Issue: May 2013

May 01, 2013

9 min read

Save

This article is more than 5 years old. Information may no longer be current.

Communication at every level crucial when discussing vaccines

Issue: May 2013

During the February 2013 meeting of the Advisory Committee on Immunization Practices, the committee debated on the exact wording of a recommendation.

The 12-3 vote followed a nearly hour-long discussion over inclusion of Hib-MenCY-TT vaccine (MenHibrix, GlaxoSmithKline) into the Vaccines for Children program. Many committee members said they felt that including the vaccine in the program might unintentionally send a message to clinicians that the vaccine was preferred over other vaccines, when in fact the committee made a recommendation at its October meeting that the Hib-MenCY-TT vaccine be used only in infants with high risk conditions for meningococcal disease.

The committee ultimately voted to approve a motion put forth by ACIP member Mark H. Sawyer, MD, professor of clinical pediatrics and a pediatric infectious disease specialist at the UC San Diego School of Medicine and Rady Children’s Hospital in San Diego, which was to “include the combination vaccine in the VFC program as an acceptable vaccine, but that an effort be made to emphasize the current recommendations.”

Just before becoming one of the three to vote against Sawyer’s proposed resolution, ACIP member Renee R. Jenkins, MD, professor and chair emeritus, department of pediatrics and child health, Howard University College of Medicine, Washington, D.C., said: “If we’re having this much confusion making a statement about this, can you imagine a practicing clinician looking at this document?”

All in the words

Jenkins’ question illustrates what many practicing clinicians deal with every day. Despite intense deliberations among experts to draft vaccine recommendations, the message sometimes gets lost in the translation, or is not what is actually practiced in the clinicians’ office.

Melinda Wharton, MD, from the CDC, said it is
important to acknowledge that vaccines are
not perfect, but that they offer the best tool
to reduce disease.

Photo courtesy of Wharton M

“For me, personally, I want these recommendations from the AAP Red Book Committee, as well as the ACIP, then I take it as gospel,” said Infectious Diseases in Children Editorial Board member Richard Lander, MD. “I like to have both groups weigh in. Unfortunately, sometimes there is a gap between the two groups. Is it semantics? I guess every now and then it might be, but often it is a matter of who is meeting when.”

The times when different groups meet sometimes mean that one group may have access to data that were not published when the other met, which can lead to variability in recommendations, Lander said.

In 2011, the ACIP implemented the Grading of Recommendations Assessment, Development and Evaluation, or GRADE, approach, which is a transparent, systematic approach for evaluating the quality of evidence and the strength of recommendations. ACIP leaders said that the GRADE framework will allow them to systematically assess the type and quality of evidence regarding a vaccine’s expected health effects and communicate that effectively to clinicians.

Crafting vaccine language

Larry K. Pickering, MD, a pediatrician and the ACIP executive secretary, said he is familiar with issues related to vaccine communication and understands the difficulty of drafting vaccine recommendations that are easily translatable into daily practice.

“Vaccines provide protection for those in the population who aren’t immunized, including children who are too young to be vaccinated, or immunocompromised people who can’t mount an adequate response,” Pickering said during a presentation at the AAP National Conference and Exhibition in New Orleans. “They are also for those whose vaccine immunity has waned.”

Although the basic message of the benefits of vaccines is clear, the committee also has to craft a message of how best to deliver the vaccines — and that is where the message sometimes gets lost. The murky waters can start out, as Jenkins said, in some of the wording that is passed down from ACIP.

An example of this was demonstrated by a survey conducted by the Association of Immunization Managers (AIM), which showed that an “initial permissive” recommendation from the ACIP regarding HPV vaccine and boys for prevention of genital warts led to substantial variation among immunization providers in how the vaccines were given.

Richard Lander

In a poster created by AIM and precented during a recent National Immunization Conference, Katelyn Wells, MS, said among 64 immunization programs, the permissive recommendations on HPV “may not translate into vaccine availability, specifically for underinsured children in private settings.” The AIM study also concluded that “ACIP permissive recommendations may result in the target group not being vaccinated, even if vaccine is available.” The permissive recommendation for HPV vaccine use in males was changed to a routine recommendation when data showed prevention against anal cancer in vaccine recipients in clinical trials.

