Cocooning to Protect Young Infants from Pertussis – 2012

American Academy of Pediatrics
AAP Cocooning Expert Meeting * March 23, 2012

“Cocooning” is a strategy that attempts to prevent serious pertussis infection by ensuring that all of cocooningpertussisan infant’s close contacts and caregivers are vaccinated with the tetanus, diphtheria toxoid, and acellular pertussis (Tdap) vaccine. The concept of cocooning babies in a circle of protection as both a family and community priority was the topic of a recent Cocooning Expert Meeting convened by the American Academy of Pediatrics (AAP), with the sponsorship of sanofi pasteur.

Pertussis Control & Cocooning Strategies

Pertussis — also known as “whooping cough” — is common in adolescents and adults but is often deadly for infants under 12 months of age. Babies under two months of age are hardest hit and are the most likely to become infected, be hospitalized, and to die from pertussis. The incidence of pertussis has been increasing since 2007 and has now surpassed the previous peak rates that were observed in 2004-2005. In 2009, there were 16,000 pertussis cases nationwide, and 12 infant deaths — although the incidence of the disease is actually thought to be much higher due to under-reporting. Pertussis is highly contagious and spreads through respiratory droplets that result from sneezing or coughing. When someone has pertussis, treating the individual early— before coughing begin6274600-2xss — can help prevent spreading it, but vaccination is the optimal way to prevent transmission of this serious disease.

Two Tdap vaccines are currently licensed by the Food and Drug Administration (FDA) in the United States:  Boostrix® (by GlaxoSmithKline), which is approved for all individuals over age 10, and Adacel® (by sanofi pasteur), which is approved for individuals aged 11-64. The federal Advisory Committee on Immunization Practices (ACIP) recommends a single dose of Tdap for adolescents, preferably at age 11-12, and a booster for all adults, especially those who are in close contact with infants under 12 months of age. The ACIP also recommends immunization for pregnant women after 20 weeks gestation so the maternal antibodies can confer protection to the developing fetus. (When a mother gets the Tdap vaccine post-partum, there is a 2-4 week period before protection against pertussis infection takes effect.)

Tragically, the vast majority of the time that an infant contracts pertussis —up to 83% of cases— the source is a household member. “Cocooning” is a strategy to prevent infection by vaccinating everyone who has contact with an infant: siblings, parents, grandparents, caregivers, and healthcare workers. Two recent studies support cocooning’s cost-effectiveness and additional studies on the strategy’s effect are currently underway. California successfully implemented a comprehensive cocooning strategy to combat its 2010 pertussis epidemic. In 2011, it reported fewer than 3,000 pertussis cases, a significant decrease from the 9,000-plus pertussis cases reported in 2010. For the first time in 20 years, California experienced no whooping cough deaths in 2011— clear evidence of the importance of a pertussis prevention strategy and the benefits of cocooning.

Key Issues in Cocooning

Throughout the Expert Meeting, participants presented on, and discussed, key issues affecting community-wide cocooning, including challenges to cocooning efforts and solutions to those challenges; effective communication strategies; and needs from specific stakeholders to support cocooning efforts. Major conversation points are summarized below:

Overcoming Challenges & Barriers to Community-Wide Cocooning Efforts4733366-2xs

Generating More Evidence on Cocooning’s Impact

The lack of evidence to support cocooning is a key challenge. The lack of data on cocooning’s outcomes makes it hard to promote the process to patients and the public, and reduces support for this strategy.  Further research is needed, particularly on the varying outcomes and levels of protection when immunization occurs before conception, during pregnancy, or postnatally. When vaccination occurs prenatally, patients worry not only about the safety of the vaccine but also about the baby’s future protection, so more research is also needed on these issues in order to answer parents’ questions and allay their concerns.

Raising Awareness and Providing Education

A lack of awareness about pertussis on the part of both providers and the public is another challenge. Tdap recommendations have been a moving target and, for those who do not live and breathe this issue, it can be hard to keep up with current guidelines. Adults and providers alike are confused about the difference between Td and Tdap, and the varying recommendations about the shots. Further, many adults do not know whether they received Td or Tdap as their last booster shot. A move toward a standardized Tdap vaccine given on a regular schedule (such as every 10 years) would simplify the situation and give clear guidance to providers and the public alike.

