Europe recommends approval of two bird flu pandemic prevention vaccines

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion Two vaccines for active immunization against the H5N1 subtype of influenza A virus (also known as avian influenza or avian influenza).

one of them, Cell epidemicdesigned to immunize during influenza outbreaks originating from animals, even when public health authorities anticipate the potential for a pandemic.

another, incelipan (Pandemic influenza vaccine (H5N1) is a pandemic preparedness vaccine that is used only when an influenza pandemic is officially declared. The benefit of Inclipan is that adults and children develop a strong vaccine three weeks after receiving two doses of the vaccine. Immune responses were separated by several weeks, as measured by hemagglutinin inhibition titers against H5N1.

In the event of a pandemic, once the virus strain causing the pandemic is identified, manufacturers can include that strain in an authorized pandemic preparedness vaccine and require that the vaccine be authorized as a “definitive” vaccine against the pandemic.

Medicines that address an unmet medical need are granted conditional marketing authorization when the immediately available public health benefits outweigh the risks inherent in the fact that additional data are still needed. Authorization of a final pandemic vaccine could be expedited now that the vaccine’s quality, safety and efficacy have been evaluated against other potential pandemic strains.

The H5N1 virus that causes bird flu has infected more than 600,000 wild birds of 400 different species in the past two years, and at least 450 million poultry have been culled to stop its spread. Concerns about the potential for an avian flu pandemic have grown when the pathogen spreads to mammals, and two incidents are particularly worrisome: One occurred in Spain, in a Galician town with 50,000 American mink. Serious disease outbreaks occur on fur farms. Another is the mass die-off of marine mammals in South America. For example, on the Patagonian coast of Argentina, 97% of elephant seal calves born this year died from bird flu.

The pathogen is now present on all continents except Oceania – including Antarctica. Although it has grabbed a lot of headlines over the past year, the fact that there have been only a handful of cases of human infection – the last of which was a child under the age of 3 in Cambodia – makes it a “minor” issue . The latest data from the World Health Organization shows that from 2003 to February 25, 2023, 21 countries recorded a total of 873 cases of human infection with avian influenza, including 458 deaths.