BILL ANALYSIS AB 354 Page 1 Date of Hearing: April 21, 2009 ASSEMBLY COMMITTEE ON HEALTH Dave Jones, Chair AB 354 (Arambula) - As Amended: April 13, 2009 SUBJECT : Health: immunizations. SUMMARY : Allows the Department of Public Health (DPH) to update vaccination requirements for children entering schools and child care facilities and adds the American Academy of Family Physicians (AAFP) to the list of entities whose recommendations DPH must consider when updating the list of required vaccinations. Specifically, this bill : 1)States the Legislature's intent to not relinquish its responsibilities relating to immunization requirements. 2)Deletes the age, grade, and date exemptions from the following vaccination requirements: a) Haemophilus influenzae type b (Hib) immunization of children who have reached the age of four years and six months; b) Mumps immunization of children who have reached the age of seven years; c) Pertussis immunization of children who have reached the age of seven years; d) Hepatitis B immunization of pupils who are above the kindergarten level; and, e) Varicella (chickenpox) immunization of pupils who were admitted to California public or private schools at or above the kindergarten level before July 1, 2001. 3)Makes changes to the list of entities whose recommendations DPH must consider when developing new disease immunization requirements, as follows: Corrects a reference to the federal affiliation of Advisory Committee on Immunization Practices (ACIP); replaces the American Academy of Pediatrics (AAP) Committee on Infectious Diseases with AAP; and, adds AAFP. AB 354 Page 2 4)Deletes a provision authorizing DPH to adopt emergency regulations to implement a varicella immunization requirement which was enacted in 2000. EXISTING LAW : 1)Prohibits the governing authority of a school or other institution from unconditionally admitting any person as a pupil of any private or public elementary or secondary school, child care center, day nursery, nursery school, family day care home, or development center, unless prior to his or her first admission to that institution he or she has been fully immunized against the following diseases: Diphtheria; Hib (except for children who have reached the age of four years and six months); measles; mumps (except for children who have reached the age of seven years); pertussis (except for children who have reached the age of seven years); poliomyelitis; rubella; tetanus; hepatitis B (for all children admitted at the kindergarten level or below, and for pupils entering the seventh grade); varicella (chickenpox) (except for children already admitted to California public or private schools at the kindergarten level or above before July 1, 2001); and any other disease deemed appropriate by DPH, taking into consideration the recommendations of ACIP and AAP. 2)Waives the requirement in 1) above for medical reasons or if the parent or guardian or adult who has assumed responsibility for the child files a letter or affidavit with the school governing authority stating that the immunization is contrary to his or her beliefs. 3)Permits a child who has had an immunization requirement waived, whenever there is good cause to believe that the person has been exposed to one of specified communicable diseases, to be temporarily excluded from the school or institution until the local health officer is satisfied that the person is no longer at risk of developing the disease. 4)Requires county health officers to organize and maintain a program to make immunizations available to all persons required to be immunized as specified under 1) above and other specified statutes, and specifies that counties shall pay costs that are not recovered from persons immunized. FISCAL EFFECT : This bill has not been analyzed by a fiscal AB 354 Page 3 committee. COMMENTS : 1)PURPOSE OF THIS BILL . According to the author, this bill is needed to allow DPH to require pertussis booster vaccines for students prior to the start of the seventh grade. The author states pertussis is the only vaccine-preventable disease that remains widespread despite high levels of vaccination in early childhood. Although childhood immunization against pertussis does not provide lasting immunity needed to control the disease and protect public health, current law limits the requirement for pertussis vaccination to children seven years old or younger. The author states that also vaccinating children upon entry to the seventh grade will reduce infection rates among adolescents and adults, which will also help protect infants who are too young to receive their first inoculations. 2)PERTUSSIS . Pertussis is a highly communicable disease that lasts for many weeks and is typically manifested in children with violent spasms of severe coughing that can cause difficulty breathing, eating, and sleeping; as well as vomiting. Sometimes a "whoop" sound occurs while gasping for breath during a coughing spell, though adults rarely have the "whoop." According to the U.S. Centers for Disease Control (CDC), pertussis is highly contagious, with up to 90% of susceptible household contacts developing clinical disease following exposure. However, pertussis is distinct from other childhood illnesses in that most children get the infection from adults, rather than children. Adolescents and adults become susceptible and can contract pertussis when immunity from childhood vaccinations wanes. They can then easily infect infants who are not fully vaccinated. In adults, pertussis can appear to be an ordinary upper respiratory tract infection, and is often not diagnosed. In infants, pertussis can be fatal. 