Brussels, 11 June 2024
Today, the Commission’s Health Emergency Preparedness and Response Authority (HERA) as part of its mandate on preparedness, has signed on behalf of participating Member States, a joint procurement framework contract for the supply of up to 665,000 pre-pandemic vaccine doses of the up-to-date Zoonotic Influenza Vaccine Seqirus, as well as an option for a further 40 million doses over the duration of the contract. Thanks to this contract the participating Member States will have access to medical countermeasures to prevent avian flu.
The vaccine is intended for those most exposed to potential transfers of avian influenza from birds or animals, such as poultry farm workers and veterinarians. It aims to prevent the spread or potential outbreaks of avian influenza in Europe, protecting citizens and livelihoods. The vaccine is the only preventive zoonotic avian influenza vaccine currently authorized in the EU.
Fifteen EU and EEA Member States are participating in this voluntary procurement with the company Seqirus UK Ltd. The contract allows each participating country to take into account their public health context and order vaccines depending on national need. The contract will run for a maximum of 4 years.
Shipments are currently being prepared to Finland for immediate vaccinations of the workers at risk of exposure, at the Member State’s request. Shipments to other participating countries will follow.
Background
Seqirus UK Ltd has an EU wide modified marketing authorisation for this vaccine for use in adults, which protects against flu caused by H5 strains of the influenza A virus.
The EU’s mechanism of joint procurement is laid down in the EU’s Joint Procurement Agreement for Medical Countermeasures, which is signed by 36 countries, including all EU and EEA Member States. The mechanism allows the participating countries to jointly procure medical countermeasures on a voluntary and flexible basis. These countermeasures include vaccines, therapeutics, medical devices, and these can be used as an alternative or to complement to procurement at national level.
The Agreement secures a more equitable access to specific medical countermeasures and improves the security of supply, together with more balanced prices for the participating countries. The Agreement also contributes to the EU-level preparedness for public health crises or pandemics.
More information
Quote(s)
While the threat of avian influenza to the general population remains low, we need to protect people at higher risk, such as poultry and farm workers or certain veterinarians. Today we announce an agreement on behalf of participating countries to secure access to over 40 million doses of avian influenza vaccine. We are ready to take further action should the situation evolve in the future. Our European Health Union serves to protect people’s lives and livelihoods, and being prepared for health threats is at the core of our work.
Stella Kyriakides, Commissioner for Health and Food Safety
Source – EU Commission
EU Commission Q&A on Avian Influenza
Brussels, 11 June 2024
What is avian influenza?
Avian influenza is a viral disease, which occurs primarily in birds. Avian influenza viruses are either high or low pathogenic viruses (highly pathogenic avian influenza (HPAI) and low pathogenic avian influenza (LPAI), respectively) depending on their ability to cause different severity of disease and mortality in chickens.
Wild birds, in particular aquatic birds, are the main reason for the evolution and spread of these viruses. Poultry infected with LPAI may show mild signs of the disease or none at all. Infections caused by HPAI can cause severe disease and death in poultry.
Why is avian influenza a concern?
Avian influenza in birds can have animal health and economic consequences, due to production losses in infected farms. Avian flu viruses have an increased ability to evolve/mutate and mix with other avian influenza viruses. This increases the risk of new, more infectious strains, or strains with the potential to infect other species, including humans. That avian influenza is being increasingly detected in mammals (e.g. cows, alpacas, mice, cats) is a trend that is kept under close surveillance.
The Commission, together with the European Centre of Disease Prevention and Control (ECDC) and the European Food Safety Authority (EFSA), monitors the avian influenza situation in the EU very closely. There are EU rules on the measures to take in the event of an outbreak in kept birds, as well as a robust framework of prevention and preparedness measures in place in case of infections in animals. With regard to human health, EU legislation on health security ensures surveillance, swift response and coordination at EU level, should a case be detected.
Can avian influenza infect species other than birds?
Avian influenza typically affects birds, but other animals (mammals such as cows, alpacas, mice, cats) can be infected with avian influenza viruses, including pigs, mink, seals, wild boars, foxes and cats. The USA has also recently reported for the first time cases of HPAI in cattle .
Is avian influenza a risk to humans?
The European Centre for Disease Prevention and Control (ECDC) currently assesses the risk for the general public as low, and the risk for those working with or exposed to infected birds and mammals as low to moderate. Most strains of avian influenza virus are relatively harmless and do not infect humans.
However, some variants may develop mutations that increase their potential to infect other species, including humans.
Human cases can range from asymptomatic or very mild symptoms (conjunctivitis, mild respiratory symptoms), to severe symptoms (pneumonia requiring hospitalisation), and in some cases death.
To date, there has been no confirmed human-to-human transmission of the H5N1 virus and there have also been no reported active cases of avian flu infection in humans in the EU/EEA.
People who are in close contact with infected animals should wear personal protective equipment and avoid unprotected direct contact with sick or dead animals, carcasses, faeces as well as potentially contaminated environments. ECDC guidance recommends active surveillance of exposed people (such as monitoring symptoms or testing), preventive measures and/or vaccinating risk groups.
The ECDC monitors the situation continuously and updates its risk assessments accordingly. The Commission has also set up a well-functioning surveillance and early warning systems, to allow early warning of any event in humans or animals. Should a strain of highly pathogenic avian influenza emerge that is infectious between humans, preparedness and swift action would be key.
More information related on risks for public health of avian influenza viruses can be found on the ECDC webpage dedicated to avian influenza.
How has the Commission responded to recent human cases of avian influenza in humans in USA and other third countries?
The Commission works on the basis of a One Health approach to better prevent, predict, detect and respond to any emerging threat. This approach is based on the principle that human, animal and environmental health are closely interlinked: they need to be tackled together. This entails working across policies and sectors, including public health, animal health and food safety.
