800 mcg (Figure 1). Local adverse events (AEs) (injection site pain, redness, swelling) and systemic AEs (fever, chills, headache, fatigue, myalgia, arthralgia, nausea, vomiting, diarrhea) were solicited through Day 8. Clinical laboratory panels (chemistry, hematology, coagulation) were performed on Days 1 (pre-dose), 8, and 29. Serious AEs were collected through Day 365. Antibodies to PT were assessed at all visits. Figure 1. Study Design Results Blinded safety data from the first four groups (n=48) through Day 8 were analyzed, including 2 subjects/group receiving aP alone. All solicited AEs were mild or moderate (Figure 2). Local AEs, mainly injection site pain, occurred in 75% of subjects (mild 65%, moderate 10%). The incidence of total local AEs increased with TQL1055 dose, from 50% at 25 mcg to 92% at 200 mcg. The mean duration of local AEs was 1.8 days and also increased with TQL1055 dose, from 1.3 days at 25 mcg to 2.1 days at 200 mcg. Systemic AEs, mostly fatigue, headache, and nausea, occurred in 63% of subjects (mild 40%, moderate 23%), with no fevers. The mean duration of systemic AEs was 1.4 days, with no association with TQL1055 dose. No severe or serious adverse events were reported. Figure 2. Solicited Adverse Events by Severity and TQL1055 Dose Conclusion In this early analysis, the safety profile of aP + TQL1055 appears similar to that of licensed aP vaccines, without severe or prolonged injection site pain. These data support further dose escalation and assessment of immunogenicity. Disclosures Sean R. Bennett, MD PhD, Adjuvance Technologies (Employee) Tyler Martin, MD, Adjuvance Technologies (Employee, Shareholder)

Acute Ischaemic Stroke Incidence after Coronavirus Vaccine in Indonesia: Case Series

Background: Coronavirus disease-19 (COVID-19) is an infectious disease with high morbidity and mortality rates. Indonesia had reported a 2.8% of mortality rate up to June 2021. A strategy to control the virus spreading is by vaccination. The Indonesian Food and Drug Monitoring Agency had approved the use of CoronaVac, an inactivated virus vaccine developed by Sinovac. Most adverse events following immunization (AEFI) for CoronaVac are mild, and the most common symptoms are injection-site pain, headache, and fatigue. Neurovascular adverse events, including thrombosis or ischaemic stroke after receiving CoronaVac have not previously been reported. Correspondingly, we reported three patients with an Acute Ischaemic Stroke (AIS) after the administration of CoronaVac in our hospital.

Adverse reactions to BNT162b2 mRNA COVID-19 vaccine in medical staffs with a history of allergy.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, COVID-19) vaccination is progressing globally. Several adverse reactions have been reported with vaccination against COVID-19. It is unknown whether adverse reactions to COVID-19 vaccination are severe in individuals with allergies. We administered the COVID-19 vaccine to the medical staff at Yamagata University Hospital from March to August 2021. Subsequently, we conducted an online questionnaire-based survey to investigate the presence of allergy and adverse reactions after vaccination and examined the association between allergy and adverse reactions after immunization. Responses were collected from 1586 subjects after the first vaccination and 1306 subjects after the second administration of the BNT162b2 mRNA COVID-19 vaccine. Adverse reactions included injection site pain, injection site swelling, fever, fatigue or malaise, headache, chills, nausea, muscle pain outside the injection site, and arthralgia. The frequency and severity of most adverse reactions were higher after the second vaccination compared to the first. The frequency of some adverse reactions and their severity were higher, and the duration of symptoms was longer in subjects with allergies than in subjects without allergies. Although several participants visited the emergency room for treatment after the first and second vaccinations, nobody was diagnosed with anaphylaxis. Given the serious consequence of COVID-19 and the reported high efficacy of this vaccine against this disease, we conclude that vaccination of allergic individuals is generally recommended.