In addition, educational campaigns are needed to raise awareness about the dangers of pertussis and the benefits of the Tdap vaccine. Many people do not know that adults can carry pertussis and can infect infants and children. Sadly, patients may not be informed about these issues by their health care providers — thereby missing a key avenue for raising awareness and encouraging immunization uptake. For example, at a recent National Cocooning Summit, some mothers reported that their obstetrician-gynecologists (OBs) had not discussed pertussis prevention with them during pregnancy, so the patients did not think it was important to get the Tdap vaccine.

Health care providers are trusted and valued sources for advice, so it is vital that providers promote cocooning and the Tdap vaccine to their patients. To do so, providers themselves need to be informed about pertussis prevention and offer immunization services. A pregnant woman may ask for the Tdap vaccine, but if her OB does not offer the shot, she (and other family members) will need to go elsewhere to get immunized. Providers who do not offer Tdap themselves should promote access to these services elsewhere, such as through pharmacies or retail-based clinics. Engaging providers who serve the whole family (such as family physicians), and facilities that serve pregnant women and new parents (such as birthing hospitals) will help reach family members with appropriate services.

Providers also need assistance to implement cocooning strategies, such as guidance on how to code and bill for immunization services. Provider groups (such as the AAP and the American Congress of Obstetricians and Gynecologists [ACOG]) can encourage vaccination uptake by issuing strong statements to their members in favor of immunization and cocooning practices. More broadly in the health care arena, there is a need for information and incentives to encourage health care workers to get immunized, such as requiring quality improvement measures on workers’ vaccination rates. (The Joint Commission [TJC] is expected to include such quality measures for hospitals and other facilities within the decade.) Finally, other key stakeholders, such as policymakers and school staff, also need information about pertussis prevention so they too can support community-wide vaccination efforts.

Addressing Financial & Payment Issues5117130-2xs

Financial and insurance issues present broad challenges to immunization. In terms of publically funded programs, restrictions and funding shortages hamper vaccination and cocooning efforts. For example, many states use the federal Public Health Service Act’s “Section 317” funds (known as “317 funding”) to fund immunization efforts, including cocooning. But, if a natural disaster occurs, states may need to redirect 317 funds to emergency activities like outreach, education, disease surveillance, outbreak control, and/or service delivery. Further, after 2013, 317 funds may not be used to provide services to individuals who have health insurance, which will complicate efforts to use these funds for cocooning efforts. The American Reinvestment and Recovery Act’s (ARRA) “Adult Immunization Program” created funds for vaccination efforts, but this money will soon be expended, and adult-focused vaccine programs are likely to cease when funding ends.

Age restrictions also complicate cocooning efforts. For example, some state Medicaid programs do not cover vaccines for adults, and the federal Vaccines for Children (VFC) funds can only be used for individuals under age 19. More flexibility in the use of Federal funds will help states and communities support cocooning programs. The VFC program could be used to solve this challenge, if it were expanded to cover adult vaccines. If the federal Affordable Care Act (ACA) is fully implemented in 2014, immunization services will be covered and promoted through its exchanges and prevention services.

Payment is a barrier with private payers as well. Postpartum vaccination in the hospital is often reimbursed through a “bundled payment,” which provides one payment for a set of related services. The bundled payment for childbirth typically includes prenatal care and the actual delivery, but does not cover vaccination services for the infant or his/her family members. In addition, because insurance typically covers vaccines under the medical benefit rather than the pharmacy benefit, pharmacists encounter difficulty in providing the Tdap and other vaccines. Private payers can help prevent pertussis by ensuring that vaccine and immunization services are covered separately from bundled payments and available in a variety of settings that are convenient for adults.

Improving the Legal & Regulatory Environment

A final challenge discussed by the Expert Meeting participants was the legal and regulatory environment, which impacts cocooning in several ways. First, laws and regulations guide what specific providers can offer immunization services to the public. For example, pharmacists require state legislative and/or regulatory authority to provide the Tdap vaccine. Regulatory bodies can expand access to vaccines by granting this authority to pharmacists; private payers can help by removing differential co-pays that prevent pharmacists from acting as immunization providers for adults.

