Short term safety of booster immunization with BNT162b2 mRNA COVID-19 vaccine in healthcare workers

Open Forum Infectious Diseases ◽

10.1093/ofid/ofab656 ◽

2021 ◽

Author(s):

Yael Paran ◽

Esther Saiag ◽

Avishay Spitzer ◽

Yoel Angel ◽

Michal Yakubovsky ◽

...

Keyword(s):

Safety Profile ◽

Healthcare Workers ◽

Short Term ◽

Booster Immunization ◽

Systemic Reactions ◽

Local Reactions

Abstract This study demonstrated good short-term safety profile after a third dose of BNT162b2 vaccine among HCWs. There were more frequent local reactions and less systemic reactions compared to the second dose. HCW's who reported reactions had higher pre-booster titer of anti-S1 antibodies compared to those reported no reactions.

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Reactogenicity of homologous and heterologous prime-boost immunization with BNT162b2 and ChAdOx1-nCoV19: a prospective cohort study

10.1101/2021.05.19.21257334 ◽

2021 ◽

Author(s):

David Hillus ◽

Pinkus Tober-Lau ◽

Hana Hastor ◽

Elisa T. Helbig ◽

Lena J. Lippert ◽

...

Keyword(s):

Cohort Study ◽

Healthcare Workers ◽

Age Groups ◽

Booster Vaccination ◽

Observational Cohort Study ◽

Vaccination Regimen ◽

Systemic Reactions ◽

Boost Immunization ◽

Observational Cohort ◽

Local Reactions

Heterologous prime-boost vaccination is of increasing interest for COVID-19 vaccines. Evidence of rare thrombotic events associated with ChAdOx1-nCoV19 (Vaxzevria, ChAdOx) has lead several European countries to recommend a heterologous booster with mRNA vaccines for certain age groups (e.g. persons <60years in Germany), who have already received one dose of ChAdOx, although data on reactogenicity and safety of this vaccination regimen are still missing. Here we report reactogenicity data of homologous BNT162b2 (Comirnaty, BNT) or heterologous ChAdOx/BNT prime-boost immunisations in a prospective observational cohort study of 326 healthcare workers. Reactogenicity of heterologous ChAdOx/BNT booster vaccination was largely comparable to homologous BNT/BNT vaccination and overall well-tolerated. No major differences were observed in the frequency or severity of local reactions after either of the vaccinations. In contrast, notable differences between the regimens were observed for systemic reactions, which were most frequent after prime immunisation with ChAdOx (86%, 95CI: 79-91), and less frequent after homologous BNT/BNT (65%, 95CI: 56-72), or heterologous ChAdOx/BNT boosters (48%, 95CI: 36-59). This interim analysis supports the safety of currently recommended heterologous ChAdOx/BNT prime-boost immunisations with 12-week intervals.

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Short-term tolerability and safety profile of a novel diclofenac potassium liquid filled capsule formulation

Journal of Pain ◽

10.1016/j.jpain.2010.01.153 ◽

2010 ◽

Vol 11 (4) ◽

pp. S36

Author(s):

J. Jones ◽

S. Boesing

Keyword(s):

Safety Profile ◽

Short Term ◽

Capsule Formulation ◽

Term Tolerability

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The results of an Open, Randomized Comparative Clinical Study to Assess the Reactogenicity, Safety and Immunogenicity of the Vaccine EntseVir in Children Aged 3 to 17 Years

Epidemiology and Vaccinal Prevention ◽

10.31631/2073-3046-2015-14-2-66-72 ◽

2015 ◽

Vol 14 (2) ◽

pp. 66-72

Author(s):

S. M. Kharit ◽

A. A. Ruleva ◽

I. V. Fridman ◽

E. P. Nacharova ◽

L. A. Alekseeva ◽

...

Keyword(s):

Clinical Study ◽

Safety Profile ◽

Randomized Study ◽

Reference Drug ◽

Post Vaccination ◽

Childhood Infections ◽

Good Safety Profile ◽

Tick Borne Encephalitis ◽

Comparative Clinical Study ◽

Local Reactions

In 2011 - 2012 years in the Institute of childhood infections followed by an open comparative randomized study of tick-borne encephalitis vaccine EntseVir («Microgen») at a dose of 0.25 ml of the two schemes, planned and emergency in children aged 3 - 17 years. As a reference drug used vaccine FSME-Immun junior production (Baxter, AG, Austria). The results of clinical studies have shown that Entsevir at a dose of 0.25 ml has a good safety profile, low reactogenicity. Mostly recorded transient local reactions such as pain at the injection site weak degree. Severe reactions and post-vaccination complications were absent. EntseVir has no immunosuppressive, immunopathological action, highly immunogenic and can be recommended for mass prophylaxis tick-borne encephalitis in children 3 - 17 years on two schemes of vaccination (planned with an interval of 60 days and emergency with an interval of 14 days).

