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1.
Egyptian Journal of Hospital Medicine ; 87:1442-1448, 2022.
Article in English | Academic Search Complete | ID: covidwho-1824213

ABSTRACT

Background: Pfizer vaccine has been approved for use in Saudi Arabia. Although the vaccine efficacy has been frequently addressed, little knowledge is available regarding the real-world post-vaccination menstrual disturbances. Objective: The aim was to evaluate the possible association between Pfizer vaccine and the post-vaccination menstrual irregularities among Saudi citizen and resident women. Subjects and methods: A self-administered validated questionnaire was used to obtain the data. It was distributed all over Riyadh City, KSA through social media and 731 females responded to the survey. Results: Overall, 50.9% of the participants reported a menstrual change after vaccination, in particular, those who received the 2 doses. There was a significant and positive correlation between the number of doses and the experience of menstrual changes being associated with the 2 dosed women. In details, 60.5% mentioned a menstrual delay, 30.4% reported early onset, and 9.1% mentioned a menstrual change other than in the date. 43.3% reported a decrease in the amount of menstrual flow, 34.9 % mentioned an increase. 62.4% declared an increase in the severity of pain while 11% reported a decrease. Interestingly, only 60.8% of the respondents mentioned the persistence of the menstrual changes each following cycle. However, the changes were positively correlated with the age and negatively associated with the marital status being less in married. Conclusion: It was concluded that the post-vaccination menstrual changes might be related to the age, marital status, and those receiving 2 doses and these changes could be related to the immune response frequently associated with vaccines. [ FROM AUTHOR] Copyright of Egyptian Journal of Hospital Medicine is the property of Egyptian Journal of Hospital Medicine and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

2.
Ceylon Med. J. ; 66(4):177-184, 2021.
Article in English | Web of Science | ID: covidwho-1792290

ABSTRACT

Introduction: The acceptability of a vaccine is an important factor during mass vaccination programs and this is largely dependent on the symptoms of local and systemic reactogenicity. There is paucity of data on the systemic and local reactions experienced by COVID-19 vaccine recipients in South Asia. Objectives: To identify the early local and systemic reactogenicity of ChAdOx1 nCoV-19 vaccine. Method: A multicenter observational study was performed to identify the reactogenicity to ChAdOx1 nCoV-19 vaccine in healthcare workers following the first dose. Results: There were 4478 participants with a median age of 42 years (IQR 34-51) and 2863 (63.9%) were females. At least one symptom of reactogenicity was reported by 4151 (92.7%). Local reactions were reported by 2612 (58.3%). Systemic reactions were bodyache (3244,72.4%), fatigue (2379, 53.1%), headache (2277, 50.8%), fever (2290, 51.1%), feverishness (1912, 42.7%) and chills (2295, 51.3%). Lower age (p<0.0001) and female gender (p 0.002) were associated with a higher frequency of developing systemic reactions. There was no association between reactogenicity and comorbidities. There were 342 (7.6%) reports of palpitations and one case of ventricular bigeminy. There was one report of anaphylaxis and hospital admissions were reported by 24 (0.5%). One vaccine recipient was managed for possible aseptic meningitis. Conclusion: This study demonstrates that early systemic and local reactions are common. Systemic reactions were more frequent in females and in the younger population. Most symptoms were self-limiting and did not require medical attention or hospital admission. ChAdOx1 nCoV19 vaccine appears safe in the studied population.

