Category: Covid-19 Vaccine

A retrospective cohort was constructed from linked electronic health records (EHR) in each country. Country- specific (level) relative VE (rVE) was estimated on a monthly basis, using a study period covering an eight-week follow-upperiod.Eachmonththestudyperiodwasshiftedforwardtothe followingmonth.Countryestimateswere then pooledtogether. The study period coveredin this report is April 2022 to March 2023. The rVE of first, second and third booster doses was estimated and compared to the VE of complete primary vaccination received at least 24 weeks ago (24 weeks).

BetweenApril2022andMarch2023,thenumberofindividualsincludedintheanalysisineachstudyperiodvaried between 0.5 million and 1.3 million individuals with complete primary vaccination series 24 weeks ago but without a booster, between 3.1 million and 13.2 million individuals completely vaccinated with a first booster, between no individuals and 6.8 million individuals completely vaccinated with a second booster and between no individualsand0.7millioncompletelyvaccinatedwithathirdbooster.About31 900hospitalisationsduetoCOVID- 19 and 13 100 COVID-19-related deaths were recorded across the different sites throughout the study period.

The highest number of person-months contributing to the analysis was observed for Belgium and Portugal, followed by Norway, Denmark, Navarre (Spain), and Luxembourg. In persons aged80 years, Belgium and Portugalrolledoutthesecondboosterdoseoverspring2022andthethirdbooster doseinautumn2022,whilethe administration of a second booster began in autumn 2022 in the remaining participating countries.

At the beginning of the study period, most of the study population had received a first booster dose, while the proportionofindividualscompletelyvaccinatedwithprimarydoseswithoutaboosterwasverylow,especiallyin

65years(Figure2).Asecondboosterdosewasadministratedinitiallyinpersonsaged80yearsfromJuly2022 onwardsinmostparticipatingcountries exceptforBelgiumandPortugal,whereitstartedearlierinspring2022in those aged80 followed by 5079year olds in autumn 2022. In these two countries, the third booster dose was then deployed in80-year-olds in OctoberNovember 2022.

Compared to complete primary vaccination, the first boosterdose rVE against hospitalisation due to COVID-19 was mostly 50% between April 2022 and March 2023 in all age groups (with a few point estimates >50%). It waned 12 weeks after administration and dropped even lower after 24 weeks. In the most recent estimate, between February and March 2023, the first booster (mostly administered >24 weeks) showed little to no added protection:rVEestimatesrangedbetween-1317%,amongthedifferentagegroups.VEestimatesagainstCOVID- 19-related mortality were similar, although estimates had high uncertainty due to a low number of events, particularly in the groups <65 years.

Compared to complete primary vaccination, rVE of a second boosterrestored protection shortly after administration in the autumn of 2022 in65-year-olds, to 7679% against hospitalisation due to COVID-19 and to 7685% against COVID-19 related death. Relative vaccine effectiveness also waned with time, falling to 50% after24weeks.Inthemostrecentestimate,between FebruaryandMarch2023,rVEofthesecondboosterranged between 3349% against hospitalisation and 5063% against mortality 1224 weeks after administration and between3.543%againsthospitalisationand50%againstmortality(estimatedonlyin80yearolds)after24weeks.

Comparedtocompleteprimaryvaccination,rVEofthethirdboostercouldonlybeestimatedinindividualsaged

80 years in Portugal and Belgium. Relative vaccine effectiveness against hospitalisation due to COVID-19 was 72%shortlyafteradministration but wanedrapidly, being zero beyond12 weeks of administration. The lowerrVE could possibly be related to the higher proportion of individuals with comorbidities among those with a third booster(beingapopulationthathadpreviouslyacceptedasecondboosterinthespringof2022). Relativevaccine effectiveness against mortality was 64% initially (<12 weeks after administration) and waned rapidly thereafter (<50% 1224 weeks after administration with large confidence intervals). In FebruaryMarch 2023, the rVE of a third booster 1224 weeks after administration was 3% (95% CI: -26 709; 100).

Overall,resultsindicatedthat boosterdosesrestoredprotectionshortlyafteradministration,butitwanedinthe period up to 24 weeks after administration.

During the autumn of 2022, the effectiveness of third booster doses (in Portugal and Belgium where second boosters had been administered over spring 2022) and second booster doses (in those remaining participating countries)weresimilar.Thisresultsuggeststhatthetimesincethelastdosewasmoreimportantthanthetotal number of doses administered in the level of protection against both COVID-19 hospitalisation and death.

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Interim analysis of COVID-19 vaccine effectiveness against ... - European Union

Ethics statements

All animal work related to this study was conducted following code of ethics for the care and use of animals as guided by the Public Health Service (PHS) Policy on Human Care and Use of Laboratory Animals, an in compliance with the Housing and handling of the animals following the standards of AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care International). Studies were approved by institutional animal care and use committees(IACUC) at Charles River Laboratory and Bioqual Inc, ensuring that all experimental procedures were performed in compliance with applicable animal welfare laws and regulations. Animals were housed in suitable facilities with access to food, water, and environmental enrichment. Trained personnel performed the procedures, minimizing the number of animals used and optimizing their welfare. All mice were euthanized at terminal study timepoints by CO2 asphyxiation. Hamsters were euthanized via isoflurane inhalation and terminal bleed followed by bilateral thoracotomy. All methods were in accordance with ARRIVE guidelines.

