Category: Vaccine

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Immune response induced by standard and fractional doses of 17DD yellow fever vaccine | npj Vaccines – Nature.com

March 8, 2024

Study population

This is an observational cross-sectional investigation comparing two cohorts of vaccinees defined by vaccine dosage (fractional and standard doses) carried out in the metropolitan area of So Paulo (SP, Brazil) by the Collaborative Group for Studies of Yellow Fever Vaccine. The study protocol was submitted and approved by research ethics committees at Instituto Ren RachouFundao Oswaldo Cruz (CAAE: 82357718.5.0000.5091), Instituto Nacional de Infectologia Evandro Chagas/INIFundao Oswaldo Cruz (CAAE: 82357718.5.3001.5262), Secretaria Municipal da Sade de So Paulo - SMS/SP (CAAE: 82357718.5.3003.0086) and Instituto de Infectologia Emlio RibasIIER (CAAE: 82357718.5.3002.0061). The study population comprised a non-probabilistic convenience sampling including whole blood specimens (n=322 samples) collected from healthy subjects of both genders (Males=142 samples; Females=180 samples), with age ranging from 11 to 65years (Mean=4114), further categorized into two groups referred as Fractional Dose (FD) and Standard Dose (SD). Written informed consent was given from all participants that have joined this study. Only volunteers with negative results of YF-specific neutralizing antibodies prior to vaccination were enrolled in the present study.

The FD group was enrolled between January and July 2018 at primary care medical centers, during the large-scale vaccination campaign with the fractional dose (1/5 of SD) of the 17DD-YF vaccine in three cities at the metropolitan area of So Paulo (Diadema, Mau and Santo Andr). This group included 225 samples (Males=99; Females=126), with age ranging from 11 to 65years (Mean=4314).

Between April and August 2019, the SD group was selected during the routine 17DD-YF vaccination at primary care medical centers in So Paulo. This group included 97 samples (Males=44; Females=53), aged 1763years (Mean=3512).

Blood samples (10mL) were collected at baseline (D0) and at distinct timepoints after primary 17DD-YF vaccination (from D1 throughout D15 and at D30-45) by venipuncture using a gel separation vacuum system without anticoagulant. Aiming to assess the kinetics timeline of distinct parameters, categorical day intervals were defined by grouping D1 to D15 depending on the number of samples available.

Blood specimens were processed to obtain serum samples and peripheral blood mononuclear cells (PBMC) as previously described by Reis et al.30. Whole blood samples were submitted to centrifugation at 10002000g for 10min at room temperature to obtain serum samples, and aliquots stored at 80C at Laboratrio de Investigao Mdica from Universidade de So Paulo (USP) for further viremia quantification, YF-specific IgM, IgG and neutralizing antibodies detection, as well as analysis of soluble mediators. Clots were processed at Laboratrio de Biomarcadores from Instituto Ren Rachou (IRR, FIOCRUZ-Minas) for PBMC isolation. Clots were removed from the gel separation system, sliced into 12mm fragments, and minced with sterile syringe plungers through 100m filters attached to 50mL conical tubes containing RPMI-1640 medium and resuspended with RPMI supplemented with 10% Fetal Bovine Serum to obtain a final volume of 10mL. The suspension was slowly applied over 5mL Ficoll-Paque PLUS cushion (1077g/mL) and submitted to centrifugation at 410g for 40min at room temperature. PBMC were transferred to 50mL conical tubes and washed once with 15mL supplemented RPMI-1640 medium by centrifugation at 300g for 7min at 4C. Thereafter, the supernatant was discarded and the cell pellet was treated with ammonium chloride solution (155mM NH4Cl, 10mM KHCO3, 0.1mM EDTA, pH 7.2) for 10min at room temperature to lyse the remaining red blood cells. Following centrifugation at 300g for 7min at 4C, the PBMC pellet was washed once with RPMI-1640 and resuspended in 1mL. Aliquots of 10L were stained with Trypan Blue (0.4%) to estimate cell viability using the Countess Automated Cell Counter. PBMC suspensions were maintained at 4C for further use for immunophenotyping staining.

