<h2>RSV Is a Common Respiratory Virus With Symptoms Varying by Age-Group</h2>

Abbreviation

References

<h2>RSV Causes Substantial Disease Burden for Newborns and Infants Globally</h2>

Based on 2019 global data.

Reference

RESPIRATORY-SYNCYTIAL-VIRUS

VACCINES

Burden of Disease

<h2>RSV is a Leading Cause of LRTIs Among Infants Worldwide1,2</h2>
Estimated Percentage of acute LRTI attributable to RSV infection

LRTI, lower respiratory tract infection. 
 Data&nbsp;are derived from different studies and over different years.
aOnly includes hospitalizations due to bronchiolitis; bRSV was a cause of 28% of all hospitalization cases in infants in France.&nbsp;

<h2>Prevalence in RSV hospitalized with bronchiolitis during seasonal epidemics</h2>

&nbsp;aCoronavirus type OC43, 229E, NL63, and HKU1. Age range of children not specified.

<h2>RSV Average Hospitalization days</h2>

<h3>6.5 days in hospital</h3>
total of 754 beds (502 inpatient beds, 56 emergency beds, 77 ICU beds, 32 psychiatry beds, and 87 special auxiliary beds).

AComorbidities assessed: congenital cardiopathies, 2.3%; congenital defects with cardiac affectation, 0.7%; prematurity, 0.3%; &#xb;bronchopulmonary dysplasia, 1%.

<h2>RSV Causes Substantial Hospitalization Among All Infants and Young Children In Spain</h2>
Epidemiologic survey in Spain estimating the burden of RSV in all&nbsp;children &lt;5 years of age during a 15-year period (1997–2011)1

Due to bronchiolitis in children &lt;5 years of age

326,175
 hospital discharges

on average in children ≤2 years of age

5.9 days
 in hospital

highest incidence among all age ranges

4,136/100,000 incidence of hospitalization during 1st year of life

355 (80%)&lt;12 months of age 335 (75%) without comorbidities*

446
 deaths

Only 3.2% of children &lt;5 years of age presented with ≥1 comorbidity*

96.8 %&nbsp;of children were otherwise healthy

<h2>RSV Classification</h2>
RSV is a 15 kb negative sense single stranded RNA virus encoding 11 proteins1,2

Abbreviations

Humans and chimpanzees are the&nbsp;only known natural hosts&nbsp;for human RSV, although a variety of small animal species may be experimentally infected with RSV (Calves, Ferrets, Rodents)2. Currently, there is&nbsp;no known RSV reservoir&nbsp;in the off-season5.

RSV is one of the&nbsp;last major causes&nbsp;of serious paediatric infections for which&nbsp;no vaccine&nbsp;or other&nbsp;wide-scale intervention&nbsp;is available1

RSV History

<h2>RSV is classified into two subtypes – RSV-A and RSV-B; based on variation in the G protein1</h2>

<h3>Appearance of RSV-A and RSV-B genotypes and dominance over time (1961–2014)1</h3>

<ul>
 <li>RSV-A and -B diverged in 17664</li>
 <li>RSV-A and RSV-B co-circulate</li>
 <li>Dominance shift between RSV-A and RSV-B types every 1-2 years2</li>
 <li>There are no significant differences in severity between RSV-A and B2</li>
</ul>
RSV-A
<ul>
 <li>9-16 distinct genotypes(GA1-GA7, SAA1, NA1-4 and ON1)3,5</li>
</ul>
RSV-B
<ul>
 <li>22-32 distinct genotypes(BA1-14, GB1-GB5, SAB1-4, URU1-2, NZB1-2, BA-CCA, BA-CCB, BA-C, CBB and CB)4,5</li>
</ul>
No consensus on RSV genotype definition6

<ul>
 <li>RSV&nbsp;is an enveloped, medium-sized (120 to 300 nm)&nbsp;RNA&nbsp;virus2</li>
 <li>Nonsegmented, single-stranded, negative-sense genome2</li>
 <li>The&nbsp;viral envelope&nbsp;has a bilipid layer derived from the plasma membrane of the host cells2</li>
 <li>Its surface has transmembrane surface glycoprotein spikes 11 to 12 nm in length and 6 to 10 nm apart2</li>
 <li>The&nbsp;10 viral genes&nbsp;are depicted by the divided bars2</li>
 <li>Each viral gene transcribes a single messenger RNA (mRNA) encoding a single protein, with the exception of M2 mRNA, which transcribes two proteins, M2-1 and M2-22</li>
</ul>

