In 2011, the Advisory Committee on Immunization Practices (ACIP) recommended that people with a mild egg allergy receive IIV. Noting that egg allergy is most prevalent in younger children, she pointed out that Flucelvax or Flublok are not approved in children, and that there is no recommendation for off-label use of these vaccines in egg-allergic children.
Dr. Dunkle said that Protein Sciences is conducting additional studies in younger and older people, and the company expects that licensure of the vaccine will be expanded to include adults aged 50 years and older for the 2013-2014 season. At the FDA’s request, the company is planning a Flublok pregnancy registry. Reproductive toxicology tests of the vaccine in rats were negative, and during clinical trials, 20 women who received Flublok became pregnant, and with 75% follow-up, there have been no birth defects among the live births or vaccine-related adverse events, she said.
The panel also reaffirmed the recommendation for annual influenza vaccination for people aged 6 months and older, with the caveat that younger children through age 8 years receive two doses at least 20 days apart.
There are 15 experts in immunization-related fields on ACIP, which develops written recommendations for the routine administration of vaccines to children and adults in the civilian population.
Information on approved influenza vaccines is available here.