ABSTRACT
The concept of pharmaceutical care (PC) has existed as a professional philosophy for more than 30 years. However, for a long period of time, little had been done for its integration into the regular practice of healthcare provision. The COVID-19 pandemic and the resulting increase in patient influx in the community pharmacies (CP) encouraged the exploration and establishment of new healthcare services provided within the CP. Nevertheless, these services of PC are still novel, and more can be done to expand the community pharmacists' current role in primary healthcare. This can be achieved by improving and expanding the newly established services, all while incorporating new ones, for the benefit of public health and the reduction of avoidable healthcare expenditures. This article reviews information about the benefits of this service regarding patient health and the reduction of financial expenses pertinent to adverse drug events within the setting of the CP. Adverse drug events account for significant healthcare expenses and patient distress due to relevant symptoms, emergency doctor visits, and increased hospitalization rates. Several studies conducted internationally have investigated the positive impact of PC practiced by community pharmacists. In spite of results sometimes presenting a non-continuous pattern, PC applied under specific conditions has tangible positive outcomes. Congestive heart failure and type 2 diabetes mellitus patients presented fewer hospital admissions, better symptom control, and higher adherence in comparison to control groups, while a study on asthma patients revealed improved inhalation techniques. All intervention groups reported psychological improvement and a better understanding of their treatment. Special reference is made to the importance of this service for patients receiving anti-cancer treatment and how community pharmacists can have a crucial role in designing, monitoring, and re-designing these therapeutic schemes whose complexity and related adverse drug events negatively affect patient adherence. The role of community pharmacists was very important, especially for primary care, for both patients and healthcare systems during the pandemic, and it seems that it will remain decisive in the post-COVID era as well. The increased complexity of therapy and polypharmacy creates the need for organized, active participation of pharmacists in healthcare provision so that they can use their knowledge and skills under continuous cooperation with other healthcare professionals, thus providing coordinated services for the benefit of the patient.
Subject(s)
COVID-19 , Community Pharmacy Services , Diabetes Mellitus, Type 2 , Drug-Related Side Effects and Adverse Reactions , Pharmacies , Humans , Pandemics , COVID-19/epidemiology , Pharmacists/psychologyABSTRACT
GCSF prophylaxis is recommended in patients on chemotherapy with a >20% risk of febrile neutropenia and is to be considered if there is an intermediate risk of 10−20%. GCSF has been suggested as a possible adjunct to immunotherapy due to increased peripheral neutrophil recruitment and PD-L1 expression on neutrophils with GCSF use and greater tumour volume decrease with higher tumour GCSF expression. However, its potential to increase neutrophil counts and, thus, NLR values, could subsequently confer poorer prognoses on patients with advanced NSCLC. This analysis follows on from the retrospective multicentre observational cohort Spinnaker study on advanced NSCLC patients. The primary endpoints were OS and PFS. The secondary endpoints were the frequency and severity of AEs and irAEs. Patient information, including GCSF use and NLR values, was collected. A secondary comparison with matched follow-up duration was also undertaken. Three hundred and eight patients were included. Median OS was 13.4 months in patients given GCSF and 12.6 months in those not (p = 0.948). Median PFS was 7.3 months in patients given GCSF and 8.4 months in those not (p = 0.369). A total of 56% of patients receiving GCSF had Grade 1−2 AEs compared to 35% who did not receive GCSF (p = 0.004). Following an assessment with matched follow-up, 41% of patients given GCSF experienced Grade 1−2 irAEs compared to 23% of those not given GCSF (p = 0.023). GCSF prophylaxis use did not significantly affect overall or progression-free survival. Patients given GCSF prophylaxis were more likely to experience Grade 1−2 adverse effects and Grade 1−2 immunotherapy-related adverse effects.