The quantification of YF viral copies in serum samples collected from D3 throughout D15 after primary immunization with SD or FD of 17DD-YF vaccine was performed through Real-Time Quantitative Reverse Transcription PCR (qRT-PCR) at Laboratrio de Tecnologia Virolgica in Bio-Manguinhos (LATEV, FIOCRUZ), as previously described by Martins et al.15. The limit of detection (LOD) of the test was obtained through the validation process of the one step qPCR assay for yellow fever carried out in Bio-Manguinhos. LOD: 6.25 copies/L or 3.45 Log10 copies/mL. The results were expressed as viral copies/mL according to the standard curve included in each experimental batch.

The quantification of Anti-YF IgM was performed at the Laboratrio de Tecnologia Imunolgica from Bio-Manguinhos (LATIM, FIOCRUZ) using a standardized in-house capture enzyme-linked immunosorbent assay (ELISA). Briefly, 96-well plates were coated with 75L/well of anti-IgM antibody (10g/mL) in carbonate-bicarbonate buffer, pH 9.6, and incubated overnight at 4C in a humid chamber. Following incubation, the supernatant was discarded and plates were incubated with 200 L/well of blocking solution [BDS1, prepared as phosphate-buffered saline (PBS), pH 7.2, supplemented with 0.5% Tween-20 (PBS/T1) supplemented and 5% skimmed milk] for 30min in a humid chamber at room temperature (RT). After 5 times washing with PBS/T1, 50 L of pre-diluted serum samples and controls (1:200) in PBS/T1 were added together with 50L/well of 17DD-YF live-attenuated virus (2g/mL). The viral antigen concentration was previously determined during standardization steps using distinct protein concentrations measured by BCA protein assay kit (Pierce), according to the manufacturers instructions. The plate was incubated overnight at 4C in a humid chamber, following washing steps, and 50L/well of commercially available anti-Flavivirus antibody (6B6C-1) conjugated with Horseradish Peroxidase was added to each well for 1h at 37C. After washing steps, 75L/well of 3,3,5,5-tetramethylbenzidine substrate solution (TMB) was added to each well and plates were incubated for 10min before addition of 50 L/well of stop-solution (2M H2SO4). The endpoint measurements were performed at 450nm. The optical density (OD) values of each sample were subtracted from the negative control. The results were considered positive at OD>0.800, borderline at OD ranging from 0.800 to 0.667 and negative at OD<0.667.

The quantification of Anti-YF IgG was performed at the Laboratrio de Tecnologia Imunolgica from Bio-Manguinhos (LATIM, FIOCRUZ) using a standardized in-house enzyme-linked immunosorbent assay (ELISA). Briefly, 96-well plates were coated with 50 L/well of 17DD-YF live-attenuated virus (2.5g/mL) in carbonate-bicarbonate buffer, pH 9.6. The viral antigen concentration was previously determined during standardization steps using distinct protein concentrations measured by BCA protein assay kit (Pierce), according to the manufacturers instructions. The microplates were incubated overnight at 4C in a humid chamber and were mechanically washed 5 times with 300 L/well of phosphate-buffered saline (PBS) pH 7.4, supplemented with 0.05% Tween-20 (PBS/T2). The plates were incubated with 100L/well of blocking solution [BDS2, prepared as PBS/T2 supplemented with 0.05% bovine serum albumin (BSA), 3% fetal bovine serum (FBS) and 5% skimmed milk], for 1h at 37C. Following, 50 L of two-fold serial dilution of serum samples (1:20 to 1:160) in BDS2 were incubated for 1h at RT. The standard curve was constructed using two-fold serial dilution (10.015 UI/mL) of commercially available anti-YF serum (YFNIBSC). After incubation, plates were washed and reincubated with 100 L/well of anti-Human IgG conjugated with Horseradish Peroxidase (HRP, BD Biosciences) diluted 1:3.000 in BDS2 for 1h at RT. Following washing procedures, 100L/well of TMB solution was added to each well and the plates were incubated for 15min before addition of 100L/well of stop-solution (2M H2SO4). The endpoint measurements were performed at 450nm. The absorbances of the serum sample dilutions were plotted and the standard curve was used to determine the antibody concentration according to the 4-parameter logistic regression, using the software SoftMax Pro. The results were expressed in IU/mL relative to the reference anti-YF serum standard curve.

