Immunological responses following the third dose of the BNT162b2 SARS-CoV-2 vaccine among Japanese healthcare workers

IntroductionA limited number of studies have shown a decline in antibody titers in healthcare workers beyond six months after the second dose of the BNT162b2 vaccine, and has been insufficiently investigated yet in the respective Asian ethnic groups.MethodsWe conducted a longitudinal observational study on 187 healthcare workers and other personnel and healthy adults at least eight months after vaccination at the International University of Health and Welfare.ResultsThe baseline (before the third dose of BNT162b2) anti-receptor binding domain (RBD) IgG level was 569[377–943] AU/mL 245[240–250] days after the second dose. The mean antibody titer of participants aged 20–29 years was 4.6 times higher than that of participants aged 70–79 years. After booster vaccination, serum anti-RBD antibody levels were elevated in all participants with a median titer of 23,250[14,612–33,401] AU/mL 21[19–23] days after the third dose. The median post-booster antibody titers in the 20–29, 30–39, 40–49, 50–59, 60–69, and 70–79 years age groups were 30.6, 33.0, 33.8, 27.4, 50.1, and 90.3 times, respectively, higher than the pre-booster ones. Antibody levels were 15% lower in daily drinkers compared to nondrinkers, suggesting that daily alcohol consumption can prevent antibody levels from increasing after vaccination. Our results show decreased antibody titers after two doses of the vaccine, especially in the elderly; however, the third dose of the vaccine resulted in a significant increase in antibody titers in all age groups.ConclusionsWe provided information on antibody responses following primary and booster doses of the BNT162b2 mRNA COVID-19 vaccine in Japan.     

Antibody responses and SARS-CoV-2 infection after BNT162b2 mRNA booster vaccination among healthcare workers in Japan

IntroductionVaccine effectiveness against SARS-CoV-2 infections decreases due to waning immunity, and booster vaccination was therefore introduced. We estimated the anti-spike antibody (AS-ab) recovery by booster vaccination and analyzed the risk factors for SARS-CoV-2 infections.MethodsThe subjects were health care workers (HCWs) in a Chiba University Hospital vaccination cohort. They had received two doses of vaccine (BNT162b2) and a booster vaccine (BNT162b2). We retrospectively analyzed AS-ab titers and watched out for SARS-CoV-2 infection for 90 days following booster vaccination.ResultsAS-ab titer eight months after two-dose vaccinations had decreased to as low as 587 U/mL (median, IQR (interquartile range) 360–896). AS-ab titer had then increased to 22471 U/mL (15761–32622) three weeks after booster vaccination. There were no significant differences among age groups.A total of 1708 HCWs were analyzed for SARS-CoV-2 infection, and 48 of them proved positive. SARS-CoV-2 infections in the booster-vaccinated and non-booster groups were 1.8% and 4.0%, respectively, and were not significant. However, when restricted to those 20–29 years old, SARS-CoV-2 infections in the booster-vaccinated and non-booster groups were 2.9% and 13.6%, respectively (p = 0.04). After multivariate logistic regression, COVID-19 wards (adjusted odds ratio (aOR):2.9, 95% confidence interval (CI) 1.5–5.6) and those aged 20–49 years (aOR:9.7, 95%CI 1.3–71.2) were risk factors for SARS-CoV-2 infection.ConclusionsBooster vaccination induced the recovery of AS-ab titers. Risk factors for SARS-CoV-2 infection were HCWs of COVID-19 wards and those aged 20–49 years. Increased vaccination coverage, together with implementing infection control, remains the primary means of preventing HCWs from SARS-CoV-2 infection.     

