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PRIORITY PRESS - 11th Canadian Immunization Conference

Ottawa, Ontario / December 2-4, 2014

Ottawa – Of the 5 serogroups responsible for invasive meningococcal disease (IMD), serogroup B is by far the most common in Canada today.  IMD also disproportionately affects young infants with another peak in incidence in adolescence. A multicomponent vaccine against serogroup B, the 4CMenB vaccine, is now available and indicated for use in children aged 2 months to 17 years. Epidemiological data indicate that the vaccine can be expected to protect individuals against two-thirds or the majority of the meningococcal strains now circulating here. Both clinical trial and real-world experience support the efficacy and safety of the 4CMenB vaccine in infants and in adolescents, and experts are reporting that the vaccine can be easily given with other routine infant vaccines, simplifying its introduction into practice.

Chief Medical Editor: Dr. Léna Coïc, Montréal, Quebec

Invasive meningococcal disease (IMD) is a rare but devastating illness that affects normal healthy individuals, especially very young infants. Following successful immunization programs against meningococcal C disease across Canada, serogroup B disease has become the leading cause of IMD today. “Group B in particular causes 80% or more of IMD cases in the first year of life,” Dr. Ronald Gold, Honorary Staff, Hospital for Sick Children, Toronto, said.

In adolescents—where a second peak of IMD is observed— serogroup B disease is responsible for over 60% of all IMD cases right now. Indeed, it is the 15-  to 24-year olds who are responsible for most of the transmission of all disease-causing strains of meningococci, Dr. Gold added. “Children under the age of 10 do not normally carry these bacteria,” he noted. “It’s the young adults who are bringing it home to the infants.” 

Patients with IMD, once infected, typically progress from a non-specific malaise resembling influenza—they’ll be achy, febrile and may vomit—but within 12 to 24 hours, they can have progressed so rapidly as to require care in the  intensive care unit (ICU) where between 10 and 15% still die of the infection despite state-of-the-art care. Data from IMPACT involving 12 pediatric Canadian centres also indicates that a good quarter of IMD survivors have serious sequellae, as pointed out by Dr. Marc Lebel, Pediatric Infectious Diseases, CHU Sainte-Justine, Montreal. Currently, several monovalent conjugate vaccines are available that protect against meningococcal C disease (Menjugate, Meningitec, NeisVac-C) while two main quadrivalent conjugate vaccines are available to protect against IMD caused by serogroups A, C, Y and W-135 (Menactra, Menveo).

Over the past year, a multicomponent meningococcal vaccine against serogroup B (Bexsero) has also been approved for use in children aged 2 months to 17 years. The 4CMenB vaccine has been evaluated in clinical trials involving approximately 8,000 infants, children and adolescents. Given as a primary series at 2, 4 and 6 months of age, followed by a booster dose at 12 months, the 4CMenB vaccine has been shown to produce robust immunogenic responses to all 4 antigens in the vaccine, as Dr. Lebel noted.

In the absence of acetaminophen prophylaxis, fever that peaks some 6 hours after receiving a dose of the 4CMenB vaccine in conjunction with routine infant vaccines, does occur in infants—though not in adolescents. When acetaminophen is given at or shortly after receipt of the vaccine, local injection site reactions are the chief side effect from the vaccine. 

“We’ve given about 1000 doses of the 4CMenB vaccine now. [By using acetaminophen] and by telling parents that fever is a possibility, we've had very few phone calls or visits from worried parents because they had been warned,” Dr. John Yaremko, Assistant Professor of Pediatrics, McGill University, Montreal told delegates, referring to his clinic.

Real-World Experience

Further support underpinning the safety of the serogroup B vaccine comes from its “real-word” use in several areas where there have been recent outbreaks caused by serogroup B, one at Princeton University, another at the University of California in Santa Barbara and a third in the Saguenay-Lac-Saint-Jean region in Quebec. In the two university outbreaks alone, approximately 7,000 subjects received the 4CMenB vaccine and there were no reports of any unusual side effects.

Similarly, high rates of serogroup B disease in Saguenay-Lac-Saint-Jean region in Quebec prompted public health officials to launch the country’s first large-scale vaccination campaign against serogroup B meningococcus starting in May of 2014. As of September 5, 2014, almost 45,000 individuals between the ages of 2 months and 20 years of age have received the serogroup B vaccine. An enhanced surveillance system put into place by public health officials to monitor residents for any sign of adverse events (AEs) after the first dose failed to identify any worrisome safety signals according to an interim safety report.

“This is the largest worldwide experience with Bexsero we’ve ever had,” Dr. Lebel observed, “and so far, the safety of the vaccine has not been questioned.” 

Easy to Incorporate

Speakers also agreed that there is no reason why the 4CMenB vaccine cannot be seamlessly incorporated into the current routine infant vaccination schedule. As Dr. Yaremko and colleagues found, a survey carried out relatively recently indicated that parents already know about meningitis and fear it and they want to protect their child against meningococcal disease as much as they want to protect them against any other vaccine-preventable disease.

In fact, when told about the then-new vaccine against serogroup B disease, over 80% of parents indicated that they would want the vaccine for their child and over 90% of them felt that an extra needle required at each vaccination visit was acceptable, given the risk of this devastating infection. “It is safe to give multiple vaccines at the same time, immunologically it’s effective and if you want good compliance, doing everything that can be done at the same visit is the best way to get it,” Dr. Yaremko said. “I’ve found it very easy to incorporate the 4CMenB vaccine into my routine infant vaccine schedule.”

NACI Guidelines

Right now, the National Advisory Committee on Immunization (NACI) has issued a statement indicating that the 4CMenB vaccine may be considered on an individual basis from the age of 2 months onwards as well as in certain high-risk groups. Speakers questioned the NACI recommendation in light of the epidemiology of IMD in Canada where serogroup B predominates and in the light of who it affects, i.e. overwhelmingly healthy normal-risk children and the very young. “In my 35 years of practice, I’ve only seen one high-risk patient who got IMD, the majority of IMD I have seen has been in normal healthy children,” Dr. Tajdin Jadavji, Professor of Microbiology, Immunology & Infectious Disease, University of Calgary, Alberta said. “And now we’ve got real-world scenarios where there have been outbreaks in Princeton and Santa Barbara and in Quebec where the vaccine has worked well with minimal side effects. In my opinion, we should be using it appropriately in all age groups.”

Dr. Gold echoed these sentiments saying: “The number of cases of group B disease in the first year of life is the same as the number of cases in the 1- to 4-year old age group and at least half of the cases in the first year of life occur within the first 6 months of life. So there’s no point in delaying vaccination and I think the vaccine should be given to every eligible child.” 

Dr. Yaremko in turn reminded delegates that not funding a vaccine is not tantamount to saying it is not worthwhile. “If NACI recommends a vaccine and yet our province does not introduce it as part of our universal vaccination program, we still have a role in terms of giving parents the information they need and letting them decide if they will pay for it,” he said, adding that the information parents most want to hear from their physician is: is the vaccine safe and does their doctor recommend it?

Conclusion

“Parents still trust doctors and vaccinators and nurses,” Dr. Yaremko said. “So the opinion of the vaccinator is very important and we need to make sure we do our homework and pass on the information we have about this vaccine to help parents make that decision.”