3.
BMC Infect Dis ; 22(1): 291, 2022 Mar 26.
Article in English | MEDLINE | ID: covidwho-1765436

ABSTRACT

BACKGROUND: The aim of our study was to assess the impact the impact of gender and age on reactogenicity to three COVID-19 vaccine products: Biontech/Pfizer (BNT162b2), Moderna (mRNA-1273) and AstraZeneca (ChAdOx). Additional analyses focused on the reduction in working capacity after vaccination and the influence of the time of day when vaccines were administered. METHODS: We conducted a survey on COVID-19 vaccinations and eventual reactions among 73,000 employees of 89 hospitals of the Helios Group. On May 19th, 2021 all employees received an email, inviting all employees who received at least 1 dose of a COVID-19 to participate using an attached link. Additionally, the invitation was posted in the group's intranet page. Participation was voluntary and non-traceable. The survey was closed on June 21st, 2021. RESULTS: 8375 participants reported on 16,727 vaccinations. Reactogenicity was reported after 74.6% of COVID-19 vaccinations. After 23.0% vaccinations the capacity to work was affected. ChAdOx induced impairing reactogenicity mainly after the prime vaccination (70.5%), while mRNA-1273 led to more pronounced reactions after the second dose (71.6%). Heterologous prime-booster vaccinations with ChAdOx followed by either mRNA-1273 or BNT162b2 were associated with the highest risk for impairment (81.4%). Multivariable analyses identified the factors older age, male gender and vaccine BNT162b as independently associated with lower odds ratio for both, impairing reactogenicity and incapacity to work. In the comparison of vaccine schedules, the heterologous combination ChAdOx + BNT162b or mRNA-1273 was associated with the highest and the homologue prime-booster vaccination with BNT162b with the lowest odds ratios. The time of vaccination had no significant influence. CONCLUSIONS: Around 75% of the COVID-19 vaccinations led to reactogenicity and nearly 25% of them led to one or more days of work loss. Major risk factors were female gender, younger age and the administration of a vaccine other than BNT162b2. When vaccinating a large part of a workforce against COVID-19, especially in professions with a higher proportion of young and women such as health care, employers and employees must be prepared for a noticeable amount of absenteeism. Assuming vaccine effectiveness to be equivalent across the vaccine combinations, to minimize reactogenicity, employees at risk should receive a homologous prime-booster immunisation with BNT162b2. TRIAL REGISTRATION: The study was approved by the Ethic Committee of the Aerztekammer Berlin on May 27th, 2021 (Eth-37/21) and registered in the German Clinical Trials Register (DRKS 00025745). The study was supported by the Helios research grant HCRI-ID 2021-0272.


Subject(s)
COVID-19 Vaccines , COVID-19 , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Diphtheria-Tetanus-Pertussis Vaccine , Female , Health Personnel , Humans , Male , Vaccination
4.
Clin Microbiol Infect ; 2022 Feb 16.
Article in English | MEDLINE | ID: covidwho-1763660

ABSTRACT

OBJECTIVES: In March 2021, French authorities recommended a heterologous second dose of the mRNA vaccine for persons aged <55 years, with administration 9 to 12 weeks after the first dose of ChAdOx1 nCoV-19. This recommendation was despite a lack of data on the reactogenicity and safety of the regimen. Since then, several studies have shown an acceptable short-term safety profile of ChAdOx1 nCoV-19 and BNT162b2 heterologous vaccination, although some transient increased reactogenicity has been described. METHODS: We performed a single-centre prospective observational cohort study among health care workers (HCWs) at a tertiary care hospital to assess the reactogenicity of the BNT162b2 and mRNA-1273 vaccines administered as a second dose in participants primed with ChAdOx1 nCoV-19. RESULTS: Among 1184 HCWs, 356 (30%) agreed to participate. Of the participants, 32.3% were male, and the mean age was 35 years (standard deviation: 10.1 years). Of the participants, 229 received BNT162b2 and 127 received mRNA-1273. A systemic reaction was observed in 130 of 229 (56.8%) and 100 of 127 (78.7%) HCWs, respectively. Injection site reactions were generally limited (grade 1 or 2 in 163 of 229 (97.6%) and 90 of 127 (85.7 %) HCWs, respectively). After adjustment for age, sex, and HCW role, receiving the mRNA-1273 vaccine was associated with higher reactogenicity with more grade 3 side effects (adjusted OR (aOR): 3.34; 95% CI, 1.91-5.85), more systemic symptoms (aOR: 2.82; 95% CI, 1.69-4.7), and not being able to work (aOR: 8.35; 95% CI, 3.78-18.44) compared with receiving the BNT162b2 vaccine. DISCUSSION: Among patients receiving the mRNA1273 vaccine as a second dose, our study confirms good tolerance of the heterologous schedule with a higher risk of short-term side effects in comparison with patients receiving the BNT162b2 vaccine.

5.
Vaccine ; 40(13): 1924-1927, 2022 03 18.
Article in English | MEDLINE | ID: covidwho-1757911

ABSTRACT

High vaccine reactogenicities may reflect stronger immune responses, but the epidemiological evidence for coronavirus disease 2019 (COVID-19) vaccines is sparse and inconsistent. We observed that a fever of ≥38℃ after two doses of the BNT162b2 vaccine was associated with higher severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike IgG titers.