GLB-COV2-043 mRNA encodes for the full-length wild-type spike (S) protein of SARS-CoV-2 from the original Wuhan strain, Wuhan-Hu-1 (GenBank: QHD43416.1). The mRNA is modified and contains pseudouridine (), instead of uracil (U). It is produced by in vitro transcription and purified to generate the final 2.0mg/mL mRNA, which is stored at-65C until encapsulated in the lipid nanoparticle (LNP). The final formulated mRNA-LNP is manufactured in a multi-step process that involves mixing of aqueous GLB-COV2-043 mRNA and an organic phase of the lipid components (a proprietary cationic lipid, a saturated phospholipid, a PEG-lipid and cholesterol), of the lipid nanoparticles. After the LNPs are formed, the organic phase is removed, a buffer exchange is performed, sucrose is added, and the LNPs are diluted to the mRNA target concentration and aseptically filtered to generate the bulk mRNA-LNP dispersion. The mRNA-LNP is tested for critical attributes and stored at65C before final use. The lipid nanoparticle systems were developed by and licensed from Acuitas.

HEK293FT (Thermo Fisher), were cultured in Dulbeccos Modified Eagles Medium (DMEM, Gibco) supplemented with 10% FBS (Gibco), 1% penicillinstreptomycin (Gibco), 6mM L-glutamine (Gibco), 1mM MEM sodium pyruvate (Gibco), 0.1mM MEM non-essential amino acids (Gibco) at 37C and 5% CO2. HEK293T-hACE2 cells (SBI Biosciences) were cultured in DMEM media containing 10% FBS, 1% PenStrep, and 2g/mL puromycin (Fisher Scientific) at 37C and 5% CO2.

HEK293FT (Thermo Fisher) cells were transfected with GLB-COV2-043 mRNA encoding SARS-CoV-2 full-lengthwild-type (Wuhan-Hu-1) Spike protein using Lipofectamine MessengerMax (Thermo Fisher) following the supplier recommendations. For demonstration of cell surface expression of full-length Spike protein, 24h post transfection, cells were collected and detected with anti-Spike rabbit IgG, which in turn were detected using anti-rabbit-IgG-FITC that showed surface expression of the full-length Spike proteins. For intracellular staining of the cells, DAPI was used. For hACE2 binding, 24h post transfection, cells were collected and resuspended in FACS buffer. Cells were stained with biotinylated 1108M hACE2 (ACRO), in FACS buffer for 1h at room temperature. Thereafter, cells were washed twice with FACS buffer and incubated with PE-Streptavidin (Invitrogen) in FACS buffer for 1h at room temperature. The cells were washed and resuspended in FACS buffer, and the acquisition was performed on a BD Symphony instrument (BD Biosciences) and analyzed using FlowJo v10.8.1 software.

5105 HEK293FT cells/well were plated on a 6 well plate (Corning) and were transiently transfected with 2g GLB-COV2-043 mRNA encoding SARS-CoV-2 full lengthwild-type (Wuhan-Hu-1) Spike protein using Lipofectamine MessengerMax (Thermo Fisher) following the supplier recommendations. 20h post transfection, the cells were lysed using RIPA lysis buffer (Thermo Fisher) with protease inhibitors (Thermo Fisher) and DNAse I (NEB). The cell lysates were collected after centrifugation (4C, 12,000g for 15min), reduced with DTT (Thermo Fisher) and denatured in sample buffer (Thermo Fisher) upon heating at 95C for 5min. Cell extracts were run on a 412% BisTris gel (Invitrogen) and transferred to a nitrocellulose membrane (Bio-Rad) using Trans-Blot Turbo transfer system (Bio-Rad). The membrane was then blocked with Intercept blocking buffer (Licor) for 1h at room temperature and incubated with SARS-CoV-2 Spike RBD or anti-S2 antibodies (Sino Biological) at 4C overnight. The following day, the membrane was washed with 1PBS-0.2%Tween-20 (Fisher) and incubated with a HRPlabeled goat anti-rabbit secondary antibody (Abcam) at room temperature for 1h. The membrane was washed again with PBS-0.2% Tween-20 buffer, and the signal was detected using an Odyssey CLx Infrared Imaging System.

C57BL/6 female mice, 68weeks of age, were used for the studies that were performed at Charles River Laboratory (CRL). The protocol was conducted in compliance with CRL IACUC (Institutional Animal Care and Use Committee). Mice were separated into groups of 8 mice each (n=8), bled on day-1 and immunized on day zero with three different intramuscular (IM) doses of 10g, 1g, or 0.1g of GLB-COV2-043 mRNA encapsulated in LNP. All mice received a second dose after 3 weeks. In one study, mice received a booster dose of 10g of mRNA-LNP, 4months after primary immunization series. Monthly bleeds were performed to evaluate humoral immune responses over time, and the animals were euthanized 4 months after the booster dose, when tissues and spleens were collected for immune cells analysis. At terminal time points, blood and spleens were harvested for immune cell analysis.