The analysis of YF-specific neutralizing antibodies was performed at the Laboratrio de Tecnologia Virolgica at Bio-Manguinhos (LATEV, FIOCRUZ) using the micro plaque-reduction neutralizationHorseradish Peroxidase test (PRN-HRP), according to Simes M.67. Briefly, in 96-well plates, serial dilutions of serum samples (1:61:1458) were pre-incubated with 17D-213/77 vaccine virus (~100 PFU/well) for 2h at 37C, 5% CO2, and transferred to pre-formed Vero cells monolayer. Carboxymethylcellulose semisolid medium was overlaid on each well and plates were incubated for 48h at 37C, 5% CO2. After incubation, cell monolayers were washed and fixed with ethanol/methanol (1:1) solution and incubated with HRP-conjugated monoclonal antibody (clone 4G2) for 2h at 35C, 5% CO2, followed by the addition of True Blue Dye substrate. Thereafter, monolayers were washed, dried and photographed using the ScanLab microscope and images were used for the automated counts. The endpoint-neutralizing antibody titers were defined as the last serum dilution that reduced the number of plaques by 50% (PRN-HRP50) as compared to the virus control included in each assay. Seropositivity was defined considering the antibody titer 100 as the cut-off.

High-performance microbead array (Bio-Plex ProTM Human Assay) was used to quantify serum soluble mediators, comprising: chemokines (CCL11, CXCL8, CCL2, CCL3, CCL4, CCL5 and CXCL10), cytokines (IL-1, IL-6, TNF, IL-12, IFN-, IL-17, IL-1Ra, IL- 4, IL-5, IL-9, IL-10 and IL-13) and growth factors (FGF, PDGF, VEGF, G-CSF, IL-2 and IL-7). The assays were performed according to the manufacturers instructions. The results were expressed in pg/mL according to the standard curve of each soluble factor.

Immunophenotyping of T and B-cell subpopulations was performed in 96-well plates by incubating 5 105 live PBMC with two panels of monoclonal antibodies. The T-cell panel included anti-CD3-Qdot655 (Invitrogen, clone S4.1, dilution: 0.12:100, Cat #: Q10012), anti-CD4-BV605 (BD, clone RPA-T4, dilution: 1:100, Cat #: 562658), anti-CD8-Alexa Fluor 700 (eBioscience, clone RPA-T8, dilution: 5:100, Cat #: 56-0088-42), anti-CD45RO-BV421 (BD, clone UCHL1, dilution: 1:100, Cat #: 562641), anti-CD27-APC-H7 (BD, clone M-T271, dilution: 5:100, Cat #: 560222), anti-CXCR5-Alexa Fluor 488 (BD, clone RF8B2, dilution: 5:100, Cat #: 558112), anti-CXCR3-PE (BD, clone 1C6, dilution: 5:100, Cat #: 557185), anti-CCR6-PerCP-Cy5.5 (BD, clone 11A9, dilution: 5:100, Cat #: 560467), anti-ICOS-PE-Cy7 (Invitrogen, clone ISA-3, dilution: 5:100, Cat #: 25-9948-42) and anti-PD-1-APC (BioLegend, clone EH12.2H7, dilution: 5:100, Cat #: 329908). The B-cell panel comprised anti-CD19-PE-Cy7 (eBioscience, clone: SJ25C1, dilution: 0.20:100, Cat #: 25-0198-42), anti-CD20-BV650 (BD, clone 2H7, dilution: 2:100, Cat #: 563780), anti-CD21-FITC (eBioscience, clone HB5, dilution: 1.25:100, Cat #: 11-0219-42), anti-CD38- PE (BD, clone HIT2, dilution: 2.5:100, Cat #: 555460), anti-CD27-APC-H7 (BD, clone M-T271, dilution: 2.5:100, Cat #: 560222), and anti-IgD-Alexa Fluor 700 (BD, clone IA6-2, dilution: 2.5:100, Cat #: 561302). Cells were incubated for 20min at room temperature, washed and resuspended in PBS prior to acquisition on a LSR Fortessa Flow Cytometer (BD Biosciences). The FlowJo V10.8.1 (BD Bioscience) software was employed for data analysis using distinct gating strategies. Lymphocytes were selected based on the size and granularity properties within gated single cells. Thereafter, CD4+ and CD8+ T-cell subsets selected amongst CD3+ T cells were further characterized by additional phenotypic features. B-cell were identified as CD19+ cells within CD3- followed by further additional phenotypic analysis of cell subsets.