3)PERTUSSIS IN CALIFORNIA . DPH reports that in California, since 1976, pertussis incidence has risen cyclically with peaks every three to five years, mirroring national incidence. Between 2001 and 2006, pertussis incidence rose from 644 cases reported in 2001 to 3,160 cases in 2005, dropping down to 1,661 cases in 2006. CDC states that actual incidence may be many times greater than the reported numbers. Other areas AB 354 Page 4 of the U.S. also experience the same trend of outbreaks every three to five years. In March 2007, a pertussis outbreak in Santa Cruz resulted in the temporary closure of one middle school and treatment of over 80 students and staff of another middle school. The highest pertussis rates occur among infants, who are also at highest risk of complications. In California from 2001 through 2006, 91% of infant cases occurred in the first six months of life, before three doses of the vaccine were administered, and 74% of such cases were hospitalized. During the same period, 24 California infants under two months old died from pertussis. DPH reports that the age distribution of reported pertussis cases has been changing since the 1990s. In 1990, 11% of all reported cases in California were children over nine years old; by 2005, more than half of reported cases were children over nine years old. According to DPH, hospital charges for treating pertussis in 2005 exceeded $17 million, of which at least $12 million was paid by the Medi-Cal Program. DPH further states that the true costs are likely to be far higher, as most outpatient and some hospitalized cases of pertussis are never diagnosed but require services. DPH additionally notes that state funds also pay for the state and local health department response to pertussis cases and outbreaks. Contra Costa County Health Department calculated that it required over $50,000 of staff time to respond to a single pertussis outbreak in a school in the spring of 2008. DPH contends that several pertussis outbreaks are likely to occur in a given year, and that requiring pertussis boosters would likely nearly eliminate pertussis among adolescents. 4)PERTUSSIS VACCINE . Pertussis immunizations are given in combination with tetanus and diphtheria immunizations (called DTaP and DTP), at two, four, and six months of age. A fourth dose is given at 15 to 18 months and a fifth dose is given at four to six years of age. Because immunity from infection by the vaccine only lasts for approximately five to ten years, a booster shot is recommended in early adolescence. ACIP has recommended vaccinating adolescents and adults, in part because a newer vaccine called Tdap has greatly reduced the incidence of adverse effects observed with the earlier pertussis vaccine. Tdap is different from the DTaP vaccine currently given to babies and young children: Tdap contains AB 354 Page 5 smaller quantities of diphtheria and pertussis proteins and is therefore much less likely to cause side effects such as pain, redness and tenderness in adolescents. ACIP, AAP, and AAFP recommend Tdap booster vaccines at the age of eleven to twelve years for those who have completed the recommended childhood DTaP or DTP series and not received a tetanus diphtheria booster dose, as well as for thirteen to eighteen year olds who have not received the vaccine at the age of eleven to twelve years. According to a letter to the author from the Director of DPH, at least 50% of 11-18 year old children who are insured by Medi-Cal have received the pertussis booster vaccine through the federally funded Vaccines for Children Program. DPH estimates that requiring the Tdap booster would increase the percentage of children who receive Tdap booster vaccines to the point of nearly eliminating pertussis during adolescence in California and would reduce transmission to other age groups, including infants. DPH highlights the experience of British Columbia, which since 2004 has achieved 75-86% pertussis immunization rates of students entering the ninth grade. DPH states British Columbia now enjoys low levels of pertussis, without the expected fluctuations in incidence. 5)DPH Authority . DPH has not exercised its authority to change the list of required immunizations. DPH states the reasons it has not used this authority include the following: a) The state has achieved high immunization rates for diseases such as pneumococcal pneumonia and Hepatitis A without changing requirements. These high rates are attributed to high interest in a disease or vaccination, or because requirements for existing vaccines given at the same ages enhance uptake of vaccines; b) Limited track record of use and insufficient reimbursement mechanisms for recently introduced vaccines; c) A disease for which there is a new vaccine, such as human papilloma virus (HPV) infection, is not transmitted in the school setting; and, d) DPH lacks authority to change the existing statutory age restrictions on requirements for diseases against which children must be immunized. 6)ACIP . Federal law requires ACIP to provide advice and guidance to the Secretary of the U.S. Department of Health and Human Services, the Assistant Secretary for Health, and the AB 354 Page 6 CDC on the most effective means to prevent vaccine-preventable diseases. Another goal of ACIP is to increase the safe usage of vaccines and related biological products. ACIP consists of 15 experts in fields associated with immunization who have been selected by the Secretary, and is the only entity in the federal government which develops recommendations for the routine administration of vaccines to children and adults, along with schedules regarding the appropriate dosage, dosing intervals, precautions, and contraindications applicable to the vaccines. ACIP recommends immunizations for the following diseases that are not currently in state requirements for children entering school or day care: a) Rotavirus, which CDC states is the most common cause of severe diarrhea among children, resulting in the hospitalization of approximately 55,000 children each year in the U.S. ACIP recommends rotavirus vaccine only for infants; b) Hepatitis A, for certain high-risk groups; c) Polio; and, d) Meningococcal meningitis for certain high-risk groups. ACIP also recommends vaccines for the following diseases at ages that are not consistent with existing state law: a) Mumps: California currently requires mumps immunizations until children reach age seven; however, ACIP recommends catch-up vaccinations of the measles, mumps, and rubella vaccine for children age seven through 18 years if they have not had the recommended early childhood doses; and, b) Varicella (chickenpox): California requires varicella vaccines except for children already admitted to California public or private schools at the kindergarten level or above before July 1, 2001. ACIP recommends a varicella booster for children, adolescents, and adults who previously received only one dose of varicella vaccine, and routine vaccination of all persons age 13 years and older without evidence of immunity. 