Frankfurt The new cold season is approaching – and for the first time, vaccines to prevent infection with the respiratory virus RSV are ready for use. Last winter, the respiratory syncytial virus caused serious infections, particularly in newborns and infants. According to projections by the health insurance company DAK, around 17,000 newborns and infants had to be treated in hospital. The proportion of young children in intensive care units increased by 350 percent.
The vaccines come from the US pharmaceutical company Pfizer and the British Glaxo-Smithkline (GSK). The Pfizer product Abrysvo is intended for pregnant women who pass on immune protection in the womb and later to the infant through breastfeeding. In addition, the vaccine is suitable for active immunization of people aged 60 and over. The GSK vaccine Arexvy is also intended for this age group, but is not approved for pregnant women.
In addition, a new antibody from Astra-Zeneca and Sanofi has been available since this month that can protect infants from the pathogen in their first RSV season.
RSV is a common respiratory virus that usually causes only mild, cold-like symptoms. However, infected children and older adults can have serious consequences: The infection can cause bronchiolitis, a respiratory infection of the lower respiratory tract, and pneumonia, and can lead to attacks of shortness of breath that can be fatal.
The vaccines are opening up a potential billion-dollar market for pharmaceutical companies. The market research and consulting company Airfinity estimates that sales of around $900 million could be achieved in the G7 countries this year. By the end of the decade it should be $10.5 billion.
RSV vaccination: Stiko does not yet make a recommendation
According to the company, the Pfizer vaccine will be available in Germany from October. When vaccinating pregnant women, the protective antibodies are transferred to the child via the placenta. This passive immunization protects infants from birth to six months of age while the immune system is not yet fully developed.
Last winter, almost 80 percent of children treated in intensive care for RSV were younger than one year old. Newborns aged up to three months were the most affected group at 59 percent.
In Germany there will be no recommendation from the Standing Vaccination Commission this winter.
(Photo: AP)
The results of the registration study show that the vaccine was effective in reducing both the number of lower respiratory tract illnesses caused by RSV and the number of severe lower respiratory tract illnesses in infants within 180 days of birth. According to the Paul Ehrlich Institute, the most common side effects of vaccination in pregnant women included pain at the vaccination site, headaches and muscle pain.
However, the Standing Vaccination Commission (Stiko) will not make a recommendation for vaccination this season. The various aspects that are required for this are currently being worked out, says virologist Klaus Überla, spokesman for the RSV working group: “We want to understand to what extent the vaccines also influence the spread in the population. And then it’s important to carry out risk-benefit assessments for different indication groups.”
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The Pfizer vaccine in particular needs to be analyzed in more detail to determine the extent to which it could pose a higher risk of premature birth for pregnant women.
In the company’s previous studies, this was not statistically significant. However, there were slightly more premature births in the group of pregnant women who received the vaccine than in the women who were given a dummy drug. “Based on the available data, it is difficult to conclusively assess this risk,” says Überla.
Prophylaxis for infants and young children
Since September, all infants and small children have had the option of prophylaxis with the antibody preparation from Sanofi and Astra-Zeneca. The biologic with the trade name Beyfortus (active ingredient Nirsevimab) inhibits the process of virus entry. After an injection, infants are protected from RSV lower respiratory tract disease for at least five months, the pivotal study showed.
According to the results, the drug is well tolerated. The most common side effects such as skin rash, fever or reactions at the injection site occur in less than one percent of children and are usually mild to moderate in intensity, experts say.
The antibody preparation inhibits the process of virus entry.
(Photo: AP)
The Pfizer vaccine Abrysvo is a so-called recombinant bivalent vaccine in which certain proteins from the virus envelope of the two RSV strains A and B are artificially produced using genetically modified microorganisms. These proteins act as the main targets of the antibodies produced to fight the viral infection.
GSK vaccine has been available since August
The GSK vaccine Arexvy has been available in Germany since August. The drug, which is intended for people aged 60 and over, contains a genetically modified version of the so-called fusion protein, which is essential for infection with RSV. The immune system produces antibodies against this protein to protect against the infection. In addition, the vaccine also contains an active enhancer that increases the immune response.
Airfinity market researchers estimate the need for RSV vaccines to be high. Moderna also wants to enter the market as another provider. The US company has submitted applications for approval in the USA, Europe and various other countries for its vaccine, which is based on the mRNA technology tested in the corona vaccine. The market launch is expected next year.
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