Last weekend, NU.nl headlined: ‘Promising remedy against RS virus. Babies are going to benefit from this.” It turns out to be about the means nirsivamab, which have been researched for several years. The single injection has been shown to be safe and effective in several studies in reducing disease and hospitalization from RS virus in infants and is expected to be approved for use in Europe shortly. Whether the drug is also suitable for the most vulnerable babies needs further investigation.
A review by: the editors
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What does the headline suggest?
Where does this news item come from?
Two years ago we wrote a review about nirsivamab. Then the drug, which is a type of vaccination, was tested in premature babies. Now the research focused on healthy, term-born babies.
1500 babies up to 1 year old were divided into two groups. 994 babies were injected with nirsivamab, 496 babies got a placebo. In the placebo group, 5% of the babies developed a respiratory infection due to the RS virus, for which they had to see a doctor. That was only 1.2% in the nirsivamab-group. If we have a number needed to treat (NNT) Then you have to vaccinate 30 babies to prevent one doctor’s visit and vaccinate 100 babies to prevent one hospitalization. The product seems to protect for 5 months, which is long enough for an entire RS season. It also had no serious side effects.
The researchers themselves have an important caveat to their research. More than half of the babies studied were younger than 3 months or weighed less than 5 kg. In them, the injection seems to work only half as well, while it is precisely the babies with a high risk of a serious course of disease. In addition, it has not been investigated whether nirsivamab protects against admission to the intensive care unit, which especially the youngest and smallest babies are at risk.
Is this really something new?
There was already a remedy palivizumab (Synagis), which, with monthly injections, provides some protection against the RS virus for the most vulnerable babies, for example in case of serious illness or premature birth. Nirsivamab will probably be the first drug on the market that can also be given to healthy babies. It is emphatically not a substitute for palivizumab. As yet, no research has been done on nirsivamab for the most vulnerable group of babies. The statement that nirsivamab ‘more powerful and effective than palivizumab therefore seems unfounded.
What can we do with this now?
Until now, there was no means available to protect term-born children against the RS virus. That is likely to change now. Last week, the European Medicines Association (EMA) approved the use of the drug in Europe. If the European Commission also gives approval, the drug will be on the market. It should be given to children under one year of age before the start of their first RS virus season (December to March).
Only after approval for use will it become clearer about reimbursement of the drug and whether it will be given via general practitioners, the health clinic or will eventually be included in the National Immunization Programme.
For more information about the RS virus, also read our previous posts.