EU Approves First Monoclonal Antibody To Prevent RSV In All Children As U.S. Cases Surge

Topline

The European Commission on Friday approved the first monoclonal antibody to prevent respiratory syncytial virus (RSV) among all infants and newborns, amid a rise of cases of the highly contagious virus, which can pose a danger to infants and older adults.

Key Facts

The European Commission approved Beyfortus, an injection manufactured by AstraZeneca and Sanofi to be given to infants from birth through their first RSV season—which typically begins in late fall—to protect against the virus, which is the most common cause of lower respiratory tract infections like bronchiolitis and pneumonia in infants.

It’s the first regulatory body to approve the injection, basing its decision on clinical trial results, which showed Beyfortus was safe compared to a placebo and reduced the incidence of lower respiratory tract infections caused by RSV by 74.5%, according to the pharmaceutical companies.

The approval marks a “significant achievement for the scientific community” to address a “persistent, global unmet need in RSV prevention, Iskra Reic, the executive vice president of vaccines and immune therapies at AstraZeneca, said in a statement.

News Peg

U.S. hospitals have been overwhelmed by cases of RSV among children in recent weeks, which comes as experts also sound alarms about an earlier than expected flu season and a potential winter surge of Covid-19. Cases of RSV, an infection that blocks airways, have arrived earlier and caused more serious infections among children than usual, leading to long waits for treatment. Experts have theorized the season may be more severe because children who would have normally been exposed to the virus during the past two years were more protected due to social distancing and other health measures during the pandemic.

Big Number

2.1 million. That’s how many outpatient visits RSV leads to each year among children younger than five years old in the U.S., according to the Centers for Disease Control and Prevention. The illness causes an estimated 58,000 to 80,000 hospitalizations among children five and younger and anywhere from 100 to 300 deaths annually in that age group, the CDC says.

Key Background

RSV is a common respiratory illness and the leading cause of hospitalization among all infants, whose smaller airways leave them more vulnerable to severe illness. No vaccines in the U.S. have been authorized for RSV. A preventative monoclonal antibody injection called Synagis has been available to high-risk infants since 1998 to guard against hospitalization, but experts say the treatment is so expensive it is not always offered. Pfizer has also finished a late-stage clinical trial for a maternal RSV vaccine, which has been shown to protect infants against severe illness for the first six months after birth, while GlaxoSmithKline is working on a vaccine for older adults. Pfizer plans to apply for approval for its maternal vaccine before the end of the year, according to the Washington Post.

Further Reading

‘This Is Our March 2020’: Children’s Hospitals Are Overwhelmed by R.S.V. (New York Times)

Pfizer’s RSV vaccine, given during pregnancy, protects infants from severe illness (Washington Post)

Scientists Are Gaining on R.S.V., a Persistent Threat to Children (New York Times)

Who Can Receive The Currently Available RSV ‘Vaccine’? (Forbes)