1)SUPPORT . The California Academy of Family Physicians (CAFP) writes in support that pediatric immunizations have proven to be one of the most successful, safe, and cost-effective public AB 354 Page 7 health interventions of the 20th century, and removing existing age and date restrictions on immunization requirements is a positive step forward in improving access and public safety. CAFP states unvaccinated children can contract and spread dangerous diseases. AAP (California District) writes in support that this bill will cost the state nothing but ensures state public health officials are not hindered by antiquated law in their efforts to stop pertussis outbreaks. The California Medical Association and GlaxoSmithKline (GSK) write in support that a pertussis booster vaccine will protect public health, reduce infections among adolescents and adults, and help protect California's infants. The California School Nurses Association writes in support that an extra immunization or booster is often necessary and removing age guidelines facilitates requiring these additional immunizations. GSK and the American Federation of State, County, and Municipal Employees, AFL-CIO write that this bill will make schools safer. 2)RELATED LEGISLATION . a) AB 1021 (Emmerson), pending in the Assembly, is sponsored by DPH and is nearly identical to this bill, except that AB 1021 does not amend intent language. b) AB 1201 (V. Manuel Perez), pending in the Assembly, requires a health care service plan (health plan) or health insurer that provides coverage for childhood and adolescent immunizations to reimburse a physician or physician group the entire cost of acquiring and administering the vaccine and prohibits a health plan or insurer from requiring cost-sharing for immunizations. c) AB 977 (Skinner), pending in the Assembly, would, among other things, authorize a pharmacist to initiate and administer immunizations pursuant to a protocol with a prescriber or the immunization schedules recommended by CDC. In addition, AB 977 would require a pharmacist to maintain a specified immunization administration record, report any adverse event and administer epinephrine for severe allergic reactions, and assure proper storage and handling of vaccines. d) SB 249 (Cox), pending in the Senate, would authorize DPH to include children eleven years of age in the public AB 354 Page 8 awareness campaign about meningococcal disease that DPH is already authorized to design and implement. e) SB 158 (Wiggins), pending in the Senate, would require specified health plan contracts and insurance policies to provide coverage for the HPV vaccination, as specified. 3)PREVIOUS LEGISLATION . a) AB 2580 (Arambula) of 2008 was similar to this bill, but would also have required pupils entering the seventh grade to be fully immunized against pertussis by receiving any necessary adolescent booster immunization. AB 2580 was held on the Senate Appropriations Committee suspense file. b) SB 1179 (Aanestad) of 2008 would have removed from DPH the authority to add immunizations to the current list that is required for admission to school so that only the Legislature could determine which immunizations are necessary. SB 1179 was scheduled to be heard in the Assembly Health Committee on April 10, 2008, but the hearing was cancelled at the request of the author. c) SB 676 (Ridley-Thomas) of 2007 was similar to AB 2580. SB 676 was held on the suspense file in Assembly Appropriations Committee. d) SB 533 (Yee) of 2007 would have added pneumococcus vaccination for children under 24 months of age to the list of immunizations required prior to admission into schools, child care centers, nursery schools, day care, and development centers. The Governor vetoed SB 533, stating: "The Department of Public Health can already require that young children receive the pneumococcal vaccine. California's vaccine experts have not established a mandate as they believe it is not needed. Approximately 86 percent of children are already being vaccinated under a voluntary system." e) AB 16 (Hernandez) of 2007 would have repealed and recast immunization statutes relating to school children and would have required children to be immunized in accordance with recommendations of the CDC upon approval by the State Public Health Officer. AB 16 (Hernandez) was subsequently amended as AB 16 (Evans), which would have required health plans and health insurers that currently provide coverage AB 354 Page 9 for cervical cancer to also cover the HPV vaccine. AB 16 (Evans) was vetoed by Governor Schwarzenegger, who stated that the addition of a new mandate, no matter how small, would only serve to increase the overall cost of health care. 4)CHAPTERING ISSUE . This bill and AB 1021 amend the same code section; if both bills pass this committee, this conflict will need to be resolved. REGISTERED SUPPORT / OPPOSITION : Support American Academy of Pediatrics (California District) American Federation of State, County, and Municipal Employees, AFL-CIO California Academy of Family Physicians California Medical Association California School Nurses Association GlaxoSmithKline Opposition None on file. Analysis Prepared by : Allegra Kim / HEALTH / (916) 319-2097