Massachusetts Department of Public Health Division of Epidemiology and Immunization Agenda Introduction Richard Moriarty, MD, FAAP, Co-Director, MCAAP Immunization Initiative Pentacel Vaccine Shortage Update MMRV Vaccine (Proquad ) Update Susan M. Lett, MD, MPH, Medical Director, MDPH Immunization Program Questions Pejman Talebian, MA, MPH, Deputy Program Manager, MDPH Immunization Program Susan M. Lett, MD, MPH, Medical Director MDPH 10-12 1
Pentacel Shortage More Severe Now Only Available for One Dose in Series MDPH 10-12 2
Pentacel Vaccine Shortage Worsens Sanofi Pasteur s Pentacel DTaP-IPV-Hib vaccine has been in short supply since April 2012. CDC recently announced that availability of Pentacel will be even more limited and the shortage will continue through the end of March 2013. MA is expecting to receive only about 15% of the amount of Pentacel normally received before the shortage. Effective immediately MDPH will only be able to supply practices enough Pentacel vaccine for one dose in the series. There are sufficient single antigen vaccines and adequate amounts GlaxoSmithKline s Pediarix (DTaP-IPV-HepB) to help address the decrease in Pentacel, so no child should go unvaccinated. MDPH notified providers by email on October 4, 2012. Detailed advisory issued October 9, 2012. MDPH 10-12 3
Pentacel Supply Worsens Immunization Schedules MDPH has developed sample schedules: Transition Schedule. For children who have already received the 1st two doses as Pentacel Option #1. Use of Pentacel for the 1st dose and Pediarix for the 2 nd and 3 rd doses. Option #2. Use of Pentacel for the 1 st dose and then single antigen vaccines. Option #3. Use of Pediarix for the 1 st 3 doses of DTaP series (only if supplies are adequate). These schedules assume the single dose of Pentacel is given as the 1 st dose in the series, but providers may chose to use it for a later dose. There are many other schedules a provider may chose that work better in their setting. MDPH 10-12 4
Pentacel Supply Worsens, (cont.) In order to ensure adequate supplies, providers need to be prepared to stock all available vaccine formulations: Both Pentacel and Pediarix combination vaccines Single antigen vaccines To minimize the number of shots a child must receive, MDPH asks all providers to order some Pediarix. Providers should take advantage of those places in the schedule where there is a range of ages in which a vaccine can be given. Vaccination should NOT be delayed beyond the ages in the ACIP schedule. MDPH 10-12 5
Transition Schedule 2 Prior Doses Pentacel then Pediarix Age Vaccines Birth HepB 2 mos Pentacel, PCV13, RV, HepB 1 4 mos Pentacel, PCV13, RV 6 mos Pediarix, Hib, PCV13, RV 6 mos Influenza 9 mos -- 1 The 2nd dose of hepatitis B vaccine can also be given at 1 month of age. MDPH 10-12 6
Option #1 1 Dose Pentacel then 2 Doses of Pediarix Age Vaccines Birth HepB 2 mos Pentacel 1, PCV13, RV, HepB 2 4 mos Pediarix, Hib, PCV13, RV 6 mos Pediarix, Hib, PCV13, RV 6 mos Influenza 9 mos -- 1 Assumes Pentacel given as 1 st dose in the series. However, some providers may wish to use it for a later dose. 2 The 2 nd dose of hepatitis B vaccine can also be given at 1 month of age. MDPH 10-12 7
Option #2 1 Dose of Pentacel then Single Antigen Vaccines Age Vaccines Birth HepB 2 mos Pentacel 1, PCV13, RV, HepB 2 4 mos DTaP, IPV, Hib, PCV13, RV 6 mos DTaP, Hib, PCV13, RV 6 mos Influenza 9 mos IPV, HepB 3 1 Assumes Pentacel given as 1 st dose in the series. However, some providers may wish to use it for a later dose. 2 The 2 nd dose of hepatitis B vaccine can also be given at 1 month of age. 3 If infant is born to a mother who is HBsAg positive, dose 3 should be given at 6 months of age. MDPH 10-12 8
Option #3 3 Doses of Pediarix (Only if supplies allow) Age Vaccines Birth HepB 2 mos Pediarix, Hib, PCV13, RV 4 mos Pediarix, Hib, PCV13, RV 6 mos Pediarix, Hib, PCV13, RV 6 mos Influenza 9 mos -- MDPH 10-12 9
Pentacel Vaccine Shortage Worsens Vaccine Ordering Guidance Practices must decide which temporary schedule they plan to implement in their practice. Your vaccine ordering patterns depend on the policy chosen. Make adjustments to your regular order quantities for Pentacel ; Single antigen DTaP, Hib, IPV vaccines; Hep B (if you begin ordering Pediarix ). MDPH October Pentacel advisory includes a detailed table providing vaccine ordering guidance. Providers should monitor inventories closely to ensure all doses ordered do not go unused or expire which will result in vaccine restitution. MDPH 10-12 10
MMRV Vaccine (ProQuad ) Now Available for Ordering MDPH 10-12 11
MMRV Vaccine (ProQuad ) Now Available for Ordering MMRV Vaccine available for ordering early Nov 2012, MDPH sent advisory on 10-31-12 New recommendation for administration Guidance about vaccine eligibility and ordering Revised MDPH Childhood Vaccine Availability Table MDPH Varicella and MMRV Order and Usage Form (not changed) MDPH 10-12 12
MMRV Vaccine: Background 2005: MMRV licensed for use in those 12 mos through 12 years 2007: Shortages of MMRV more severe and then no longer available 2008: ACIP reviews initial post licensure data on febrile seizures and makes no change in recommendations 2010: ACIP reviews additional data on febrile seizures from and made some additional recommendations Data on Febrile Seizures: 1st dose: One additional febrile seizure 5-12 days after vaccination per 2,300-2,600 children who had received the 1st dose of MMRV at 12 23 months, compared to children who received these vaccines as separate injections of MMR and varicella vaccines on the same visit 2 nd dose: No additional febrile seizures in children receiving MMRV at 4-6 years of age MMWR 2010;59(RR-3).