Golden Syrian hamsters immunization and challenge studies were performed at BIOQUAL Inc. Handling samples and animals occurred in compliance with the biosafety protocols, and study was performed under an IACUC-approved protocol. 60 Golden Syrian hamsters were distributed into five groups of 12 animals each (6 female, 6 male). Animals were weighed and observed for clinical signs once daily during immunization days and before the livevirus challenge. Hamsters received 3 IM doses, 3weeks apart, of 30g or 3g of GLB-COV2-043 or an added (50:50) mix of GLB-COV2-043 (coding for wild-type Wuhan spike) plus GLB-COV2-076 (coding for Omicron BA.1 spike)mRNA-LNPs. Blood was collected for humoral immune responses analysis on each immunization day: 0, 21 (3weeks), and 42 (6weeks). On day 63 (9weeks), animals were challenged via an intranasal route with 4.8104 TCID50 of SARS-CoV-2 Omicron B.1.1.529 (BA.1 variant). Post-challenge, clinical observations were recorded twice daily (AM/PM), and body weights were recorded once daily until termination. For longitudinal viral load analysis, oral swabs were collected on days 65, 67, 68, 70, and 76 or 77. On days 67, 68, 76, and 77. At euthanasia, all animals were necropsied for lung and nasal turbinate for viral load analysis and histopathology.

The Sprague Dawley (SD) rat repeat dose toxicity study was conducted at CRL. This cGLP study, based on approved protocol and led by an American Board of Toxicology certified toxicologist, complied with all applicable sections of the Final Rules of the Animal Welfare Act regulations (Code of Federal Regulations, Title 9), the Public Health Service Policy on Humane Care and Use of Laboratory Animals from the Office of Laboratory Animal Welfare, and the Guide for the Care and Use of Laboratory Animals from the National Research Council. A total of 30 rats, 15 males and 15 females, were used; 10 of those, from each sex, were used in the main study and 5 of those, from each sex, were used in the recovery phase of the study. The rats were intramuscularly immunized with 80g dose, administered once every two weeks for a total of 3 doses. Seroconversion was determined by quantitative ELISA assessment of anti-S (Wuhan) bindingantibodies. The in-life procedures, observations (e.g., post-dose, food consumption, local irritation) and measurements (e.g., individual body weights) were performed for all main and recovery study animals. Clinical pathology included evaluation of samples for hematology parameters, coagulation parameters, clinical chemistry parameters and alpha-2-macroglobulin (2M) analysis.

ELISA 96-well plates (Thermo Scientific) were coated with 100 L solution of the soluble recombinant Wuhan, Beta, Delta, Gamma, Alpha, or Omicron BA.1 Spike S1 subunit proteins (Sino Biological) in 1PBS (0.5g/mL) and incubated overnight at 4C. The wells were then aspirated and washed 3 times with 200 L per well of 1PBS (Phosphate Buffered Saline). 200 L of blocking solution (1% BSA/1PBS) were added to each of the wells and incubated for 2h at room temperature. During the incubation period, mice serum samples were diluted with diluent solution (1% BSA, 0.05% Tween-20, 1PBS) starting at 1:500 and serially diluted 5-fold an additional 7 times to make a total of 8 dilutions. After the blocking incubation period, the blocking solution was discarded. The diluted mice serum sample solutions were added and incubated at room temperature for 2h. Plates were washed 5 times with 200 L of 0.05% Tween-20/1PBS. 100l of goat anti-mouse IgG H+L antibody conjugated to HRP (SouthernBiotech), diluted 1:5,000 in diluent solution, was added and incubated at room temperature for 1h. Plates were washed 5 times with 200 L of 0.05% Tween-20/1PBS. For detection development, 100l of TMB substrate (Fisher) was added to each well and the reaction was stopped after 15min using 100l of 1M H3PO4 (Sigma Aldrich). For avidity ELISA, one additionalstep was added in which half of the plates were incubated for exactly 12min with 100l of 1.5M KSCN (Sigma Aldrich) per well and the other corresponding plates were incubated with 1PBS under the same conditions. OD450 readings were taken using the Biotek Synergy HTX plate reader and the data was analyzed using GraphPad Prism v.9.4.1. The end-point titers were calculated as the lowest dilution that emitted an optical density (OD) value greater than 4 times the background (secondary antibody alone).

HEK293T-hACE2 cells (SBI Biosciences) were cultured in DMEM media containing 10% FBS, 1% PenStrep, and 2g/mL puromycin (Fisher Scientific) as a selection antibiotic at 37C and 5% CO2. Prior to plating cells, plates were coated with poly-d-lysine (Fisher Scientific CB-40210) at a concentration of 2.5g/well for 1h at room temperature; poly-d-lysine was removed, and plates were washed with Gibco 1PBS (Thermo Fisher Scientific) and dried. Cells were plated with 1.25104 cells/well. The following day, fivefold serial dilutions of sera were made in HEK293T-hACE2 media with a starting dilution of 1:50 in a final volume of 50L. 50L of 1107/mL replication-deficient pseudovirus expressing spike of wild-type SARS-CoV-2 Wuhan or its variants Beta, Delta, Gamma, Alpha and Omicron B.1.1.529 (BA.1) and firefly luciferase within a Moloney Murine Leukemia Virus (MLV) backbone (eEnzyme) were added to each well and incubated together for 1h at 37C and 5% CO2. Following incubation, the serum-pseudovirus mixture was added to the cells and incubated at 37C and 5% CO2 for 48h. Each plate included wells with cell-only, as positive control, and pseudovirus-only, as negative control. Following incubation, media was removed and 50L of Glo Lysis Buffer (Promega) was added to each well, incubated for 10min, and transferred to an opaque white 96-well plate. 50 L of Bright-Glo Luciferase Substrate (Promega) was added to each well and luminescence was determined using the GloMax Navigator (Promega) with an integration time of 1s. Relative luciferase units (RLU) were plotted and normalized in GraphPad Prism v.9.4.1 to the cell-only control as 100% neutralization and the pseudovirus-only control as 0% neutralization. A non-linear regression of log(inhibitor) versus normalized response with a HillSlope less than zero was used to determine the IC50 values.