Subject(s)
COVID-19 Vaccines , COVID-19 , Antibodies, Viral , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Humans , SARS-CoV-2
6.
Vaccine ; 40(13): 2062-2067, 2022 03 18.
Article in English | MEDLINE | ID: covidwho-1757901

ABSTRACT

BACKGROUND: The reactogenicity of BNT162b2 COVID-19 vaccine has been commonly reported and antipyretic medications are often used for mitigating adverse reactions. Possible associations between the reactogenicity events and specific antibody responses have not been fully investigated, nor has the influence of using antipyretics. METHODS: Serum samples were collected from hospital healthcare workers with no COVID-19 history and the SARS-CoV-2 spike-specific IgG titer after two doses was measured. Degree of solicited adverse reactions in a day, including the highest body temperature, were reported using a self-reporting diary for five days after each dose. The highest body temperature during the five days was divided into three grades (<37.0 °C, 37.0-37.9 °C, or ≥ 38.0 °C). Self-medicated antipyretics were reported using a questionnaire. RESULTS: The data of 335 participants were available for analysis. Multivariate analysis extracted the fever grade after the second dose (standardized coefficient beta = 0.301, p < 0.0001), female sex (beta = 0.196, p = 0.0014), and age (beta = -0.119, p = 0.0495) as being significantly correlated with the IgG titers. The positive correlation of the fever grade after the second dose with the IgG titers was also observed when analyzed by sex and age. The use of antipyretics did not interfere with the IgG titers irrespective of the fever grade. CONCLUSIONS: The fever intensity after the second dose was associated with the IgG titer and antipyretic medications may be beneficial to mitigate the suffering from adverse reactions, without interfering with the acquisition of sufficient antibody responses.


Subject(s)
Antipyretics , COVID-19 , Antibodies, Viral , Antibody Formation , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Female , Humans , SARS-CoV-2 , Vaccines, Synthetic
7.
J Clin Med ; 11(6)2022 Mar 21.
Article in English | MEDLINE | ID: covidwho-1753641

ABSTRACT

BACKGROUND: COVID-19 caused by the Severe Acute Respiratory Syndrome Coronavirus 2 placed the health systems around the entire world in a battle against the clock. While most of the existing studies aimed at forecasting the infections trends, our study focuses on vaccination trend(s). MATERIAL AND METHODS: Based on these considerations, we used standard analyses and ARIMA modeling to predict possible scenarios in Romania, the second-lowest country regarding vaccinations from the entire European Union. RESULTS: With approximately 16 million doses of vaccine against COVID-19 administered, 7,791,250 individuals had completed the vaccination scheme. From the total, 5,058,908 choose Pfizer-BioNTech, 399,327 Moderna, 419,037 AstraZeneca, and 1,913,978 Johnson & Johnson. With a cumulative 2147 local and 17,542 general adverse reactions, the most numerous were reported in recipients of Pfizer-BioNTech (1581 vs. 8451), followed by AstraZeneca (138 vs. 6033), Moderna (332 vs. 1936), and Johnson & Johnson (96 vs. 1122). On three distinct occasions have been reported >50,000 individuals who received the first or second dose of a vaccine and >30,000 of a booster dose in a single day. Due to high reactogenicity in case of AZD1222, and time of launching between the Pfizer-BioNTech and Moderna vaccine could be explained differences in terms doses administered. Furthermore, ARIMA(1,1,0), ARIMA(1,1,1), ARIMA(0,2,0), ARIMA(2,1,0), ARIMA(1,2,2), ARI-MA(2,2,2), ARIMA(0,2,2), ARIMA(2,2,2), ARIMA(1,1,2), ARIMA(2,2,2), ARIMA(2,1,1), ARIMA(2,2,1), and ARIMA (2,0,2) for all twelve months and in total fitted the best models. These were regarded according to the lowest MAPE, p-value (p < 0.05, p < 0.01, and p < 0.001) and through the Ljung-Box test (p < 0.05, p < 0.01, and p < 0.001) for autocorrelations. CONCLUSIONS: Statistical modeling and mathematical analyses are suitable not only for forecasting the infection trends but the course of a vaccination rate as well.

8.
SSRN; 2022.
Preprint in English | SSRN | ID: ppcovidwho-330008

ABSTRACT

We initiated a randomized, placebo-controlled, phase 1/2 trial to evaluate the safety and immunogenicity of the S-268019-b recombinant protein vaccine, scheduled as 2 intramuscular injections given 21 days apart, in 60 randomized healthy Japanese adults. We evaluated 2 regimens of the S 910823 antigen (5 μg [n=24] and 10 μg [n=24]) with an oil-in-water emulsion formulation and compared against placebo (n=12). Reactogenicity was mild in most participants. No serious adverse events were noted. For both regimens, vaccination resulted in robust IgG and neutralizing antibody production at days 36 and 50 and predominant T-helper 1-mediated immune reaction, as evident through antigen-specific polyfunctional CD4+ T-cell responses with IFN-γ, IL-2, and IL-4 production on spike protein stimulation. Based on the interim analysis, the S-268019-b vaccine is safe, produces neutralizing antibodies titer comparable with that in convalescent serum from COVID-19-recovered patients. However, further evaluation of the vaccine in a large clinical trial is warranted.

