CDC Seeks Public Input on Tough Vaccine Decisions

At the next meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP), the group will need to decide whether to recommend routine meningococcal conjugate vaccine (MCV) use in infants. Because other federal committees recently suggested that the CDC engage the public before such decisions, the agency developed a new information-gathering process involving consumers. This took the form of focus group meetings designed to be open and to elicit input from those who might hold differing opinions about vaccines.

Over the summer, four pilot group meetings were held in Concord N.H., Chicago, Seattle, and Denver. There were about 100 attendees in Chicago and Seattle, and about half that number each in New Hampshire and Denver. Participants included provaccine groups such as the Meningitis Angels, who passionately support routine meningococcal immunization for young infants, representatives of the antivaccine group, who call themselves the National Vaccine Information Center, as well as more or less "neutral" individuals recruited through local health departments. They were asked a series of hypothetical questions about their opinions on use of new/future vaccines and the extent that they’d be willing to support and pay for such vaccines. The answers would likely apply to MCV.

Insights from these focus groups will likely play a role in ACIP’s October discussions of routine infant immunization against meningococcal disease. The decision is complicated because of three potentially competing vaccine formulations that are not currently interchangeable and with potentially different schedules:

• Sanofi-Pasteur’s MenACWY-D (Menactra) is currently licensed starting at 9 months of age in select high-risk groups, but could be expanded to all infants.

• Novartis’ MenACWY-CRM (Menveo) was recently approved for children ages 2 years and above, but is before the U.S. Food and Drug Administration (FDA) for licensure at 2, 4, and 6 months of age.

• A not yet licensed GlaxoSmithKline’s HibMenCY (MenHibRix) is a combination vaccine containing Haemophilus influenzae type b and meningococcal type A and C antigens. GSK is seeking licensure for use down to 2 months of age.

In June, ACIP recommended Sanofi-Pasteur’s quadrivalent MenACWY-D for specific high-risk children aged 9-23 months, such as travelers to meningococcal disease-endemic areas, infants with complement deficiencies, those in outbreak situations, and HIV-infected infants with other indications for vaccination. The committee postponed voting on whether 9- to 23-month-olds with functional or anatomic asplenia, including sickle cell disease, should receive this vaccine. This was due to data that pneumococcal geometric mean titers were reduced when MenACWY-D was given at the same time as pneumococcal conjugate vaccine (PCV-7). The clinical impact of such lower titers (that are still in the protective range) are unclear, but pneumococcus is a higher threat than meningococcus for these groups.

So what is the rationale for waiting until 9 months of age to begin MCV? For one, it avoids the need for a potential extra injection at 2, 4, and 6 months, and there are only two, not four doses. Also, none of the candidate MCVs contains meningococcal serotype B, the most common serotype affecting children less than 3 years of age. Several manufacturers are working on a B serogroup vaccine, which is years away from release. Lastly, the absolute number of annually prevented deaths (about five per year) would be relatively small among those less than 9 months of age.

What is the rationale for giving MCV at 2 months of age? Because children aged less than 3 years have the highest attack rate for invasive meningococcal disease (about 50% serogroup B and 50% of the other serogroups combined), it also makes sense to start MCV as early as possible to maximize reduction of nonserogroup-B invasive meningococcal disease. And if one used the GSK combo DTaP-Hep B- IPV vaccine plus Hib MenCY, there would not be additional injections at 2, 4, and 6 months.

So if the licensures for use in 2-month-olds come through soon as is expected, ACIP will need to address routine infant MCV immunization. Consider the complexity. It’s unlikely that Sanofi’s MenACWY-D will be licensed for this age soon, so it remains a candidate only for routine first dosing at 9 months of age. It would become almost obsolete if ACIP recommends routine 2, 4, and 6 month MCV dosing. However, a 2, 4, and 6 month recommendation raises added questions. Should the GSK HibMenCY be preferred over the Novartis MenACWY-CRM (which does not contain Hib) if both are FDA approved for 2-month-olds? And what impact would use of HibMenCY have on the use of Sanofi’s combo DTaP-Hib-IPV vaccine? You wouldn’t use HibMenCY with DTaP-Hib-IPV, because that would be a double dose of Hib vaccine.

