scholarly journals Attitudes of Poles towards the COVID-19 Vaccine Booster Dose: An Online Survey in Poland

Vaccines ◽  
2022 ◽  
Vol 10 (1) ◽  
pp. 68
Author(s):  
Mateusz Babicki ◽  
Agnieszka Mastalerz-Migas

Introduction: COVID-19 vaccination has now become the most effective way to combat the pandemic, but there is a gradual decline in the protection that it offers over time. Therefore, the Food and Drug Administration (FDA) and EMA now recommend the use of the so-called booster dose, especially in at-risk groups. The purpose of the study was to assess the attitudes of Poles towards the recommendation to receive a booster dose of the COVID-19 vaccine and to evaluate the main reasons for refusing or delaying the decision. Material and methods: The study was based on a proprietary questionnaire distributed via the Internet. There were 1598 respondents, 54 of which did not consent to participate in the survey and/or did not complete the vaccination against SARS-CoV-2. As a result, 1528 surveys were included in the final analysis. The vast majority of the respondents, namely 1275 (83.4%), were female, and 772 (50.5%) were residents of cities with a population of over 250,000. Results: Out of all respondents, 38 (2.5%) had already received the COVID-19 vaccine booster dose and 1031 (67.4%) would like to receive it as soon as possible. Forty-five (2.9%) respondents reported that they were completely unwilling to take the booster dose. The occurrence of adverse events after primary vaccination were reported by 79.9% of the survey participants. The most common reasons why the respondents refused to be vaccinated are lack of confidence in the effectiveness of the booster dose and the occurrence of adverse events in them or their loved ones. Age, gender, residence, or relationship status were not shown to affect attitudes towards the expansion of the basic vaccination schedule. Conclusions: One in three respondents plans to delay or refrain from taking the COVID-19 vaccine booster dose. The main reason for refusal to be vaccinated is the belief that the previous vaccination provides sufficient protection.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 302-302
Author(s):  
Yoshihiko Tomita ◽  
Robert J. Motzer ◽  
Toni K. Choueiri ◽  
Brian I. Rini ◽  
Hideaki Miyake ◽  
...  

302 Background: In the phase III JAVELIN Renal 101 trial (NCT02684006), A + Ax demonstrated progression-free survival (PFS) and objective response rate (ORR) benefit across IMDC risk groups (favorable, intermediate, and poor) vs S in patients with previously untreated aRCC. Here we report efficacy of A + Ax vs S by number of IMDC risk factors (0, 1, 2, 3, and 4-6) and target tumor sites (1, 2, 3, and ≥4) at baseline from the second interim analysis of overall survival (OS). Methods: Patients were randomized 1:1 to receive A 10 mg/kg intravenously every 2 wk + Ax 5 mg orally twice daily or S 50 mg orally once daily for 4 wk (6-wk cycle). PFS and ORR per independent central review (RECIST 1.1) and OS were assessed. Results: At data cut-off (Jan 2019), median (m) follow-up for OS and PFS was 19.3 vs 19.2 mo and 16.8 vs 15.2 mo for the A + Ax vs S arm, respectively. The table shows OS, PFS, and ORR by number of IMDC risk factors and target tumor sites at baseline. A + Ax generally demonstrated efficacy benefit vs S across subgroups. Conclusions: With extended follow-up, A + Ax generally demonstrated efficacy benefit vs S across the number of IMDC risk factors and tumor sites at baseline in aRCC. OS was still immature; follow-up for the final analysis is ongoing. Clinical trial information: NCT02684006 . [Table: see text]


Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 162-162 ◽  
Author(s):  
Cecile Pautas ◽  
Xavier Thomas ◽  
Fatiha Merabet ◽  
Emmanuel Raffoux ◽  
Jean Henri Bourhis ◽  
...  