9.
Breastfeed Med ; 2022 Mar 09.
Article in English | MEDLINE | ID: covidwho-1735499

ABSTRACT

Background and Objectives: Breastfeeding women are generally excluded from clinical trials with new vaccines. The objective of the study was to explore whether the BNT162b2 mRNA and mRNA-1273 COVID-19 vaccines are safe for breastfeeding mothers and their breastfed infants. Methods: A convenience sample prospective cohort single institution study was performed on breastfeeding health care professionals, who were exposed to second dose of SARS-CoV2 vaccine at the beginning of the study period. They and their breastfed children's symptoms were followed up through online questionnaires for 14 days. Results: Of the 95 finally included participants, only 1 was lost to follow-up on day 7. Mean age of the mothers was 35.9 ± 3.9 years and that of their infants was 14.6 ± 12.1 months. At least one adverse event was reported by 85% (95% confidence interval [CI]: 76-91.5%) of the mothers. The most frequent was injection site pain in 81% of cases. Moreover, 31% (95% CI: 22-41%) observed some event in their breastfed children. Most frequently, 19% (95% CI: 13-30%) of the children were irritable. During the 14 days of follow-up, 36% of the children (95% CI: 27-46%) were diagnosed with respiratory infection. Conclusions: Most mothers' reactions were mild and transitory, generally limited to the first 3 days after vaccination. Many children's events were associated with concomitant infectious processes and we did not detect a notable peak on any particular day of follow-up. Neither mothers nor their infants developed serious adverse events nor were they diagnosed with COVID-19 within the study period.

10.
Emerg Microbes Infect ; 11(1): 885-893, 2022 Dec.
Article in English | MEDLINE | ID: covidwho-1730558

ABSTRACT

Accruing evidence suggests an increased risk of myocarditis in adolescents from messenger RNA COVID-19 vaccines. However, other potential adverse events remain under-researched. We conducted a retrospective cohort study of adolescents aged 12-18 with a territory-wide electronic healthcare database of the Hong Kong population linked with population-based vaccination records and supplemented with age- and sex-specific population numbers. Two age- and sex-matched retrospective cohorts were formed to observe 28 days following the first and second doses of BNT162b2 and estimate the age- and sex-adjusted incidence rate ratios between the vaccinated and unvaccinated. Thirty AESIs adapted from the World Health Organization's Global Advisory Committee on Vaccine Safety were examined. Eventually, the first-dose cohort comprised 274,881 adolescents (50.25% received the first dose) and the second-dose cohort 237,964 (50.29% received the second dose). Ninety-four (34.2 per 100,000 persons) adolescents in the first-dose cohort and 130 (54.6 per 100,000 persons) in the second-dose cohort experienced ≥1 AESIs. There were no statistically significant differences in the risk of any AESI associated with BNT162b2 except myocarditis [first-dose cohort: incidence rate ratio (IRR) = 9.15, 95% confidence interval (CI) 1.14-73.16; second-dose cohort: IRR = 29.61, 95% CI 4.04-217.07] and sleeping disturbances/disorders after the second dose (IRR = 2.06, 95% CI 1.01-4.24). Sensitivity analysis showed that, with myocarditis excluded as AESIs, no significantly elevated risk of AESIs as a composite outcome associated with vaccination was observed (P = 0.195). To conclude, the overall absolute risk of AESIs was low with no evidence of an increased risk of AESIs except myocarditis and sleeping disturbances/disorders.


Subject(s)
COVID-19 , Adolescent , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Child , Cohort Studies , Female , Humans , Male , Retrospective Studies
11.
Ecancermedicalscience ; 16:16, 2022.
Article in English | Web of Science | ID: covidwho-1725367

ABSTRACT

Coronavirus disease 2019 (COVID-19) vaccine development and administration have become global priorities since the beginning of the pandemic, particularly for special populations at higher risk of complications and mortality, such as patients with haematologic and solid organ malignancies. This review aims to summarise the current data for COVID19 vaccine efficacy in patients with cancer, suggest priority areas for future research and look at potential disparities at a global level. Although patients diagnosed with or receiving therapy for cancer were excluded from the initial vaccine trials, emerging evidence now supports vaccine safety with potentially diminished immune response in this group. Several studies that evaluated antibody response to COVID-19 vaccination found that patients with solid malignancies had lower serologic response rates compared to healthy controls, but better than patients with haematologic malignancies, who had the lowest seroconversion rates and antibody titres. As anticipated, poor serologic responses have been particularly observed among patients receiving B-cell depleting therapies. The data on cellular response are scarce and conflicting since not all studies have showed a difference between patients with malignancies and healthy subjects. Several questions concerning vaccination remain unanswered and require further exploration, such as response duration, need for response monitoring and rates of breakthrough infections.