So which approach would you use in your practice? It is something to consider. If ACIP recommends both for initial dosing at 2 months, vaccine buying groups may be making decisions for clinicians based on price and package deals. Regardless, it will further complicate the vaccine schedule. And if it is complicated for us, parents are going to be even less likely to understand if their child is "up to date."

The CDC organized the focus groups to help inform those decisions. One question was "Which type of disease do you think should be given priority when it comes to developing new vaccines?" Choices were those diseases that affect many people but aren’t severe; those that are relatively rare but if contracted can cause severe disability or death; or equal priority for both. The attendees had varied opinions, but 26% in Concord and 59% in Seattle chose the rare/severe option, while 34% in Chicago to 48% in Concord chose "equal priority for both."

They also asked, "How many children need to get a severe illness in a typical year in the United States to make it a good idea that children be vaccinated?" Options were 1 in 100, 1 in 1,000, 1 in 10,000, 1 in 100,000, or 1 in 1 million. While each option was picked by at least some participants, the 1 in 100 option was a frequent choice, ranging from 23% in Denver to 57% in Chicago.

When asked what they believed ACIP should recommend for MCV, most – ranging from 53% in Seattle to 86% in Chicago – chose "add the meningococcal vaccine to the schedule for infants/children, and recommend all children be vaccinated." The other choices were less popular. The "no ACIP or CDC recommendation, but add to the Vaccines for Children program" was chosen by 8%-31%, and "no ACIP/CDC recommendation and do not add to the VFC program" was chosen by 7%-21%.

And as for what they would be willing to pay out of pocket, the largest subset in Chicago (44%) and Concord (53%) agreed to pay the highest priced option for those cities (more than $150), while in Denver and Seattle, 31% and 34%, respectively, actually appeared willing to pay more than $500.

Of course, these are very small samples of likely biased data from subsets of the public having high interest in vaccines (positive or negative attitudes). Still, I think it’s a very interesting new direction the CDC has taken to elicit this kind of information when planning to discuss difficult vaccine policy decisions. At the very least, it improves transparency, which should hopefully help us when talking with our patients about new vaccine recommendations and the complicated schedules, whatever they may be.

Dr. Christopher J. Harrison is a professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospitals and Clinics, Kansas City, Mo. Dr. Harrison receives grant funding from GlaxoSmithKline for research trials of MMR.

At the next meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP), the group will need to decide whether to recommend routine meningococcal conjugate vaccine (MCV) use in infants. Because other federal committees recently suggested that the CDC engage the public before such decisions, the agency developed a new information-gathering process involving consumers. This took the form of focus group meetings designed to be open and to elicit input from those who might hold differing opinions about vaccines.

Over the summer, four pilot group meetings were held in Concord N.H., Chicago, Seattle, and Denver. There were about 100 attendees in Chicago and Seattle, and about half that number each in New Hampshire and Denver. Participants included provaccine groups such as the Meningitis Angels, who passionately support routine meningococcal immunization for young infants, representatives of the antivaccine group, who call themselves the National Vaccine Information Center, as well as more or less "neutral" individuals recruited through local health departments. They were asked a series of hypothetical questions about their opinions on use of new/future vaccines and the extent that they’d be willing to support and pay for such vaccines. The answers would likely apply to MCV.

Insights from these focus groups will likely play a role in ACIP’s October discussions of routine infant immunization against meningococcal disease. The decision is complicated because of three potentially competing vaccine formulations that are not currently interchangeable and with potentially different schedules:

• Sanofi-Pasteur’s MenACWY-D (Menactra) is currently licensed starting at 9 months of age in select high-risk groups, but could be expanded to all infants.