For the ELISpot assay, we followed the manufacturer protocol for mouse IgG B-cell ELISpot using an ELISpot Flex: Mouse IgG (ALP) kit (Mabtech). Briefly, sterile 96-well ELISpot plates with a PVDF membrane (Mabtech) were pre-treated with 15L of 70% ethanol and washed 5 times with 200L of sterile water per well. SARS-CoV-2 spikeantigens (Sino Biological) were diluted to 5g/mL in sterile 1PBS. Coated plates were wrapped in parafilm to avoid evaporation and incubated overnight at 4C. The following day, plates were washed 5 times with 200 L/well of sterile 1PBS to remove excess antigen and then blocked with 200 L/well of R10 [RPMI 1640 (Fisher Scientific), 10% fetal bovine serum (FBS) (Fisher Scientific), 1% penicillinstreptomycin (Fisher Scientific)] for at least 30min at room temperature. Cells were plated at 2.5105 cells/well in 100L using R10 and incubated in the coated plates for 1624h in a 37C humidified incubator with 5% CO2. The following day, the plates were washed 5 times with 200L/well of 1 PBS. The detection antibody, anti-IgG-biotin, was diluted to 1g/mL in 1PBS-0.5% FBS and 100 L was added to incubate for 2h at room temperature. The 5 times wash step was repeated and 100 L of streptavidinalkaline phosphatase (ALP) diluted 1:1000 in 1PBS-0.5% FBS was added to each well. After incubating for 1h at room temperature, plates were washed and 100 L of 5-bromo-4-chloro-3-indolyl phosphate/nitro blue tetrazolium (BCIP/NBT) (Mabtech) was added to each well and incubated for about 5min until spots emerged. The plates were washed with tap water extensively to stop color development and dried for 24h. The spots were counted on an ImmunoSpot S6 Ultimate M2 analyzer (CTL), using ImmunoSpot 7.0.37.0 Professional DC program.

Spleens were suspended in 1PBS and homogenized through a 70m strainer. Splenocytes were then incubated with ACK (Ammonium-Chloride-Potassium) lysis buffer and passed through a 40m strainer to prepare a cell suspension. Cells were plated at 5105 cells in 100l with T cell medium [RPMI 1640 (Fisher Scientific), 10% fetal bovine serum (FBS) (Fisher Scientific), 1% pyruvate (Fisher Scientific), 1% non-essential amino acids (NEAA) (Fisher Scientific), 0.4% MEM (minimum essential medium) vitamins (Fisher Scientific), 0.1% -MercaptoethanoL (Fisher Scientific), dimethyl sulfoxide (DMSO, Sigma)]. This was followed by stimulating the cells with an overlapping peptide pool (JPT) diluted 1:200 in medium, or 1of a stimulation cocktail (eBioscience). After the cells have incubated at 37C, 5% CO2 for 2h in the dark, media containing 1% of 10Brefeldin A (BFA) (Sigma) was added to each well. After 4h incubation, FcR blocking antibody (Fisher Scientific), diluted to 1g/ml with 0.1% BFA, was added to the cells and incubated for 15min at 4C in the dark. Cells were than stained for 30min at 4C in the dark with viability and surface markers Zombie Aqua Fixable Viability Kit (Biolegend) or eFluor 780 Fixable Viability Dye (ThermoFisher), dump channel [anti- mouse CD19 (clone 6D5, Biolegend; clone 1D3, TONBO Biosciences), F4/80 (clone BM8, Biolegend; clone BM8.1, TONBO Biosciences), Gr-1 (clone RB6-8C5, Biolegend; clone RB6-8C5, TONBO Biosciences), CD11b (clone M1/70, TONBO Biosciences), CD11c (clone N418, TONBO Biosciences), anti-mouse CD3e (clone 145-2C11 Biolegend), CD62L (clone MEL-14, Biolegend), CD4 (clone RM4-5, Biolegend or TONBO Biosciences), CD44 (clone IM7, TONBO Biosciences), CD8a (clone 536.7, TONBO Biosciences). Subsequently, cells were fixed, permeabilized, then stained with intracellular markers anti-mouse TNF-alpha (clone MP6-XT22, Biolegend), IL-2 (clone JES6-5H4, TONBO Biosciences), IL-4 (clone 11B11, Biolegend), IL-5 (clone TRFK5, Biolegend), and IFN-gamma (clone XMG1.2, TONBO Biosciences). For antigen-specific B cell analysis, splenocytes were thawed using 37C pre-warmed R10 (10% FBS in RPMI 1640) and plated in R10 incubated overnight at 37C and 5% CO2. The following day, cells were plated at 5106 cells in R10 and stained for 30min on ice in the dark with tetramers, composed of his-tagged spike protein (R&D Systems and BPS Biosciences) and labelled anti-His tag antibodies (clone J095G46, Biolegend). Cells were then stained for an additional 15min with viability and surface markers Zombie Aqua Fixable Viability Kit (Biolegend), dump channel [anti- mouse CD4 (clone RM4-4, Biolegend), CD8a (clone QA17A07, Biolegend), Gr-1 (clone RB6-8C5, Biolegend), F4/80 (clone BM8, Biolegend), CD11b (clone M1/70, Biolegend), CD11c (clone N418, Biolegend)], anti- mouse GL7 (clone GL7, Biolegend), IgD (clone 11-26c.2a, Biolegend), B220 (clone RA3-6B2, Biolegend), CD138 (clone 281-2, Biolegend), CD38 (clone 90, Biolegend), CD19 (clone 6D5, Biolegend), IgM (clone 1B4B1, SouthernBiotech) and IgG1 (clone X56, BD Biosciences). The cells were analyzed using a BD FACSymphony A3 flow cytometer and data processed using FlowJo v10.8.1 software.