Effectiveness of COVID-19 Booster on the Risk of Hospitalization Among Medicare Beneficiaries

ObjectiveTo determine the effectiveness of booster vaccinations on the risk of hospitalization with coronavirus disease 2019 (COVID-19) and how it varies by enrollee characteristics and interval from the initial vaccination to receipt of a booster.Patients and MethodsThis cohort study used 100% Medicare claims from January 1, 2020, through December 31, 2021, and matched 3,940,475 individuals who received boosters to 3,940,475 controls based on week and type of original COVID-19 vaccine and demographic and clinical characteristics. We compared the association of booster vs no booster with COVID-19 hospitalization using Cox proportional hazards regression models controlling for patient characteristics. We also determined the association of time from original vaccine to booster with COVID-19 hospitalization.ResultsOver a maximum of 130 days of follow-up, boosted enrollees had 8.20 (95% CI, 7.81 to 8.60) COVID-19 hospitalizations per million days vs 43.70 (95% CI, 42.79 to 44.64) for controls (81% effectiveness). Effectiveness varied by race, prior hospitalizations, and certain comorbidities, for example, leukemia/lymphoma (53% effectiveness), autoimmune disease (73%), and dementia (73%). Boosters received between 6 and 9 months after original vaccination varied between 81% and 85% effectiveness, while boosters received at 5 to 6 months (62%) or less than 5 months (58%) were less effective.ConclusionBoosters are highly effective in the Medicare population. Approximately 69,225 hospitalizations would be prevented by boosters in the 15 million individuals aged 65 years or older currently not boosted in a period similar to the September 2020 through January 2021 period studied. Boosters provided the greatest benefits if they were received between 6 and 9 months following original vaccinations. However, boosters were associated with substantial decreases in COVID-19 hospitalizations in all categories of enrollees.     

An open-label,nonrandomized, single-center,prospective extension,clinical trial of booster dose schedules to assess the safety profile and immunogenicity of recombinant outer-surface protein A (OspA) Lyme disease vaccine

BACKGROUND: An efficacy trial of an outer-surface protein A (OspA) Lyme disease vaccine demonstrated tolerability and efficacy against laboratory-confirmed Lyme disease after a primary series of 3 doses at 0, 1, and 12 months.OBJECTIVES: This extension of the efficacy study assessed the immunogenicity and tolerability of booster vaccinations administered at 24 and/or 36 months after the first vaccination. METHODS: This open-label, nonrandomized, single-center, prospective extension, clinical trial was conducted in the general community in New Haven, Connecticut, where Lyme disease is endemic. Blood samples (to determine anti-OspA titer) were collected before administration of the booster doses at months 24 and 36, and at 1 and 12 months after each booster dose was administered. Immune response was assessed via total immunoglobulin G (IgG) anti-OspA antibody titers and the proportion of subjects with titers >or=1400 EL.U/mL. Adverse events (AEs) were recorded by the study volunteers on diary cards. RESULTS: A total of 318 volunteers (173 women and 145 men) received at least 1 booster dose of Lyme disease vaccine, administered at 12 or 24 months after the third vaccination of the primary series (months 24 and 36, in relation to the primary series). Eighty-eight subjects of those who received a month-24 booster received a second booster dose at month 36 (12 months after the first booster). Overall, the mean age of the volunteers was 55 years (range, 19 to 73 years). The demographic characteristics of the groups were similar. Most AEs were limited induration and were rated by investigators and subjects as mild to moderate in severity. Administration of I or 2 booster doses did not elicit any patterns of AEs different from those reported in the efficacy trial. After the first booster dose, all volunteers had an anamnestic response and positive test results for total IgG antibody. Geometric mean titers increased at least 12-fold 1 month after the first booster dose at month 24 or 36. More than 96% of volunteers had titers>1400 EL.U/mL and 100% had titers >400 EL.U/mL (minimum seroprotective level) 1 month after the booster dose at month 24 or 36. CONCLUSIONS: All booster doses were well tolerated, and the incidence of AEs did not increase after the second booster dose. The immune response generated after the 3-dose primary series waned; booster doses administered at 12 and/or 24 months after the primary series increased antibody levels above seroprotective levels.     

Adverse reactions to the BNT162b2 and mRNA-1273 mRNA COVID-19 vaccines in Japan

IntroductionThe 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.MethodsWe 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.ResultsAfter 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.ConclusionsAdverse reactions were more frequently reported in females, younger individuals, and after the mRNA-1273 vaccine.     