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Pharmacokinetics and pharmacodynamics of natalizumab in pediatric patients with RRMS

Neurology Neuroimmunology & Neuroinflammation ◽

10.1212/nxi.0000000000000591 ◽

2019 ◽

Vol 6 (5) ◽

pp. e591 ◽

Cited By ~ 1

Author(s):

Angelo Ghezzi ◽

Giancarlo Comi ◽

Luigi Maria Grimaldi ◽

Lucia Moiola ◽

Carlo Pozzilli ◽

...

Keyword(s):

Safety Profile ◽

Time Course ◽

Pediatric Patients ◽

Short Term ◽

Elimination Phase ◽

Relapsing Remitting ◽

Distribution Phase

ObjectiveThis phase I study investigated pharmacokinetic (PK) and pharmacodynamic (PD) profiles of natalizumab in pediatric patients with relapsing-remitting MS (RRMS).MethodsPediatric patients with RRMS who were prescribed natalizumab 300 mg IV every 4 weeks were enrolled. Blood samples were collected on days 1, 2, 8, 15, and 22 and at weeks 4, 8, 12, and 16 to estimate PK parameters; PD properties were evaluated by measuring α4-integrin saturation and lymphocyte counts over time. Natalizumab's safety profile was also evaluated.ResultsPK parameters were similar to those reported in adult patients; natalizumab concentrations peaked approximately 1 day after infusion in most of the participants (Cmax 142.9 μg/mL, AUClast 47389.4 hr*μg/mL), followed by a biphasic decline with a rapid distribution phase and a slow elimination phase, with a terminal half-life of 215.1 hours. In terms of PD, both time course and magnitude of α4-integrin saturation and increase in lymphocyte counts were similar to those observed in adults. During the 16-week study follow-up, 3 adverse events attributed to natalizumab were observed; no unexpected safety events occurred.ConclusionsPK profile, α4-integrin saturation, lymphocyte counts, and safety observed in these pediatric patients are comparable to those reported in adults.Classification of evidenceThis study provides Class I evidence that natalizumab PK/PD parameters and safety profile are similar in adults and pediatric patients in the short term. Longer studies, also including a larger number of younger subjects (aged 10–12 years), are required to further inform about long-term PK and PD parameters in pediatric patients with MS.

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24 Short-Term Effectiveness and Safety Profile of Ranolazine in Patients with Refractory Angina

Heart ◽

10.1136/heartjnl-2015-308066.24 ◽

2015 ◽

Vol 101 (Suppl 4) ◽

pp. A13.2-A14

Author(s):

Peysh Patel ◽

Chia Yau ◽

Simerjit Thapar ◽

James Foley ◽

Murad Khan ◽

...

Keyword(s):

Safety Profile ◽

Refractory Angina ◽

Short Term

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Chronic HBV treatment with one year of pegylatyed-interferon alpha-2b (PEG-IFN) has a comparable safety profile to short term conventional interferon alpha-2b

Journal of Hepatology ◽

10.1016/s0168-8278(03)80884-x ◽

2003 ◽

Vol 38 ◽

pp. 179 ◽

Cited By ~ 2

Author(s):

M. van Zonneveld ◽

A.B. van Nunen ◽

R.A. de Man ◽

S.W. Schalm ◽

H.L.A. Janssen

Keyword(s):

Interferon Alpha ◽

Safety Profile ◽

Short Term ◽

Interferon Alpha 2B ◽

Chronic Hbv ◽

Conventional Interferon ◽

One Year

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Battling the COVID-19 Pandemic: Is Bangladesh Prepared?

10.1101/2020.04.29.20084236 ◽

2020 ◽

Cited By ~ 3

Author(s):

Hasinur Rahaman Khan ◽

Tamanna Howlader ◽

Md. Mazharul Islam

Keyword(s):