Abstract Background: For many years the ALFA Group has used high dose DNR, i.e 80 mg/m2/day for 3d as part of the induction regimen for untreated adult AML pts. As the equivalence of DNR and Ida is not known we conducted a phase III study to compare high dose DNR to Ida. We also tested the effect of IL2 for maintenance. Methods: Newly diagnosed AML, aged 50 to 70 years, were randomized to receive AraC 200 mg/m2/day IV x 7 d with either DNR: 80 mg/m2/d x 3 d (arm 1) or Ida: 12 mg/m2/d x 3 d (arm 2) or x 4 d (arm 3). Pts who failed could receive a salvage course with Mitoxantrone x 2 d and AraC1g/m2 12 hrs x 4d. Response was assessed after induction+/− salvage chemotherapy. CR pts received 2 consolidation courses according to the induction arm with DNR: 80 mg/m2 or Ida:12 mg/m2 for 1 day (first course) or 2 days (2nd course) and AraC:1g/m2/12 hrs x 4 days. Pts in CCR after the two consolidation courses were randomized to receive or not a maintenance immunotherapy with IL2: 5.106/m2 for 5 days monthly for12 months. Results: From 2001 to 2006, 468 pts were included (median age: 60 years). The 3 treatment arms were well matched for pretreatment characteristics. CR was achieved in 360/468 pts (77%): 109 (70%) pts arm 1, 129 (83%) arm 2, 122 (78%) arm 3 (p=0.02).70 pts, (45%) pts in the DNR arm reached CR after 1 course vs 97 (62%) and 90 (57%) in Ida arms (p= 0.006). Pts in Ida arms experienced more grade 3 or 4 mucositis (p=0.004) but no differences were observed between the 3 arms for duration of hospitalization, time to PMN or plts recovery, incidence of grade 3 or 4 infectious episodes and treatment related mortality. 3 year cumulative incidence of relapse was 69%, 63%, 62% resp in arms 1,2,3 (p=NS). 3 year EFS was 19%, 30%, 26% resp (p=0.06 for arm 1 vs arms 2 and 3). 3 year OS was 31%, 40% 41% resp in arms 1,2,3 (p=NS). Age (< or >60 years), sex, initial WBC counts, initial LDH (nl or >nl), DNR or Ida arms, need for a salvage course were not predictive for relapse, while 2yCIR was 43%, 64%, 77% among respectively fav, intermediate and unfav cytogenetic risk groups resp (p=0.0046). Of the 219 pts alive in CR after consolidations, 161 (73%) were randomized for maintenance. Only 22 of the 77 pts randomized for IL2 completed the 1 year treatment. 32 and 23 pts stopped IL2 resp because of relapse or intolerance. There were no differences in relapse or OS in both maintenance arms. Conclusion: Ida treatment even when compared to high doses of DNR yields higher CR rate and more CR after one course. This effect translated in slightly better EFS but not better CIR or OS. IL2 maintenance treatment at least as scheduled in this trial was difficult to apply and showed no impact on disease course.


2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S378-S378
Author(s):  
Shon A Remich ◽  
Nicholas Kitchin ◽  
Michael W Pride ◽  
Annaliesa S Anderson ◽  
Ping Li ◽  
...  

Abstract Background Clostroidides difficile (C difficile) is a common cause of antibiotic-associated diarrhea. To date, there is no vaccine to prevent C. difficile infection (CDI). This extension of a phase 2 study explores the immunogenicity, safety, and tolerability of a 4th dose, and antibody persistence of a three-dose regimen of a toxoid-based C difficile vaccine in 300 healthy adults 65 to 85 years of age in the United States. Methods The first stage of this study was conducted from 16 July 2015 to 7 March 2017, in which subjects were enrolled and randomized to receive one of two antigen dose levels (100µg or 200µg total toxoid A and B) or placebo, administered in one of two three-dose regimens: Days 1, 8 & 30 or Months 0, 1 & 6. Immunogenicity testing was conducted on samples obtained at each of nine study visits through 12 months post dose 3. In this extension stage, subjects who had received vaccine in the first stage were re-randomized at 12 months post dose 3 to receive either a booster dose or placebo in a 1:1 ratio. Subjects were followed for immunogenicity three (3) years post booster (four years post dose #3) Results Peak antibody response to vaccination was observed between day 8 and 30 following booster administration. Both regimens demonstrated robust anamnestic responses with peak levels above the three-dose peak (stage 1). Toxin A geometric mean concentrations (GMCs) remained above pre-booster GMCs, 3 years post booster for both dose levels and regimens. Antibody persistence for both groups demonstrated stable antibody levels four years after the primary vaccination series among subjects who did not receive a booster dose. No Grade 4 reactogenicity was reported during the study. Pain was the most common local reaction. Adverse event rates per subject were similar between both regimens and placebo. There were no Serious Adverse Events (SAEs) considered related to the investigational product at any dose or regimen. The safety profile was consistent with what was seen in the first stage of the study. Conclusion A booster dose of Clostroidides difficile vaccine candidate is highly immunogenic, well tolerated and demonstrates an acceptable safety profile in both dose groups for the Day and the Month regimens. Antibody persistence remains stable from 12 months to 4-year post dose 3. Disclosures Nicholas Kitchin, MD, Pfizer, Inc (Employee) Michael W. Pride, PhD, Pfizer (Employee, Shareholder) Annaliesa S. Anderson, PhD, Pfizer (Employee, Shareholder) Chris Webber, MD, Pfizer Inc (Employee, Shareholder)


