Norwegian health officials are reviewing their plans to tackle mass vaccination of the population before the next expected influenza pandemic.
There are currently no indications suggesting one is imminent, or which type it will be, but Institute of Public Health (FHI) director Geir Stene-Larsen has warned one will strike sooner or later, stating Norway had “better be prepared”.
In an email to The Foreigner, FHI Division of Infectious Disease Control director Hanne Nøkleby MD says, “The Norwegian pandemic preparedness plan will be updated in 2012. We have also been asked by the Ministry of Health and Care Services to start the preparations for establishing an agreement about delivery of vaccine in a pandemic situation.”
“That means a general agreement with one or more producers of flu vaccine about delivery of vaccines if a pandemic should strike. Details about what we want from such an agreement are not decided yet, but discussions between the various institutions in the central health administration have started. The government will decide if Norway shall conclude such an agreement.”
How has the FHI planned to announce applicable measures and vaccination programmes to the public?
“As you will understand we have no measures or programme planned yet. If Norway enters into an agreement with vaccines producing companies as part of the preparations for a new pandemic, which will of course be announced. But such an agreement will not describe any details about how and when the vaccines can be used, as that will depend on the situation when the vaccine is needed.”
Although perhaps not specifically related to this, US vaccine manufacturer Baxter International Inc has received European Commission (EC) approval to market its product Vepacel in all EU member states and Iceland, Lichtenstein, and Norway.
According to the company, the pre-pandemic influenza vaccine is designed to provide protection against bird/avian flu (H5N1), a subtype of influenza A (A/Vietnam1203/2004) to people 18 and over. Approximately 4,700 individuals aged 18-60 were tested.
Baxter International writes in a press release, “As the influenza virus continuously mutates, it has the ongoing potential to evolve into a highly pathogenic strain to which people have little or no immunity and may rapidly spread, resulting in a pandemic. Vaccination is effective in providing protection against strains of this type and may be given either during or before a pandemic occurs, the latter known as pre-pandemic vaccination.”
Pandemrix manufacturers GlaxoSmithKline have also sought US FDA (Food and Drug Administration) approval for its influenza A and B-type vaccine for 3-year-olds and up. The European Medicines Agency (EMA) has already approved its use, which goes by the name of Pumarix.
The EMA states two separate studies were carried out, involving 5,250 people. Reported side effects from both Vepacel are Pumarix trials are pain at the site of injection, headache, and fatigue. Pumarix also caused joint pain and muscle ache.
Meanwhile, Norwegian health authorities are still processing compensation applications following possible links between the Pandemrix H1N1 ‘swine flu’ vaccine and narcolepsy.
What steps will the FHI be taking this time around to ensure the best possible testing before vaccination?
“Any vaccine to be used in Norway will need sufficient testing to receive a marketing authorisation from the European and Norwegian Medicines Agencies. FHI has no possibilities to ensure or demand more testing of a marketed vaccine,” states Hanne Nøkleby MD.
“But if, or when a pandemic strikes, the recommendations for vaccine use will be discussed, taking the probable severity of disease and the possibility for totally unknown adverse events into consideration. The experiences from the 2009 pandemic will be an important background for such discussions.”
The World Health Organisation (WHO) classifies H5N1 influenza viruses as a "significant health risk to people for several reasons. Although this type of influenza does not infect humans often, when it does, approximately 60% of those infected die. In addition, because these viruses can cause such severe illness in people, scientists are especially concerned that this type of influenza could one day mutate so it spreads easily between people and causes a very serious influenza pandemic.”
Latest WHO H5N1 figures show 349 of 592 people died after contracting avian flu on a worldwide basis between 2003 and 2012.