Media advertising campaign for “infant injection” against RSV

Editor Professor Pietro Vernazza was chief physician of infectious diseases/hospital hygiene at the St.Gallen Cantonal Hospital until summer 2021. A guest post.

This week the media once again beat the drum hard: It’s about a new syringe that we’re supposed to use to prevent the risk of a “dangerous virus” with a syringe starting this winter. CH-Media reported widely about it.

The “respiratory syncitial virus” (RSV) has been known for decades as a cause of respiratory tract infections, which can be particularly severe in infants. In young infants, especially in the first three months, a lung infection can quickly lead to a complicated course due to the still very small airways and is, according to the Federal Office of Public Health the most common cause of hospitalization for newborns in the winter months. The infection can – about the same frequency as influenza – lead to severe and fatal courses, even in older people (see here). There are therefore good reasons to promote prevention of this disease.

Antibodies against RSV

A newly approved injection in Switzerland with an antibody injection (Nirsevimab, Beyfortus®) administered once after birth or during the months at risk is intended to protect the infant in the first few months against such an infection, which is almost never fatal in healthy children. The treatment was tested in a total of three studies in 11,000 infants with different risk profiles (published in 2023 in «Jama Networks Open»). Overall, the treatment was able to prevent 75 percent of infections and the same number of hospitalizations. The treatment appears to be safe.

75 percent effect – relative!

We are used to pharmaceutical companies (and recently also uncritical media) telling us the impressive relative effect of a measure. In this respect, a risk reduction of 75 percent is impressive. But anyone who knows what they’re doing knows that we always have to consider the absolute risk when making an intervention. Because very few children who receive an injection will also become ill with RSV.

Therefore, we also have to consider the absolute risk reduction. To do this, we refer to the published figures: In the largest study, which also included children with a “normal” risk of developing the disease, around 4,000 children were treated and the same number received placebo.

One in 80 children benefit

1.5 percent of children in the placebo group and 0.3 percent in the nirsevimab group were hospitalized. This means that the treatment can prevent hospitalization in 1.2 percent (1.5 minus 0.3) of children. That is the absolute risk reduction.

From this number we can calculate how many children we need to treat to prevent hospitalization: 100 percent divided by 1.2 percent gives us the number of around 80 treatments to prevent hospitalization, the so-called “number needed to vaccinate.” (NNV). This also means that 80 children are at risk of an adverse reaction, but only one child is prevented from hospitalization.

Exorbitant price

We can also use the NNV to estimate the costs of a hoped-for drug effect. A dose of Nirsevimab costs around 400 francs in Switzerland. This means that the costs of preventing hospitalization amount to a good 30,000 francs. This is a multiple of the costs incurred through hospitalization. Two European studies, one Danish and one French (both published in «BMC Infectious Diseases»), put the costs of hospitalization at a maximum of 3000 euros. The younger the sick children, the more difficult the hospitalization is, as can be seen from the illustration from the French study:

This is how much it cost to hospitalize a child with RSV infection in France. On the left the information in euros, below horizontally the age of the child in months. (Indicated are the average costs (gray line), the median costs (orange squares) and the range of fluctuation in most cases (crosses or black diamonds).

Indirect costs of the disease

It is quite possible that the costs for hospitalization in Switzerland are slightly higher. But the price of 30,000 francs per prevented hospitalization seems exorbitant.

Of course, one can still argue that treatment can reduce other costs, such as lost work if a parent has to stay at home because of a child’s illness, even if this will be rare in the first three months of risk due to maternity leave. Consequential costs, such as asthma as a subsequent illness, could also arise. But no matter how you want to spin it: the high price of the drug is difficult to understand.

Breastfeeding as effective prevention

If you read the media reports, you might think that the “infant injection” finally brings the solution to the “dangerous virus” (“St. Galler Tagblatt» from 10/1/24). Now expectant parents are suddenly being mobilized to think about the risk of RSV infection in their newborn. You might think that we haven’t had any options to protect ourselves from RSV.

However, no media release mentioned that breastfeeding is also an effective method of preventing respiratory infections. But we have known for a long time that breastfeeding for three to six months not only significantly reduces the risk of RSV, but also of other respiratory infections in the infant. An older one Meta-analysis concluded that babies who were not breastfed were 3.6 times more likely to develop a respiratory infection. The effectiveness of breastfeeding in reducing the risk of RSV disease was published in a 2022 study Meta-analysis confirmed again. Anyone who writes about preventing RSV risks should also point out this important information.

And anyone who is interested in how the innate immune system works has long known that the effect of this immune system is largely dependent on a good supply of vitamin D.

Risk of infection was related to vitamin D levels

Over ten years ago, two studies (here and here) showed that the risk of RSV infection in infants is related to vitamin D levels related. In the linked one Dutch study The risk of RSV infection in infants who had normal umbilical cord blood vitamin D levels (more than 75 nmol/L) was six times lower than the risk of those with vitamin D deficiency (less than 50 nmol/L) .

Numerous other studies have well documented the connection between vitamin D deficiency and the occurrence of respiratory infections in infants and have also described the suspected route of action of vitamin D. It should also be mentioned that this too Risk of developing asthma caused by RSV or another respiratory infection is significantly reduced through a good supply of vitamin D.

Vitamin D as a miracle cure

Critics will now object that it has not yet been shown that a daily vitamin D supply for pregnant women and infants can reduce the risk. Unfortunately, that is true. But it has been well shown that vitamin D is necessary for the good functioning of the innate immune system and that the formation of “interferon”, which is important for virus defense, clearly depends on the vitamin D supply.

A recently published study by Danish experts examined the effect of administering vitamin D to pregnant women: It was shown that a high dose (3600 international units daily, abbreviated IU) is clearly superior to a low dose (400 IU/day) for good care of the newborn. In the group that received a high dose, only 11 percent of newborns were vitamin D deficient, compared to 51 percent in the group that received a low dose of vitamin D during pregnancy.

In this context, one could certainly also mention the numerous other advantages of a good supply of vitamin D. The “Mavidor” study compared the effect of vitamin D (1000 IU) during pregnancy versus placebo. In the just published Analyse In this study, the authors found significantly better bone mineralization in children aged six to seven years if their mothers had received vitamin D.

Lack of effectiveness comparison

In an ideal world, we would expect a pharmaceutical company to compare a new drug like this antibody shot to the best standard of care. Based on what we know about vitamin D today, one would expect it to be included in the pivotal study allen would have ensured a good supply of vitamin D for participants. But this was not the case in any approval study.

Given the six-fold increased risk of RSV disease for newborns with a vitamin D deficiency compared to newborns without this deficiency, it could well be that the effect of the “infant injection” would no longer be detectable if there was a good supply of vitamin D. A licensing authority could require such an effectiveness comparison before declaring such an expensive measure to be eligible for health insurance. Could.

Doctors are also required

But recognizing the broad effectiveness of vitamin D on our innate immune system is difficult. As long as many doctors do not dare to declare a good vitamin D supply as standard, it will be easy for the pharmaceutical industry to introduce new, expensive drugs whose effectiveness depends on the fitness of our innate immune system.

Subject-related interests of the author

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