• Novartis’ MenACWY-CRM (Menveo) was recently approved for children ages 2 years and above, but is before the U.S. Food and Drug Administration (FDA) for licensure at 2, 4, and 6 months of age.

• A not yet licensed GlaxoSmithKline’s HibMenCY (MenHibRix) is a combination vaccine containing Haemophilus influenzae type b and meningococcal type A and C antigens. GSK is seeking licensure for use down to 2 months of age.

In June, ACIP recommended Sanofi-Pasteur’s quadrivalent MenACWY-D for specific high-risk children aged 9-23 months, such as travelers to meningococcal disease-endemic areas, infants with complement deficiencies, those in outbreak situations, and HIV-infected infants with other indications for vaccination. The committee postponed voting on whether 9- to 23-month-olds with functional or anatomic asplenia, including sickle cell disease, should receive this vaccine. This was due to data that pneumococcal geometric mean titers were reduced when MenACWY-D was given at the same time as pneumococcal conjugate vaccine (PCV-7). The clinical impact of such lower titers (that are still in the protective range) are unclear, but pneumococcus is a higher threat than meningococcus for these groups.

So what is the rationale for waiting until 9 months of age to begin MCV? For one, it avoids the need for a potential extra injection at 2, 4, and 6 months, and there are only two, not four doses. Also, none of the candidate MCVs contains meningococcal serotype B, the most common serotype affecting children less than 3 years of age. Several manufacturers are working on a B serogroup vaccine, which is years away from release. Lastly, the absolute number of annually prevented deaths (about five per year) would be relatively small among those less than 9 months of age.

What is the rationale for giving MCV at 2 months of age? Because children aged less than 3 years have the highest attack rate for invasive meningococcal disease (about 50% serogroup B and 50% of the other serogroups combined), it also makes sense to start MCV as early as possible to maximize reduction of nonserogroup-B invasive meningococcal disease. And if one used the GSK combo DTaP-Hep B- IPV vaccine plus Hib MenCY, there would not be additional injections at 2, 4, and 6 months.

So if the licensures for use in 2-month-olds come through soon as is expected, ACIP will need to address routine infant MCV immunization. Consider the complexity. It’s unlikely that Sanofi’s MenACWY-D will be licensed for this age soon, so it remains a candidate only for routine first dosing at 9 months of age. It would become almost obsolete if ACIP recommends routine 2, 4, and 6 month MCV dosing. However, a 2, 4, and 6 month recommendation raises added questions. Should the GSK HibMenCY be preferred over the Novartis MenACWY-CRM (which does not contain Hib) if both are FDA approved for 2-month-olds? And what impact would use of HibMenCY have on the use of Sanofi’s combo DTaP-Hib-IPV vaccine? You wouldn’t use HibMenCY with DTaP-Hib-IPV, because that would be a double dose of Hib vaccine.

So which approach would you use in your practice? It is something to consider. If ACIP recommends both for initial dosing at 2 months, vaccine buying groups may be making decisions for clinicians based on price and package deals. Regardless, it will further complicate the vaccine schedule. And if it is complicated for us, parents are going to be even less likely to understand if their child is "up to date."

The CDC organized the focus groups to help inform those decisions. One question was "Which type of disease do you think should be given priority when it comes to developing new vaccines?" Choices were those diseases that affect many people but aren’t severe; those that are relatively rare but if contracted can cause severe disability or death; or equal priority for both. The attendees had varied opinions, but 26% in Concord and 59% in Seattle chose the rare/severe option, while 34% in Chicago to 48% in Concord chose "equal priority for both."

They also asked, "How many children need to get a severe illness in a typical year in the United States to make it a good idea that children be vaccinated?" Options were 1 in 100, 1 in 1,000, 1 in 10,000, 1 in 100,000, or 1 in 1 million. While each option was picked by at least some participants, the 1 in 100 option was a frequent choice, ranging from 23% in Denver to 57% in Chicago.