The GraphPad Prism V8.0 (GraphPad-Software) was used for statistical analyses and graphical arts. Data normality distribution was assessed by the Shapiro-Wilk test. MannWhitney test or Student t-test were used for comparison between two groups. KruskalWallis or ANOVA variance analysis followed by Dunns or Tukey post-test were employed for multiple comparisons. In all cases, significance was considered at p<0.05.

The baseline fold change indices were calculated as the ratio between the results observed for individual samples at distinct timepoints after primary 17DD-YF vaccination divided by the baseline values obtained for the same volunteer before vaccination. Chi-square test was used for the comparison of baseline fold changes categorized as decreased (<1), unaltered (=1) or increased (>1). Significance was considered at p<0.05. Venn Diagram analysis, available at (http://bioinformatics.psb.ugent.be/webtools/Venn/), was employed to assess the common and selective serum soluble mediators with increased (>1.5) or decreased (<0.5) baseline fold-change profiles at distinct timepoints.

Correlation analyses were carried out using Pearson and Spearman rank tests. The r scores of significant correlations (p<0.05) were employed to build correlation matrices and to assemble networks, using the corrplot package of the R software (Project for Statistical Computing Version 3.0.1) and the open-source Cytoscape software platform (available at https://cytoscape.org), respectively. Networks were compiled to arrange clusters of antibodies, chemokines, cytokines, growth factors, T and B-cell subsets. Nodes were used to represent each parameter and connecting lines were employed to identify positive (continuous line) and negative (dashed line) correlations. The node sizes are proportional to the number of correlations between parameters. Line thickness illustrates the correlation strength, ranging from weak/moderate (r scores from 0.1 to 0.5 or 0.5 to 0.1, thin lines) to strong correlations (r scores from 0.5 or0.5, thick lines).

Further information on research design is available in the Nature Research Reporting Summary linked to this article.

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Immune response induced by standard and fractional doses of 17DD yellow fever vaccine | npj Vaccines - Nature.com

Urgent warning over whooping cough as cases spike to decade high: Health chiefs beg parents to get children va – Daily Mail

March 8, 2024

By Emily Stearn, Health Reporter For Mailonline 18:04 07 Mar 2024, updated 18:08 07 Mar 2024

Health officials today begged parents to get their children vaccinated amid spiralling cases of whooping cough.

Experts blame the resurgence of the '100-day cough' on a slump in vaccine uptake among kids and mothers-to-be, as well as a post-Covid resurgence caused by less immunity due to pandemic social distancing.

UK Health Security Agency (UKHSA) bosses received 553 lab-confirmed reports of whooping cough cases in England alone in January.

It marks a 61-fold rise on the nine logged over the same month in 2023 and comes after MailOnline earlier this year revealed that cases of whooping cough were at a decade high.

For comparison, there were 858 cases recorded in total last year.

Health officials warned the infection is initially difficult to tell apart from a cold, with the first signs typically being a runny nose and sore throat.

But around a week later, sufferers may develop coughing bouts which last minutes, struggle to breathe after coughing and make a 'whoop' sound between coughs.

Other signs of pertussis, as it is medically known, include bringing up a thick mucus that can cause vomiting and becoming red in the face.

UKHSA surveillance figures show, of the 553cases confirmed in January, more than half (287) were among those aged 15 years or older.

Just under a third (29.1 per cent) were in children aged 10 to 14 (161).

Whooping cough is caused by the pertussis bacteria and is spread by coughing and sneezing.

The infection is initially difficult to tell apart from a cold, as the first signs are a runny nose and sore throat.

But around a week later, sufferers may develop coughing bouts that last minutes, struggle to breathe after coughing and make a 'whoop' sound between coughs.

Other signs of whooping cough include bringing up a thick mucus that can cause vomiting and becoming red in the face.

Sufferers are infectious from around six days aftercold-like symptoms develop to three weeks after their cough starts.

Doctors dish out antibiotics as treatment if the whooping cough is detected within three weeks. However, if a person has been infected for longer, antibiotics will not speed up their recovery.

The infection can be fatal, with up to 3 per cent of newborns dying from it, according toProfessor Paul Hunter, an expert in infectious diseases from the University of East Anglia.

Additionally, most babies under six months with whooping cough are hospitalised with complications, such as dehydration, breathing difficulties and pneumonia.

