ACIP rules on GSK, Novartis and Sanofi vaccines
Good news for Novartis and its partner on a Japanese encephalitis vaccine, Intercell Biomedical ($ICLL), emerged from the meeting in Atlanta. New Phase III data prompted FDA to extend the label of the Novartis-distributed vaccine, Ixiaro, last month to allow immunization of kids from two months of age onward. At last week's meeting ACIP made the same changes to its guidelines. Before the decisions Ixiaro was restricted to people aged 17 years and older.
Whooping cough was also on the agenda. Incidence of the disease has risen since the 1980s, a trend many attribute to the switch to acellular vaccines from GlaxoSmithKline and Sanofi. Protection provided by the shots seems to wane with time, prompting ACIP to assess whether a booster shot would help and make financial sense. The committee estimated it would cost the U.S. $77 million to give a booster jab to 16-year-olds, yet it would have little impact on incidence of the disease. It estimated it would cost the U.S. about $270,000 for each case of whooping cough that was prevented. That led the committee to recommend against adding a booster shot to the CDC vaccination schedule. A follow-up debate on whether high-risk groups should get a booster is now planned, LiveScience reports.
ACIP was more amenable to Protein Sciences' influenza vaccine FluBlok. The trivalent vaccine is the first flu shot approved by FDA to use an insect virus expression system and recombinant DNA technology. ACIP unanimously recommended use of FluBlok for people age 18 to 49 who have an egg allergy, regardless of severity, CIDRAP News reports. The recommendation gives Protein Sciences access to a subpopulation which might decide against using new quadrivalent vaccines--and traditional trivalent shots--because of allergy concerns.