National Immunisation Advisory Committee Recommendations for the seasonal influenza campaign 2011-2012
The National Immunisation Advisory Committee (NIAC) makes any recommendations based on a review of evidence from published studies and international best practice. These recommendations are then sent to the Department of Health to be adopted as policy and then forwarded to the HSE for implementation.
There are several examples over many years where NIAC recommendations supersede the information contained in the Summary of Product Characteristics (SPC) and the Patient Information Leaflet (PIL) so this issue is not new. These refer to many different vaccines but specifically related to influenza vaccine are:
1. Seasonal influenza vaccine is recommended for pregnant women (at any stage in pregnancy)
NIAC considered evidence that pregnant women are at increased risk from complications if they contract flu and particularly from the H1N1v strain. NIAC also looked at studies on the safety of flu vaccine in pregnancy which showed that inactivated flu vaccine can be safely and effectively administered during any trimester of pregnancy and that no study to date has demonstrated an increased risk of either maternal complications or adverse foetal outcomes associated with inactivated influenza vaccine. NIAC also reviewed a number of studies which show that seasonal flu vaccination during pregnancy provides passive immunity against influenza to babies in the first few months of life.
This is not included in the SPC.
2. Seasonal influenza vaccine and egg allergy
NIAC considered good evidence that those with confirmed egg anaphylaxis and non anaphylactic egg allergy can be safely given an influenza vaccine with an low ovalbumin content and recommended that this group could be given an influenza vaccine with an ovalbumin content <0.06µg per dose.
This is not included in the SPC.
3. Co-administration of seasonal influenza vaccine with PCV13
NIAC reviewed vaccine safety data from the United States earlier this year which reported a small but increased risk of febrile convulsions among children aged 12-23 months who received PCV13 at the same time as inactivated influenza vaccine in the 2010-2011 season (risk approximately 1 in 1,640 vaccinees).
NIAC recommended that for children aged 12-23 months of age it may be prudent to separate PCV13 and seasonal influenza vaccines by an interval of at least one week to decrease the risk of febrile seizures occurring.
This is not included in the SPC.
These recommendations have also been made by expert groups in other countries such as the USA/UK/Australia although there are some differences between their recommendations and ours.
The USA has recommended seasonal flu vaccine be given to all pregnant women at any stage of pregnancy for many years. Only the USA issued the recommendation about co-administration with PCV13 and the UK recommend that those with egg allergy can be given an influenza vaccine with an ovalbumin content of <<0.12µg per dose.
There are no medico-legal issues in adhering to these changes as clinicians are following national policy recommendations based on clinical evidence – indeed it could be argued that to not follow these recommendations would leave vulnerable people at risk of developing severe complications from influenza.
4. All children in at risk groups receive a full dose of seasonal influenza vaccine (0.5mls)
NIAC has recommended that all children over 6 months of age in at risk groups receive a full dose (0.5mls) of seasonal influenza vaccine (Inactivated Influenza Vaccine (Split Viron) BP) as there is evidence that the full dose provides a better immune response.
The SPC recommends a dose of 0.5mls for adults and children from 36 months and that clinical data are limited on dosage from 6 months to 35 months- dosages of 0.25 ml or 0.5 ml have been used. |