2021 ◽  
Author(s):  
Giuseppe Lippi ◽  
Camilla Mattiuzzi ◽  
Brandon M. Henry

Abstract Background: We carried out a literature search for summarizing currently published evidence on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron (B.1.1.529) variant neutralizing properties of serum or plasma collected from recipients of coronavirus disease 2019 (COVID-19) vaccines.Methods: An electronic search was conducted in Medline and Scopus, using the keywords “vaccine” AND “Omicron” OR “B.1.1.529” AND “SARS-CoV-2” AND “neutralization” OR “antibodies”, with no language or date limits (i.e., up to December 27, 2021). Studies with complete information on neutralization properties of COVID-19 vaccines against the Omicron variant, with or without the adjunctive effects of booster vaccine doses, were included.Results: Our final analysis included 10 published studies. In all, decreased neutralisation of SARS-CoV-2 Omicron B.1.1.529 variant was evidenced in post-vaccination samples, ranging between -4.3 folds to absence of neutralization compared to an ancestral SARS-CoV-2 strain. In all studies the COVID-19 vaccine booster dose was effective to elicit sustained enhancement of SARS-CoV-2 Omicron B.1.1.529 neutralisation, with such increase being comprised between 10-42 folds compared to the pre-booster period.Conclusion: Vaccine boosters seem strongly advisable for limiting the risk of SARS-CoV-2 Omicron (B.1.1.529) breakthrough infections.


2012 ◽  
Vol 3 (1) ◽  
pp. 13-16 ◽  
Author(s):  
BK Paul ◽  
AKMF Huque ◽  
SML Kabir ◽  
J Alam ◽  
SC Badhy

The study was carried out to evaluate the vaccination programmes with Nobilis® Gumboro D78 (Intervet, Netherland) against Gumboro disease with persistance of maternally derived antibody in broiler chickens during two month period from August to September 2003 in Sherpur district of Bangladesh. A total of seven farms were selected, of which owners of five farms practiced their own vaccination programme i.e., primary vaccination at 5 (three farms), 7 and 8 days old with no booster against infections bursal disease (IBD) whereas imposed vaccination schedule (primary vaccination at 14 days old with a booster at 28 days old) was implemented in the remaining two farms. The vaccination programmes were evaluated by determining the antibody titres before and after vaccination and by morbidity and mortality of the vaccinated chickens against Gumboro disease. The present investigation demonstrated that mortality of chickens occurred in farms in which the birds were vaccinated between 5 to 7 days of age. The present result revealed that 7 days after primary vaccination the titer level decreased significantly (p < 0.05) in all the farms in which the farmers followed their own vaccination schedule. The present result also demonstrated that the mean titer before primary vaccination was 1276.8 ± 43.84 but seven days after vaccination it increased (1434.2 ± 29.97) insignificantly (p > 0.05) and this increasing rend continued up to 14 days after vaccination that is upto the age of 28 days (1549.6 ± 33.38) and seven days after booster dose that is at the age of day 35 the mean titer increased (2886.60 ± 80.67) significantly (p < 0.05) in the remaining two farms where the imposed vaccination programme was implemented. The present results obviously demonstrated that maternal antibody level decreasing about half within five days and decreased to negative level (364.00 ± 9.25) by the day 20. From the present study it may be concluded that broiler birds may primarily be vaccinated at the age of around day 14 with a booster at 28 days old.


Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 3547-3547 ◽  
Author(s):  
Heinz Gisslinger ◽  
Robert Kralovics ◽  
Mirjana Gotic ◽  
Jercy Holowiecki ◽  
Miroslav Penka ◽  
...  