Effectiveness of the third dose of BNT162b2 vaccine on neutralizing Omicron variant in the Japanese population

IntroductionThe vaccine against SARS-CoV-2 provides humoral immunity to fight COVID-19; however, the acquired immunity gradually declines. Booster vaccination restores reduced humoral immunity; however, its effect on newly emerging variants, such as the Omicron variant, is a concern. As the waves of COVID-19 cases and vaccine programs differ between countries, it is necessary to know the domestic effect of the booster.MethodsSerum samples were obtained from healthcare workers (20–69 years old) in the Pfizer BNT162b2 vaccine program at the Toyama University Hospital 6 months after the second dose (6mA2D, n = 648) and 2 weeks after the third dose (2wA3D, n = 565). The anti-SARS-CoV-2 antibody level was measured, and neutralization against the wild-type and variants (Delta and Omicron) was evaluated using pseudotyped viruses. Data on booster-related events were collected using questionnaires.ResultsThe median anti-SARS-CoV-2 antibody was >30.9-fold elevated after the booster (6mA2D, 710.0 U/mL [interquartile range (IQR): 443.0–1068.0 U/mL]; 2wA3D, 21927 U/mL [IQR: 15321.0–>25000.0 U/mL]). Median neutralizing activity using 100-fold sera against wild-type-, Delta-, and Omicron-derived variants was elevated from 84.6%, 36.2%, and 31.2% at 6mA2D to >99.9%, 99.1%, and 94.6% at 2wA3D, respectively. The anti-SARS-CoV-2 antibody levels were significantly elevated in individuals with fever ≥37.5 °C, general fatigue, and myalgia, local swelling, and local hardness.ConclusionThe booster effect, especially against the Omicron variant, was observed in the Japanese population. These findings contribute to the precise understanding of the efficacy and side effects of the booster and the promotion of vaccine campaigns.     

Antibody responses induced by the BNT162b2 mRNA COVID-19 vaccine in healthcare workers in a single community hospital in Japan

IntroductionThe effectiveness of several vaccines against coronavirus disease (COVID-19) has been reported in the real-world setting. However, it is still unknown how long antibodies persist following vaccination and whether or not the persistence of antibodies has a protective effect against COVID-19.MethodsHealthcare workers who had received two doses of the BNT162b2 mRNA COVID-19 vaccine were enrolled, and a single-center study was conducted at the National Hospital Organization Hakodate National Hospital. Serum samples from all participants were collected 13–21 weeks (median: 20 weeks) after the second dose of vaccination. The antibody titers were measured using an electrochemiluminescence immunoassay (Elecsys® Anti-SARS-CoV-2 S). Data on characteristics of the participants were gathered from patient records and interview sheets.ResultsA total of 401 participants, among whom 70.1% were women and the median age was 42 years, were evaluated in this study. None of the participants had a definite COVID-19 history, and all participants who received complete vaccination showed positive antibody titers. The antibody titer was observed to be higher in participants with younger age (p < 0.001) and those who were females (p = 0.028). Despite the higher risk of infection than that of the general public, no vaccinated staff developed breakthrough infections.ConclusionsThis study demonstrates the significant contribution of the BNT162b2 vaccine in the acquisition of anti-SARS-CoV-2S antibodies; therefore, the general population should benefit from these two vaccine doses, which are expected to be protective for at least five months.     