Subject(s)
Carcinoma, Non-Small-Cell Lung , Drug-Related Side Effects and Adverse Reactions , Lung Neoplasms , Humans , Carcinoma, Non-Small-Cell Lung/pathology , Lung Neoplasms/pathology , Progression-Free Survival , Immunotherapy/adverse effects , Retrospective StudiesABSTRACT
The recent reports of oral side effects (SEs) following COVID-19 vaccination warrant further investigation into their prevalence, severity, and aetiology. This study was conducted to synthesize the first-ever population-level evidence about oral SEs of COVID-19 vaccines in Europe. The European Union Drug Regulating Authorities Pharmacovigilance (EudraVigilance) database was accessed in August 2022 to extract summary data of all potential oral SEs reported after COVID-19 vaccination. The data were reported descriptively and cross-tabulated to facilitate sub-group analysis per vaccine type, sex, and age group. Dysgeusia was the most commonly reported oral SE (0.381 case per each 100 received reports), followed by oral paraesthesia (0.315%), ageusia (0.296%), lip swelling (0.243%), dry mouth (0.215%), oral hypoaesthesia (0.210%), swollen tongue (0.207%), and taste disorder (0.173%). Females had significantly (Sig. < 0.001) a higher prevalence of all most common (top 20) oral SEs, except for salivary hypersecretion, which was equally prevalent among females and males. The present study revealed a low prevalence of oral SEs, with taste-related, other sensory and anaphylactic SEs being the most common SEs in Europe, similar to what was found earlier among the US population. Future studies should explore the potential risk factors of oral sensory and anaphylactic SEs to verify whether they are causally linked to COVID-19 vaccines.
Subject(s)
Anaphylaxis , COVID-19 Vaccines , COVID-19 , Female , Humans , Male , Adverse Drug Reaction Reporting Systems , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Drug-Related Side Effects and Adverse Reactions , Europe/epidemiologyABSTRACT
BACKGROUND: The response to the vaccine may vary among individuals. Hence, it is important to know how often individuals experience side effects after immunization against COVID-19. OBJECTIVE: This study aimed to assess the incidence of side effects following COVID-19 vaccination across different vaccine recipients in Southern Pakistan and identify the potential factors associated with these side effects in the population. METHODS: The survey was conducted across Pakistan through Google-forms Links from August to October 2021. The questionnaire included demographic information and COVID-19 vaccine information. Chi-square (x2) was performed for comparative analysis to check the significance level with P <0.05. The final analysis included 507 participants who had received COVID-19 vaccines. RESULTS: Of the total 507 COVID-19 vaccines recipients, 24.9% received CoronaVac, 36.5% received BBIBP-CorV, 14.2% received BNT162b2, 13.8% received AZD1222, and 10.7% received mRNA-1273. The most prominent side effects after the first dose were fever, weakness, lethargy, and pain at the site of injection. Moreover, the most commonly reported side effects after the second dose were pain at the injection site, headache, body ache, lethargy, fever, chills, flu-like symptoms, and diarrhea. CONCLUSION: Our results suggested that the side effects due to COVID-19 vaccination can vary between the first and second doses and type of COVID-19 vaccine. Our findings suggest continuing monitoring of vaccine safety and the importance of individualized risk-benefit assessment for COVID-19 immunization.
Subject(s)
COVID-19 , Drug-Related Side Effects and Adverse Reactions , Vaccines , Humans , COVID-19 Vaccines , Prevalence , BNT162 Vaccine , ChAdOx1 nCoV-19 , Lethargy , Pakistan , FeverABSTRACT
OBJECTIVE: Describe the effects of the COVID-19 pandemic on subject enrollment in a multicenter randomized controlled trial. STUDY DESIGN: We assessed the number of eligible infants approached and consented for enrollment over five separate epochs including baseline, peak pandemic, and gradual but incomplete recovery. RESULT: The pandemic had a major effect on ability to approach parents for consent. Parents approached dropped from 95.4% baseline to 13.1% in the peak pandemic epoch and has not recovered to baseline even in the just-completed post-pandemic epoch (84.9%). Despite the decrease in subjects approached, there was no significant change in the overall consent rate for the study CONCLUSION: The pandemic has significantly limited ability to approach parents of eligible infants for consent, with only partial recovery. Opportunities for interactions of investigators and study coordinators with parents continue to present challenges limiting full recovery.
