The CDC's Advisory Committee on Immunization Practices (ACIP) voted last year to issue a Category B(www.cdc.gov) recommendation for the use of two serogroup B meningococcal (MenB) vaccines in patients ages 16-23 for short-term protection against the disease, with a preference for administration between ages 16 and 18.
Previously, the ACIP had recommended the vaccines -- Pfizer's Trumenba, which is given as a three-dose series, and Novartis' Bexsero, which is given as a two-dose series -- only for people ages 10 and older who are at increased risk for serogroup B meningococcal disease. High-risk groups include those with persistent complement component deficiencies, anatomic or functional asplenia, microbiologists working with serogroup B meningitis, and populations at risk because of outbreaks.
Because the latest recommendation is not a Category A or "routine" recommendation, family physicians and their patients may have questions. That's why 2015-2016 AAFP Vaccine Science Fellows Nina Ahmad, M.D., and Melissa Martinez, M.D., created a frequently asked questions (FAQ) document about the vaccines for family physicians as part of their fellowship.
Martinez told AAFP News that the MenB vaccines weren't on her radar before she started her fellowship. But the first event she attended during her time as fellow was the June ACIP meeting where the vaccines were debated and given the Category B label.
- The 2015-2016 AAFP Vaccine Science Fellows created a frequently asked questions resource for family physicians about the two serogroup B meningococcal vaccines.
- The major argument in favor of getting one of the vaccines is that they protect patients from a disease that results in a high incidence of death and disability.
- One argument against it is that this disease already is rare and seems to be getting rarer.
"It's a bit of a confusing vaccine, so Dr. Ahmad and I spent a lot of time writing about and thinking about the pros and cons of the vaccine," she said.
Ahmad told AAFP News that she understands the reason for the B recommendation but said it is a challenging situation.
"The discussion about MenB vaccination between the physician and patient can be a difficult one," she said. "Also, access to the vaccine for patients can be challenging as not all (practices) will carry it. And for the physician, storage and implementation can be an issue."
Fellows Address Vaccine Questions
In their FAQ, the vaccine science fellows touched on a number of issues surrounding the MenB vaccines. These included explaining how common MenB infections are in the first place.
"All serotypes of meningococcal disease are rare, and the incidence seems to be decreasing. The incidence of all meningococcal B serotype infections in the United States is estimated to be about 200 cases per year among persons of all ages," the FAQ said.
The incidence of MenB is highest in children age 5 or younger, with an estimated 75-100 cases per year, but the MenB vaccines are not licensed in the United States for this age group, the FAQ said. The estimated average number of cases in patients ages 11-24 is 54-67 per year.
The fellows also pointed out that these MenB cases can occur in clusters or strike individuals unexpectedly. Since 2009, seven outbreaks of serogroup B meningococcal disease have occurred on college campuses. Cases have been reported in the general public, as well.
As to how effective the MenB vaccines are in preventing meningococcal B infections, the fellows said clinical trials of vaccine effectiveness are not practical or possible because the incidence of disease is so low.
"Instead, vaccine efficacy was based on 'complement mediated antibody killing' detected in the serum of individuals who received the vaccines, a surrogate measure of protection," the FAQ said.
In separate studies, vaccines were given to populations of patients ages 11-65, the report explained. Based on immunogenicity studies to four strains of meningococcus B that occur in the United States, 84 percent of patients who received three doses of Trumenba and 63 to 94 percent who received two doses of Bexsero were considered immune, the FAQ said. Additional strains will be tested in the future.
The two MenB vaccines are fairly pricey, with Trumenba's three-dose series carrying a CDC private sector price of $115.75 per dose or $347.25 for the series, the fellows said. Bexsero's two-dose series has a CDC price of $160.75 per dose or $321.50 for the series.
"Assuming a birth cohort of 4 million, the cost of vaccinating all 16- to 23-year-olds would be over a billion dollars," the FAQ said. "The ACIP estimates the cost per quality adjusted life year to be in excess of $4 million."
The FAQ also explained that under the Patient Protection and Affordable Care Act, the vaccines should be covered by insurance. In addition, the Vaccines for Children Program covers qualified children under age 18.
Pros and Cons of MenB Vaccines
Ahmad said that as vaccine science progresses and companies are more quickly able to make advances in production and create new vaccines, the ACIP could issue more Category B recommendations. And more Category B recommendations could lead to more confusion for family physicians.
"Considering how to implement B recommendations may need to be brought up in future discussions and reevaluated," she said. "Though the situation is challenging and needs to be individualized, it can also be used as an opportunity to reemphasize the importance of vaccination for other preventable conditions where the vaccine has been shown to be effective, and a means to investigate how to implement B recommendations into practices."
Martinez said unfortunately, the burden is now on family physicians -- who already are busy -- to make time in their visits to talk about the pros and cons of the MenB vaccines.
The major pro of getting the vaccines is protection from a disease that results in a high incidence of death and disability. "And as far as we know, the vaccine seems fairly safe," she added.
The cons include the fact that this disease already is rare and seems to be getting rarer. "We also don't know how well the vaccine works as it has not been tested clinically -- just in test tubes," Martinez said. "We don’t know if it covers all of the strains or if its effectiveness wanes over time." Martinez added that there also may be side effects of the MenB vaccines that aren't understood yet.
"More than one physician has contacted the (vaccine science) fellowship and asked if they should order this vaccine or not," she said. "It's not a black and white issue; it has a gray area. I think mostly, people need to order the vaccine and have a conversation about it with their patients."
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CDC Releases 2016 Immunization Schedules