Immunogenicity and Safety of the inactivated SARS-CoV-2 vaccine (BBIBP-CoV) in patients with malignancy

Objective: Patients with malignancy suffer from a compromised immune system due to either the effects of malignancies or treatments. Cancer patients are at higher risk of different infections particularly SARS-CoV2 and usually produce weaker response to vaccines. The aim of this study was to evaluate the safety and immunogenicity of the inactivated SARS-CoV-2 vaccine (Sinopharm, BBIBP-CoV) in patients with malignancy. Material and Method: In total 364 patients with cancer (median age: 54 years old, F/M ratio: 217/147) who received two doses of Sinopharm vaccine were enrolled in this study. Vaccine related side effects was assessed by a questionnaire and the presence of SARS-CoV-2 anti-Spike protein (S) IgG and neutralizing antibody two months following vaccination were measured by immunological methods. Results: Injection site pain and fever were the most common local and systemic side effects in vaccine receivers. Two months after the first dose, anti-S IgG and neutralizing antibody were detectable in 77.1% and 80.7% of all participants, respectively with an overall response to either or both measured in 86.9% of patients The rate of seroconversion was lower in older age, those with hematological malignancies and chemotherapy receivers. Conclusion: The result of study confirmed the safety and short-term efficacy of Sinopharm inactivated vaccine (BBIBP-CorV) in patients with different type of malignancies.

COVID-19 Vaccine and Fitness to Fly

INTRODUCTION: On December 2020 the U.S. Food and Drug Administration (FDA) authorized the emergency use of Pfizer-BioNTech COVID-19 vaccine. This new vaccine has several side effects that can potentially impair function, which warrants special attention regarding aircrews fitness to fly following vaccination.METHODS: A survey was conducted in the Israeli Air Force (IAF) Aeromedical Center in order to characterize the side effects and their duration following Pfizer-BioNTech COVID-19 vaccine administration to aviators.RESULTS: The most common side effect was injection site pain. Headache, chills, myalgia, fatigue, and weakness were more common following the second dose administration. The difference is statistically significant. Following the second vaccine, duration of side effects was longer compared to the first vaccine (P-value 0.002).CONCLUSION: The IAF Aeromedical center policy for Pfizer-BioNTech COVID-19 vaccine recipients among aircrew members, based on side effects duration and severity, is to temporarily ground from flight duties for 24 and 48 h following the first and the second dose, respectively.Gabbai D, Ekshtein A, Tehori O, Ben-Ari O, Shapira S. COVID-19 vaccine and fitness to fly. Aerosp Med Hum Perform. 2021; 92(9):698701.

Qualitative Assessment of Early Adverse Effects of Pfizer–BioNTech and Sinopharm COVID-19 Vaccines by Telephone Interviews

Vaccines are considered the best approach for countering the COVID-19 pandemic. In this study, we compared early side effects associated with vaccination with the Sinopharm and Pfizer–BioNTech COVID-19 vaccines. Participants of this observational cohort were interviewed based on semi-structured telephone interviews, with enquiries about side effects that developed after vaccination with each dose of these vaccines. Overall, 1004 participants were enrolled, of which 51.1% received Sinopharm vaccine and 48.9% received the Pfizer–BioNTech vaccine. After the first dose, 46.3% of participants had an adverse reaction, with injection site pain most commonly being reported (33.2%). Participants who received the Pfizer–BioNTech vaccine had significantly higher frequencies of all types of adverse reactions (p < 0.01), with no significant differences in the duration of adverse reactions between the two vaccines. Regarding the second dose, 48.6% of participants had adverse reactions, with injection site pain being most commonly reported (29%). Those who received the Pfizer vaccine reported higher frequencies of all adverse reactions (p < 0.01). However, a longer duration of adverse reactions was seen among Sinopharm vaccine recipients as compared to Pfizer–BioNTech vaccine recipients (p = 0.01). In conclusion, early adverse effects are reported following all types of vaccines but these are more likely to be encountered following the administration of new-generation vaccines. These side effects are mostly mild and treatable.