The European Medicines Agency (EMEA) has issued a press release stating that a new review of data on Pandemrix® and other vaccines against H1N1 shows that it is sufficient to use a single dose of vaccine for adults, elderly people and children aged 10 and older.
Regardless of the press release from EMEA, the National Board of Health’s recommendations concerning the vaccination still apply in Denmark. You can find the National Board of Health’s recommendations via the factbox to the right.
EMEA’s press release follows below:
EMEA reaffirms efficacy and safety of H1N1 vaccines
The European Medicines Agency has reviewed further data on the centrally authorised pandemic vaccines Celvapan®, Focetria® and Pandemrix®. The new data reaffirms that the vaccines have a positive balance of benefits and risks in the context of the current H1N1 influenza pandemic.
The data on Focetria® and Pandemrix® indicate that a single dose of one of these vaccines is able to trigger an immune response that may be sufficient to provide protection against the H1N1 pandemic influenza in some age groups. For both vaccines, a single dose may be used in adults aged between 18 and 60 years and in children and adolescents (from the age of 9 years for Focetria, and from 10 years for Pandemrix).
Moreover, a single dose of Pandemrix may also be used in the elderly. For certain groups, such as younger children under the specified ages and immunocompromised patients, the recommendation remains that two doses should be given to ensure that their immune system responds adequately to the vaccination. Further data will become available in the coming months. EMEA is still assessing data on Celvapan®.
EMEA also concluded that Focetria® and Pandemrix® can be co-administered with seasonal flu vaccines.
The European Medicines Agency, together with the national competent authorities, is continuously monitoring the safety profile of the H1N1 pandemic influenza vaccines. With vaccination campaigns ongoing in the European Union, about 5 million people have been vaccinated so far. To date, the side effects reported have mainly been mild symptoms such as fever, nausea, headache, allergic reactions and injection site reactions, confirming the expected safety profile of the three vaccines.
Among the reported side effects, there is a very small number of cases of the Guillain-Barré syndrome (paralysis of arms and legs) and abortion reported in patients previously vaccinated with a pandemic vaccine. EMEA is still in the process of gathering all relevant information and evaluating the data. However, on the basis of the available information, there is no evidence to link these severe occurrences to the vaccines.
EMEA will continue to evaluate all information that becomes available and make further recommendations as necessary.
For further information, please contact Chief Medical Officer Marianne Orholm, tel. +45 4488 9740.
Danish Medicines Agency, 20 November 2009 (updated 24 November 2009)
