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The table of eligible persons (**determining date for calculating chronological age - 1/11)

What is the RSV virus?

RSV - Respiratory Syncytial Virus - The RSV virus is the main cause of lower respiratory tract infections in children and premature infants. The virus causes an upper respiratory tract infection (URTI) in adults and children, but in premature infants it often develops into a more serious infection affecting the lower respiratory tract (LRTI) and may cause prolonged hospitalization, a stay in intensive care, and even death.

The RSV virus appears seasonally from autumn to spring. The infection is transmitted through sneezing, coughing and the baby's contact with surfaces contaminated with the virus (surfaces/objects that have been in contact with a sick baby or child).

There is no adequate treatment for this virus, therefore prophylactic treatment is extremely important as the right solution to prevent RSV and the complications of the disease.

The symptoms of RSV usually appear for the first time in the form of a mild flu: low fever, runny nose and ear infections. After 3-5 days, the symptoms may worsen if the virus has spread to the lower respiratory tract and manifest itself in coughing, difficulty breathing, rapid breathing and wheezing resulting from the respiratory tract difficulties.

Dr. Bader, Director of the Neonatal and Premature Intensive Care Departments at Bnei Zion Hospital in Haifa, affiliated to the Technion's Faculty of Medicine, explains:

"The RSV virus is most common in the winter months and attacks the entire population of children up to the age of two. If the virus attacks a baby in the first two months of its life, the disease is more severe and develops into pneumonia (bronchiolitis), which in severe cases can cause shortness of breath, respiratory arrest and the need to hospitalize the baby.

In severe cases of the disease, there is even a need to admit the baby to the intensive care unit. Recent studies in the field have shown that newborns at the beginning of their lives or prematures who have developed a serious illness due to RSV, develop short bronchial growth (asthma)."

Premature babies, regardless of the severity of the prematurity, are at risk of serious morbidity due to RSV compared to babies born on time (full term)

The increased risk of RSV morbidity stems directly from 2 main factors:

Lack of antibodies transferred to the fetus through the umbilical cord (maternal antibody) - The passage of the antibodies through the umbilical cord occurs in the third trimester after the 28th week of pregnancy. The level of antibodies at birth is directly related to the week of pregnancy at birth, in addition the level of antibodies is affected by birth weight.
It can be seen that the level of antibodies even at 32-35 weeks is lower in 50% than those of a baby born on time.
Also, only in the 37th week of pregnancy, the level of antibodies is above the desired norm. The level of antibodies that are transferred to the baby from its mother is lower in 53% in premature babies than in full-term babies.

Lack and limited visual development - Premature babies' lungs are not fully developed at birth. Although the lung tissues are present in some premature babies by the 32nd week, they are not fully developed until the 36th week of pregnancy.

Why is the RSV virus dangerous for premature babies?

Risk in the immediate term

  • The virus is highly contagious and can cause severe morbidity in young babies
  • About half of all babies become infected with the virus by the age of one and 85%-100% are infected by the age of two
  • The chance of a premature infected with the virus to be hospitalized is 2 times greater than that of a baby born on time
  • Premature babies born in relatively late weeks are also more likely to be hospitalized after contracting the virus than children born on time
  • The RSV virus is the number one cause of hospitalization in infants up to one year of age and the main cause of viral pneumonia in children up to 5 years of age
  • The RSV virus causes about 40% of all hospitalizations from pneumonia in children and may cause prolonged hospitalization and even a stay in intensive care
  • Tens of thousands of babies in the world die from this virus

Long term risk

Prematurity virus can cause complications in the lower respiratory tract in the long term. New studies have found that in addition to the danger posed by the prematurity virus in the immediate term, it may cause complications in the lower respiratory tract throughout childhood. Epidemiological data show a link between hospitalization at a young age as a result of RSV infection and chronic respiratory complications such as recurrent wheezing and asthma that may persist into adolescence.

In several large studies, it was found that the development of lower respiratory tract infections due to RSV infection in the first two years of life is a risk factor for the future development of wheezing and repeated wheezing up to the age of 11.

RSV prophylaxis

There is a preventive treatment called Abbosynagis that is given every month during the winter months (November-March) that is included in the health basket and is given free of charge to those who are eligible:

  • Premature babies, who have chronic lung disease and need oxygen treatment - up to two years of age.
  • Premature infants, with lung disease diagnosed by a typical chest x-ray and clinical signs (BPD - bronchopulmonary dysplasia) at a corrected age of 36 weeks of pregnancy and who required treatment with one of these: oxygen, diuretics, corticosteroids (steroids) or bronchodilators - up to the age of one year.
  • Premature babies born up to week 32+6, if they are not yet one year old on the first of November in that winter season (a baby born after the first of November will also be vaccinated in the next season).
  • Premature babies born up to week 34+6, if they are not yet six months old on the first of November in the same season.
  • Babies, regardless of the week of birth, born under the weight of 1 kg - up to the age of one year.
  • Babies, regardless of the week of birth, who suffer from severe chronic lung disease - up to the age of one year.
  • Babies who suffer from congenital heart disease and if one of the following conditions is met, up to the age of one year:
    • - Babies receiving medical treatment for heart failure
    • - Babies with moderate to severe pulmonary hypertension
    • - Babies with cyanotic (cyanotic) heart disease

The first vaccination was given in preterm infants near release (in season only). The baby will receive the following vaccinations in the community and will be summoned to receive them by the health insurance fund.

All children entitled to preventive treatment must continue to be given the preparation until the end of the overactive season of the virus.

It is important for parents to be aware of their eligibility and assert their right to receive the vaccine.