It is less severe in older children and adults but can still cause sore ribs, a hernias, ear infections and urinary incontinence among these groups.

The 6-in-1 vaccine, given to babies at eight, 12 and 16 weeks, and the 4-in-1 pre-school booster, administered to children aged three years and four months, is vital for protecting against catching whooping cough.

Pregnant women are also encouraged to get the vaccine to protect their baby from catching the infection in the first few weeks of their life.

Some 22 infants aged under three-months, who are too young to be fully vaccinated, were also diagnosed.

The 6-in-1 vaccine, given to babies at eight, 12 and 16 weeks, and the 4-in-1 pre-school booster, administered to children aged three years and four months, is vital for protecting against catching whooping cough.

Pregnant women are also encouraged to get the vaccine to protect their baby from catching the infection in the first few weeks of their life.

Parents have been urged to check their kids have had both jabs.

Without the jabs, experts warn people risk becoming seriously ill from the infection and passing it on to others.

However, uptake of the 6-in-1 vaccine (92.6 per cent) and 4-in-1 jab (83.3 per cent) both slumped to all-time lows in 2023, according to NHS England data.

Meanwhile, just 61.5 per cent of expectant mothers had the whooping cough jab in 2022 the smallest number in seven years.

Dr Gayatri Amirthalingam, UKHSA's consultant epidemiologist at UK Health Security Agency, said: 'Whooping cough can affect people of all ages but for very young infants, it can be particularly serious.

'However, vaccinating pregnant women is highly effective in protecting babies from birth until they can receive their own vaccines.

'Parents can also help protect their children by ensuring they receive their vaccines at the right time or catching up as soon as possible if they have missed any.

'If you're unsure, please check your child's red book or get in touch with your GP surgery.'

Steve Russell, national director for vaccinations and screening at NHS England, added: 'With whooping cough on the rise, it is important that families come forward to get the protection they need.

'If you are pregnant and have not been vaccinated yet, or your child is not up-to-date with whooping cough or other routine vaccinations, please contact your GP as soon as possible, and if you or your child have symptoms ask for an urgent GP appointment or get help from NHS 111.'

Whooping coughis caused by the pertussis bacteria and is spread by coughing and sneezing.

Doctors dish out antibiotics as treatment if the whooping cough is detected within three weeks.

However, if a person has been infected for longer, antibiotics will not speed up their recovery.

Pre-pandemic, between 2,500 and 4,500 suspected cases were logged each year. This fell to around 500 during thecoronavirus crisis as social distancing curbed the spread of most bugs.

But cases hit 1,728 in 2023 because of the post-pandemic rebound, in a trend that experts say is down to lower societal immunity as a result of the Covid era.Similar trends were seen for bugs like flu and RSV.

However, rates are still nowhere near the annual high of 170,000 logged in the 1940s. Routine vaccination against whooping cough in the 1950s dramatically slashed levels.

Health officials also acknowledgedcases of whooping cough rise cyclically every few years. The last peak year 2016 logged 5,949 cases.

Vaccines for babies under 1 year old

8 weeks

12 weeks

16 weeks

Vaccines for children aged 1 to 15

1 year

2 to 15 years

3 years and 4 months

12 to 13 years

14 years

Source: NHS Choices

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Urgent warning over whooping cough as cases spike to decade high: Health chiefs beg parents to get children va - Daily Mail

BCG-booster vaccination with HSP90-ESAT-6-HspX-RipA multivalent subunit vaccine confers durable protection … – Nature.com

March 8, 2024

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BCG-booster vaccination with HSP90-ESAT-6-HspX-RipA multivalent subunit vaccine confers durable protection ... - Nature.com

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 March 2024 | European … – European Medicines Agency |

March 8, 2024

EMAs safety committee (PRAC)concluded that there was insufficient evidence to establish a causal association between the COVID-19 vaccines Comirnaty and Spikevax and cases of postmenopausal bleeding.

Postmenopausal bleeding is commonly defined as vaginal bleeding occurring one year or more after the last menstrual period. Postmenopausal bleeding is always considered abnormal and can be a symptom of serious medical conditions.

Recently, new information emerged from the medical literature as well as post-authorisation data that prompted investigation into postmenopausal bleeding with the two vaccines.

The PRAC assessed all available data, including findings from literature, and available post-marketing spontaneous reports of suspected adverse reactions.

