ACIP recommends meningitis B vaccine for high-risk groups

The US Advisory Committee on Immunization Practices (ACIP) today voted unanimously to recommend the use of meningococcal group B vaccines in high-risk groups, such as those with low immunity and college students threatened by outbreaks.

The recommendation comes in the wake of federal approval of two serogroup B vaccines in recent months—Wyeth's Trumenba last October and Novartis's Bexsero in January.

Before those approvals, the United States had no licensed vaccine for group B meningococcal disease, though there were vaccines for the A, C, Y, and W-135 serogroups. When small outbreaks struck two campuses in 2013, the Food and Drug Administration allowed importation of group B vaccines under special rules.

In noting the ACIP's action today, Novartis officials welcomed the ACIP action but said they hope the committee will make a broader recommendation at its next meeting.

"Today's high-risk recommendation does not cover the majority of adolescents and young adults in the US, who are at risk for contracting MenB," said Andrin Oswald, head of Novartis Vaccines, in an e-mailed statement.

"The MenB cases in recent weeks at Providence College, University of Oregon and Yale University all serve as a sobering reminder of the importance to act before additional individuals contract this potentially life-threatening disease," he added. "We hope that ACIP will soon include MenB vaccines in a broader recommendation to help ensure everyone in this age range is aware of and has access to the vaccine."

Novartis officials said many colleges require students to get the vaccine for meningitis A, C, W, and Y, but a group B vaccine is not yet required.

The ACIP's recommendations are normally approved by the Centers for Disease Control and Prevention.
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Related Jan 23 CIDRAP News item

Study notes high pneumonia burden in young children

Children younger than 5 years old account for 70% of pediatric pneumonia hospitalizations and viruses are far more often to blame for pneumonia in kids than are bacteria, according to a study today in the New England Journal of Medicine.

The study, by Centers for Disease Control and Prevention (CDC) researchers, looked at data from 2,358 kids who had radiographically confirmed pneumonia in children's hospitals in Memphis, Nashville, and Salt Lake City from January 2010 to June 2012.

Among 2,222 of those who had specimens available for both bacterial and viral testing, a pathogen was detected in 1,802 (81%). One or more viruses were detected in 1,472 (66%) of these children. Bacteria were detected in 175 (8%), and bacteria and viruses were present in 155 (7%).

The researchers estimated an annual pneumonia incidence of 15.7 per 10,000 children. If that number were projected to a US population of roughly 74 million kids, it would mean more than 116,000 children are hospitalized each year from pneumonia in the United States. The highest incidence was among children younger than 2 years old (62.2/10,000).

Respiratory syncytial virus (RSV), which was found in 28% of specimens, was the most common pathogen detected, followed by rhinovirus (27%) and human metapneumovirus (HMPV, 13%). RSV, adenovirus, and HMPV were more common in children younger than 5 compared with older children, while the reverse was true for Mycoplasma pneumoniae.

Coauthor Andrew Pavia, MD, chief of pediatric infectious diseases at the University of Utah School of Medicine, said in a university press release, "Our results are consistent with previous findings, and support continuing immunization efforts to maintain the reduction in bacterial pneumonia."

CDC Director Tom Frieden, MD, MPH, said in a CDC news release, "This ground-breaking study shows how badly we need faster, less-expensive diagnostic tests for doctors to accurately diagnose the cause of pneumonia so they can effectively treat it." He said that the annual hospital cost of pneumonia in US children is about $1 billion.
Feb 26 N Engl J Med abstract
Feb 25 University of Utah press release
Feb 25 CDC news release

FDA approves new antibiotic, Avycaz

Today the US Food and Drug Administration (FDA) approved Avycaz (ceftazidime-avibactam), a new antibiotic, to treat adults who have limited or no alternative treatment options. The specific conditions the drug is approved for are complicated intra-abdominal infections, in which the agent is used in combination with metronidazole, and complicated urinary tract infections, including pyelonephritis, a type of kidney infection.

Avycaz is a fixed-combination drug containing ceftazidime, a previously approved cephalosporin, and avibactam, a new beta-lactamase inhibitor, the FDA said in a press release.

"It is important that the use of Avycaz be reserved [for] situations when there are limited or no alternative antibacterial drugs for treating a patient's infection," said the FDA's Edward Cox, MD, MPH.

Avycaz is the fifth approved antibacterial designated as a Qualified Infectious Disease Product (QIDP), the agency said. A QIDP is given to antibiotics to treat serious infections, and the designation allowed Avycaz an expedited review process.
Feb 26 FDA press release