<h2>RSV Is Seasonal, With Peak Incidence Varying by Region1,2</h2>

<ul>
 <li>Temperate countries in the&nbsp;Northern Hemisphere&nbsp;generally experience the start of the RSV season between September and January.</li>
 <li>Those in the&nbsp;Southern Hemisphere&nbsp;generally experience the start of the RSV season between March and June, closely aligned with colder temperatures.</li>
 <li>The seasonality of RSV in&nbsp;(sub)tropical climates&nbsp;appears less consistent—with studies indicating peak of RSV season closely aligns with the rainy season and/or higher temperatures.</li>
</ul>

black

<h2>RSV is a highly transmissible viral disease</h2>

<ul>
 <li>RSV&nbsp;is transmitted by respiratory droplets and considered “highly contagious”9-11</li>
 <li>R0&nbsp;of&nbsp;&nbsp;4.5 
 mean R0&nbsp;ranging from 1.7 to 8.212</li>
</ul>

<h2>RSV shedding in Infants, toddlers and immunecompromised</h2>

Duration of Virus Shedding in Infants and Toddlers

Duration of Virus Shedding in Immunecompromised patients

<h2>Most Infants Are Exposed to RSV Infection in the Community and Through Other Children1-3</h2>

Crowding and day-care exposure significantly increased the risk of severe RSV disease4-6

In the United States,&nbsp;more than 50 per cent of under-ones&nbsp;are in some form of childcare;&nbsp;~75% from the age of 4 months7
Network showing the sources of infection to the infant, as identified by social relationships in Kenya.1 The size of the circles is proportional to the number of cases.

All Infant Protection

RSV is a leading cause of hospitalization in all infants

All infants need protection from RSV

<h2>Most Hospitalizations for RSV occur in Healthy Full Term Infants1-3</h2>

<a href="https://publications.aap.org/pediatrics/article-abstract/132/2/e341/31332/Respiratory-Syncytial-Virus-Associated?redirectedFrom=fulltext?autologincheck=redirected">Respiratory Syncytial Virus–Associated Hospitalizations Among Children Less Than 24 Months of Age | Pediatrics | American Academy of Pediatrics (aap.org)</a>
aEstimate includes previously healthy premature subjects &lt;37 weeks’ gestation, and less than 2 years old.

<h2>RSV Infant ICU Admissions and Mechanical Ventilation in the US1</h2>
Surveillance through the Influenza Hospitalization Surveillance Network from October 2014-April 2015

Infant RSV ICU Admissions&nbsp;(n=336) 
 &nbsp;
<ul>
 <li>26%&nbsp;(221/851) of hospitalized&nbsp;healthy term infants&nbsp;were admitted to&nbsp;ICU1</li>
</ul>

Infant RSV Requiring Mechanical Ventilation&nbsp;(n=82)
<ul>
 <li>22% (49/221)&nbsp;of ICU admitted&nbsp;healthy term infants&nbsp;required&nbsp;mechanical ventilation1</li>
</ul>

CMC: chronic medical condition (includes chronic lung disease, cardiovascular disease, upper airway abnormality, asthma, neurologic/neuromuscular conditions, blood disease, renal disorder, immunocompromised, chronic metabolic disease, liver disease, and other);&nbsp;ICU: Intensive Care Unit; Preterm: born at &lt;37 weeks gestational age; Term: born at 37+ weeks gestational age. Data from the US, % of Infant RSV ICU admissions may vary in other countries.
<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7107566/">Estimated Burden of Community-Onset Respiratory Syncytial Virus–Associated Hospitalizations Among Children Aged &lt;2 Years in the United States, 2014–15 - PMC (nih.gov)</a>

<h3>"There is an urgent and universal need to develop products to reduce child mortality and morbidity through prevention of RSV disease"+</h3>
Ruth A. Karron, 
 MD Center for Immunization Research Department of International Health Johns Hopkins Bloomberg School of Public Health Baltimore, MD, USA Science. May 14, 2021:Vol. 372, Issue 6543, pp 686-687.