Vaccine variability

Complicating matters for those who make recommendations on vaccines is that despite strong efforts to provide strong data on vaccine efficacy, there is variability in vaccine efficacy, as was seen with the 2012-2013 influenza seasonal vaccine.

At the ACIP meeting in February, Mark Thompson, PhD, said data obtained from Dec. 3, 2012, to Jan. 19, 2013, put overall vaccine effectiveness at about 56%, with efficacy hovering around 50% for influenza A viruses, and slightly better at 67% for influenza B viruses. Thompson and several others at the ACIP meeting said the coverage illustrated the need for better influenza vaccines.

Unfortunately, this information on the influenza vaccines from this year — plus a plethora of misrepresented information about vaccines on the Internet — has led to a pushback about vaccination, said Melinda Wharton, MD, acting director for the National Center for Immunization and Respiratory Diseases at CDC.

Communication from clinician to parent

Editorial Board Member Henry H. Bernstein, DO, told Infectious Diseases in Children that an emphasis on the overall importance of health literacy is valued in all of medicine. Bernstein cited the Quick Guide to Health Literacy from the DHHS Office of Disease Prevention and Health Promotion and said the following should be considered as a way to improve the usability of health information and how it’s delivered to patients and parents: 1) be sure the information is appropriate for the users; 2) ensure the information is easy to use; and 3) speak clearly and listen carefully.

In an interview with Infectious Diseases in Children, Wharton used the 2012-2013 influenza season as an example of how to discuss important information with parents and patients. She urged clinicians to put such data into context for those who may be reluctant to get vaccinated.

Larry Pickering

“When I talk to people who don’t want to get influenza vaccine, in particular — which is usually adults — I usually tell them, ‘I’m really glad for you that you haven’t gotten the flu, but I don’t want you to rely on luck to avoid getting sick,’” she said. “I want to do the things I can to prevent my family from getting sick.”

Wharton said it is important to acknowledge that vaccines are not perfect, but that they offer the best tool to reduce disease.

“I do think it’s important to not overstate vaccine benefits, but we should emphasize they are still the most effective tool we have,” she said.

Grading clinical studies

Wharton also said it is important to educate families about the process involved in recommending vaccines, including the GRADE approach.

According to the CDC, key factors considered in development of recommendations include balance of benefits and harms, type or quality of evidence, values and preferences of the people affected, and health economic analyses. According to the GRADE system: category A recommendations are made for all people in an age- or risk factor-based group; Category B recommendations are made for individual clinical decision making; and evidence tables are used to summarize the benefits and harms and the strengths and limitations of the body of evidence.

Officials with the ACIP said they hope that the GRADE framework will enable clinicians to better communicate with families about vaccines, as well as with other clinicians, because the system is used by several clinical organizations, including the Infectious Diseases Society of America.

GRADE uses several categories of evidence and ranks them into four categories ranging from randomized controlled trials (RCTs) to clinical experience and observations.

Writing in the Morbidity and Mortality Weekly Report about the GRADE system last year, Faruque Ahmed, PhD, lead epidemiologist, Immunization Services Division, National Center for Immunization and Respiratory Diseases, at the CDC, said: “Randomized trials often cannot be used to assess the safety and efficacy of vaccination on rare or long-term outcomes, and such trials might be unethical to conduct for vaccines that are already licensed. Observational studies frequently are conducted for such assessments. The GRADE framework allows evaluation of evidence derived from immunogenicity or other intermediate outcomes as well as evaluation of evidence based on extrapolations from findings with similar vaccines in similar populations or other indirect forms of evidence.”

In the paper, Ahmed said this standardized and more explicit process for developing ACIP recommendations is expected to enhance transparency, consistency and communication.

In an interview with Infectious Diseases in Children, Ahmed said: “It has been a positive experience using the GRADE system. It’s transparent, and it is a structured format.”

He said the committee’s recent recommendation on pneumococcal conjugate vaccine for children aged 6 to 18 years with immunocompromising conditions is a good example of the GRADE system in action.

“It points out not only what the recommendation should be, but also points out what are the strengths and limitations of the studies surrounding the recommendations,” Ahmed said.