Snap-frozen hamster tissue samples were homogenized in 2mL ice-cold assay medium (DMEM+10% FBS+Puromycin+P/S) for approximately 20s using a hand-held tissue homogenizer (Omni International). The samples were centrifuged (300g, 4C, 10min) to remove cellular debris. Clear flat-bottom 96-well culture microplates (BD Falcon) were seeded with Vero TMPRSS2 cells at 2.5104 cells per well in growth media (DMEM+10% FBS+Puromycin+P/S) and incubated at 37C, 5% CO2 until 80100% confluent. Growth media was aspirated out and replaced with 180L of diluent media (DMEM+2% FBS+Puromycin+P/S) per well. Next, 20L of processed tissue sample was added to the top row of the plate in quadruplicate, mixed via pipetting, and then serially diluted down the rows by 20L (tenfold dilution). Plates were incubated at 37C, 5% CO2 for 4days. After incubation, the presence of cytopathic effects (CPE) in each well was recorded, and the TCID50 value was calculated using the Read-Muench formula.

Arithmetic or geometric means are represented by symbols or the heights of bars, and error bars represent the corresponding SEM (Standard Error of the Mean). Dotted lines indicate assay's lower limits of quantification (LLOQ). Two-sided MannWhitney U-tests were used to compare two experimental groups and two-sided Wilcoxon signed-rank tests to compare the same animals at different time points. To compare more than two experimental groups, Kruskal Wallis ANOVA with Dunns multiple comparisons tests were applied. For pseudovirus neutralization assay, a nonlinear regression of log(inhibitor) versus normalized response with a HillSlope less than zero was used to determine the IC50values. Statistical analyses were done using GraphPad Prism v.9.4.1. *p<0.05, **p<0.01, ***p<0.001, ****p<0.000.

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Safety, immunogenicity and efficacy of an mRNA-based COVID-19 ... - Nature.com

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Only 5% of Milwaukee residents have gotten the updated COVID-19 ... - Milwaukee Journal Sentinel

TOPLINE:

Two doses of an mRNA COVID-19 vaccine slashes COVID-19-related hospitalizations and emergency department (ED) visits in kids aged 6 months to 4 years by 40%, according to a new study by the Centers for Disease Control and Prevention (CDC).

SARS-CoV-2 infection can severely affect children who have certain chronic conditions.

Researchers assessed the effectiveness of COVID-19 vaccines in preventing emergency ED visits and hospitalizations associated with the illness from July 2022 to September 2023.

They drew data from the New Vaccine Surveillance Network, which conducts population-based, prospective surveillance for acute respiratory illness in children at seven pediatric medical centers.

The period assessed was the first year vaccines were authorized for children aged 6 months to 4 years; during that period, several Omicron subvariants arose.

Researchers used data from 7434 infants and children; data included patients' vaccine status and their test results for SARS-CoV-2.

Of the 7434 infants and children who had an acute respiratory illness and were hospitalized or visited the ED, 387 had COVID-19.

Children who received two doses of a COVID-19 vaccine were 40% less likely to have a COVID-19-associated hospitalization or ED visit compared to unvaccinated youth.

One dose of a COVID-19 vaccine reduced ED visits and hospitalizations by 31%.

"The findings in this report support the recommendation for COVID-19 vaccination for all children aged 6 months and highlight the importance of completion of a primary series for young children," the researchers reported.

The study was led by Heidi L. Moline, MD, of the CDC.

Because the number of children with antibodies and immunity against SARS-CoV-2 has grown, vaccine effectiveness rates in the study may no longer be as relevant. Children with preexisting chronic conditions may be more likely to be vaccinated and receive medical attention. The low rates of vaccination may have prevented researchers from conducting a more detailed analysis. The Pfizer-BioNTech vaccine requires three doses, whereas Moderna's requires two doses; this may have skewed the estimated efficacy of the Pfizer-BioNTech vaccine.

The authors report a variety of potential conflicts of interest, which are detailed in the article.

Brittany Vargas is a medicine, mental health, and wellness journalist.

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Cite this: COVID Vaccines Lower Risk of Serious Illness in Kids-Medscape-Dec01,2023.

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COVID Vaccines Lower Risk of Serious Illness in Kids - Medscape

As winterrespiratory illness season hits families at full force, COVID-19 continues to be one of the biggest public health challenges the world is facing today.Vaccines are a safe and effective way for babies ages 6 months and older, young children, and adults to fight against the virus.

In September, the Centers for Disease Control and Prevention (CDC) recommended that everyone ages 6 months and older get the updated vaccine for the 2023-2024 season.

