A MUCH-anticipated vaccine to prevent meningococcal B infection is waiting TGA approval after being given the go-ahead by European health authorities.
“It is the holy grail. It is the last big cause of meningitis and blood poisoning,” said Professor Robert Booy, head of clinical research at the National Centre for Immunisation Research and Surveillance, Sydney.
The vaccine, called Bexsero (Novartis), has been approved by the European Commission for use in infants from two months.
The European Medicines Agency said it was the first vaccine to provide broad coverage against meningococcal group B strains.
The sponsor confirmed the vaccine was under review by the TGA.
“We hope that we will in time see a similar registration in Australia,” a Novartis spokesperson said.
The company said Bexsero would complement vaccines that protect against the other main serotypes of meningococcal disease.
Professor Booy said it could be given at any age after two months but for a public health program it wouldn’t be possible to vaccinate everyone.
He suggested it could be implemented in a similar way to the meningococcal C vaccine in 2003, with toddlers and teenagers targeted initially.
“I think governments will be interested,” Professor Booy said. “I am sure it will be considered carefully at federal level for funding.
“It is certainly possible that Australia will be one of the first few countries to introduce it. That is my guess, my prediction.”
Professor Booy said meningococcal B meningitis was rare and affected 200–300 people a year in Australia, mostly children and teenagers.
Health department figures show a total of 222 cases of invasive meningococcal disease were reported in 2012.
Studies suggest mortality from the B strains is 5–10%.
“My data is nearer 5%,” Professor Booy said. “We’ve improved the medical care but in terms of the complication rate it is still 20%.
“That includes deafness, severe scarring, psychological problems, depression, amputation and hearing loss.”
Taken from http://www.medicalobserver.com.au/news/meningococcal-b-vaccine-under-tga-review – By Niamh Mullen
24th Jan 2013