The Commission is closely monitoring the situation of highly pathogenic avian influenza worldwide, in close collaboration with Member States, EFSA, ECDC, EMA, the European Union Reference Laboratory (EURL) for Avian Influenza, the World Health Organization (WHO) and the World Organisation for Animal Health (WOAH). It is also carefully tracking any genetic evolution of the virus.
The Commission remains in regular contact with Member States and is ready to react very quickly should the situation evolve. Since July 2023, the EU Health Security Committee (HSC) has been holding regular meetings to discuss prevention and preparedness measures against avian influenza, including joint meetings with EU veterinary authorities (Chief Veterinary Officers) whenever needed. In December 2023, the Health Security Committee issued an Opinion on zoonotic influenza with recommendations for coordinated actions by Member States, to promote prevention and preparedness against possible outbreaks.
The Commission and Member States are also regularly in contact with the authorities in the US and other third countries, as well as international organisations, to exchange information on the disease situation, including measures for prevention and management. For example, at the end of May, the Commission invited the US authorities, as well as FAO and WHO, to present their testing and preparedness activities at the joint meeting of the EU Health Security Committee and EU Chief Veterinary Officers.
A new Global Health Security Initiative working group on respiratory infections with pandemic potential has also been set up, to make it easier for G7 countries to exchange information quickly.
What is the state of EU preparedness in medical countermeasures?
The European Medicines Agency (EMA) has authorised certain antiviral medicines to treat human influenza cases in the EU (Dectova, Ebilfumin, Tamiflu, Xofluza).
The Commission organised joint procurement contracts signed with Seqirus (2019) and GSK (2022) for their pandemic influenza vaccines, Foclivia and Adjupanrix, respectively. These joint procurements ensure that the companies will deliver adapted pandemic vaccines to the participating Member States once a pandemic is declared by WHO. HERA has also signed, on behalf of participating Member States, a joint procurement framework contract for pre-pandemic doses of the up-to-date Zoonotic Influenza Vaccine Sequirus, intended for those most exposed to potential transfers of avian influenza from birds or animals, such as poultry farm workers and veterinarians.
In addition, medical countermeasures stockpiles are being organised under rescEU, which can be released in case of pandemics.
What measures must be taken when avian influenza is found in poultry to prevent infection spreading?
Under EU animal health legislation, eradication measures must be taken as soon as highly pathogenic avian influenza is detected.
Member State authorities must immediately implement measures to stamp out the disease in the infected establishment, including culling of all birds, safe disposal of carcasses and potentially contaminated materials, and cleaning and disinfection. In addition, a restricted zone must be established at least 10 km around the affected establishment, with additional control measures applied to establishments in that zone where birds are kept. Movement restrictions must be enforced by the national authorities with regard to the infected establishment and other establishments located in the restricted zone. If deemed necessary, stamping-out measures can also be extended to poultry farms in the vicinity or to farms that have had contacts with an infected farm.
Extra monitoring and surveillance measures in birds are put in place to assess the disease situation and control the spread. Those measures are maintained for at least 30 days after the virus has been eradicated from the infected establishment.
Additionally, EU zoning is carried out to prevent the spread of the disease, and avoid any unnecessary disturbance of trade. The EU regionalisation/zoning (separating disease-free zones from those with infection) is regularly published in the Official Journal of the EU.
Are there rules on the trade of birds and animals infected with avian influenza?
The international trade of poultry and poultry products has to comply with the standards of the World Organization for Animal Health. The presence of HPAI in poultry results in restrictions in international trade in live birds and poultry meat from the infected region/country.
While avian influenza is not a listed disease in mammals, the general animal health requirements continue to apply. In particular, only healthy animals may be traded and veterinary certification is required for trade of animals to other countries.
Is it safe to eat poultry meat and poultry products?
According to EFSA, there is no evidence that avian influenza can be transmitted to humans through the consumption of contaminated poultry products. In any case, meat and poultry products from infected flocks are destroyed and do not enter the food chain. Safe handling of raw meat and other raw food ingredients, thorough cooking and good kitchen hygiene can prevent or reduce the risks posed by contaminated food.
What measures must be taken when avian influenza is found in wild birds?
Bio-security measures in farms are the first line of protection against the introduction and spread of avian influenza viruses in poultry or captive birds, when there is an outbreak in wild birds. The European Food Safety Authority (EFSA) has provided detailed guidance on the type of measures that should be taken. These include, amongst other things:
- restricting wild birds’ access to and contact with poultry;
- avoiding ponds or other water surfaces on poultry premises that wild birds would have access to;
- confining domestic birds indoors as much as possible in high-risk periods;
- using hygiene locks and restricting access of people to poultry houses.
Do vaccines for birds against avian flu exist?
Vaccination against avian influenza may be applied under specific conditions. Currently, vaccination campaigns for poultry (France) or zoos (The Netherlands, Spain) are being implemented.
There are currently several avian influenza vaccines authorised in the EU. It is up to the Member States to decide whether they use these vaccines on their territories, to prevent or control disease as appropriate and necessary.
In 2023, the Commission provided the legal instrument to enable the vaccination of birds against highly pathogenic avian influenza, which enlarged the EU disease prevention and control “toolbox”. It ensures that Member States have the best science-based options available to respond to the disease situation and local circumstances. The European Food Safety Authority (EFSA) recently published a new scientific opinion on vaccination against HPAI, to help Member States make their vaccination strategies even more efficient and effective.
According to the international standards (Terrestrial Code of the World Organisation for Animal Health), vaccination will not affect the HPAI-free status of a country or zone if proper surveillance shows that there is no infection with the virus.
Source – EU Commission