The importance of giving 5 doses of vaccine during the RSV

All studies, including the registration study, tested the treatment effectiveness of 5 monthly treatments during the entire RSV season.

Hand and colleagues showed in a study published in 2008 in Pediatr Infect Dis that among premature infants who missed 1 in 5 vaccines, an increased rate of RSV-only hospitalizations and unplanned doctor visits was observed.

Administering consecutive monthly treatments throughout the season allows reaching serum levels of over 40 micrograms per milliliter, while inconsistent administration at a monthly level during the season does not allow reaching this desired level, resulting in an increase in hospitalizations.

Summary of a study indicating a decrease of 50% in repeated wheezes among premature infants who received Abbosynagis compared to the control group:

The purpose of the study:

Children who experienced RSV infection in the lower respiratory tract at the beginning of their lives have an increased risk of repeated wheezing in the respiratory system. Palivizumab (monoclonal antibody) showed efficacy of 80% in preventing hospitalizations due to RSV among premature infants without chronic lung disease.

It is hypothesized that preventing RSV infection among premature infants may reduce recurrent wheezing among premature infants.

Methods:

191 premature infants who received prophylactic treatment against the RSV virus were compared to 230 premature infants who did not receive prophylactic treatment. A prospective follow-up was carried out for two years, when rates of repeated wheezes were checked, both by parental reports and by a doctor.

Results:

Among the premature infants who received the preventive treatment, a decrease of 50% was observed in rates of repeated wheezes, including repeated wheezes diagnosed by a doctor (26% vs. 16% and 13% vs. 8%).

conclusion:

The study indicates that preventing infection with the RSV virus - in the lower respiratory tract by giving prophylactic treatment, can reduce repeated wheezing among premature infants

The clinical experience in Israel

In Israel, as in the Western world, hospitalizations for respiratory reasons are the main cause of hospitalization among newborns up to one year of age. In Israel, the number of hospitalizations caused by RSV is estimated at about 4,100 hospitalizations (Prof. Somech, 2008).

It can also be seen from the data of the infectious diseases unit in Soroka that infections in the lower respiratory tract are the main reason for visits to the emergency room, both among the Jews and among the Bedouins.

The effectiveness of the treatment in Israel was studied at Shaare Zedek Hospital, which has a birth rate of about 12,000 births per year, and the Soroka Medical Center, which is the leader in the number of births in Israel (about 16,000 births per year).

At the Shaare Zedek Medical Center, a review was performed on the data of premature infants up to week 29 who received vaccination during 5 consecutive years 2002-2007 (5 consecutive winters) and it was found that out of 159 premature infants, no one was hospitalized with a diagnosis of RSV during 5 consecutive seasons. It can be seen that the average duration of hospitalization was 4.96 days among the non-vaccinated population.

At the Soroka Medical Center headed by Prof. Asher Tal, Director of the Pediatric Department B, the effectiveness of the vaccine in reducing the average length of hospitalization for those hospitalized due to RSV out of 94 premature infants up to week 29 was investigated against a control group (premature infants who did not get vaccinated at all or received less than 3 vaccinations), between The years 2001-2007.

The average duration of hospitalization decreased by 46%. From 9.4 days on average among the control group to 5.1 among the children who received Abbosynagis.

Activity of the Lehab association to expand the basket of medicines

The year 2001

  • Premature babies and babies born prematurely up to the age of two who have chronic lung diseases and need oxygen therapy
  • Premature babies and infants born prematurely up to one year of age with pulmonary disease (BPD) diagnosed on a chest x-ray at a corrected age of 36 weeks of gestation and required treatment with one of the following: oxygen, diuretics, corticosteroids or bronchodilators
  • Premature babies and babies born prematurely and before they are one year old, if they were born before 28 weeks of pregnancy

The year 2009

  • Premature babies born between the 29th week of pregnancy and the 31st week + six days - up to one year after birth

The year 2011

  • Premature babies and those who were born prematurely and less than a year old, if they were born before 32 weeks of pregnancy + 6 days. (expansion of the label included in the basket)

The year 2014

  • Expanding the framework of inclusion in the basket for prematures and those born prematurely and less than six months old, if they were born before 34 weeks of pregnancy + 6 days.

2021-2022 year

  • Due to the corona epidemic, the overall winter illness broke out late and as of May 21 we witnessed an alarming outbreak of infection with the RSV virus. The vaccine for the RSV virus is usually given in the period between fall and spring, and premature babies then receive a vaccine against it, the vaccine is included in the medicine basket, but due to the unusual outbreak, we worked to promote the vaccine.
  • An advisory committee to the Ministry of Health met in June and recommended that the vaccination season be brought forward and we bLHB association We worked hard to implement this recommendation, including Appeal to the Minister of Health, Mr. Nitzan Horowitz.
  • The unusual morbidity season lasted from August 1, 2021 to October 31, 2021, after which the vaccine was given according to the usual guidelines.
  • Towards the end of the "normal" season, already on February 22, we recognized that there is no decline in RSV cases and that it will not be enough to vaccinate the premature babies until the end of March only. In light of data on continued high morbidityWe turned to the Ministry of Health with concern and the association of neonatologists to consider continuing the vaccination of premature infants, as long as the level of morbidity is so high.
  • On 3/27/22, following the letters of the Lehab association, the vaccination committee at the Ministry of Health unanimously recommended extending the continuation of premature RSV vaccination due to high activity of the virus in Israel, to at least April and May.
  • On 4/4/22, the Ministry of Health issued a directive to vaccinate all eligible premature infants. The meaning: all premature babies who are released from the nursery should receive a vaccination in the nursery. All premature babies who received a vaccine dose in March will receive another dose in April.

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