Learn more about the latest guidelines on COVID-19 vaccines and how you and your family can stay informed and healthy.

Wondering whether you really need to be vaccinated against COVID-19 when youre pregnant? Read on to learn why its so crucial.

To protect your entire family from COVID-19, its important to follow all recommended vaccination guidelines. Heres an age-by-age breakdown:

Children 6 months to 4 years old. Children ages 6 months to 4 years should receive the updated COVID-19 vaccine. If this is their first time getting the vaccine, they should complete a multidose initial series (two doses of the Moderna or three doses of the Pfizer-BioNTech COVID-19 vaccine).

Everyone 5 years of age and older. Everyone ages 5 years and older should receive an updated COVID-19 vaccine.

While children with underlying medical conditions face a higher risk of severe illness due to COVID-19, it's important to note that many children hospitalized with COVID-19 dont have any underlying medical conditions. Getting an updated COVID-19 vaccine helps your body maintain a strong immune system and strengthens your response to infection, especially as the virus continues to change and new variants emerge.

Bystaying up-to-date with COVID-19 vaccine recommendations, you and your loved ones of all ages can reduce the risk of serious illness, hospitalization and death due to COVID-19. Talk with your health care provider if you have questions about COVID-19 or COVID-19 vaccines.

From the What to Expect editorial team andHeidi Murkoff,author ofWhat to Expect When You're Expecting. What to Expect follows strict reporting guidelines and uses only credible sources, such as peer-reviewed studies, academic research institutions and highly respected health organizations. Learn how we keep our content accurate and up-to-date by reading ourmedical review and editorial policy.

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The Latest COVID-19 Vaccine Guide for Pregnant Women and Kids - What To Expect

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by Mayo Clinic News Network

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The Centers for Disease Control and Prevention has recommended the 20232024 COVID-19 (mRNA) vaccine for everyone six months or older. The COVID-19 vaccine is strongly recommended for people who face the highest risk of experiencing complications from the virus. This group includes older people, those with compromised immune systems and chronic medical conditions such as diabetes and heart disease, and very young children.

If you're young and healthy, the vaccine may not benefit you as much, but you still should consider getting it if you live with someone in one of these categories or want to reduce the risk of a COVID-19 infection.

Overall, there is little to no harm in getting the vaccine for protection. For most of the population, the risks from the vaccine are much less significant than the risks from COVID-19 itself. While getting the vaccine does not prevent all COVID-19 cases, the latest vaccines aim to reduce the number of hospitalizations, severe illnesses and deaths from the virus.

Even if you have had COVID-19 previously or have been vaccinated, it is important to get the updated COVID-19 vaccine because the immunity from previous vaccines and infections decreases over time. Another benefit has to do with immune innovationwhen the virus changes, it can escape the antibodies you've formed in reaction to the previous versions of the vaccine. By getting the updated vaccine, you are protecting yourself against the strains that are currently circulating.

The 20232024 COVID-19 vaccines produced by Moderna and Pfizer target a different strain of COVID-19 than was in the original vaccine. Think influenza vaccinesthey are all flu vaccines, but the strains they protect against change year after year.

The updated vaccine targets the XBB.1.5 strain that has been circulating throughout the U.S. and most parts of the world since the start of 2023. The World Health Organization has labeled XBB.1.5 as the most transmissible omicron strain to date.

The updated 20232024 COVID-19 vaccine is the only COVID-19 vaccine currently available. Essentially, with the approval of the new vaccine, the older vaccines have lost their approval.

Other methods to protect yourself from COVID-19 include getting enough sleep and exercise. Avoid highly crowded indoor spaces and consider wearing a mask when you cannot avoid those situations. If you become sick, wear a mask to protect those around you and stay home to avoid exposing people at your workplace and elsewhere.

The COVID-19 vaccine and the influenza vaccine can be given at the same time. Keep in mind that there is no way to tell the difference between flu, cold, respiratory syncytial virus (RSV) or COVID-19 symptoms besides testing.

2023 Mayo Clinic News Network. Distributed by Tribune Content Agency, LLC.

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CDC advice on who should get the latest COVID-19 vaccine - Medical Xpress

The Dare County Department of Health & Human Services encourages residents to protect themselves from respiratory illness this winter by getting vaccinated for influenza and COVID-19.

As cases of respiratory illness continue to rise as we head into the colder months, local health officials urge flu and COVID-19 vaccinations for everyone six months of age and older.

The flu is a contagious respiratory virus that can cause mild to severe illness, and at times can lead to death. Those at high risk for serious flu complications include older people, young children, pregnant women, people with certain health conditions or compromised immune systems. Some of those same groups are also at high risk of complications from COVID-19.

COVID-19 is an infectious disease caused by the SARS-CoV-2 virus. Most people infected with the virus will experience mild to moderate respiratory illness and recover without requiring special treatment. However, some will become seriously ill and require medical attention.

Like the annual flu vaccine, the updated COVID-19 vaccine is designed to match the evolving virus and helps protect people from serious illness, hospitalization and death.

Please contact the Dare County Health & Human Services or your primary provider for more information or to schedule a flu or COVID-19 vaccine. For appointments in Manteo or the northern beaches, please call 252-475-5003 or 252-475-9320 for Frisco and Hatteras Island.

