Europe Approves Single-dose RSV Option for Infants

The European Commission became the first regulatory body to approve preventing respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season with passive immunization.

AstraZeneca and Sanofi’s Beyfortus® (nirsevimab) approval in the European Union was announced on November 4, 2022.

However, the actual availability date in Europe was not disclosed today.

Beyfortus is the first single-dose immunization against RSV for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions.

Beyfortus has also been granted regulatory designations to facilitate expedited development by several major regulatory agencies worldwide, including China, Japan, and the U.S.

It was developed to offer newborns and infants direct RSV protection via an antibody to help prevent lower respiratory tract infections (LRTI) caused by RSV. 

RSV is a common respiratory virus. According to the U.S. CDC, most people recover in a week or two, but RSV can be serious, especially for infants and older adults.

Recent CDC surveillance has shown an increase in RSV-associated emergency department visits and hospitalizations in multiple U.S. regions, with some regions nearing seasonal peak levels. 

The recommended dose of Beyfortus is a single intramuscular injection of 50 mg for infants with body weight <5 kg and a single intramuscular injection of 100 mg for infants with body weight ≥5 kilograms.

Unlike vaccines, long-acting monoclonal antibodies (mAbs) do not require the activation of the immune system to help offer timely, rapid, and direct protection against disease.

Single-dose long-acting mAbs have the potential to be used within the routine immunization schedule.

mAbs are, in general, more expensive to produce than vaccines.

However, given the small dose of mAb required to protect infants against RSV and given new manufacturing technologies, the cost of preventive RSV mAbs could be relatively low.

World Health Organization (WHO) recently published preferred product characteristics for maternal and pediatric RSV vaccines and monoclonal antibodies to prevent severe RSV disease in infants. 

The WHO is also developing regulatory considerations on the preclinical and clinical evaluation of mAbs for infectious diseases, including a supplementary document specific to preventive RSV mAbs.

Manufacturers will need to apply for WHO prequalification of licensed products to facilitate procurement by UN agencies and Gavi financing.

Additional RSV vaccine and mAbs development news are posted at PrecisionVaccinations.com/RSV.

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