US panel calls for individual decisions on use of GlaxoSmithKline, Pfizer's meningitis B vaccines

The US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) voted 14-1 on the partial endorsement of meningitis B vaccines from GlaxoSmithKline and Pfizer, calling for decisions to be made on an individual basis. Pfizer's Trumenba was approved by the FDA in October last year, while Bexsero, which GlaxoSmithKline recently gained rights to from Novartis, was cleared in January.

In February, the ACIP recommended that the vaccines should only be used in people aged 10 to 25 at increased risk for meningococcal disease. At the time, Pfizer and Novartis argued that the population was too narrow and did not cover the majority of adolescents and young adults at risk for contracting meningitis B.

In its new recommendations, the ACIP backed use of the vaccines in people aged 16 to 23, but made no mention of risk factors. The panel suggested that the best time to be immunised is at ages 16 to 18. The category B recommendation leaves the decision to vaccinate up to individual doctors along with patients or their parents.

At the meeting, a number of panel members cited uncertainties about how long the vaccines last, whether a booster will be needed and how immunisation prevents spread of the disease. Meanwhile, some committee members raised uncertainties about the vaccine's safety. "There are some red flags with safety for this vaccine," noted Edward Belongia. Panel member Douglas Campos-Outcalt added "as we go into the future with more vaccines against rarer and rare diseases, we're not going to be able to recommend every vaccine for every person every time."

Both Trumenba and Bexsero are licensed for use in people aged 10 to 25. Pfizer's product is administered as a three-dose series at $115 per injection, while GlaxoSmithKline's vaccine is given in two doses at a retail price of $160 per dose.

Earlier this month, the UK introduced plans for the world's first national vaccination programme against meningitis B with Bexsero to be given to babies starting at two months of age, followed by a second dose at four months and a booster at 12 months.

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