Many parents are waiting to get a new preventive antibody for their babies to prevent them from getting sick with bronchiolitis. Experts and officials say the product is a victim of its success.
Isabelle, a 41-year-old mother in France, has been waiting for a dose of the new preventive antibody nirsevimab for her two-month-old baby since it was first rolled out in mid-September.
Marketed as Beyfortus, it is the first intervention widely available to prevent severe disease caused by respiratory syncytial virus (RSV), a common infection that is a leading cause of paediatric hospitalisation in Europe.
Isabelle received a prescription from her paediatrician right away, but her pharmacy in the Paris region only received 10 doses of the medicine despite having requests in the first two weeks for 30, she said.
She feels "very angry" that her son, who was born too soon to benefit from receiving the antibody in the hospital at birth, weighed too little to receive the higher dose of the medication (100mg for babies over 5kg) at his pharmacy.
Her newborn is already sick with COVID-19, and she worries about the possibility of him getting RSV, which causes cold-like symptoms but can lead to bronchiolitis and be very dangerous for newborns and older adults.
Officials say the demand for this new antibody, which was authorised in the European Union last year, is unprecedented for a non-mandatory preventive intervention.
The French government had ordered 200,000 doses of Beyfortus but had such high demand from parents after they launched an immunisation campaign in September, that not even two weeks after the roll-out, they decided to reserve certain doses of it for maternity wards to manage the available stocks.
The country’s health ministry said it was due to the “success” of the campaign, adding that typically preventive interventions like this one have a much lower adherence rate.
A representative from the pharmaceutical company Sanofi, which is producing the antibody Beyfortus along with AstraZeneca, confirmed that the adhesion rate was abnormally high.
They expected that 5 to 10 per cent of people would want the medicine but the rate in France has been closer to 60 to 80 per cent in certain hospitals.
The company says there is no production problem but rather that the doses are based on each government’s contracts since it is a new intervention.
So far, the product has been launched in the United States, France, and Spain, Sanofi said.
Effective prevention for disease without treatment
Dr Rick Malley, a professor of paediatrics at Harvard Medical School and physician at Boston Children’s Hospital in the US, told Euronews Next that there are two ways to protect people against infection.
One is by providing a vaccine to help a person’s body prevent an infection and the other is to provide an antibody, which can neutralise a virus immediately. Beyfortus is a monoclonal antibody so it’s directed against a specific protein of RSV.
Another antibody that exists to protect babies against RSV is palivizumab, which is marketed as Synagis, but this requires monthly doses and doesn’t last as long as Beyfortus.
“You don't have to give monthly injections, you just give one one dose, one shot, and then the baby is protected for the RSV season in clinical trials,” Malley said of the new intervention.
Beyfortus resulted in a 75.7 per cent reduction of severe RSV in babies under 12 months of age who received the antibody in phase III clinical trials.
There is optimism that it could help to reduce hospitalisations as there are no effective medications for RSV or bronchiolitis.
"The management of a sick child with RSV is supportive. That doesn't mean it's not effective, but you give oxygen and you may need to assist their breathing. You make sure they're well-hydrated and they're safe in the hospital context," Malley said.
High demand prompts prioritisation of certain newborns
Caroline Combot, president of France’s National Union of Midwives, told Euronews Next that she spoke to many parents who were interested in the preventive intervention once it became available.
"The moms I have seen told me that when they were offered this, they said yes straight away because their first or second child had experienced episodes of bronchiolitis which were severe, and you don't want to repeat that experience at all," she said.
Combot added that health workers were also careful to tell parents that it was a "preventive treatment" instead of a vaccine, wording that she thinks "de-dramatised" the medicine, making parents more amenable to providing it for their children.
In France, there was also a "peak in births in September and October," meaning there were more parents of newborns seeking doses of the antibody as it was rolled out.
The government has focused its messaging about winter immunisation campaigns around preventing the triple epidemic that many countries experienced last year, with COVID-19, flu, and RSV all co-circulating during the winter season.
Attention to last year’s thinly stretched health services may also have led to high demand.
Now, the French government has reserved the smaller 50 mg dose of Beyfortus for babies under 5 kg only for maternity wards.
"In an ideal world, if we could have the treatment for everyone, that would be great, but the feedback we have from some [maternity] services indeed is that they have to prioritise certain children [who are more at risk] than others," Combot said.
In the US, the limited supply of Beyfortus has prompted the Centres for Disease Control and Prevention (CDC) to recommend prioritising the higher dose of Beyfortus (for babies over 5 kg) for newborns at risk of severe RSV disease, including infants under 6 months and those with underlying conditions.
Parents in France are having a hard time understanding why the high demand isn’t being met.
“The government carried out a campaign [for the medicine] which worked, and they are surprised that parents want to protect their children from bronchiolitis,” Isabelle said.
“They just didn't order enough doses, while it is easy to know the number of unborn children and the age to receive this vaccine”.
Her concerns are similar to those of 33-year-old Clémence Bonnin, whose twin daughters were born in July in the Loire region.
Bonnin’s pharmacist never received the doses they were prescribed but she still hopes to get some soon.
“I asked other pharmacies who told me they didn't have any,” she added. For Bonnin, it’s concerning because her twins are in daycare with other babies so they could easily contract the virus.
“It's stressful because I saw that already the epidemic threshold has been exceeded in certain regions of France. So I'm a little afraid, that they will catch it and that it will end badly,” said Bonnin.
Most children globally will get RSV at some point in their first two years of life, with many adults getting it later on as a cold, but until recently there weren’t many preventive options, explained Malley.
But in addition to this monoclonal antibody for newborns, two new vaccines have been approved to prevent severe RSV. The vaccine Abrysvo can also be given to pregnant women in the European Union to prevent newborns from getting RSV.
“So we went from really just Synagis, which was approved for kids at high risk for RSV, and now we have all these other options in addition that we are very much looking forward to seeing what their impact will be once they get implemented more widely,” said Malley.