Second, laws and regulations guide what information is collected on vaccines and who can use this information. Statewide vaccine registries should be expanded (and adult Tdap vaccines added to existing registries) to help track adult immunizations, minimize over-vaccination and duplicate doses, and alert consumers about needed vaccinations. In some areas, the state-wide registry is prohibited from sharing information with local cities and communities, which complicates effective use of these registries. Pharmacists also need access to registries and medical records to obtain this information. Establishment of a national registry could assist, as well.

Conducting Effective Communication Strategies

Communication is absolutely critical to a successful pertussis prevention strategy — including those focused on providers, patients, and the general public. Provider organizations must inform about, and engage their members in, immunization efforts. For example, ACOG is about to distribute a Tdap information packet to all practicing OBs that includes a provider script, patient FAQ, and information on billing and coding. Specific types of providers can reach out to their clients with information about pertussis and cocooning. For example, pharmacists have been very successful in providing education about the influenza vaccine, and can target messages about pertussis prevention and the Tdap vaccine to their patients as well.

Personal stories about families’ pertussis experiences are very effective in reaching the public in order to raise awareness and motivate vaccination uptake. There are several on-going public education efforts that have been highly successful as well, including the national Healthy Mothers, Healthy Babies (HMHB) Coalition’s free “Text4baby” service, which provides timely health information to women via cell phones during pregnancy and through the babies’ first year.

Sanofi pasteur’s public education campaign, the Sounds of Pertussis, also raises awareness about pertussis and alerts those who are in close contact with an infant about the importance of the Tdap vaccine.

Needs from Other Stakeholders376928-2xs

 Community-wide cocooning requires the engagement and participation of a variety of stakeholders. First, support for cocooning from governmental agencies is critical to this issue. A primary stakeholder is the Centers for Disease Control and Prevention (CDC), which can fund and support research to build the evidence base about cocooning. In addition, official statements from non-profit organizations (i.e., ACOG and other health care organizations) and government agencies (i.e., the CDC, U.S. Department of Education) supporting cocooning and the Tdap vaccine will help communicate the dangers of pertussis and the importance of immunization.

For specific organizations and provider offices, it is vital to build alliances and networks in order to address challenges like billing, accessing medical records, reaching fathers and other family members, etc. Support for cocooning needs to occur not only across organizations but also within organizations. An identified best practice is for facilities like medical groups and hospitals to identify a cocooning champion who can lead these efforts.

Conclusion

While no clear recommendations on cocooning emerged from the Expert Meeting, participants learned a great deal from the conference.

The group identified a definite need for more data on outcomes and more evidence on cocooning. There are good data (including safety data) on vaccinating pregnant women in order to protect infants early in life, when they are most at risk. More research is needed, however, on how to address repeat pregnancies; whether a vaccine given to a woman one or two years before conception confers any protection to the newborn; and if women who got Tdap post-partum and are pregnant again should get another Tdap. A forthcoming CDC study will provide good information on these issues. It was noted that both GSK and sanofi have vaccine registries and review safety data regularly; these data, while limited, are reassuring.

The participants noted that vaccinating pregnant women with Tdap after 20 weeks of gestation has the strongest evidence for not only protecting the mother but also preventing infant morbidity in the first 4-8 weeks of life. Vaccinating new mothers post-partum is the second-best model, and there is a clear audience and provider support for this strategy. The ACIP seems to be moving towards recommending universal Tdap vaccination, which will help provide clarity for providers and the public, and hopefully encourage vaccine uptake.

Stakeholders for promoting family cocooning goals include: (1) Providers who treat pregnant women; (2) Providers who treat women and babies post-partum; (3) Providers who treat parents and children; and (4) Providers who treat women before conception (i.e., all women of childbearing age). Key audiences include obstetrician-gynecologists, nurse midwifes, nurse practitioners, birthing hospital staff, pediatricians, and family physicians. The Emergency Room setting was noted as providing opportunities for vaccination.