Subject(s)
COVID-19 , Drug-Related Side Effects and Adverse Reactions , Infant , Humans , Pandemics , ParentsABSTRACT
As COVID-19 vaccination becomes widely available and administered globally, there have been several reports of side effects attributed to the vaccine. This report highlights a patient who developed stroke 2 days following the administration of the COVID-19 vaccine, although its association remains uncertain. A man in his late 30s developed acute neurological symptoms 2 days after receiving the booster dose of the BNT162b2 (Pfizer-BioNTech) mRNA COVID-19 vaccine. History and neurological examination suggested a posterior circulation stroke, which was confirmed by MRI, as a right-sided posterior inferior cerebellar artery stroke. Full workup did not suggest other causes of the stroke. Due to the patient's age and well-controlled risk factors, it was presumed to be a rare adverse effect of the vaccine. Medical management with aspirin, statin therapy and rehabilitation led to the improvement of symptoms and enabled ongoing restoration of function. Further cases of stroke following administration of COVID-19 vaccine have been documented in the literature, but the association is yet to be established.
Subject(s)
Brain Stem Infarctions , COVID-19 , Drug-Related Side Effects and Adverse Reactions , Stroke , Male , Humans , COVID-19 Vaccines/adverse effects , BNT162 Vaccine , COVID-19/prevention & control , Stroke/etiologyABSTRACT
BACKGROUND: mRNA vaccination is an effective, safe, and widespread strategy for protecting pregnant women against infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. However, information on factors such as perinatal outcomes, safety, and coverage of mRNA vaccinations among pregnant women is limited in Japan. Therefore, this study aimed to investigate the perinatal outcomes, coverage, adverse effects, and short-term safety of mRNA vaccination as well as vaccine hesitancy among pregnant women. METHODS: We conducted a multicenter online survey of postpartum women who delivered their offspring at 15 institutions around Tokyo from October 2021 to March 2022. Postpartum women were divided into vaccinated and unvaccinated groups. Perinatal outcomes, COVID-19 prevalence, and disease severity were compared between the two groups. Adverse reactions in the vaccinated group and the reasons for being unvaccinated were also investigated retrospectively. RESULTS: A total of 1,051 eligible postpartum women were included. Of these, 834 (79.4%) had received an mRNA vaccine, while 217 (20.6%) had not, mainly due to concerns about the effect of vaccination on the fetus. Vaccination did not increase the incidence of adverse perinatal outcomes, including fetal morphological abnormalities. The vaccinated group demonstrated low COVID-19 morbidity and severity. In the vaccinated group, the preterm birth rate, cesarean section rate, and COVID-19 incidence were 7.2%, 33.2%, and 3.3%, respectively, compared with the 13.7%, 42.2%, and 7.8% in the unvaccinated group, respectively. Almost no serious adverse reactions were associated with vaccination. CONCLUSIONS: mRNA vaccines did not demonstrate any adverse effects pertaining to short-term perinatal outcomes and might have prevented SARS-CoV-2 infection or reduced COVID-19 severity. Concerns regarding the safety of the vaccine in relation to the fetus and the mother were the main reasons that prevented pregnant women from being vaccinated. To resolve concerns, it is necessary to conduct further research to confirm not only the short-term safety but also the long-term safety of mRNA vaccines.