12.
FASEB BioAdvances ; n/a(n/a), 2022.
Article in English | Wiley | ID: covidwho-1672269

ABSTRACT

Increased COVID-19 vaccine hesitancy presents a major hurdle in global efforts to contain the COVID-19 pandemic. This study was designed to estimate the prevalence of adverse events after the first dose of the Covishield (AstraZeneca) vaccine among physicians in Bangladesh. A cross-sectional study was conducted using an online questionnaire for physicians (n=916) in Bangladesh. Physicians who received at least one dose of the COVID-19 vaccine were included. The study was carried out from April 12 to May 31, 2021. More than 58% of respondents (n=533) reported one or more adverse events. Soreness of the injected arm (71.9%), tiredness (56.1%), fever (54.4%), soreness of muscles (48.4%), headache (41.5%), and sleeping more than usual (26.8%) were the most commonly reported adverse events. Most vaccine-related reactogenicities were reported by the younger cohorts (< 45 years). The majority of respondents reported severity of reactogenicity as ?mild,? experienced on the day of vaccination, and lasting for 1 to 3 days. The most common reactogenicity was pain at the injection site;the second most common was tiredness. Almost half (49.2%) of physicians took acetaminophen (paracetamol) to minimize the effects of vaccine reactogenicity. Multivariate logistic regression analyses showed that physicians with diabetes and hypertension (OR = 2.729 95% CI: 1.282-5.089) and asthma with other comorbidities (OR = 1.885 95% CI: 1.001-3.551) had a significantly higher risk of vaccine-related reactogenicities than physicians without comorbidities. Further safety studies with larger cohorts are required to monitor vaccine safety and provide assurance to potential vaccine recipients.

13.
Biomed Pharmacother ; 147: 112650, 2022 Mar.
Article in English | MEDLINE | ID: covidwho-1635955

ABSTRACT

BACKGROUND: The objective of the present work was to assess the reactogenicity and immunogenicity of heterologous COVID-19 vaccination regimens in clinical trials and observational studies. METHODS: PubMed, Cochrane Library, Embase, MedRxiv, BioRxiv databases were searched in September 29, 2021. The PRISMA instruction for systemic review was followed. Two reviewers independently selected the studies, extracted the data and assessed risk of bias. The quality of studies was evaluated using the New Castle-Ottawa and Cochrane risk of instrument. The characteristics and study outcome (e.g., adverse events, immune response, and variant of concern) were extracted. RESULTS: Nineteen studies were included in the final data synthesis with 5 clinical trials and 14 observational studies. Heterologous vaccine administration showed a trend toward more frequent systemic reactions. However, the total reactogenicity was tolerable and manageable. Importantly, the heterologous prime-boost vaccination regimens provided higher immunogenic effect either vector/ mRNA-based vaccine or vector/ inactivated vaccine in both humoral and cellular immune response. Notably, the heterologous regimens induced the potential protection against the variant of concern, even to the Delta variant. CONCLUSIONS: The current findings provided evidence about the higher induction of robust immunogenicity and tolerated reactogenicity of heterologous vaccination regimens (vector-based/mRNA vaccine or vector-based/inactivated vaccine). Also, this study supports the application of heterologous regimens against COVID-19 which may provide more opportunities to speed up the global vaccination campaign and maximize the capacity to control the pandemic.


Subject(s)
COVID-19 Vaccines/therapeutic use , COVID-19/prevention & control , Immunogenicity, Vaccine , /therapeutic use , Arthralgia/chemically induced , /therapeutic use , Diarrhea/chemically induced , Fatigue/chemically induced , Fever/chemically induced , Headache/chemically induced , Humans , Immunization, Secondary , Injection Site Reaction/etiology , Myalgia/chemically induced , SARS-CoV-2 , Vaccination , Vaccines, Subunit/therapeutic use
14.
Vaccine ; 40(7): 970-976, 2022 02 11.
Article in English | MEDLINE | ID: covidwho-1621089