<h3>"Because most children hospitalized with RSV have no underlying medical condition or history of prematurity, interventions against RSV used to broadly target all young infants are likely to result in the greatest impact. "</h3>
Brian Rha, MD MSPH 
 Division of Viral Diseases Centers for Disease Control and Prevention Atlanta, GA, USA Pediatrics. July 2020: Vol. 146, Issue 1, p. e20193611.

<h3 style="text-align: center;">Methods</h3>

Compare passive immunization with LA mAb for all infants to the current standard of care using a static decision-analytic model in a cohort of KSA infants experiencing their first RSV season 
 &nbsp;
Subpopulations: 
 &nbsp;
<ul>
 <li>term and late preterm infants (≥35 wGA)</li>
 <li>Healthy preterm infants (29w GA - 34w6d GA, not eligible for palivizumab)</li>
 <li>palivizumab-eligible infants* 
 According to the SIBRO guidelines</li>
</ul>

STUDY DESIGN

Entire KSA infant birth cohort(&lt;12 months of age) during their 1st RSV season 
 (October – March)

PARTICIPANTS &amp; SEASON

Standard of Care:&nbsp;healthy infants born at least 29w GA, administered monthly to eligible infants during the season LA mAb (Nirsevimab) Single dose administered to all infants at the beginning of the RSV season or at birth

IMMUNIZATION STRATEGIES

Static decision-analytic model 
 RSV burden and nirsevimab impact were considered and stratified by: 
 &nbsp;
<ul>
 <li>Population-based approach (comorbidities, monoclonal antibody)</li>
 <li>Age-based approach</li>
</ul>

ANALYSIS

<h3 style="text-align: center;">Assumptions</h3>
Hospitalizations rates per age groups &amp; subpopulations in local birth cohort in KSA
2021 Saudi birth = 509,139

<h4>Highest risk of hospitalizations</h4>
Per subpopulation
<ul>
 <li>Palivizumab eligible: early preterm ≤28 weeks of GA, with CHD or CLDP</li>
 <li>Preterm infants &gt;28 weeks of GA</li>
</ul>
Per chronological age
<ul>
 <li>with risk decreasing with increasing age in months</li>
</ul>

CHD,&nbsp;congenital heart disease;&nbsp;CLDP,&nbsp;chronic lung disease of prematurity;&nbsp;GA,&nbsp;gestational age; mo, month. 
 Ahmed A, Parveen S, Al-Hassinah SM, Al-Amery SF. An overview of respiratory syncytial virus infections in Saudi Arabia. The Journal of Infection in Developing Countries. 2018;12(11):929-36

<h3 style="text-align: center;">Results</h3>
Disease burden under the current standard of care

<h3 style="text-align: center;">428,264 RSV cases 
 84%&nbsp;from KSA birth cohort</h3>
Distribution of RSV MALRTIs by health event over the first RSV season of KSA infants 
 &nbsp;

<h3 style="text-align: center;">SAR ~607 million</h3>
Direct economic burden of RSV in infants
Distribution of RSV MALRTIs by related direct medical costs over the first RSV season of KSA infants

Percentages may not add to 100% due to rounding. All costs are in 2021 United States dollars. ED,&nbsp;emergency department;&nbsp;ICU,&nbsp;intensive care unit;&nbsp;MV,&nbsp;mechanical ventilation;&nbsp;LRTI,&nbsp;lower respiratory tract illness;&nbsp;MA,&nbsp;medically attended;&nbsp;RSV,&nbsp;respiratory syncytial virus;&nbsp;SoC,&nbsp;standard of care;&nbsp;US,&nbsp;United States.

