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Vaccines and treatments against RSV, on an ever closer horizon

Half the world’s health systems are facing what has been defined ‘triplemia’: the coincidence in time of respiratory syncytial virus (RSV), influence yes COVID-19. Particular attention should be paid to the first of these, since pediatric units have (and are) suffering from overcapacity due to the alarming rate of hospitalizations of children under 5 in the United States and Europe.

For example, in Spain, this virus —cause of most bronchiolitis in infants—, did register the emergency services 50% increase in episodes witnessedcompared to what was calculated in the months of November of the other years.

RSV is a pathogen that infects the respiratory tract. In infants and toddlers, it affects the lower respiratory tract (IRT) and is the most common cause of bronchiolitis and pneumonia in children younger than 1 year.. The virus can also infect the upper respiratory tract (TRS) in adults and causes a picture similar to a common cold. And while it’s more common in infants and children, it’s starting to be a leading cause of breathing problems in older adults. In fact, it has been identified as the cause of approximately 10% of hospital admissions in the elderly population..

Unlike the other two respiratory diseases that make up the aforementioned ‘tripledaemia’, it is the only one for which there are no approved vaccines yet. Now that may change soon.

Earlier this month, Pfizer announced that the US agency FDA had accepted for priority review the biological license application (BLA) of your RSV vaccine candidate (PF-06928316 or RSVpreF) in people over the age of 60, thanks to the results of the RENOIR Atelier.

If approved, what could happen in May as highlighted Nature, would become the first vaccine against this pathogen. Similarly, in another clinical study by the company, MATISSEthe same vaccine has also shown positive results against the virus in pregnant women. Specifically, yese A vaccine efficacy of 81.8% against severe disease was observed in neonates from birth to the first 90 days of life, and an efficacy of 69.4% during the first six months of life.

The effectiveness of the vaccine PF-06928316 or RSVpreF is supported by Phase 3 clinical trial results (NCT05035212) RENOIR: Study on the efficacy of the RSV vaccine in the elderly immunized against the virus.

Phase 3 clinical study (NCT04424316) MATISSE evaluates the efficacy and safety of RSVpreF in infants born to women vaccinated during pregnancy.

For his part, GSK’s vaccine candidate for the elderly against RSV shows a reduction in severe disease of 94.1% and overall efficacy of 82.6% in a clinical study.

The data, which was presented in the IDWeek Congress 2022have been hailed as “truly exceptional”, since VRS today “continues to be one of the major infectious diseases without vaccinedespite more than 60 years of research”, as stated by Tony Wood, Chief Scientific Officer of GSK.

It was observed a high efficacy of the GSK vaccine against serious diseases of the lower respiratory tract (TRI) (94.1 percent), consisting of adults aged 70 to 79 years (93.8 percent) and adults with underlying comorbidities (94.6 percent).

Monoclonal antibodies

In addition to vaccines, when it comes to treatments, until a few months ago only one drug was available to combat RSVthe monoclonal antibody Synagogue (palivizumab), originally developed by the pharmaceutical company MedImmune, in Gaithersburg, Maryland (USA). However, the high cost and its monthly administration do not allow its use as a universal prophylaxis.

However, on November 4, Beyfortus (nirsevimab, Sanofi and AstraZeneca) has received authorization from the European Commission (EC) for the prevention of TRI infection caused by RSV in neonates and infants.

beyfortus is a monoclonal antibody directed against the Ø epitope of the prefusion configuration of the protein F, which is 50 times more potent than palivizumab and with a single injection maintains protective levels for at least 150 days, according to the Spanish Association of Pediatrics (AEV).

Therefore, an important therapeutic arsenal may soon be available to combat RSV.

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