ABSTRACT

OBJECTIVES: To explore factors that are associated with reactogenicity in general and systemic after the first dose of COVID-19 vaccine in the Netherlands. DESIGN: A web-based prospective cohort design using patient reported outcomes (PROs). SETTING: Any person who has been vaccinated with any brand of COVID-19 vaccine in the Dutch COVID immunization programme. PARTICIPANTS: 22,184 participants. Of these, 13,959 (62.9%) experienced reactogenicity in general and 11,979 (54.0%) systemic reactogenicity within 7 days after vaccination. MAIN OUTCOME MEASURES: Factors that are associated with the occurrence of reactogenicity after COVID-19 vaccination. RESULTS: Compared to the Comirnaty® vaccine, the highest odds ratio (OR) for developing reactogenicity was for the Vaxzevria® vaccine (OR 5.18) followed by Spikevax® (OR 2.16), and Janssen (OR 1.65). Participants with a history of COVID-19 disease had a 3.10 increased odds for reactogenicity. Women had a 2.08 increased odds compared to men. Older participants experienced less reactogenicity. Compared to the age group < 50, the ORs for the age groups 50-60, 61-79, and ≥80 were 0.36, 0.15, and 0.10 respectively. The use of an antipyretic drug, or a drug for nervous system disorders gave an increased odds of 1.34 and 1.16 respectively. A body mass index of 25.0-29.9 and over 30 was negatively associated with reactogenicity (OR 0.87 and OR 0.72 respectively). Comorbidities that were associated with reactogenicity were cardiac disorders (OR 1.26), respiratory disorders (OR 1.31), psychiatric disorders (1.37), reproductive disorders (OR 1.54), and eye disorders (OR 1.55). The factors associated with systemic reactogenicity were mostly comparable, but there were differences for comorbidities, drug use, and the strength of the regression coefficient. CONCLUSIONS: This extensive study with over 22,000 vaccine recipients in the Netherlands demonstrated that, taken into account all factors in the model, the Comirnaty® vaccine gave the least and the Vaxzevria® vaccine the most reactogenicity in general and systemic after the first dose. Also a person with a history of COVID-19 disease, female sex and younger age had an increased odds for experiencing reactogenicity after vaccination.


Subject(s)
COVID-19 Vaccines , COVID-19 , Female , Humans , Male , Netherlands , Patient Reported Outcome Measures , Prospective Studies , SARS-CoV-2
15.
J Infect Chemother ; 28(4): 576-581, 2022 Apr.
Article in English | MEDLINE | ID: covidwho-1616600

ABSTRACT

INTRODUCTION: The BNT162b2 and mRNA-1273 COVID-19 vaccines are the main vaccines that have been used for mass vaccination in Japan. Information on adverse reactions to COVID-19 vaccines in the Japanese population is limited. METHODS: We conducted an online survey on self-reported adverse reactions in individuals who had received two doses of the BNT162b2 or mRNA-1273 vaccine. The incidence of adverse events after each dose of vaccine was investigated. Propensity score matching was used to compare the incidence of adverse reactions after the second dose of the BNT162b2 and mRNA-1273 vaccines. RESULTS: After the first and second doses of the BNT162b2 vaccine, and the first and second doses of the mRNA-1273 vaccine, 890, 853, 6401, and 3965 individuals, respectively, provided complete responses. Systemic reactions, including fever, fatigue, headache, muscle/joint pain, and nausea were significantly more common in females, individuals aged <50 years, and after the second dose. The incidence of injection site pain did not differ significantly according to the dose. The incidence of delayed injection site reactions after the first dose of mRNA-1273 vaccine was 3.9% and 0.8% among females and males, respectively, and 10.6% among females aged 40-69 years. Local and systemic reactions after the second dose, including fever, fatigue, headache, muscle/joint pain, nausea, and skin rash were more common in individuals who had received the mRNA-1273 vaccine. CONCLUSIONS: Adverse reactions were more frequently reported in females, younger individuals, and after the mRNA-1273 vaccine.


Subject(s)
COVID-19 , Adult , Aged , COVID-19 Vaccines/adverse effects , Female , Humans , Japan/epidemiology , Male , Middle Aged , RNA, Messenger/genetics , SARS-CoV-2
16.
European Review for Medical and Pharmacological Sciences ; 25(23):7516-7525, 2021.
Article in English | Web of Science | ID: covidwho-1576272