<h2>Red Flags</h2>
<ul>
 <li>
 84 % from KSA birth cohort infected annually by RSV</li>
 <li>
 Among those hospitalized, 18% were admitted to a PICU , and 2% required MV</li>
 <li>
 RSV hospitalized cases accounted for &lt;6% of overall RSV-LRTIs burden, the associated with 60% direct cost.</li>
 <li>
 607 million Annually direct cost of RSV burden in Saudi Arabia</li>
 <li>
 Indirect effects were not captured, so potential benefits on indirect costs and virus spread were not estimated</li>
</ul>

<h3 style="text-align: center;">Results</h3>
Impact of LA mAb for all KSA infants
Cases Vs budget saving

<h3>Reduce RSV cases by more than 50% and associated healthcare costs by more than 60%</h3>
*Includes hospitalization that resulted in ICU admission or MV.
ED,&nbsp;emergency department;&nbsp;ICU,&nbsp;intensive care unit;&nbsp;MV,&nbsp;mechanical ventilation;&nbsp;RSV,&nbsp;respiratory syncytial virus;&nbsp;US,&nbsp;United States.

RSV Burden in Infants

Rattle is a global&nbsp;network of RSV experts&nbsp;that leverages up-to-date&nbsp;scientific content and evidence&nbsp;to engage in&nbsp;multichannel medical education&nbsp;and reinforce the need to&nbsp;protect all infants&nbsp;against RSV. Rattle is being developed to provide healthcare providers, or HCPs, the latest scientific and clinical information to challenge the status quo in RSV by:
<ul>
 <li>Increasing awareness of RSV</li>
 <li>Facilitating dialogue around RSV</li>
 <li>Deepening understanding of RSV</li>
 <li>Supporting knowledge exchange about the need for protection against RSV in all infants Rattle&nbsp;uses a sharing-best-practice philosophy for its programs, protagonized by a global network of RSV experts who guide the development of resources to support HCP educational needs regarding RSV for audiences worldwide.</li>
</ul>

Rattle

<h2>RSV is a highly transmissible viral disease</h2>
<h3>Vision</h3>
A world-known medical education program that shattered the status quo and brought to life the need for an all-infant focus
<h3>Mission</h3>
Leverage high-quality medical evidence and global experts through a medical education program to reinforce the need to protect all infants

<ul>
 <li>
 <h3>RSV Epidemiology</h3></li>
 <li>
 <h3>RSV Burden&nbsp;of&nbsp;Disease</h3></li>
 <li>
 <h3>RSV Immunology&nbsp;&amp; Pathophysiology</h3></li>
 <li>
 <h3>RSV Prevention</h3></li>
 <li>
 <h3>RSV Clinical&nbsp;Management</h3></li>
</ul>

Learn more about the Rattle Education programme

Eligibility considerations regarding Nirsevimab were as follows:
<ul>
 <li>Clinicians should target the administration of Nirsevimab in the 1st week of life for infants born shortly before and during the RSV season.</li>
 <li>ALL infants aged 12 months born during or going into their first RSV season are recommended to receive one dose of Nirsevimab.</li>
 <li>Toddlers aged 13–24 months who are at increased risk of severe RSV disease are recommended to receive one dose of Nirsevimab.</li>
 <li>An immunoprophylaxis strategy in the KSA for all infants during their first RSV season is strongly recommended to dramatically reduce the RSV burden and use of health‐care resources.</li>
</ul>

The SIBRO panel recommends RSV mAb as a prevention strategy that&nbsp;should be inserted into routine immunization calendars
RSV:&nbsp;Respiratory syncytial virus;&nbsp;mAb:&nbsp;monoclonal antibody

<h2>Saudi Initiative of Bronchiolitis Diagnosis, Management, and Prevention (Nirsevimab administration guide)</h2>

