BELGIUM — The European Commission (EC) has granted approval for AstraZeneca and Sanofi’s Beyfortus (nirsevimab) to prevent respiratory syncytial virus (RSV) lower respiratory tract disease (LRTI) in newborns and infants.

Indicated for usage in infants during their first RSV season, Beyfortus is said to be the first single-dose RSV passive immunization for this population. Beyfortus is a long-acting antibody.

It can be used in infants including those at term or preterm, born healthy, or with some health conditions.

RSV is a common respiratory virus that typically causes mild, cold-like symptoms, but it can cause serious illness, particularly in older adults and infants.

RSV kills approximately 102,000 children each year around the world. Half of these deaths occur in infants under the age of six months, with the vast majority occurring in developing countries.

RSV bronchiolitis is the leading cause of infant hospitalization due to viral respiratory illness, which causes respiratory distress and can lead to death.

RSV has no specific treatment, only supportive care measures such as oxygen and fluids. There is currently no RSV vaccine available.

The European Commission became the first regulatory body to approve the antibody injection, clearing it for use in all newborns before their first RSV season, Sanofi said in a statement.

In clinical trials, a single shot reduced the likelihood that the babies would require medical attention for pathogen-induced lower respiratory tract infections.

The recommended dosage is 50mg intramuscular dose of Beyfortus in infants with body weight less than 5kg, and 100mg for those weighing 5kg and above.

AstraZeneca and Sanofi have also submitted the clinical trial data to the FDA and expect to finalize their application to the agency by the end of this year.

Analysts expect Beyfortus, which is being developed under a 2017 agreement between the companies, to generate sales of more than US$800 million in 2026.

Synagis, developed by AstraZeneca but sold in the United States by Swedish Orphan Biovitrum, is an existing preventive option only for high-risk infants. To cover a typical RSV season, up to five injections are required.

New options for protecting babies are likely to emerge. Pfizer has announced that its experimental RSV vaccine was effective in preventing severe infections in infants when given to pregnant women in the second half of their pregnancy.

Pfizer’s vaccine candidate is administered to pregnant women who then make antibodies that cross the placenta and protect the baby after birth.

The vaccine demonstrated nearly 82% efficacy against severe RSV in infants from birth to the first 90 days of life in the clinical trial.

Following that, the vaccine demonstrated a still-high efficacy of 69.4% during the first six months of life.

Pfizer’s RSV vaccine candidate, if approved, could be the first maternal vaccine available to help prevent RSV in young infants.

Pfizer is currently the only company developing an RSV vaccine for both infants and older adults.

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