Subject(s)
COVID-19 , Drug-Related Side Effects and Adverse Reactions , Premature Birth , Infant, Newborn , Pregnancy , Female , Humans , Japan/epidemiology , Pregnant Women , Cesarean Section , Retrospective Studies , COVID-19/epidemiology , COVID-19/prevention & control , SARS-CoV-2 , Premature Birth/epidemiology , Vaccination/adverse effects , Surveys and QuestionnairesABSTRACT
There are case reports of mouth ulcers caused by the coronavirus disease 2019 (COVID-19) messenger ribonucleic acid (mRNA) vaccine; however, the actual number and characteristics of cases are unknown. Therefore, we examined this issue using the Japanese Adverse Drug Event Report (JADER), a large Japanese database. We calculated the reported odds ratio (ROR) of drugs that may be specifically associated with mouth ulcers and assumed that a signal was present if the lower limit of the calculated ROR's 95% confidence interval (CI) was > 1. In addition, the time to symptom onset after administration of the COVID-19 mRNA and influenza HA vaccines was investigated. We found that the JADER database contained 4,661 mouth ulcer cases between April 2004 and March 2022. The COVID-19 mRNA vaccine was the eighth most common causative drug for mouth ulcers, with 204 reported cases. The ROR was 1.6 (95% CI, 1.4-1.9) and a signal was detected. There were 172 mouthulcer cases associated with the Pfizer-BioNTech's COVID-19 mRNA vaccine, 76.2% of which were female. The outcome was no unrecovered cases with the influenza HA vaccine, whereas the COVID-19 mRNA vaccine showed unrecovered cases (Pfizer-BioNTech: 12.2%, Moderna: 11.1%). The median time-to-onset of the mouth ulcers was two days for the COVID-19 mRNA vaccine and one day for the influenza HA vaccine, indicating that mouth ulcers caused by the COVID-19 mRNA vaccine were delayed adverse events. In this study, the COVID-19 mRNA vaccine was shown to cause mouth ulcers in a Japanese population.
Subject(s)
COVID-19 , Drug-Related Side Effects and Adverse Reactions , Influenza Vaccines , Influenza, Human , Oral Ulcer , Female , Humans , Male , Pharmaceutical Preparations , COVID-19 Vaccines/adverse effects , Oral Ulcer/chemically induced , Oral Ulcer/epidemiology , East Asian People , COVID-19/prevention & control , RNA, Messenger/genetics , mRNA Vaccines , Adverse Drug Reaction Reporting SystemsABSTRACT
Acetaminophen and hydroxychloroquine are widely used drugs during COVID situations. Residual concentrations of acetaminophen and hydroxychloroquine have been detected in pharmaceutical industry wastewater, effluent treatment plants, and surface water. The present study was carried out on the bioremediation of acetaminophen (paracetamol) and hydroxychloroquine by using the bacterial isolate Kosakonia cowanii JCM 10956(T) (GenBank: OQ733302.1). Identification of the isolate was done using the 16S rRNA sequencing technique. The LC50 values for bacteria were determined for acetaminophen and hydroxychloroquine as 2186.70 and 1735.13 ppm, respectively. Isolate was found to degrade acetaminophen (1500 ppm) into hydroquinone after five days of incubation with an 81% biodegradation rate. Hydroxychloroquine (1000 ppm) was found to be degraded into oxalic acid with 7-chloroquinoline-4-amine and 4-aminoquinoline-7-ol as intermediates. After 15 days of incubation, 60% of hydroxychloroquine was found to be degraded. Acetaminophen and hydroxychloroquine biodegradation followed a first-order kinetic model with a rate constant of 0.339 d− 1 and 0.0618 d− 1, respectively. Half-lives for acetaminophen and hydroxychloroquine were found to be 2.05 and 11.2 days, respectively. Based on the analytical techniques of UV-visible spectra, HPLC, mass spectra, and proton nuclear magnetic spectroscopy (1H NMR) studies, biodegradative metabolites were identified. Ecotoxicological testing of the parent drug and degradative product was done using algal inhibition and shrimp lethality assays. The biodegradative product of acetaminophen, hydroquinone, has more algal toxicity and less toxicity against shrimp as compared to the parent drug. Whereas for the hydroxychloroquine biodegradative product, oxalic acid has less algal toxicity and more toxicity against shrimp compared to the parent drug. Industrial applications of hydroquinone and the metal leaching role of oxalic acid will give new insight into the bioconversion of expired paracetamol and hydroxychloroquine into value-added products.