Respiratory syncytial virus; mAb: monoclonal antibody

<table border="1" cellpadding="1" cellspacing="1" style="width:100%;">
 <tbody>
 <tr>
 <td colspan="4">Recommendations for Nirsevimab Immunoprophylaxis</td>
 </tr>
 <tr>
 <td colspan="4">*The recommended interval between the last dose of palivizumab and a dose of Nirsevimab (in High-risk Infants) is 1 month (similar to the interval if the infant were to receive another dose of palivizumab).[5]</td>
 </tr>
 <tr>
 <td colspan="4">&amp; The recommendations for Nirsevimab for high-risk children apply to infants and children recommended to receive palivizumab. [1]</td>
 </tr>
 <tr>
 <td colspan="4">
 <ul>
 <li>To realize the full benefits of mAbs before each season, it is recommended that age-eligible infants be recalled at the start of the RSV season before they become ineligible based on age if nirsevimab is available</li>
 <li>Administering nirsevimab through the end of the season is important because the risk of severe disease is highest during the first few months of life [31]</li>
 </ul></td>
 </tr>
 <tr>
 <td colspan="4">
 #&nbsp;Maternal vaccination efficacy is not established in:
 <ul>
 <li>Women with high-risk pregnancies such as multiple pregnancy, pregnancy induced or chronic diseases, evidence of placental insufficiency or fetus/newborn with major congenital anomaly</li>
 <li>Infants who have undergone cardiopulmonary bypass or extracorporeal membrane oxygenation leading to loss of maternal antibodies.</li>
 <li>Infants with substantial increased risk for severe RSV disease (eg, hemodynamically significant congenital heart disease, intensive care admission and requiring oxygen at discharge).</li>
 <li>Infant born within 14 days of maternal RSV vaccine [58]</li>
 </ul></td>
 </tr>
 <tr>
 <td colspan="4">@&nbsp;High-risk infants who are hospitalized or still in NICU during the season should get the recommended schedule. Also, eligible infants at the beginning of the season and ready for discharge from NICU should receive the first dose up to 72 hours prior to discharge. [28]</td>
 </tr>
 <tr>
 <td colspan="4">^The mAb included Palivizumab &amp; Nirsevimab does not interfere with the immune response to live or inactivated vaccines. The childhood immunization schedule should be followed for all children, regardless of mAb use [30]</td>
 </tr>
 <tr>
 <td colspan="1" rowspan="5">Intramuscular (IM) injection Use a 22–25-gauge needle. [5]</td>
 <td style="text-align: center; vertical-align: middle;">Age</td>
 <td style="text-align: center; vertical-align: middle;">Needle length</td>
 <td style="text-align: center; vertical-align: middle;">Injection site</td>
 </tr>
 <tr>
 <td style="text-align: center; vertical-align: middle;">Newborns (1st 28 days)</td>
 <td style="text-align: center; vertical-align: middle;">⅝"a</td>
 <td style="text-align: center; vertical-align: middle;">Anterolateral thigh muscle</td>
 </tr>
 <tr>
 <td style="text-align: center; vertical-align: middle;">Infants (1–12 months)</td>
 <td style="text-align: center; vertical-align: middle;">1"</td>
 <td style="text-align: center; vertical-align: middle;">Anterolateral thigh muscle</td>
 </tr>
 <tr>
 <td style="text-align: center; vertical-align: middle;">Toddlers (1–2 years)</td>
 <td style="text-align: center; vertical-align: middle;">1–1¼"</td>
 <td style="text-align: center; vertical-align: middle;">Anterolateral thigh muscle c</td>
 </tr>
 <tr>
 <td style="text-align: center; vertical-align: middle;">&nbsp;</td>
 <td style="text-align: center; vertical-align: middle;">⅝b–1"</td>
 <td style="text-align: center; vertical-align: middle;">Deltoid muscle of arm</td>
 </tr>
 </tbody>
</table>
RSV=Respiratory syncytial virus, CLD=Chronic lung disease, IM=Intramuscular, mAbs=Monoclonal antibodies, NICU=Neonatal intensive care unit

<ul>
 <li>Immunoprophylaxis for high-risk infants should be administered during the regular follow-up in high-risk infants’ specialized clinics.</li>
 <li>The first choice of RSV immunoprophylaxis is Nirsevimab. Alternatively, Palivizumab is to be considered in case of unavailability of Nirsevimab.</li>
 <li>If Palivizumab was administered in the previous RSV season.&nbsp;Nirsevimab is to be given for the next season.</li>
 <li>If Palivizumab was administered initially for &lt;5 doses in the season,&nbsp;one dose of Nirsevimab is recommended. No further Palivizumab is needed.</li>
 <li>In the context of a limited supply of Nirsevimab, it is recommended to suspend using Nirsevimab in Palivizumab-eligible children.</li>
</ul>

Considerations for high-risk infants

RSV: Respiratory syncytial virus

The first choice of RSV prevention is Nirsevimab;
  alternatively, palivizumab is to be considered in case of unavailability of Nirsevimab.

Saudi initiatives on Bronchiolitis Recommendations

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Respiratory syncytial virus

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