An epidemiological evaluation of COVID-19 in La paz,Bolivia

IntroductionThe Plurinational State of Bolivia (Bolivia) has experienced four major waves of coronavirus disease 2019 (COVID-19) so far. Although the ministry of health has been tracking morbidity and mortality through each wave, epidemiology of COVID-19 in Bolivia is not well defined, despite a need for more accurate measurement of the number of cases and deaths to allow for forecasting of the pandemic. This study examined prevalence of COVID-19 at community level, determinants of its occurrence and vaccine effectiveness.MethodsWe conducted a cross-sectional study in La Paz city on 2,775 individuals between March 2020 and February 2022. A structured questionnaire was used to collect data on COVID-19 morbidity, mortality and vaccination status.ResultsOf the 2,775 participants, 1,586 (57.1%) were infected with COVID-19, and 187 (6.7%) were suspected cases. The mortality rate was 2.9%. Sinopharm, Johnson & Johnson, Gamaleya, Pfizer-BioNtech, Moderna and AstraZeneka vaccines are in use, and all vaccines have demonstrated effectiveness in reducing the risk of onset. Risk for mortality was significantly lower in the vaccinated group with an odds ratio of 0.037 (95％ confidential interval: 0.01–0.10, p-value: <0.001).ConclusionsActual prevalence of COVID-19 in La Paz (the prevalence rate: 63.8%, including suspected case) was higher than that reported by the Ministry of Health and Sports in Bolivia (7.5%). In addition, vaccination has contributed significantly to the control of the COVID-19 epidemic in Bolivia. We believe that our report will be useful for COVID-19 prevention strategies in Bolivia for the future.     

Adverse reactions to the first and second doses of Pfizer-BioNTech COVID-19 vaccine among healthcare workers

IntroductionIn the current coronavirus infection 2019 (COVID-19) pandemic, the messenger RNA vaccines have been shown to help protect high-risk groups from COVID-19. Among healthcare workers vaccinated with Pfizer-BioNTech COVID-19 vaccine, a survey was conducted to analyze the relationship between the incidence and severity of adverse reactions after vaccination.MethodsWe conducted a prospective self-reported survey of adverse reactions among healthcare workers vaccinated with the Pfizer-BioNTech COVID-19 vaccine (Comirnaty®) in Japan. After the first and second dose of vaccine, local and systemic reactions for 8 days after vaccination were reported by volunteer participants using a website. After receiving vaccination, 374 respondents participated in this matched-pair study.ResultsBoth the incidence and severity of adverse reactions tended to be higher after the second vaccine dose than after the first dose. However, the incidence and numeric rating scale (NRS) score of muscle and skin pain were nearly the same after the first and second doses. In a comparison by sex, women had significantly higher incidence and NRS scores for adverse reactions such as headache, skin pain, erythema, and itching. The results also showed that younger age groups had higher incidence rates and NRS scores for all adverse reactions investigated, except for muscle pain, compared with older age groups.ConclusionSome adverse reactions to the Pfizer-BioNTech Comirnaty® COVID-19 vaccine showed gender and age differences. However, generally speaking, all side reactions disappear within a week. Therefore, these side reactions are not a significant concern in recommending vaccination.     

Dynamic observation of SARS‐CoV‐2 IgM,IgG, and neutralizing antibodies in the development of population immunity through COVID‐19 vaccination

BackgroundCurrently, mass vaccine inoculation against coronavirus disease‐2019 (COVID‐19) has been being implemented globally. Rapid and the large‐scale detection of serum neutralizing antibodies (NAbs) laid a foundation for assessing the immune response against SARS‐CoV‐2 infection and vaccine. Additional assessments include the duration of antibodies and the optimal time for a heightened immune response.MethodsThe performance of five surrogate NAbs—three chemiluminescent immunoassay (CLIA) and two enzyme‐linked immunosorbent assays (ELISAs)—and specific IgM and IgG assays were compared using COVID‐19‐vaccinated serum (n = 164). Conventional virus neutralization test (cVNT) was used as a criterion and the diagnostic agreement and correlation of the five assays were evaluated. We studied the antibody responses after the two‐dose vaccine in volunteers up to 6 months.ResultsThe sensitivity and specificity of five surrogate NAb assays ranged from 84% to 100%. Our cVNT results indicated great consistency with the surrogate assays. At 28 days after primary vaccination, the seropositivities of the NAbs, IgG, and IgM were 6%, 4%, and 13%, respectively. After the booster dose, seropositivities reached 14%, 65%, and 97%, respectively. Six months after receipt of the second dose, the NAb positive rate was eventually maintained at 66%. In all COVID‐19 convalescents, patients were detected with 100% NAb sat three months after discharge.ConclusionCOVID‐19 vaccine induced a humoral immune response lasting at least six months. Rapid serological detection was used as a proxy for identifying changes in immunity levels and as a guide to whether an individual may require a booster vaccination.     