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Barnhill Contracting Company will receive sealed proposals for Manns Harbor EMS/Fire Facility (EMS-8), Kitty Hawk EMS/Fire Facility (EMS-9), Manteo Youth Center on January 09, 2024. Times to be given on via addendum #01. See the following SCOPE OF WORK: BP 100 General Trades, BP 105 Final Cleaning, BP 205 Demolition, BP 390 Turnkey Concrete, BP 400 Turnkey Masonry, BP 500 Turnkey Structural Steel & Misc. Steel, BP 505 Light Gauge Metal Trusses, BP 740 Roofing, BP750 Siding, BP 790 Caulking/Sealants, BP 800 Turnkey Doors/Frames/Hardware/Toilet Specialties/Accessories/Division 10, BP 840 Curtainwall/Storefront/Glass/Glazing, BP 925 Drywall/Framing, BP 960 Resilient Flooring/Carpet/Base/Epoxy, BP 980 Acoustical Ceilings, BP 990 Painting and Wall Coverings, BP 1230 Finish Carpentry and Casework, BP 1250 Window Treatments, BP 2100 Fire Protection, BP 2200 Plumbing, BP 2300 HVAC, BP 2600 Electrical, BP 3100 Earthwork/Turnkey Site, BP 3213- Site Concrete, BP 3290 Landscaping. Scopes of work may be added and/or deleted at the discretion of the Construction Manager.

Bid Location and Time: Bid opening will be held in the Barnhill Contracting Rocky Mount Training & GPS Technology Room: 800 Tiffany Bvld, Rocky Mount, NC 27804. Time is as follows: January 09, 2024 at 10:00am and 2:00pm. Times per packages to be given on via addendum #01.

Barnhill Contracting Company will receive, open, and read publicly all bids received in person in the Training & GPS Technology Room at the main office and listed with the virtual viewing at the link to be posted on Barnhills Plan Room.

Bids will not be accepted from bidders that are not pre-qualified. No facsimile or email submissions are permitted. Sealed bids are to be hand delivered to the bid opening location noted above or mailed Sealed Bids can be delivered before 9:00am the day of the bid to the Barnhill Contracting Company Office at 800 Tiffany Blvd., Suite 200 Rocky Mount, NC 27804. Attention Clint Hardison.

The pre-bid meeting will be held in Person & Zoom Meeting on December 06, 2023 at 10:00 am at the Barnhill Contractings Rocky Mount Main Conference Room: 800 Tiffany Bvld, Rocky Mount, NC 27804.

The pre-bid meeting link can be located on Barnhills online Building Division Plan Room ( https://app.buildingconnected.com/public/54da832ce3edb5050017438b) and below. A preferred brand alternates meeting will be held via the same link at the end of the Prebid meeting.

Bid Documents can be viewed or downloaded through Barnhills online Building Division Plan Room (https://app.buildingconnected.com/public/54da832ce3edb5050017438b) after 12/04/2023.

All Bidders are strongly encouraged to include opportunities for HUB participation wherever possible in their respective Bid submission. HUB participation is a part of this contract and must comply with all requirements set forth in the Bid Documents.

The Construction Manager and Owner reserve the right to add pre-qualified bidders. The Construction Manager and Owner reserve the right to reject any and all bids. Should you require additional direction, please call Barnhill Contracting Company, (Clint Hardison 252-802-0740).

Clint Hardison is inviting you to a scheduled Zoom meeting.

Topic: Dare EMS Phase 2 Pre-Bid Conference

Time: Dec 6, 2023 10:00 AM Eastern Time (US and Canada)

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Meeting ID: 823 9069 2985

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Local health officials encourage flu, COVID-19 vaccines to protect ... - The Outer Banks Voice

(Image Credit: AdobeStock/Near)

Korean researchers reported that ptosis was associated with COVID-19 vaccination, particularly with the ChAdOx1 vaccine (AstraZeneca), while Guillain-Barr syndrome/Miller Fisher syndrome was associated with the COVID-19 infection,1 according to first authors Jae Yong Han, MD, and Sunyeup Kim, MD, from, respectively, the Department of Ophthalmology, Institute of Vision Research, Yonsei University College of Medicine, Seoul, Republic of Korea, and the Department of Medical AI, Sungkyunkwan University School of Medicine, Suwon, Republic of Korea.

With the number of infected individuals and vaccine recipients rising, a growing number of ocular adverse events, including neuro-ophthalmic adverse events, have been reported in individuals with the COVID-19 infection and vaccinated individuals.2-6 Other studies reported that COVID-19 was associated with optic neuritis7-9 and ophthalmoplegia was related to third or sixth cranial nerve palsy.10-16 Adverse events caused by the vaccine have been reported.1721 However, the investigators explained, it is unclear if COVID-19 infection and vaccination are related directly to neuro-ophthalmic adverse events.

They conducted a large nationwide, population-based, retrospective cohort study to determine if there is an association between COVID-19 infection and vaccination with neuro-ophthalmic adverse events.

About 8.5 million patients in the Korean National Health Claim Database were classified into 1 of 3 groups: controls, those with the COVID-19 infection, and those vaccinated against COVID-19. The researchers separately analyzed the early phase (within 60 days) and late phases (61180 days) to estimate the incidence rates and hazard ratio (HR) for each neuro-ophthalmic adverse event that included optic neuritis, papilledema, ischemic optic neuropathy, third nerve palsy, fourth nerve palsy, sixth nerve palsy, facial palsy, nystagmus, ptosis, blepharospasm, anomalies of pupillary function, and Guillain-Barr syndrome/Miller Fisher syndrome.