When asked what they believed ACIP should recommend for MCV, most – ranging from 53% in Seattle to 86% in Chicago – chose "add the meningococcal vaccine to the schedule for infants/children, and recommend all children be vaccinated." The other choices were less popular. The "no ACIP or CDC recommendation, but add to the Vaccines for Children program" was chosen by 8%-31%, and "no ACIP/CDC recommendation and do not add to the VFC program" was chosen by 7%-21%.

And as for what they would be willing to pay out of pocket, the largest subset in Chicago (44%) and Concord (53%) agreed to pay the highest priced option for those cities (more than $150), while in Denver and Seattle, 31% and 34%, respectively, actually appeared willing to pay more than $500.

Of course, these are very small samples of likely biased data from subsets of the public having high interest in vaccines (positive or negative attitudes). Still, I think it’s a very interesting new direction the CDC has taken to elicit this kind of information when planning to discuss difficult vaccine policy decisions. At the very least, it improves transparency, which should hopefully help us when talking with our patients about new vaccine recommendations and the complicated schedules, whatever they may be.

Dr. Christopher J. Harrison is a professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospitals and Clinics, Kansas City, Mo. Dr. Harrison receives grant funding from GlaxoSmithKline for research trials of MMR.

At the next meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP), the group will need to decide whether to recommend routine meningococcal conjugate vaccine (MCV) use in infants. Because other federal committees recently suggested that the CDC engage the public before such decisions, the agency developed a new information-gathering process involving consumers. This took the form of focus group meetings designed to be open and to elicit input from those who might hold differing opinions about vaccines.

Over the summer, four pilot group meetings were held in Concord N.H., Chicago, Seattle, and Denver. There were about 100 attendees in Chicago and Seattle, and about half that number each in New Hampshire and Denver. Participants included provaccine groups such as the Meningitis Angels, who passionately support routine meningococcal immunization for young infants, representatives of the antivaccine group, who call themselves the National Vaccine Information Center, as well as more or less "neutral" individuals recruited through local health departments. They were asked a series of hypothetical questions about their opinions on use of new/future vaccines and the extent that they’d be willing to support and pay for such vaccines. The answers would likely apply to MCV.

Insights from these focus groups will likely play a role in ACIP’s October discussions of routine infant immunization against meningococcal disease. The decision is complicated because of three potentially competing vaccine formulations that are not currently interchangeable and with potentially different schedules:

• Sanofi-Pasteur’s MenACWY-D (Menactra) is currently licensed starting at 9 months of age in select high-risk groups, but could be expanded to all infants.

• Novartis’ MenACWY-CRM (Menveo) was recently approved for children ages 2 years and above, but is before the U.S. Food and Drug Administration (FDA) for licensure at 2, 4, and 6 months of age.

• A not yet licensed GlaxoSmithKline’s HibMenCY (MenHibRix) is a combination vaccine containing Haemophilus influenzae type b and meningococcal type A and C antigens. GSK is seeking licensure for use down to 2 months of age.

In June, ACIP recommended Sanofi-Pasteur’s quadrivalent MenACWY-D for specific high-risk children aged 9-23 months, such as travelers to meningococcal disease-endemic areas, infants with complement deficiencies, those in outbreak situations, and HIV-infected infants with other indications for vaccination. The committee postponed voting on whether 9- to 23-month-olds with functional or anatomic asplenia, including sickle cell disease, should receive this vaccine. This was due to data that pneumococcal geometric mean titers were reduced when MenACWY-D was given at the same time as pneumococcal conjugate vaccine (PCV-7). The clinical impact of such lower titers (that are still in the protective range) are unclear, but pneumococcus is a higher threat than meningococcus for these groups.