Trends in adolescent COVID-19 vaccination receipt and parental intent to vaccinate their adolescent children,United States,July to October, 2021

IntroductionThere was a five-fold increase in COVID-19 hospitalization case counts among children and adolescents between June and October 2021. However, polls suggest that adolescent COVID-19 vaccination coverage has plateaued in the United States.MethodsUsing the Census Bureau’s Household Pulse Survey, we assessed trends in COVID-19 vaccination among adolescents ages 12–17 years, parents’ intention to vaccinate their adolescent children, and their reasons for not intending to vaccinate their children from July to October 2021 using a large, nationally representative survey of U.S. households (n = 59,424). Trends in COVID-19 adolescent vaccination coverage, nationally and by sociodemographic characteristics, factors associated with adolescent vaccination status and parental intent to vaccinate their adolescent children, as well as changes in reasons for non-vaccination were examined using regression models.ResultsReceipt of ≥1 dose of a COVID-19 vaccine among adolescents ages 12–17 years increased five percentage points, from 56% (July) to 61% (October), with significant increases across most sociodemographic variables. However, there were no significant changes in parental intention to vaccinate their adolescent children during the same time period. Approximately one-quarter of parents were unsure about or reluctant to vaccinate their children, which remained consistent from July to October. Among those who had not vaccinated their children, lack of trust in the government and vaccines, and the belief that the COVID-19 vaccine is not needed or effective, was higher in October compared to July.ConclusionsParental intention to vaccinate their children has remained relatively stable throughout the late summer and early fall of 2021. Encouraging paediatricians to discuss the importance and safety of COVID-19 vaccines, addressing concerns and misinformation, as well as recommending and offering vaccines are important for increasing parental confidence in vaccines as well as vaccination uptake among adolescents.

KEY MESSAGE

• Receipt of ≥1 dose of a COVID-19 vaccine among adolescents ages 12–17 years increased five percentage points, from 56% (July) to 61% (October), with significant increases across most sociodemographic variables.
• Approximately one quarter of parents were unsure about or reluctant to vaccinate their children, which remained consistent from July to October.
• Encouraging paediatricians to discuss the importance and safety of COVID-19 vaccines, addressing concerns and misinformation, as well as recommending and offering vaccines is important for increasing parental confidence in vaccines as well as vaccination uptake among adolescents.

     

Association between COVID-19 vaccines and the menstrual cycle in young Japanese women

IntroductionAlthough several studies have investigated the association between coronavirus disease 2019 (COVID-19) vaccines and the menstrual cycle, available data are limited. Therefore, this study investigated the effect of COVID-19 vaccines on the menstrual cycle and the effect of the menstrual cycle phase on the vaccine side effects during vaccine administration in Japan.MethodsA self-administered questionnaire was used to collect data on the date of vaccination; type of vaccine; type, grade, and duration of the side effects; regularity of menstruation; normal length of the menstrual cycle; and the day one date of menstruation around vaccination. The survey was conducted from October 2021 to March 2022.ResultsThe difference between the predicted and actual menstrual cycle length was 1.9 ± 3.0, 1.6 ± 2.8 (p = 0.557), and 2.5 ± 3.8 (p = 0.219) days before vaccination and after the first and second dose of the vaccine, respectively. In participants who received vaccinations twice within a single menstrual cycle, this difference was 1.3 ± 3.5 and 3.9 ± 3.3 (p = 0.045) days before and after vaccination, respectively. The grade and proportion of the side effects after the second dose of the vaccine was highest during the menstrual period and lowest during the ovulation period, with a significant effect on headache and chills.ConclusionCOVID-19 vaccines tended to prolong the menstrual cycle. The side effects of the COVID-19 vaccine tended to be at a maximum when vaccination occurred during the menstrual period and minimal during the ovulation period.     