Subject(s)
Drug-Related Side Effects and Adverse ReactionsABSTRACT
MOTIVATION: Predicting molecule-disease indications and side effects is important for drug development and pharmacovigilance. Comprehensively mining molecule-molecule, molecule-disease and disease-disease semantic dependencies can potentially improve prediction performance. METHODS: We introduce a Multi-Modal REpresentation Mapping Approach to Predicting molecular-disease relations (M2REMAP) by incorporating clinical semantics learned from electronic health records (EHR) of 12.6 million patients. Specifically, M2REMAP first learns a multimodal molecule representation that synthesizes chemical property and clinical semantic information by mapping molecule chemicals via a deep neural network onto the clinical semantic embedding space shared by drugs, diseases and other common clinical concepts. To infer molecule-disease relations, M2REMAP combines multimodal molecule representation and disease semantic embedding to jointly infer indications and side effects. RESULTS: We extensively evaluate M2REMAP on molecule indications, side effects and interactions. Results show that incorporating EHR embeddings improves performance significantly, for example, attaining an improvement over the baseline models by 23.6% in PRC-AUC on indications and 23.9% on side effects. Further, M2REMAP overcomes the limitation of existing methods and effectively predicts drugs for novel diseases and emerging pathogens. AVAILABILITY AND IMPLEMENTATION: The code is available at https://github.com/celehs/M2REMAP, and prediction results are provided at https://shiny.parse-health.org/drugs-diseases-dev/. SUPPLEMENTARY INFORMATION: Supplementary data are available at Bioinformatics online.
Subject(s)
Drug-Related Side Effects and Adverse Reactions , Humans , Drug Development , Electronic Health Records , Neural Networks, Computer , PharmacovigilanceABSTRACT
SARS-CoV-2 can infect cells through endocytic uptake, a process which can be targeted by inhibition of lysosomal proteases. However, clinically this approach fared poorly with an oral regimen of hydroxychloroquine that was accompanied by significant toxicity due to off-target effects. We rationalized that an organelle-targeted approach will avoid toxicity while increasing the concentration of the drug at the target. Here we describe a lysosome-targeted, mefloquine-loaded poly(glycerol monostearate-co-{varepsilon}-caprolactone) nanoparticle (MFQ-NP) for pulmonary delivery via inhalation. Mefloquine is a more effective inhibitor of viral endocytosis than hydroxychloroquine in cellular models of COVID-19. MFQ-NPs are less toxic than molecular mefloquine, 100-150 nm in diameter, and possess a negative surface charge which facilitates uptake via endocytosis allowing inhibition of lysosomal proteases. MFQ-NPs inhibit coronavirus infection in mouse MHV-A59 and human OC43 coronavirus model systems and inhibit SARS-CoV-2-WA1 and its Omicron variant in a human lung epithelium model. This study demonstrates that organelle-targeted delivery is an effective means to inhibit viral infection.