At Risk ◽

Spatial Distribution ◽

Healthcare System ◽

Healthcare Workers ◽

Polynomial Regression ◽

Spatial Cluster ◽

Short Term ◽

Hospital Capacity ◽

Order Polynomial ◽

Frontline Healthcare Workers

Following detection of the first few COVID-19 cases in early March, Bangladesh has stepped up its efforts to strengthen capacity of the healthcare system to avert a crisis in the event of a surge in the number of cases. This paper sheds light on the preparedness of the healthcare system by examining the spatial distribution of isolation beds across districts and divisions, forecasting the number of ICU units that may be required in the short term and analyzing the availability of frontline healthcare workers to combat the pandemic. As of May 2, COVID-19 cases have been found in 61 of the 64 districts in Bangladesh with Dhaka District being the epicenter. Seventy-one percent of the cases have been identified in 6 neighboring districts, namely, Dhaka, Narayanganj, Gazipur, Narsingdi, Munsiganj and Kishoreganj, which appear to form a spatial cluster. However, if one takes into account the population at risk, the prevalence appears to be highest in Dhaka, followed by Narayanganj, Gazipur, Kishorganj, Narsingdi and Munshiganj. These regions may therefore be flagged as the COVID-19 hotspots in Bangladesh. Among the eight divisions, prevalence is highest in Dhaka Division followed by Mymensingh. The number of cases per million exceeds the number of available isolation beds per million in the major hotspots indicating that there is a risk of the healthcare system becoming overwhelmed should the number of cases rise. This is especially true for Dhaka Division, where the ratio of COVID-19 patients to doctors appears to be alarmingly high. Mymensingh Division also has a disproportionately small number of doctors relative to the number of COVID-19 patients. Using second order polynomial regression, the analysis predicts that even if all ICU beds are allocated to COVID-19 patients, Bangladesh may run out of ICU beds soon after May 15, 2020. We conclude that in spite of a significant increase in hospital capacity during 2005-15 and a 57 % rise in the number of doctors during the same period, the healthcare system in Bangladesh and Dhaka Division in particular, may not be fully prepared to handle the COVID-19 crisis. Thus, further steps need to be taken to flatten the curve and improve healthcare capacity.

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Evaluation of the Safety and Pharmacokinetic Profile of a New, Pasteurized, Human Tetanus Immunoglobulin Administered as Sham, Postexposure Prophylaxis of Tetanus

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.42.2.298 ◽

1998 ◽

Vol 42 (2) ◽

pp. 298-305 ◽

Cited By ~ 7

Author(s):

Rémi Forrat ◽

Rafaele Dumas ◽

Michael Seiberling ◽

Michael Merz ◽

Charles Lutsch ◽

...

Keyword(s):

Placebo Group ◽

Injection Site ◽

Pharmacokinetic Profile ◽

Vaccine Group ◽

Assay Method ◽

Enzyme Linked Immunosorbent Assay ◽

Postexposure Prophylaxis ◽

Systemic Reactions ◽

Antibody Titers ◽

Local Reactions

ABSTRACT In a monocentric, double-blind, randomized trial, we examined the safety and pharmacokinetic profile of a new, pasteurized, human tetanus immunoglobulin (P-HTIG). As part of the purification process, P-HTIG has undergone a heat treatment step (10 h at 60°C) and the removal of Merthiolate. Forty-eight adults with a history of tetanus vaccination were randomized into four groups (n = 12 per group) to receive one of two different batches of this P-HTIG simultaneously with either tetanus-diphtheria (Td) vaccine (sham, postexposure prophylaxis of tetanus) or placebo. Local reactions at the injection site were followed for the first 3 days after injection, and systemic reactions were followed during the entire study period, i.e., up to 42 days posttreatment. Blood samples for tetanus antibody titer determination (enzyme-linked immunosorbent assay method) were drawn prior to treatment on day 0 and on days 1, 2, 3, 7, 14, 21, 28, 35, and 42. A normalization of tetanus antibody titers (subtraction of the day 0 value for each subject at each time period) was performed to assess the additive effect of P-HTIG on tetanus antibody titers. The pharmacokinetic parameters were determined by both a compartmental analysis (modelization) and a noncompartmental analysis. No severe adverse reactions were reported. The rate of local reactions at the P-HTIG injection site was 27%. All local reactions were mild and resolved within 2 days. In contrast, local reactions at the vaccine injection site were seen in 79% of the subjects. The rate of systemic reactions was similar in the P-HTIG plus Td vaccine group (33%) and in the P-HTIG plus placebo group (21%), and all these reactions were mild. In the P-HTIG plus placebo group, tetanus antibody titers rose to a maximum of 0.313 ± 2.49 IU/ml after 4.4 days; in the P-HTIG plus Td vaccine group, a maximum concentration of 15.2 ± 2.42 IU/ml was reached 19 days postinjection. In both groups, 100% of the patients had seroprotective levels of tetanus antibodies (≥0.01 IU/ml) 2 days following treatment. An anamnestic response to Td vaccine appeared 7 days postimmunization. In conclusion, P-HTIG has a good safety and pharmacokinetic profile. Our results confirm that immunoglobulin should be associated with vaccine in the treatment of tetanus-prone wounds.

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