Severity of COVID-19 Symptoms among University of Belgrade Students during the July–September 2021 Pandemic Wave: Implications for Vaccination

ObjectiveThe aim of this study was to identify the intensity of COVID-19 symptoms during the pandemic wave during July–September 2021 and to identify factors associated with having moderate and severe symptoms of COVID-19 among affected students in the University of Belgrade.Material and MethodsThis study was carried out at the Institute for Students'' Health (ISH) in Belgrade, Serbia. The ISH is the referral institution for health care delivery at primary and secondary levels. This analysis includes students who presented from July 1 until September 30, 2021, when the latest pandemic wave of COVID-19 was observed among university students. Data were extracted from students'' electronic medical records. Three levels of COVID-19 symptom intensity were defined: mild, moderate, and severe.ResultsOf students seeking medical care at the ISH who were diagnosed with COVID-19, 27.3% had mild disease and the majority, 59.3%, had moderate disease, and 13.4% had severe symptoms. Of all students, 124 (21.8%) were fully vaccinated with 2 doses of Sinopharm (81, 60.9%), Pfizer-BioNTech (38, 28.6%), Sputnik V (7, 5.3%), or the Oxford-AstraZeneca vaccine (7, 5.3%). The multiple multinomial regression model suggests that students who were vaccinated against COVID-19 were 78% less likely to develop moderate symptoms and 96% less likely to develop severe symptoms of COVID-19.ConclusionStudents who are vaccinated against COVID-19 are at lower risk of developing moderate and severe symptoms of the disease.     

Changes in COVID-19 vaccination receipt and intention to vaccinate by socioeconomic characteristics and geographic area,United States,January 6 – March 29, 2021

IntroductionPrevious studies suggested that almost one-third of U.S. adults did not plan to get a COVID-19 vaccine once it is available to them. The purpose of this study was to examine changes in vaccine intentions and attitudes by sociodemographic characteristics and geographic areas, factors associated with vaccination intent, and reasons for non-vaccination among a nationally representative sample of U.S. adults.MethodsData from six waves of the Household Pulse Survey (6 January – 29 March 2021) were analyzed. Differences between January and March were assessed using t-tests. Factors associated with vaccination intent were examined in multivariable logistic regression models.ResultsFrom early January to late March, vaccination receipt of ≥1 dose of the COVID-19 vaccine or intention to definitely get vaccinated increased from 54.7 to 72.3%; however, disparities in vaccination intent continued to exist by age group, race/ethnic groups, and socioeconomic characteristics. Vaccine receipt and the intent were the lowest for region 4 (southeastern U.S.) throughout this period. Adults who had a previous COVID-19 diagnosis or were unsure if they have had COVID-19 were less likely to intend to get vaccinated [prevalence ratio = 0.92 (95%CI: 0.90–0.93) and 0.80 (95%CI: 0.74–0.85), respectively]. The belief that a vaccine is not needed increased by more than five percentage points from early January to late March.ConclusionIntent to definitely get a COVID-19 vaccine increased by almost 18 percentage points from early January to late March; however, younger adults, adults who are non-Hispanic Black or other races, adults of lower socioeconomic status, and adults living in the southeastern U.S. region (Region 4) continue to have higher coverage gaps and levels of vaccine hesitancy. Emphasizing the importance of vaccination among all populations, and removing barriers to vaccines, may lead to a reduction of COVID-19 incidence and bring an end to the pandemic.

KEY MESSAGES

• Receipt of ≥1 dose of the COVID-19 vaccine and intent to probably or definitely get vaccinated increased from early January to late March; however, disparities in vaccine intent continued to exist by age group, race/ethnic groups, and socioeconomic characteristics.
• Vaccine receipt and the intent were the lowest for region 4 (southeastern U.S.) compared to other regions during this period.
• Adults who had a previous COVID-19 diagnosis or were unsure if they have had COVID-19 were less likely to intend to get vaccinated; overall, the belief that a vaccine is not needed to be increased by more than 5% points from early January to late March.