Subject(s)
Coronavirus Infections , Drug-Related Side Effects and Adverse Reactions , COVID-19 , Virus DiseasesABSTRACT
The World Health Organization declared COVID-19 a global pandemic on March 11, 2020 (1). As strategies to mitigate the pandemic were implemented, concerns were raised that the containment efforts through quarantine and social distancing practices were negatively affecting the mental and physical health of children and adolescents (2). Suicide is a growing public health problem in the United States. In 2020, suicide was the second leading cause of death among persons aged 10-14 years and the third leading cause among those aged 15-24 years (3). The National Poison Data System (NPDS) database was used to examine trends in suspected suicide attempts by self-poisoning among persons aged 10-19 years before and during the COVID-19 pandemic. Compared with 2019 (prepandemic), during 2021, the overall rate of suspected suicide attempts by self-poisoning increased by 30.0% (95% CI = 28.6%-30.9%), rates among children aged 10-12 years, adolescents aged 13-15 years, and females increased 73.0% (67.4%-80.0%), 48.8% (46.7%-50.9%), and 36.8% (35.4%-38.2%), respectively, and these trends continued into the third quarter of 2022. Substances most frequently involved in overdoses were acetaminophen, ibuprofen, sertraline, fluoxetine, and diphenhydramine. Acetaminophen-involved overdoses increased 71% (67.4%-74.9%) in 2021 and 58.0% (54.5%-61.6%) in 2022. Diphenhydramine-involved overdoses increased 24.2% (19.9%-28.7%) in 2021 and 35.8% (31.2%-40.5%) in 2022. A comprehensive public health approach to suicide prevention, focused on children and adolescents and involving a partnership between families, school teachers, mental health professionals, and public health leadership is needed. The 9-8-8 Suicide and Crisis Lifeline provides crisis support for persons experiencing mental health-related distress and assists community members who are concerned about persons experiencing a mental health crisis.
Subject(s)
COVID-19 , Drug Overdose , Poisoning , Suicide, Attempted , Adolescent , Child , Female , Humans , COVID-19/epidemiology , Drug-Related Side Effects and Adverse Reactions , Pandemics , Suicide Prevention , United States/epidemiology , Drug Overdose/epidemiology , Poisoning/epidemiologyABSTRACT
Background: Globally, there is an increased risk of COVID-19 infection among front-line health workers (FHW). This study aimed to evaluate the knowledge, attitude, and practices of FHW of Pakistan after receiving the COVID-19 vaccine. Methods: A population web-based survey on COVID-19 vaccine was conducted on 635 FHW in Pakistan between April 15, 2021, and July 15, 2021. The survey focused on four main sections consisting of socio-demographic data, knowledge, attitude, and practices after receiving the COVID-19 vaccine. The data was analyzed on SPSS. p < 0.05 was considered significant. Results: Overall, 60% of FHW were nervous before getting vaccinated, with the leading reason to get vaccinated being their concern to protect themselves and their community (53.4%). A majority of FHW had fear about the unseen side effects of the COVID-19 vaccine (59.7%) used in Pakistan, with the most common side effect reported as soreness at the injection site (39%). It has been noted that almost all of the FHW observed preventive practices after getting vaccinated. The results showed that married respondents had favorable practices towards COVID-19 vaccines (B = 0.53, p < 0.01) (B, unstandardized regression coefficient). It was also found that more informational sources (B = 0.19, p < 0.01), higher knowledge of vaccination (B = 0.15, p < 0.001), and favorable attitude toward vaccine (B = 0.12, p < 0.001) significantly predicted favorable practices toward COVID-19 vaccination. Conclusion: The findings reflect that FHW, though they were worried about its side effects, have good knowledge and a positive attitude after getting the COVID-19 vaccine. This study is significant as the FHWs are a symbol for guidance, a reliable source of information, and an encouraging means of receiving COVID-19 vaccine for the general public. This study also reported that post-vaccination side effects were mild which will aid in reducing the vaccine hesitancy among the general Pakistani population.