The authors reported that neuro-ophthalmic adverse events, except for ptosis and Guillain-Barr syndrome/Miller Fisher syndrome, showed no significant increase after COVID-19, and their incidence rates were extremely low. The incidence rates of ptosis in the early and late phases were significantly higher in patients who received the COVID-19 vaccination (HR = 1.65 in the early phase and 2.02 in the late phase) compared with the control group. The BNT162b2 (PfizerBioNTech) vaccine was associated with a lower ptosis risk than the ChAdOx1 vaccine. Guillain-Barr syndrome/Miller Fisher syndrome occurred significantly more often during the early phase (HR = 5.97) in patients with COVID-19 infection than in the control group.

The authors concluded, Ptosis was associated with the COVID-19 vaccination, particularly with the ChAdOx1 vaccine, while Guillain-Barr syndrome/Miller Fisher syndrome was associated with the COVID-19 infection. In contrast, no association was found between other neuro-ophthalmic adverse events and COVID-19 infection or vaccination. These results may provide helpful insights for diagnosing and treating neuro-ophthalmologic adverse events after COVID-19.

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Neuro-Ophthalmic adverse events associated with COVID-19 ... - Ophthalmology Times

Japans Ministry of Health, Labour and Welfare (MHLW) has approved CSL and Arcturus Therapeuticsself-amplifying mRNA (sa-mRNA) Covid-19 vaccine, ARCT-154.

The vaccine is intended for preliminary vaccination and as a booster in those aged 18 years and above.

The development is based on positive data from clinical trials of ARCT-154. The studies include a 16,000-participant trial in Vietnam and a Phase III Covid-19 booster trial.

In the booster trial, the vaccine demonstrated increased immunogenicity and a favourable safety profile versus a standard mRNA Covid-19 vaccine.

CSL vaccines innovation unit senior vice-president Jonathan Edelman stated: The approval marks a historic and exciting milestone as the first sa-mRNA vaccine in the world to be registered, and supports CSLs promise to protect global public health.

We are committed to working with health authorities around the world to ensure this important vaccine technology will be available to people at risk for Covid-19.

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CSLs vaccine business Seqirus collaborated with Meiji Seika Pharma to supply ARCT-154 in Japan.

It is the first sa-mRNA Covid-19 vaccine across the globe to gain approval.

In 2022, CSL and Arcturus entered into a worldwidepartnership and licencing deal for the vaccine platform technology.

It was agreed that CSL would hold an exclusive licence to use Arcturus mRNA technology for influenza, Covid-19 and other respiratory viral ailments.

CSL also has a non-exclusive licence for the technology in the area of multi-pathogen pandemic readiness.

Arcturus Therapeutics CEO Joseph Payne stated: We are proud of the role that Arcturus has played in this collaboration to develop and validate the first approved sa-mRNA product in the world.

This approval for the sa-mRNA Covid-19 vaccine is a major achievement, and we are excited to embark on future endeavours that utilise our innovative sa-mRNA vaccine platform alongside our global exclusive partner, CSL.

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.

Give your business an edge with our leading industry insights.

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Japan grants approval for CSL and Arcturus' Covid-19 vaccine - Pharmaceutical Technology

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COVID-19 cases have been on the rise for the last three weeks according to the latest data from the Centers for Disease Control and Prevention.

Now that Thanksgiving is over, Dr. Ed Lifshitz, medical director of communicable disease service for the New Jersey Health Department, expects the trend to continue.

The past few years following the Thanksgiving holidays we have seen an increase in cases as people do congregate together, he said.

Epidemiologist Dr. Stanley H. Weiss, a professor at the Rutgers New Jersey Medical School and a professor of biostatistics and epidemiology at the Rutgers School of Public Health, said its hard to predict exactly how respiratory diseases will increase from year to year.

There is always, though, an increase as were bearing into these winter months, so with some certainty I can tell you yes, we can expect COVID is going to increase, he said.

Dr. Lifshitz said an increase in COVID-19 cases will result in a higher number of COVID-19-related deaths, and a similar uptick in flu-related deaths is also expected to happen this time of year.

He noted that while the public health emergency phase of the pandemic is over, the total number of COVID-related deaths is still much higher than the number of flu-related deaths, but its difficult to get exact figures because COVID-related mortality is tracked much more carefully.

It is what is known as reportable, meaning every case of COVID that a doctor or a lab discovers has to get reported to public health authorities, and the same is not true for influenza, he said.

When it comes to determining death caused by the flu, Dr. Lifshitz said that those numbers are estimates based on larger studies.

He said the CDC estimates between 12,000 and 52,000 Americans a year die from flu-related illness, and New Jersey has approximately 3% of the national population. So just based upon that calculation I would estimate that about 360 to 1,680 people die of the flu every year in New Jersey, and again thats just a rough estimate.

He added that last year New Jersey had a fairly normal flu season, which suggests that about a thousand or so New Jerseyans likely died from the flu in 2022.

He said for all of last year the CDC reported 6,461 COVID-related deaths in New Jersey, so no matter how you look at it we continue to see about five times the number of people dying in New Jersey from COVID as from flu.

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COVID-19 still a deadly threat. Here's where cases stand in New ... - WHYY