After careful review, thePRACconsidered that the available data do not support a causal association and an update of theproduct informationfor either vaccine is not warranted.

The committee will continue to monitor this issue for both Comirnaty and Spikevax through the established safety monitoring practices.

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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 March 2024 | European ... - European Medicines Agency |

Liverpool: New 450m vaccine manufacturing hub announced in Budget – BBC.com

March 8, 2024

6 March 2024

The vaccine hub will be built on AstraZeneca's existing site in Speke

A 450m vaccine manufacturing hub is set to be built in the north west of England, the chancellor has announced.

Jeremy Hunt said in his Budget speech that AstraZeneca planned to invest the 450m in Speke in Liverpool as part of a total investment of 650m in the UK.

The Treasury said the investment was dependent on "mutual agreement with the UK government and third parties".

AstraZeneca said it demonstrated their "ongoing confidence in UK life sciences".

As part of the 650m total investment the pharmaceutical company said it would also expand its footprint on the Cambridge Biomedical Campus.

Mr Hunt said: "AstraZeneca's investment plans are a vote of confidence in the attractiveness of UK as a life sciences superpower and strengthen our resilience for future health emergencies."

The investment in Liverpool was said by the government to be for the research, development, and manufacture of vaccines, "building on the site's current role in supplying the world leading childhood vaccination programme".

The new facility would be designed and built to be operationally net zero with power supplied from renewable energy sources.

AstraZeneca's chief executive officer, Sir Pascal Soriot, said the planned investment would "enhance the UK's pandemic preparedness and demonstrates our ongoing confidence in UK life sciences".

He added: "We will continue to support the UK in driving innovation and patient access, building on the strong foundations which have been put in place."

Dr Isabel Oliver, chief scientific officer at the UK Health Security Agency, said: "This investment will bolster the development of the UK's vaccine capabilities and life sciences sector - critical components of the country's resilience to future health threats."

In a statement to announce the plans, the Treasury said the investment needed the agreement of the UK Government and "third parties" and depended on "successful completion of regulatory processes".

Originally posted here:

Liverpool: New 450m vaccine manufacturing hub announced in Budget - BBC.com

New RSV vaccine 90% effective at preventing infant hospitalizations – WXYZ 7 Action News Detroit

March 8, 2024

New Centers for Disease Control and Prevention datais showing that newly released RSV vaccines are highly effective at keeping infants from becoming hospitalized.

The CDC says nirsevimab was 90% effective at preventing RSV-associated hospitalization in infants during their first RSV season. Nirsevimab wasapproved for babies and toddlers in July 2023.

The real-world usage of nirsevimab so far has outperformed data from clinical trials. Prior to its release, officials said nirsevimab reduced the risk of hospitalizations related to RSV among infants by 70%-75%.

"The current RSV season is the first time nirsevimab was available to protect infants from severe RSV, so the data released today are the first United States estimates of nirsevimab effectiveness in protecting infants against RSV-related hospitalization in their first season of potential exposure to the virus," the CDC said.

The study looked at 699 infants from October 2023 through February 2024. CDC officials did caution that its overall effectiveness may be lower once a full RSV season is complete. Generally, RSV activity declines in late March.

According to the CDC, RSV causes 58,000 hospitalizations annually among children under age 5.

SEE MORE: CDC: 128 pregnant people and 25 infants received the wrong RSV shot

The CDC said those most at risk for RSV include premature infants; very young infants, especially those 6 months and younger; and children younger than 2 years old with chronic lung disease or congenital heart disease.

Adults and older children who are healthy tend to have mild cases if infected. Early symptoms tend to include a runny nose, a decrease in appetite, and cough. Those symptoms can worsen, causing inflammation of the small airways in the lung.

The vaccine is recommended for all infants younger than 8 months born during or entering their first RSV season, if their mother did not get a maternal RSV vaccine. Another option is for pregnant people to get vaccinated during weeks 32 through 36 of their pregnancy if that period falls between September and January.

Trending stories at Scrippsnews.com

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New RSV vaccine 90% effective at preventing infant hospitalizations - WXYZ 7 Action News Detroit

Babies in WA will soon be immunised against RSV but not with a vaccine – The Conversation

March 8, 2024

This week, Western Australia announced a state government-funded immunisation program against respiratory syncytial virus (RSV). Its the first Australian state or territory to do so.