Subject(s)
COVID-19 Vaccines , COVID-19 , Humans , COVID-19/epidemiology , COVID-19 Vaccines/administration & dosage , Cross-Sectional Studies , Drug-Related Side Effects and Adverse Reactions , Health Knowledge, Attitudes, Practice , Pakistan/epidemiology , Vaccination/psychologyABSTRACT
BACKGROUND: After introducing Covid-19 vaccines, a few side effects were reported, pityriasis rosea being one of them. Therefore, this study will systematically review its manifestation afteradministration. METHODS: Databases were searched, covering a timeline from December 1, 2019 to February 28, 2022. Data were independently extracted and accessed for bias. SPSS statistical software version 25 was used for appropriate inferential statistics. RESULTS: Thirty-one studies were included for data extraction after screening following the eligibility criteria. A total of 111 people were identified to have developed pityriasis rosea or pityriasis rosea-like eruptions after vaccination, out of which 36 (55.38%) were female. The average age of incidence was calculated to be 44.92 years, and 63 (62.37%) people presented after administration of the first dose. It was found popularly in the trunk area, either asymptomatically or with mild symptoms. Meantime the onset, was 8.58 days, and meantime it took to recover, was 6.44 weeks. CONCLUSION: The association between pityriasis rosea and pityriasis rosea-like eruptions after Covid-19 vaccines was established, but given the scarcity of studies, there is a need to conduct different clinical trials to confirm this association further and study the etiology and mechanism of the disease.
Subject(s)
COVID-19 , Drug-Related Side Effects and Adverse Reactions , Pityriasis Rosea , Humans , Female , Adult , Middle Aged , Male , Pityriasis Rosea/epidemiology , Pityriasis Rosea/etiology , Pityriasis Rosea/diagnosis , COVID-19 Vaccines/adverse effects , COVID-19/epidemiology , VaccinationABSTRACT
OBJECTIVE: To compare the reactogenicity between the types of mRNA Commirnaty® (Pfizer) and Spikevax® (Moderna) vaccines against COVID-19 in a healthcare population. METHODS: Cross sectional study of short-term adverse effects and their consequences (sick leave, limitations of daily life, etc.) after the administration of the first and second doses of both vaccines in professionals and students of a health institution. A questionnaire on symptoms and their consequences was administered seven days after each vaccination dose. The prevalence and 95% confidence interval (95%CI) were calculated. Differences between vaccines were quantified using the odds ratio (OR) and its 95%CI. RESULTS: The questionnaire was completed by 1924 and 1170 healthcare providers (response rates 62.2% and 39.1%) after the first and second doses, respectively, of the Commirnaty® vaccine, and 410 (56.0%) and 107 (15.0%) of Spikevax®. After the first dose of Comirnaty®, 67.4% presented some adverse effect, and 76.1% for Spikevax® (OR 1.5 95%CI 1.2-1.9). In general, women and young people showed greater reactogenicity and differences between vaccinSpain. Consequences of adverse effects were more frequent for Spikevax®. The reactogenicity was higher after the second than the first dose, for both vaccines (Comirnaty®: 67.4% vs. 75.6%; Spikevax®: 76.1% vs. 87.9%. CONCLUSIONS: The greater reactogenicity and its consequences, for the first and second dose of the Spikevax® vaccine compared to Comirnaty®, and of the second dose compared to the first dose of both vaccines, provides useful knowledge for planning vaccination against COVID-19 campaigns in healthcare settings.
OBJETIVO: Comparar la reactogenicidad entre los tipos de vacuna RNAm Commirnaty® (Pfizer) y Spikevax® (Moderna) frente a la COVID-19 en población sanitaria. Métodos: Estudio de prevalencia de los efectos adversos a corto plazo y sus consecuencias tras la administración de la primera y segunda dosis en profesionales y estudiantes de una institución sanitaria. Se administró un cuestionario de síntomas y sus consecuencias a los 7 días de la vacunación. Se calculó la prevalencia e intervalo de confianza del 95% (IC95%). Las diferencias entre vacunas se cuantificaron mediante las odds ratio (OR) e IC95%. RESULTADOS: Completaron el cuestionario 1924 y 1170 sanitarios (tasas de respuesta 62.2% y 39.1%) tras la primera y la segunda dosis, respectivamente, de la vacuna Commirnaty®, y 410 (56.0%) y 107 (15.0%), de Spikevax®. Después de la primera dosis de Comirnaty® un 67,4% presentó algún efecto adverso, y un 76,1% para Spikevax® (OR 1,5 IC95% 1,2-1,9). En general mujeres y jóvenes mostraron mayor reactogenicidad y diferencias entre vacunas. Las consecuencias de los efectos adversos fueron más frecuentes para Spikevax®. La reactogenicidad fue superior tras la segunda dosis que tras la primera, para las dos vacunas (Comirnaty® 67,4% vs. 75,6%; Spikevax® 76,1% vs. 87,9%). CONCLUSIONES: La mayor reactogenicidad y sus consecuencias, para la primera y segunda dosis de la vacuna Spikevax® respecto a Comirnaty®, y de la segunda dosis respecto a la primera dosis de ambas vacunas, aporta conocimiento útil para la planificación de campañas de vacunación frente a la COVID-19 en el entorno sanitario.