Abstract The ANAHYDRET study group involving 27 centers in 11 countries, sponsored by the AOP Orphan Pharmaceuticals, initiated a prospective randomized single blind multicenter phase III trial in order to compare efficacy and tolerability of anagrelide with hydroxyurea in high risk ET patients diagnosed according to the WHO classification. The study was designed as a non-inferiority trial as the limited number of treatment naïve ET patients available and the expected low number of ET related events following treatment with a cytoreductive therapy would not have allowed the conduct of a conventional superiority trial. At the stage of final analysis 258 patients with high risk ET previously untreated, were randomized to receive anagrelide (n=122, median age 58,1 years, rage 19–90 years; 46 male, 76 female) or to receive hydroxyurea (n=136, median age 56,4 years, range 22–83 years, 47 male, 89 female). Anagrelide, a novel non-immediate release formulation, was started with a dose of 1mg/day and hydroxyurea was initiated using a dose of 1500mg/day. Confirmatory proof of non inferiority of anagrelide after 6 months therapy (short term objective) was achieved based on predefined equivalence criteria for the course of platelet and white cell counts, hemoglobin levels, (difference of +/− 10% within CI 95%), and for the rate of ET related events (Odds ratio &gt;0,404, medium sized difference corresponding to Cohens’s standardized difference of 0.5). Neutrophile counts remained unchanged in the anagrelide arm but were significantly reduced by hydroxyurea. There was no difference in the number of patients with at least 1 adverse event between the anagrelide treated group (73%) and the hydroxyurea treated group (73%). Five patients were discontinued in each group because of adverse events. However, the results showed an advantage of anagrelide over hydroxyurea concerning leukopenia and flue like symptoms while the angrelide treated patients had more frequently tachycardia, palpitations and headache. The final data analysis after 12 months therapy revealed that non- inferiority of anagrelide compared to hydroxyurea with regard to the platelet lowering effect, hemoglobin levels and ET related symptoms was maintained (p&lt;0,025). During the entire study period of 12 months, 8 major ET related complications occurred in the anagrelide arm (2 myocardial infarctions, 1 coronary arterial disease, 1 peripheral arterial disease, 1 mesenteric vein thrombosis and 3 bleedings) and also 8 major events were seen in the hydroxyurea arm (1 myocardial infarction, 1 peripheral arterial disease, 1 stroke, 1 pulmonary embolism, 2 deep vein thromboses and 2 bleedings). Twenty two minor ET related events occurred in the anagrelide arm as compared to 23 such events in the hydroxyurea arm. The frequency of adverse events and withdrawals remained balanced in both treatment arms at the stage of final analysis after 12 months therapy. In addition, all these parameters will also be analysed with respect to the JAK2 mutation. In summary the study provides evidence for non-inferiority of anagrelide compared to hydroxyurea in the treatment of ET diagnosed according to the WHO classification.


Author(s):  
Aditi Dey ◽  
Han Wang ◽  
Helen Quinn ◽  
Rona Hiam ◽  
Nicholas Wood ◽  
...  

This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) for 2017 reported to the Therapeutic Goods Administration and describes reporting trends over the 18-year period 1 January 2000 to 31 December 2017. There were 3,878 AEFI records for vaccines administered in 2017; an annual AEFI reporting rate of 15.8 per 100,000 population. There was a 12% increase in the overall AEFI reporting rate in 2017 compared with 2016. This increase in reported adverse events in 2017 compared to the previous year was likely due to the introduction of the zoster vaccine (Zostavax®) provided free for people aged 70–79 years under the National Immunisation Program (NIP) and also the state- and territory-based meningococcal ACWY conjugate vaccination programs. AEFI reporting rates for most other individual vaccines in 2017 were similar to 2016. The most commonly reported reactions were injection site reaction (34%), pyrexia (17%), rash (15%), vomiting (8%) and pain (7%). The majority of AEFI reports (88%) described non-serious events. Two deaths were reported that were determined to have a causal relationship with vaccination; they occurred in immunocompromised people contraindicated to receive the vaccines.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1955.1-1956
Author(s):  
T. Santiago ◽  
M. Voshaar ◽  
M. De Wit ◽  
P. Carvalho ◽  
M. Boers ◽  
...  