ABSTRACT

OBJECTIVE: Coronavirus-2019 (COVID-19) vaccination is the game-changing approach that tops all other strategies to contain the pandemic spread. A growing interest has been raised to heterologous prime-boost and booster COVID-19 vaccination to tackle vaccine shortage and to increase the vaccine's immunogenicity. This study aimed to evaluate the willingness and acceptance of Jordanians to receive heterologous prime-boost COVID-19 vaccination and vaccine boosters. MATERIALS AND METHODS: A web-based cross-sectional study was conducted using a validated online questionnaire. Adult Jordanian participants were recruited using several social media platforms. The questionnaire link was randomly posted by researchers on public groups in Jordan. Participant's demographics, medical history, knowledge of mixed and booster COVID-19 vaccination and their willingness to receive them were obtained and analyzed. RESULTS: Approximately 50.5% and 49.3% of the respondents stated former knowledge of the mixed and booster COVID-19 vaccination, respectively. Approximately 50% of respondents acknowledged that the side effects could preclude them from taking mixed and booster vaccines, and 45.3% responded that taking a third dose of the vaccine would increase the side effects. The respondents with previous history of COVID-19 and influenza vaccination were more likely to agree on mixed vaccines compared to those not vaccinated (29.5% vs. 6.5%, p <0.0001;38.0% vs. 24.5%, p=0.0078, respectively). Moreover, both previous history of COVID-19 and seasonal influenza vaccine was an encouraging response for acceptance of mixed and booster vaccines when compared to those who did not receive the vaccines (54.5% vs. 11.3%;p<0.0001, 69.0% vs. 45.5%;p <0.0001, respectively). CONCLUSIONS: The current study showed that nearly half of the respondents were familiar with COVID-19 mixed and booster vaccine programs;however, a high percentage still expressed reticence to receive the mixed vaccines. We consider these results to emphasize the importance and need of awareness campaigns that accentuate the safety profile of such updated vaccination programs.

17.
Front Immunol ; 12: 794642, 2021.
Article in English | MEDLINE | ID: covidwho-1581317

ABSTRACT

Background: The relationships of the coronavirus disease 2019 (COVID-19) vaccination with reactogenicity and the humoral immune response are important to study. The current study aimed to assess the reactogenicity and immunogenicity of the Pfizer and AstraZeneca COVID-19 vaccines among adults in Madinah, Saudi Arabia. Methods: A cross-sectional study, including 365 randomly selected adult Pfizer or AstraZeneca vaccine recipients who received a homologous prime-boost vaccination between February 1st and June 30th, 2021. Data of height and weight were collected to assess the weight status of percipients. An evaluation of seropositivity for anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies was assessed using enzyme-linked immunosorbent assay (ELISA). Results: Among the participants, 69% (n = 250) reported at least one vaccine-related symptom. Pain at the injection site was the most frequently reported vaccine-related symptom. The mean total score for vaccine-related symptoms was significantly higher among participants who received the AstraZeneca vaccine, women, and participants with no previous COVID-19 infection (p < 0.05). Spike-specific IgG antibodies were detected in 98.9% of participants after the receipt of two vaccine doses, including 99.5% of Pfizer vaccine recipients and 98.3% of AstraZeneca vaccine recipients. Significantly, higher proportions of participants in the <35-year age group developed a humoral immune response after the first vaccine dose compared with the participants in other age groups. Conclusion: Participants who received the Pfizer COVID-19 vaccine reported fewer vaccine-related complications compared with those who received the AstraZeneca COVID-19 vaccine, but no serious side effects were reported in response to either vaccine. Health status and age were factors that may influence COVID-19 vaccine effectiveness for the generation of antibodies against the SARS-CoV-2 spike protein.


Subject(s)
COVID-19 Vaccines/immunology , COVID-19 Vaccines/standards , COVID-19/prevention & control , Immunogenicity, Vaccine , SARS-CoV-2/immunology , Adult , Aged , Antibody Formation/immunology , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19/virology , Cross-Sectional Studies , Factor Analysis, Statistical , Female , Host-Pathogen Interactions/immunology , Humans , Immunization, Secondary , Immunoglobulin G , Male , Middle Aged , Online Systems , Public Health Surveillance , Surveys and Questionnaires
18.
Vaccine ; 39(51): 7367-7374, 2021 12 17.
Article in English | MEDLINE | ID: covidwho-1586285

ABSTRACT

We examined the impact of pre-existing SARS-CoV-2-specific cellular immunity on BNT162b2 mRNA COVID-19 vaccine reactogenicity. Of 96 healthcare workers (HCWs), 76% reported any vaccine reaction (first dose: 70%, second dose: 67%), none of which was severe. Following first dose, systemic reactions were significantly more frequent among HCWs with past infection than in infection-naïve individuals, and among HCWs with pre-existing cellular immunity than in those without it. The rate of systemic reactions after second dose was 1.7 and 2.0-times higher than after first dose among infection-naïve HCWs and those without pre-existing cellular immunity, respectively. Levels of SARS-CoV-2-specific T-cells before vaccination were higher in HCWs with systemic reactions after the first dose than in those without them. BNT162b2 vaccine reactogenicity after first dose is attributable to pre-existing cellular immunity elicited by prior COVID-19 or cross-reactivity. Reactogenicity following second dose suggests an immunity-boosting effect. Overall, these data may reduce negative attitudes towards COVID-19 vaccines. Study Registration. The study was registered on clinicaltrials.gov, NCT04402827.