Subject(s)
COVID-19 Vaccines , COVID-19 , Drug-Related Side Effects and Adverse Reactions , Adolescent , Female , Humans , 2019-nCoV Vaccine mRNA-1273 , BNT162 Vaccine , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Cross-Sectional Studies , mRNA Vaccines , VaccinationABSTRACT
BACKGROUND: The COVID-19 pandemic has caused significant changes to the global health care system AIMS: It is unknown whether the COVID-19 pandemic influenced the occurrence of adverse drug reactions (ADR) of antidepressive agents, benzodiazepines, and antipsychotics plus mood stabilizers (AaMS). The study was designed in order to compare the incidence of ADR during the COVID-19 pandemic with the period preceding the pandemic in Poland and Australia, different in terms of their COVID-19 prevention strategy. METHOD: We analysed ADR from the three surveyed pharmacological groups of drugs observed in Poland and Australia in the period prior to, and during the COVID-19 pandemic RESULTS: In Poland, a noticeable increase in the reported ADR of the assessed drug groups was observed during the COVID-19 pandemic. The highest was for antidepressive agents, but the reporting of ADR for benzodiazepines and AaMS drugs also increased significantly. In the case of ADR in Australian patients, the increase in the number of reported ADR for antidepressive agents was modest compared to that seen in Poland, but still noticeable, and there was a significant increase in ADR for benzodiazepines CONCLUSIONS: This study showed that the COVID-19 pandemic has had an impact on the incidence of ADR reported among both Polish and Australian patients but the modality of this was different.
Subject(s)
COVID-19 , Drug-Related Side Effects and Adverse Reactions , Humans , Poland , Pandemics , Adverse Drug Reaction Reporting Systems , Australia , Psychotropic DrugsABSTRACT
BACKGROUND: The incidence of vaccine hesitancy is increasing in many countries. This study aims to determine parents` attitudes and related factors regarding COVID-19 vaccine acceptance for themselves and their children aged 12-18. METHODS: A cross-sectional survey was conducted on parents between 16th November and 31st December 2021, after COVID-19 vaccines were initiated for children in Türkiye. In the survey, the sociodemographic characteristics of the parents, whether they and their children were vaccinated against COVID-19, and if not, the reasons for this were asked. Multivariate binary logistic regression analysis was used to evaluate the factors affecting parents` refusal to vaccinate their children for COVID-19. RESULTS: Three hundred and ninety-six mothers and fathers were included in the final analysis. Overall, 41.7% of parents reported vaccine refusal for their children. COVID-19 vaccine refusal was higher in mothers younger than 35 (ß = 6.5, p = 0.002, 95% CI: 2.0-23.1), children aged 15 and younger (ß = 2.3, p = 0.001, 95% CI: 1.4-3.7). Concerns about the side effects of the COVID-19 vaccine (29.7%) and their children not wanting to be vaccinated (29.0%) were the most common causes of COVID-19 vaccine refusal. CONCLUSIONS: In the present study, the rate of children not vaccinated due to COVID-19 vaccine refusal was relatively high. Parents` concerns about vaccine side effects, as well as their children`s unwillingness to be vaccinated, suggest that both parents and adolescents should be informed about the importance of COVID-19 vaccines.