     

Examining the association between vaccine reactogenicity and antibody titer dynamics after the third dose of BNT162b2 vaccine using a mixed-effects model

BackgroundTo mitigate the COVID-19 pandemic, many countries have recommended the use of booster vaccinations. The relationship between the degree of adverse vaccine reactions and elevated antibody titers is of interest; however, no studies have investigated the temporal changes in antibody titers based on repeated measurements after a third dose of the BNT162b2 vaccine.MethodsThis prospective longitudinal cohort study was conducted with 62 healthcare workers who received a third dose of the BNT162b2 at Okayama University Hospital, Japan. Venous blood draw and fingertip whole blood test sample collection were conducted at the early (3–13 days) and 1-month time points; only FWT sample collection was conducted at the 2-month time point. Information on adverse reactions within 1 week after vaccination was also obtained. The association between fever of 37.5 °C or higher and antibody titers after the third dose of BNT162b2 was examined using a mixed-effects model and Poisson regression with robust variance.ResultsA trend toward higher antibody titers in the early period after vaccination was observed in the febrile individuals, but the differences were not significant at 1 and 2 months post-vaccination (the partial regression coefficient for fever was 8094.3 [-1910.2, 18,098.8] at 1 month after vaccination, and 1764.1 [-4133.9, 7662.1] at 2 months after vaccination in the adjusted models).ConclusionThe findings suggest that the presence of fever after the third vaccine does not predict a sustained elevation in serum antibody titers.     

SARS-CoV-2 infection and vaccination trigger long-lived B and CD4+ T lymphocytes with implications for booster strategies

BACKGROUNDImmunization against SARS-CoV-2, the causative agent of COVID-19, occurs via natural infection or vaccination. However, it is currently unknown how long infection- or vaccination-induced immunological memory will last.METHODSWe performed a longitudinal evaluation of immunological memory to SARS-CoV-2 up to 1 year after infection and following mRNA vaccination in naive individuals and individuals recovered from COVID-19 infection.RESULTSWe found that memory cells are still detectable 8 months after vaccination, while antibody levels decline significantly, especially in naive individuals. We also found that a booster injection is efficacious in reactivating immunological memory to spike protein in naive individuals, whereas it was ineffective in previously SARS-CoV-2–infected individuals. Finally, we observed a similar kinetics of decay of humoral and cellular immunity to SARS-CoV-2 up to 1 year following natural infection in a cohort of unvaccinated individuals.CONCLUSIONShort-term persistence of humoral immunity, together with the reduced neutralization capacity versus the currently prevailing SARS-CoV-2 variants, may account for reinfections and breakthrough infections. Long-lived memory B and CD4⁺ T cells may protect from severe disease development. In naive individuals, a booster dose restored optimal anti-spike immunity, whereas the needs for vaccinated individuals who have recovered from COVID-19 have yet to be defined.FUNDINGThis study was supported by funds to the Department of Experimental and Clinical Medicine, University of Florence (Project Excellence Departments 2018–2022), the University of Florence (project RICTD2122), the Italian Ministry of Health (COVID-2020-12371849), and the region of Tuscany (TagSARS CoV 2).     

Safety of and antibody response to the BNT162b2 COVID-19 vaccine in adolescents and young adults with underlying disease