Background:The Glucocorticoid Low-dose Outcome in Rheumatoid Arthritis Study (GLORIA) is an international investigator-initiated pragmatic randomized trial designed to study the effects of low-dose glucocorticoids (GCs) in elderly patients with Rheumatoid Arthritis (RA).The research team is also committed to promote a better understanding of the risks and benefits of these drugs among health professionals and patients. In order to achieve these goals, it is important to assess the current ideas and concerns of patients regarding GCs.Objectives:To evaluate the current patient perspective on the efficacy and risks of GCs in RA patients who are or have been treated with GCs.Methods:Patients with RA completed an online survey (with 5 closed questions regarding efficacy and safety) presented in their native language. RA patients were recruited through a variety of patient organizations representing three continents. Patients were invited to participate through national patient organizations. In the USA, patients were also invited to participate through MediGuard.org. Participants were asked for their level of agreement on a 5-point Likert scale.Results:1344 RA patients with exposure to GCs, from Brazil, USA, UK, Portugal, Netherlands, Germany and 24 other countries** participated: 89% female, mean age (SD) 52 (14) years and mean disease duration 13 (11) years. The majority of participants (84%) had ≥10 years of education. The duration of GCs exposure was 1.6 (4.2) years. The majority of participants had read articles or pamphlets on the benefits or harms of GC therapy.Regarding GCs efficacy (table 1), high levels of endorsement were found: about 2/3 of patients considered that GCs as very useful in their case, more than half considered that GCs were effective even at low doses, and agreed that GC improved RA symptoms within days.Regarding safety (table 1), 1/3 of the participants reported having suffered some form of serious adverse events (AEs) due to GCs, and 9% perceived this as “life-threatening. Adverse events had a serious impact on quality of life, according to about 1/3 of the respondents.Conclusion:Patients with RA exposed to GC report a strong conviction that GCs are very useful and effective for the treatment of their RA, even at low doses. This is accompanied by an important prevalence of serious AEs. Understanding the patient perspective can improve shared decision-making between patient and rheumatologist.Funding statement:This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 634886.Disclosure of Interests:Tânia Santiago: None declared, Marieke Voshaar Grant/research support from: part of phd research, Speakers bureau: conducting a workshop (Pfizer), Maarten de Wit Grant/research support from: Dr. de Wit reports personal fees from Ely Lilly, 2019, personal fees from Celgene, 2019, personal fees from Pfizer, 2019, personal fees from Janssen-Cilag, 2017, outside the submitted work., Consultant of: Dr. de Wit reports personal fees from Ely Lilly, 2019, personal fees from Celgene, 2019, personal fees from Pfizer, 2019, personal fees from Janssen-Cilag, 2017, outside the submitted work., Speakers bureau: Dr. de Wit reports personal fees from Ely Lilly, 2019, personal fees from Celgene, 2019, personal fees from Pfizer, 2019, personal fees from Janssen-Cilag, 2017, outside the submitted work., Pedro Carvalho: None declared, Maarten Boers: None declared, Maurizio Cutolo Grant/research support from: Bristol-Myers Squibb, Actelion, Celgene, Consultant of: Bristol-Myers Squibb, Speakers bureau: Sigma-Alpha, Frank Buttgereit Grant/research support from: Amgen, BMS, Celgene, Generic Assays, GSK, Hexal, Horizon, Lilly, medac, Mundipharma, Novartis, Pfizer, Roche, and Sanofi., José Antonio P. da Silva Grant/research support from: Pfizer, Abbvie, Consultant of: Pfizer, AbbVie, Roche, Lilly, Novartis


Vaccines ◽  
2021 ◽  
Vol 9 (7) ◽  
pp. 765
Author(s):  
Amel Ahmed Fayed ◽  
Abeer Salem Al Shahrani ◽  
Leenah Tawfiq Almanea ◽  
Nardeen Ibrahim Alsweed ◽  
Layla Mohammed Almarzoug ◽  
...  

This study aimed to assess the willingness to receive the coronavirus disease 2019 (COVID-19) and seasonal influenza vaccines and vaccine uptake during the early stage of the national vaccination campaign in Saudi Arabia. A cross-sectional online survey was conducted among adult Saudis between 20 January and 20 March 2021. The questionnaire addressed vaccine hesitancy, perceived risk, willingness, and vaccine uptake. Approximately 39% of the participants expressed vaccine hesitancy, and 29.8% and 24% felt highly vulnerable to contracting COVID-19 and seasonal influenza, respectively. The majority (59.5%) were willing to receive the COVID-19 vaccine, although only 31.7% were willing to receive the flu vaccine. Adjusted analysis showed that vaccine hesitancy (OR 0.34, 95% CI 0.27–0.43) and the perception of being at high risk (OR 2.78, 95% CI 1.68–4.60) independently affected the intention to be vaccinated. Vaccine hesitancy was similar among those who were willing to be vaccinated (29.8%) and those who had already been vaccinated (33.1%). The perceived risk was significantly higher among those who had been vaccinated (48.1%) than among those who were willing to be vaccinated but had not yet been vaccinated (29.1%). In conclusion, the acceptance of the COVID-19 vaccine in Saudi Arabia is high. Saudis who received the vaccine had a similar level of vaccine hesitancy and a higher level of perceived risk.


Vaccine ◽  
2021 ◽  
Author(s):  
Jordana Rodrigues Barbosa Fradico ◽  
Ana Carolina Campi-Azevedo ◽  
Vanessa Peruhype-Magalhães ◽  
Jordana Grazziela Alves Coelho-dos-Reis ◽  
Elaine Spezialli Faria ◽  
...  

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