All babies under eight months old and those aged eight to 19 months at increased risk of severe RSV infection will be eligible for the immunisation in WA this year.

RSV can cause serious illness in children, and news headlines have welcomed WAs impending rollout of vaccinations against the virus.

But this immunisation differs from other routine childhood vaccines.

RSV is the most common cause of respiratory infection in young children. By the age of two, almost all children show evidence theyve been exposed to the virus.

Estimates suggest 2-3% of infants are hospitalised with RSV with infection involving the airways and lungs. Infants under three months are at highest risk. RSV can also have long-lasting effects on children theres a well-established link between RSV and subsequent wheezing illnesses and asthma.

RSV can also be a problem for the elderly and people with underlying health conditions such as those with weakened immune systems.

Read more: An RSV vaccine has been approved for people over 60. But what about young children?

Antibodies are a key part of the immune system that protect people against many viral infections, including RSV. Theyre usually generated in response to infection or a vaccine, and work by attaching to proteins on the surface of RSV, therefore preventing the virus from invading the cells that line the airways and lungs.

The problem in newborn babies (who are at the highest risk of severe RSV infection) is that previous vaccines have not generated sufficient antibodies to provide protection.

So, two strategies have been developed to protect young children against RSV. These strategies are both referred to as passive immunisation, because children receive protective antibodies from outside the body. This is different to active immunisation where we give a child a vaccine so they can generate their own antibodies.

One way to deliver passive immunity to young infants is by vaccinating their mothers during pregnancy. Maternal immunisation has been shown to be effective at protecting infants from other infections, including influenza, whooping cough (pertussis), tetanus and COVID.

By delivering a single RSV vaccine to pregnant women, antibodies are generated by the mother and transported across the placenta, providing passive immunity and protection to the baby for around the first six months of life. In a clinical trial, giving an RSV vaccine in late pregnancy reduced RSV in young infants by approximately 70%. But RSV vaccines for pregnant women are not yet available in Australia.

Read more: RSV is everywhere right now. What parents need to know about respiratory syncytial virus

The other passive immunisation strategy relies on manufactured long-acting antibodies (known as monoclonal antibodies), which can be delivered by injection to young children.

This is what will be offered in WA. Nirsevimab (also known as Beyfortus) is a long-acting antibody that Australias Therapeutic Goods Administration (TGA) approved in November 2023.

Nirsevimab binds specifically to RSV and remains in the body for several months after injection. In a key clinical trial nirsevimab was shown to reduce RSV infections by about 75% for up to five months.

Several European countries have recently implemented infant programs with nirsevimab and are reporting significantly lower RSV hospitalisation rates in babies.

Antibody therapies in various forms have been used for more than a century for the prevention and treatment of a range of conditions, dating from serotherapy for tetanus, diphtheria and snake bite in the late 1800s.

Licensed antibody products are rigorously tested in clinical trials and through post-marketing surveillance to ensure their safety.

For nirsevimab specifically, the clinical trial mentioned above included over 1,400 infants. Adverse events were reported at similar rates in the nirsevimab and placebo groups, and no serious adverse events relating to treatment were reported. No significant safety concerns have been identified in the real-world rollout in the northern hemisphere either.

RSV usually takes hold just before the flu season in southern states, and circulates year-round in tropical areas. While influenza almost disappeared during the COVID pandemic, there were ongoing cases of RSV, albeit with a disruption to the normal seasonal pattern.

Since 2022, RSV has resumed its normal seasonal pattern. The WA government says the immunisations will be available from April, which is timely in anticipation of the 2024 season.

Read more: RSV is a common winter illness in children. Why did it see a summer surge in Australia this year?

Free access to an immunisation against RSV should significantly benefit young children and families in WA, keeping children out of hospital this winter.

Whether other states will follow WAs lead is uncertain at this stage, and we dont yet know whether nirsevimab will in time become part of the National Immunisation Program, meaning it would be available for free nation-wide.

Ensuring equitable access, particularly for those at greatest risk of severe RSV infection, must be prioritised to ensure maximum benefit for all children and families.

Nirsevimab is likely to be the first of many tools to prevent RSV in children. A maternal RSV vaccine is currently under assessment by the TGA and Pharmaceutical Benefits Advisory Committee (PBAC). A vaccine for older Australians, Arexvy, is registered and is also being assessed by the PBAC, with additional vaccines expected to be available in the future.