BackgroundData are limited regarding the safety of and antibody response to the BNT162b2 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) messenger ribonucleic acid vaccine in adolescents and young adults with underlying disease.MethodsThis prospective observational study enrolled patients age 12–25 years with chronic underlying disease who received 2 doses of BNT162b2. A 18-item questionnaire was used to assess adverse events within 7 days post-vaccination, and data regarding severe adverse events were collected from electronic medical records. An antibody titer for the receptor-binding domain of the spike protein in SARS-CoV-2 was used to assess antibody response after the second vaccine dose.ResultsStudy participants were 429 patients (241 [56.2%] age 12–15 years; 188 [43.8%] age 16–25 years). The most common underlying diseases were genetic or chromosomal abnormalities and/or congenital anomalies, followed by endocrine or metabolic diseases; 32% of participants were immunocompromised. Severe adverse events were observed after the second dose in 1 (0.4%) patient age 12–15 years and in 2 (1.1%) patients age 16–25 years; all patients recovered. Seropositivity after the second vaccine dose was 99.0%. The geometric mean antibody titer was higher in patients age 12–15 years versus 16–25 years (1603.3 [1321.8–1944.7] U/mL vs. 949.4 [744.2–1211.0] U/mL). Compared with immunocompetent patients, immunocompromised patients had a lower antibody titer (2106.8 [1917.5–2314.7] U/mL vs. 467.9 [324.4–674.8] U/mL).ConclusionsVaccination with BNT162b2 was acceptably safe and immunogenic for adolescents and young adults with underlying disease.     

Bell’s palsy after inactivated COVID-19 vaccination in a patient with history of recurrent Bell’s palsy: A case report

BACKGROUNDWith rapid and extensive administration of inactivated coronavirus disease 2019 (COVID-19) vaccine to the general population in China, it is crucial for clinicians to recognize neurological complications or other side effects associated with COVID-19 vaccination.CASE SUMMARYHere we report the first case of Bell’s palsy after the first dose of inactivated COVID-19 vaccine in China. The patient was a 36-year-old woman with a past history of Bell’s palsy. Two days after receiving the first dose of the Sinovac Life Sciences inactivated COVID-19 vaccine, the patient developed right-side Bell’s palsy and binoculus keratoconjunctivitis. Prednisone, artificial tears and fluorometholone eye drops were applied. The patient’s symptoms began to improve by day 7 and resolved by day 54.CONCLUSIONAs mRNA COVID-19 vaccine trials reported cases of Bell’s palsy as adverse events, we should pay attention to the occurrence of Bell’s palsy after inactivated COVID-19 vaccination. A history of Bell’s palsy, rapid increase of immunoglobulin M and immunoglobin G-specific antibodies to severe acute respiratory syndrome coronavirus 2 may be risk factors for Bell‘s palsy after COVID-19 vaccination.     

Acceptance of a COVID-19 Vaccine and Its Related Determinants among the General Adult Population in Kuwait

ObjectiveThe objective of this study was to determine the acceptance of a coronavirus disease 2019 (COVID-19) vaccine among the general adult population in Kuwait and assess its determinants.Subjects and MethodsA web-based cross-sectional study was conducted by enrolling adults living in Kuwait (n = 2,368; aged ≥21 years). Acceptance of a COVID-19 vaccine was inferred if participants indicated that they “definitely or probably will accept vaccination against COVID-19 once a vaccine is available.” Associations were explored by applying a modified Poisson regression to estimate and infer adjusted prevalence ratios (aPR) and their 95% confidence intervals (CI).ResultsIn total, 53.1% (1,257/2,368) of the participants were willing to accept a COVID-19 vaccine once available. Male subjects were more willing to accept a COVID-19 vaccine than females (58.3 vs. 50.9%, p < 0.001). Subjects who viewed vaccines in general to have health-related risks were less willing to accept vaccination (aPR = 0.39, 95% CI: 0.35–0.44). Moreover, participants who previously received an influenza vaccine were more likely to accept a COVID-19 vaccine (aPR = 1.44, 95% CI: 1.31–1.58). Willingness to get vaccinated against COVID-19 increased as the self-perceived chances of contracting the infection increased (p < 0.001).ConclusionOverall, 53.1% of the study participants demonstrated willingness to get vaccinated against COVID-19. We found several factors influencing the level of acceptance. Since vaccination appears to be an essential preventive measure that can halt the COVID-19 pandemic, factors relating to low vaccine acceptance need to be urgently addressed by public health strategies.