So what is the rationale for waiting until 9 months of age to begin MCV? For one, it avoids the need for a potential extra injection at 2, 4, and 6 months, and there are only two, not four doses. Also, none of the candidate MCVs contains meningococcal serotype B, the most common serotype affecting children less than 3 years of age. Several manufacturers are working on a B serogroup vaccine, which is years away from release. Lastly, the absolute number of annually prevented deaths (about five per year) would be relatively small among those less than 9 months of age.

What is the rationale for giving MCV at 2 months of age? Because children aged less than 3 years have the highest attack rate for invasive meningococcal disease (about 50% serogroup B and 50% of the other serogroups combined), it also makes sense to start MCV as early as possible to maximize reduction of nonserogroup-B invasive meningococcal disease. And if one used the GSK combo DTaP-Hep B- IPV vaccine plus Hib MenCY, there would not be additional injections at 2, 4, and 6 months.

So if the licensures for use in 2-month-olds come through soon as is expected, ACIP will need to address routine infant MCV immunization. Consider the complexity. It’s unlikely that Sanofi’s MenACWY-D will be licensed for this age soon, so it remains a candidate only for routine first dosing at 9 months of age. It would become almost obsolete if ACIP recommends routine 2, 4, and 6 month MCV dosing. However, a 2, 4, and 6 month recommendation raises added questions. Should the GSK HibMenCY be preferred over the Novartis MenACWY-CRM (which does not contain Hib) if both are FDA approved for 2-month-olds? And what impact would use of HibMenCY have on the use of Sanofi’s combo DTaP-Hib-IPV vaccine? You wouldn’t use HibMenCY with DTaP-Hib-IPV, because that would be a double dose of Hib vaccine.

So which approach would you use in your practice? It is something to consider. If ACIP recommends both for initial dosing at 2 months, vaccine buying groups may be making decisions for clinicians based on price and package deals. Regardless, it will further complicate the vaccine schedule. And if it is complicated for us, parents are going to be even less likely to understand if their child is "up to date."

The CDC organized the focus groups to help inform those decisions. One question was "Which type of disease do you think should be given priority when it comes to developing new vaccines?" Choices were those diseases that affect many people but aren’t severe; those that are relatively rare but if contracted can cause severe disability or death; or equal priority for both. The attendees had varied opinions, but 26% in Concord and 59% in Seattle chose the rare/severe option, while 34% in Chicago to 48% in Concord chose "equal priority for both."

They also asked, "How many children need to get a severe illness in a typical year in the United States to make it a good idea that children be vaccinated?" Options were 1 in 100, 1 in 1,000, 1 in 10,000, 1 in 100,000, or 1 in 1 million. While each option was picked by at least some participants, the 1 in 100 option was a frequent choice, ranging from 23% in Denver to 57% in Chicago.

When asked what they believed ACIP should recommend for MCV, most – ranging from 53% in Seattle to 86% in Chicago – chose "add the meningococcal vaccine to the schedule for infants/children, and recommend all children be vaccinated." The other choices were less popular. The "no ACIP or CDC recommendation, but add to the Vaccines for Children program" was chosen by 8%-31%, and "no ACIP/CDC recommendation and do not add to the VFC program" was chosen by 7%-21%.

And as for what they would be willing to pay out of pocket, the largest subset in Chicago (44%) and Concord (53%) agreed to pay the highest priced option for those cities (more than $150), while in Denver and Seattle, 31% and 34%, respectively, actually appeared willing to pay more than $500.

Of course, these are very small samples of likely biased data from subsets of the public having high interest in vaccines (positive or negative attitudes). Still, I think it’s a very interesting new direction the CDC has taken to elicit this kind of information when planning to discuss difficult vaccine policy decisions. At the very least, it improves transparency, which should hopefully help us when talking with our patients about new vaccine recommendations and the complicated schedules, whatever they may be.

Dr. Christopher J. Harrison is a professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospitals and Clinics, Kansas City, Mo. Dr. Harrison receives grant funding from GlaxoSmithKline for research trials of MMR.