MMRV Vaccine ACIP Recommendations Providers should discuss the risks and benefits of vaccination options with parents VIS a helpful tool 1 st Dose in those 12-47 months: Unless the parent expresses a preference for MMRV vaccines, ACIP recommends MMR and varicella be given as separate injections for this age groups. 2 nd Dose in those15 months 12 years or 1 st dose in those 48 months or older: MMRV is generally recommended over separate injections in this age group. Providers should use clinical judgment. Considerations include: provider assessment, parental preference and the potential for adverse events MMWR 2010;59(RR-3). (Note: AAP states either MMRV or MMR and varicella can be used for either the 1st or 2nd doses)
CDC VIS Website www.cdc.gov/vaccines/pubs/vis Downloadable pdf files Links to rtf files Links to translations Link to one-page instruction sheet with essential VISs information New Format includes 2-D bar codes Sign up for email alerts when VISs are updated.
MMRV Vaccine ACIP Recommendations Providers should discuss the risks and benefits of vaccination options with parents VIS a helpful tool 1 st Dose in those 12-47 months: Unless the parent expresses a preference for MMRV vaccines, ACIP recommends MMR and varicella be given as separate injections for this age groups. 2 nd Dose in those15 months 12 years or 1 st dose in those 48 months or older: MMRV is generally recommended over separate injections in this age group. Providers should use clinical judgment. Considerations include: provider assessment, parental preference and the potential for adverse events MMWR 2010;59(RR-3). (Note: AAP states either MMRV or MMR and varicella can be used for either the 1st or 2nd doses)
MMRV Vaccine ACIP Recommendations, cont. Precaution: Personal or family (ie., parent or sibling) history of seizures of any etiology is now a precaution. These children should generally receive separate injections of MMR and varicella vaccines. Recent studies have not shown that antipyretics (e.g., acetaminophen or ibuprofen) prevent febrile seizures Other Contraindications and Precautions: Remain unchanged MMWR 2010;59(RR-3).
MMRV Vaccine Ordering, Shipping and Storage MMRV can be ordered using the Varicella and MMRV Order and Usage Form available at www.mass.gov/dph/imm (click on Vaccine Management). Initial order should be for a 2-month supply. Reduce monthly order for MMR and varicella vaccines by same number of doses of MMRV being ordered. Reorder MMRV when have a 1-month supply (or other order point) Allow 2-4 weeks for MMRV and/or varicella vaccine order to arrive. MMRV shipped directly from Merck, same conditions as varicella vaccine. When vaccine arrives, open container immediately, inspect contents, and place vaccine (not diluent) in freezer. MMRV and varicella vaccines should be stored between -50 0 C and -15 0 C (-58 0 F and +5 0 F). Diluent can be stored at room temperature. MDPH 10-12 18
MMRV Vaccine Eligible Groups for State-Supplied Vaccine Only for those in these 2 cohorts listed who require a dose of both MMR and varicella vaccines and meet the criteria outlined below: 1 st dose 1 2 nd dose 1 for : Kindergarten entry ( 4-6 years) 7th grade entry (11-12 years), if not yet received 2 nd dose Very limited catch-up vaccination 2-12 year olds who are underinsured for vaccines AND: high risk as defined by ACIP exposed during out breaks; or school-entry For catch-up of VFC-eligible children 2-12 years and household contacts of immunocompromised individuals 1-12 years 1 Providers should discuss risks and benefits of vaccination options with parents and take under consideration the ACIP recommendations discussed during this presentation. 2 Insurance does not cover this vaccine. MDPH 10-12 19
For More Information Massachusetts Immunization Program For questions about immunization recommendations, disease reporting, etc, 617-983-6800 888-658-2850 For questions about vaccine ordering MDPH Vaccine Management Unit 617-983-6828. Website http://www.mass.gov/dph Ordering MDPH materials http://www.mass.gov/eeohhs2/docs/dph/cdc/educational_materials_catalo g.pdf CDC/NIP 800-232-4636 (1-800-CDC-INFO) for both English and Spanish 888-232-6348 TTY (M-F 10 AM 10 PM) Email CDC: cdcinfo@cdc.gov Website http://www.cdc.gov/vaccines MDPH 10-12 9-12 20
QUESTIONS?? Pentacel MMRV MDPH 10-12 9-12 21