Subject(s)
COVID-19 Vaccines , COVID-19 , Humans , RNA, Messenger/genetics , SARS-CoV-2
19.
Vaccine ; 39(48): 7066-7073, 2021 11 26.
Article in English | MEDLINE | ID: covidwho-1525975

ABSTRACT

BACKGROUND: Post-authorization monitoring of mRNA-based COVID-19 vaccines is needed to better characterize their reactogenicity. We assessed reactions reported during the 2 weeks after receipt of BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) vaccines. METHODS: We monitored persons who enrolled in v-safe after vaccination health checkerSM, a U.S. smartphone-based vaccine monitoring system, after receiving BNT162b2 or mRNA-1273. V-safe participants received text message prompts to complete web-based surveys. We analyzed responses from persons who received BNT162b2 or mRNA-1273 from December 14, 2020 through March 14, 2021 and completed at least one survey by March 28, 2021. We measured the proportion of participants reporting local and systemic reactions solicited in surveys completed days 0 through 7 post-vaccination. For day 14 surveys, participants described new or worsening symptoms in a free-text response. We assessed the proportion of participants reporting new or worsening local and systemic reactions. RESULTS: One-third of participants were aged <45 years, two-thirds were female, and approximately half received BNT162b2 vaccine. A total of 4,717,908 participants reported during the 7 days after dose 1 and 2,906,377 reported during the 7 days after dose 2. Most reported at least one injection-site reaction (68.5% after dose 1; 72.9% after dose 2) or at least one systemic reaction (50.6% after dose 1; 69.5% after dose 2). Reactogenicity was greater after dose 2 and among mRNA-1273 recipients, persons aged <45 years, and females. New or worsening local and systemic reactions were uncommon during week 2 after either dose; the most frequent were local reactions for dose 1 mRNA-1273 recipients (2.6%). These reactions were reported more often among females after dose 1 mRNA-1273 (3.6%). CONCLUSIONS: During post-authorization monitoring among >4 million vaccinees, local and systemic reactions were commonly reported following mRNA-based vaccines. Reactions were most common during the first week following dose 2 and among persons aged <45 years, females, and mRNA-1273 recipients.


Subject(s)
COVID-19 Vaccines , COVID-19 , Centers for Disease Control and Prevention, U.S. , Female , Humans , RNA, Messenger , SARS-CoV-2 , United States
20.
Aging Clin Exp Res ; 33(11): 3151-3160, 2021 Nov.
Article in English | MEDLINE | ID: covidwho-1525638

ABSTRACT

BACKGROUND: The BNT162b2 SARS-CoV-2 mRNA vaccination has mitigated the burden of COVID-19 among residents of long-term care facilities considerably, despite being excluded from the vaccine trials. Data on reactogenicity (vaccine side effects) in this population are limited. AIMS: To assess reactogenicity among nursing home (NH) residents. To provide a plausible proxy for predicting vaccine response among this population. METHODS: We enrolled and sampled NH residents and community-dwelling healthcare workers who received the BNT162b2 mRNA vaccine, to assess local or systemic reactogenicity and antibody levels (immunogenicity). RESULTS: NH residents reported reactions at a much lower frequency and lesser severity than the community-dwelling healthcare workers. These reactions were mild and transient with all subjects experiencing more local than systemic reactions. Based on our reactogenicity and immunogenicity data, we developed a linear regression model predicting log-transformed anti-spike, anti-receptor-binding domain (RBD), and neutralizing titers, with a dichotomous variable indicating the presence or absence of reported reactions which revealed a statistically significant effect, with estimated shifts in log-transformed titers ranging from 0.32 to 0.37 (all p < 0.01) indicating greater immunogenicity in subjects with one or more reported reactions of varying severity. DISCUSSION: With a significantly lower incidence of post-vaccination reactions among NH residents as reported in this study, the BNT162b2 mRNA vaccine appears to be well-tolerated among this vulnerable population. If validated in larger populations, absence of reactogenicity could help guide clinicians in prioritizing vaccine boosters. CONCLUSIONS: Reactogenicity is significantly mild among nursing home residents and overall, subjects who reported post-vaccination reactions developed higher antibody titers.


Subject(s)
COVID-19 , Vaccines , COVID-19 Vaccines , Health Personnel , Humans , Nursing Homes , RNA, Messenger/genetics , SARS-CoV-2
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