These developments highlight the future of RSV prevention and also the significant potential for monoclonal antibodies to play a greater role in preventing infections as part of public health programs.

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Babies in WA will soon be immunised against RSV but not with a vaccine - The Conversation

New RSV vaccine 90% effective at preventing infant hospitalizations – TMJ4 News

March 8, 2024

New Centers for Disease Control and Prevention datais showing that newly released RSV vaccines are highly effective at keeping infants from becoming hospitalized.

The CDC says nirsevimab was 90% effective at preventing RSV-associated hospitalization in infants during their first RSV season. Nirsevimab wasapproved for babies and toddlers in July 2023.

The real-world usage of nirsevimab so far has outperformed data from clinical trials. Prior to its release, officials said nirsevimab reduced the risk of hospitalizations related to RSV among infants by 70%-75%.

"The current RSV season is the first time nirsevimab was available to protect infants from severe RSV, so the data released today are the first United States estimates of nirsevimab effectiveness in protecting infants against RSV-related hospitalization in their first season of potential exposure to the virus," the CDC said.

The study looked at 699 infants from October 2023 through February 2024. CDC officials did caution that its overall effectiveness may be lower once a full RSV season is complete. Generally, RSV activity declines in late March.

According to the CDC, RSV causes 58,000 hospitalizations annually among children under age 5.

SEE MORE: CDC: 128 pregnant people and 25 infants received the wrong RSV shot

The CDC said those most at risk for RSV include premature infants; very young infants, especially those 6 months and younger; and children younger than 2 years old with chronic lung disease or congenital heart disease.

Adults and older children who are healthy tend to have mild cases if infected. Early symptoms tend to include a runny nose, a decrease in appetite, and cough. Those symptoms can worsen, causing inflammation of the small airways in the lung.

The vaccine is recommended for all infants younger than 8 months born during or entering their first RSV season, if their mother did not get a maternal RSV vaccine. Another option is for pregnant people to get vaccinated during weeks 32 through 36 of their pregnancy if that period falls between September and January.

Trending stories at Scrippsnews.com

Go here to read the rest:

New RSV vaccine 90% effective at preventing infant hospitalizations - TMJ4 News

General Hospital actor fired over vaccine mandate returns to show – NewsNation Now

March 8, 2024

(NEXSTAR) More than two years after being removed from the ABC soap opera General Hospital following a dispute over the COVID-19 vaccine, actor Steve Burton has returned to the show.

Burton appeared on Mondays episode of General Hospital, roughly one month after the actor teased his return in an Instagram video apparently filmed on the shows set.

Hey hey, back at home, Burton told fans at the time.

Burton, who joined the show in 1992 as Jason Morgan, had first revealed to fans in November 2021 that the producers let [him] go because of the vaccine mandate. He explained at the time that he had applied for medical and religious exemptions, but was denied.

ABC confirmed the decision to The Hollywood Reporter in 2021, explaining that the networks policy required cast and crew working in areas where actors werent masked to be vaccinated.

The verified Instagram page for General Hospital shared a video of Burton, 53, on Tuesday.

It just feels really good to be back on set with my people, Burton says during the clip, which also shows him walking on set and explaining how hes approaching his character upon his return.

After leaving General Hospital, Burton reprised his Days of Our Lives role as Navy SEAL Harris Michaels on the shows spin-off miniseries Beyond Salem in 2022, and also on Days last year, USA Today reports. Burton announced last month that he would be leaving the series, but a spokesperson told USA Today that his character will remain on the show for the coming months.

Shortly before Burton left General Hospital, the show parted ways with Ingo Rademacher, who had played Jasper Jax Jacks on the soap opera since 1996, for refusing to complywith the shows vaccine mandate. Rademacher later sued ABC over the mandate, but a Los Angeles judge sided with ABC in the case in June 2023.

In November 2022, most Disney shows dropped their vaccine mandates, Deadline reported. (The Walt Disney Company owns ABC.)

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General Hospital actor fired over vaccine mandate returns to show - NewsNation Now

Health officials recommend additional dose of updated COVID-19 vaccine for people 65+ – RiverheadLOCAL

March 8, 2024

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Health officials recommend additional dose of updated COVID-19 vaccine for people 65+ - RiverheadLOCAL

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