Wharton also said it is important to communicate when there are changes to the schedule and new vaccines are licensed or new recommendations to existing vaccines are made. This will be particularly important as new technologies enable other vaccines to come to market. – by Colleen Zacharyczuk

References:

CDC. Advisory Committee on Immunization Practices (ACIP). Available at: www.cdc.gov/vaccines/acip/recs/GRADE/index.html. Accessed April 16, 2013.
CDC. MMWR. 2012;61;327-327.
CDC. MMWR. 2013;62(RR02);1-22.
DHHS. Quick Guide to Health Literacy from the Department of Health and Human Services Office of Disease Prevention and Health Promotion. Available at: www.health.gov/communication/literacy/quickguide/healthinfo.htm. Accessed April 16, 2013.
Wells K. Abstract 25480. Presented a: 45th National Immunization Conference; March 28-31, 2011; Washington, D.C.

For more information:

Faruque Ahmed, PhD, can be reached at fahmed@cdc.gov.
Henry H. Bernstein, DO, can be reached at: 269-01 76th Ave., New Hyde Park, NY 11040; Hbernstein@NSHS.edu.
Mark H. Sawyer, MD, can be reached at 3020 Children’s Way, #5041, San Diego, CA 92123; email: mhsawyer@ucsd.edu.

Disclosure: Ahmed, Bernstein, Jenkins, Pickering, Wharton and Zucker report no relevant financial disclosures.

Should FluMist become the recommended influenza vaccine for children aged younger than 18 years?

Public health policy is misguided for FluMist. It should be the preferred vaccine for healthy patients aged 2 to 18 for the following reasons:

It was convincingly twice as effective as the flu shot for children aged 12 months to 6 years in a large randomized clinical trial.

A single dose is 90% efficacious compared with 0% to 20% efficacy for a single dose of flu shot in vaccine-naive children. About 50% of vaccine-naive children will not return for the second dose, leaving most flu shot recipients unprotected.

It is significantly more effective than the flu shot when an antigenic drift occurs among flu strains.

It is a much more durable vaccine because up to 55% of children will have persistent protection for up to 2 years —a really important fact if they miss the flu dose the next year.

Although the Flumist has been considered contraindicated for asthmatic patients, minimal data support this viewpoint except in children aged 6 to 12 months. Two European trials have shown no increased risk of wheezing in asthmatic children. No increased risk of hospitalization for asthma was demonstrated in any of the US trials in children older than 12 months.

The FluMist formulation for next year (and beyond) will be quadrivalent and will protect against both lineages of flu B – which has been a particularly weak spot for prior single B-strain vaccines in the past (Only the thimerosal-free Sanofi injectable product will have two flu B lineages next year).

It is very well tolerated, and the nasal vaccine is usually preferred by children.

Overall, the public health benefits of quadrivalent FluMist far outweigh any disadvantages when compared with the flu shot. The estimated number of prevented hospitalizations, office visits and pharmaceutical costs would be markedly decreased with a preferential FluMist policy for healthy (or even non-severe asthmatic) children older than 24 months of age.

Stan L. Block, MD, is a pediatrician in private practice in Bardstown, Ky., and is also professor of clinical pediatrics at the University of Kentucky College of Medicine, Lexington, Ky., and professor of clinical pediatrics at the University of Louisville Medical School, Louisville, Ky., Block is also a member of the Infectious Diseases in Children Editorial Board. Disclosure: Block reports receiving honorarium for a website video on FluMist administration.

There are very good data that show in children younger than age 5, that FluMist works for a variety of reasons.

But if you tell the public to "use vaccine X for all children under 5 years," that may mean that some children don’t get immunized at all. The ACIP, in general, are reluctant, unless there are strong data showing one over another, to state a preference. We hate doing that because there have been vaccine shortages, and then if you have only one manufacturer in the game, that becomes a problem.

However, if you could show a real benefit in terms of a clinical trial or a post-marketing trial, that may change things. Despite the fact that the safety and immunogenicity for FluMist have been excellent, we still need more of a disease comparison, and those studies have not been done.

Carol J. Baker, MD, is professor of molecular virology andmicrobiology at Baylor College of Medicine in Houston. Disclosure: Baker reports no relevant financial disclosures.