Home Medizin Europa gibt grünes Licht für zwei Vogelgrippe-Impfstoffe

Europa gibt grünes Licht für zwei Vogelgrippe-Impfstoffe

von NFI Redaktion

The Committee for Human Medicinal Products of the European Medicines Agency has recommended the approval of two vaccines for active immunization against the H5N1 subtype of the Influenza A virus, which causes avian influenza or bird flu.

Celldemic is a zoonotic H5N1 influenza vaccine intended for active immunization of adults and infants from 6 months old in the event of influenza outbreaks caused by animals, including situations where health authorities foresee a potential pandemic.

Incellipan is an H5N1 vaccine for pandemic preparedness and should only be used upon official declaration of a flu pandemic. Once the responsible virus strain is identified, the manufacturer can incorporate it into the approved vaccine. They must then apply for the approval of this vaccine as the „final“ pandemic vaccine. The expedited approval process for the final pandemic vaccine is facilitated by the prior evaluation of its quality, safety, and efficacy against other potential pandemic strains.

Most cases of avian flu in humans are due to transmission from birds. However, there have also been transmissions from other sources, such as a contaminated environment. While some avian viruses in humans do not cause illness or are known to only cause mild illnesses, others, like the H5N1 subtype of the Influenza A virus, are known to cause severe illnesses or even death.

Symptoms range from asymptomatic or mild cases with conjunctivitis or mild flu-like symptoms of the upper respiratory tract to severe illnesses requiring hospitalization, such as pneumonia. Commonly reported symptoms include fever or feeling feverish, cough, sore throat, runny or stuffy nose, muscle or body aches, headaches, fatigue, as well as shortness of breath or difficulty breathing. Less common symptoms include diarrhea, nausea, vomiting, or seizures.

Celldemic will be available as an injection suspension with a dose of 7.5 µg per 0.5 ml. It consists of hemagglutinin and neuraminidase surface antigens purified from inactivated viruses of the A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG 23) produced in MDCK cell cultures, along with the adjuvant M59C.1.

Celldemic induces a strong immune response in adults and children 3 weeks after 2 doses administered at 3-week intervals, as measured by hemagglutination inhibition titers against H5N1. Common side effects in adults include pain at the injection site, fatigue, headaches, malaise, myalgia, and arthralgia. The most common side effects in children aged 6 to 18 years include pain at the injection site, myalgia, fatigue, malaise, headaches, loss of appetite, nausea, and arthralgia. In children aged 6 months to under 6 years, tenderness at the injection site, irritability, drowsiness, changes in eating habits, and fever are the most common side effects.

Incellipan is offered as an injection suspension with a dose of 7.5 µg per 0.5 ml. Similar to Celldemic, it contains hemagglutinin and neuraminidase surface antigens purified from inactivated viruses of the A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG 23) produced in MDCK cell cultures, and the adjuvant M59C.1.

Incellipan also triggers a strong immune response in adults and children 3 weeks after administration of 2 doses at 3-week intervals, as measured by hemagglutinin inhibition titers against H5N1. Common side effects align with those of Celldemic, including pain at the injection site, fatigue, headaches, malaise, myalgia, arthralgia, and other age-specific reactions.

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