New data show that one single vaccine dose against influenza A (H1N1) given to children aged from six months to three years provides a good immune response, but that the second vaccine dose presumably provides even better protection against the influenza.
The European Medicines Agency (EMEA) has reviewed new data from the vaccine manufacturer GlaxoSmithKline, derived from an ongoing clinical trial in children aged from six months to three years.
The data also show that young children experience more adverse reactions from the second dose than they do from the first dose. In particular, more children developed fever above 38°C, had more soreness at the injection site, experienced drowsiness, irritability and loss of appetite. These observations correspond to those already made in the countries where the Pandemrix® vaccine is given.
The Committee for Medicinal Products for Human Use (CHMP) under EMEA notes that this increased reaction from the second dose was not expected because no such observations were made with the H5N1 mock-up vaccine.
EMEA recommends to continue giving two vaccine doses to children at an interval of three weeks and to inform parents that their child may develop fever, possibly high fever, after vaccination. If considered necessary by the parents, children may be given paracetamol to reduce fever.
However, it should be added that the Danish National Board of Health maintains its recommendation of vaccinating only children who belong to an at-risk group.
The announcements made by EMEA are available in the factbox to the right.
For further information, please contact Chief Medical Officer Marianne Orholm, Licensing Division, tel. +45 4488 9740.
Danish Medicines Agency, 4 December 2009
