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Use of Bexsero in early infancy may not provide long-term protection
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Results from a phase 2 open-label, single-center extension study indicated children who received Bexsero as infants had waning immunity against serogroup B meningococcal disease by age 5 years, even after receiving a booster dose at age 3.5 years.
Bexsero (4CMenB; Novartis) is licensed for use in the European Union, Australia and Canada and was approved for use in the United States by the FDA in January. It was recommended in 2014 that the vaccine be included in the United Kingdom's routine childhood vaccination schedule and a vaccine campaign using Bexsero was recently conducted in Quebec. The Public Health Agency of Canada, however, recommends Bexsero for those in high-risk groups only.
This study served as a 40-month follow-up on 70 of 147 infants who participated in a previous study that assigned infants to receive Bexsero or a three-component recombinant meningococcal serogroup B vaccine (rMenB) at ages 2, 4, 6 and 12 months or to receive one of these vaccines at age 12 months only.
In the current study, infants who originally received four doses received one additional dose at age 40 months and those who originally received one dose received two additional doses, one at ages 40 and 42 months.
Among children who received Bexsero in early infancy, 44% to 88% had protective antibody titers against strains found in the vaccine vs. 31% to 100% of children who were vaccinated later, at ages 40 and 42 months.
Children who were vaccinated at age 5 years commonly reported pain at injection site as an adverse event, but had lower rates of fever compared with younger children.
“There remains a need for more information about the effects of the 4CMenB vaccine on nasopharyngeal carriage, the likely breadth of strain coverage and long-term persistence,” McQuaid and colleagues wrote. “Introduction of the 4CMenB vaccine into the U.K.’s routine immunization schedule provides an ideal opportunity to assess the effect of this vaccine in a real-world setting and will guide implementation of 4CMenB vaccination in Canada and worldwide.” – by Amanda Oldt
Disclosure : McQuaid reports no relevant financial disclosures. Please see the full study for a list of all other authors' relevant financial disclosures. The study was funded by Novartis Vaccines.
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