2016 Combined Recommended Immunization Schedule for Persons Aged 0 Through 18 Years
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(ACIP) General Best Guidance for Immunization
8. Altered Immunocompetence Updates This section incorporates general content from the Infectious Diseases Society of America policy statement, 2013 IDSA Clinical Practice Guideline for Vaccination of the Immunocompromised Host (1), to which CDC provided input in November 2011. The evidence supporting this guidance is based on expert opinion and arrived at by consensus. General Principles Altered immunocompetence, a term often used synonymously with immunosuppression, immunodeficiency, and immunocompromise, can be classified as primary or secondary. Primary immunodeficiencies generally are inherited and include conditions defined by an inherent absence or quantitative deficiency of cellular, humoral, or both components that provide immunity. Examples include congenital immunodeficiency diseases such as X- linked agammaglobulinemia, SCID, and chronic granulomatous disease. Secondary immunodeficiency is acquired and is defined by loss or qualitative deficiency in cellular or humoral immune components that occurs as a result of a disease process or its therapy. Examples of secondary immunodeficiency include HIV infection, hematopoietic malignancies, treatment with radiation, and treatment with immunosuppressive drugs. The degree to which immunosuppressive drugs cause clinically significant immunodeficiency generally is dose related and varies by drug. Primary and secondary immunodeficiencies might include a combination of deficits in both cellular and humoral immunity. Certain conditions like asplenia and chronic renal disease also can cause altered immunocompetence. Determination of altered immunocompetence is important to the vaccine provider because incidence or severity of some vaccine-preventable diseases is higher in persons with altered immunocompetence; therefore, certain vaccines (e.g., inactivated influenza vaccine, pneumococcal vaccines) are recommended specifically for persons with these diseases (2,3). Administration of live vaccines might need to be deferred until immune function has improved. -
Supplemental Information and Guidance for Vaccination Providers Regarding Use of 9-Valent HPV Vaccine
Supplemental information and guidance for vaccination providers regarding use of 9-valent HPV A 9-valent human papillomavirus (HPV) vaccine (9vHPV, Gardasil 9, Merck & Co.) was licensed for use in females and males in December 2014.1,2,3,4 The 9vHPV was the third HPV vaccine licensed in the United States by the Food and Drug Administration (FDA); the other vaccines are bivalent HPV vaccine (2vHPV, Cervarix, GlaxoSmithKline), licensed for use in females, and quadrivalent HPV vaccine (4vHPV, Gardasil, Merck & Co.), licensed for use in females and males.5 In February 2015, the Advisory Committee on Immunization Practices (ACIP) recommended 9vHPV as one of three HPV vaccines that can be used for routine vaccination of females and one of two HPV vaccines for routine vaccination of males.6 After the end of 2016, only 9vHPV will be distributed in the United States. In October 2016, ACIP updated HPV vaccination recommendations regarding dosing schedules.7 CDC now recommends two doses of HPV vaccine (0, 6–12 month schedule) for persons starting the vaccination series before the 15th birthday. Three doses of HPV vaccine (0, 1–2, 6 month schedule) continue to be recommended for persons starting the vaccination series on or after the 15th birthday and for persons with certain immunocompromising conditions. Guidance is needed for persons who started the series with 2vHPV or 4vHPV and may be completing the series with 9vHPV. The information below summarizes some of the recommendations included in ACIP Policy Notes and provides additional guidance.5-7 Information about the vaccines What are some of the similarities and differences between the three HPV vaccines? y Each of the three HPV vaccines is a noninfectious, virus-like particle (VLP) vaccine. -
Adenoviral Vector COVID-19 Vaccines: Process and Cost Analysis
processes Article Adenoviral Vector COVID-19 Vaccines: Process and Cost Analysis Rafael G. Ferreira 1,* , Neal F. Gordon 2, Rick Stock 2 and Demetri Petrides 3 1 Intelligen Brasil, Sao Paulo 01227-200, Brazil 2 BDO USA, LLP, Boston, MA 02110, USA; [email protected] (N.F.G.); [email protected] (R.S.) 3 Intelligen, Inc., Scotch Plains, NJ 07076, USA; [email protected] * Correspondence: [email protected] Abstract: The COVID-19 pandemic has motivated the rapid development of numerous vaccines that have proven effective against SARS-CoV-2. Several of these successful vaccines are based on the adenoviral vector platform. The mass manufacturing of these vaccines poses great challenges, especially in the context of a pandemic where extremely large quantities must be produced quickly at an affordable cost. In this work, two baseline processes for the production of a COVID-19 adenoviral vector vaccine, B1 and P1, were designed, simulated and economically evaluated with the aid of the software SuperPro Designer. B1 used a batch cell culture viral production step, with a viral titer of 5 × 1010 viral particles (VP)/mL in both stainless-steel and disposable equipment. P1 used a perfusion cell culture viral production step, with a viral titer of 1 × 1012 VP/mL in exclusively disposable equipment. Both processes were sized to produce 400 M/yr vaccine doses. P1 led to a smaller cost per dose than B1 ($0.15 vs. $0.23) and required a much smaller capital investment ($126 M vs. $299 M). The media and facility-dependent expenses were found to be the main contributors to the operating cost. -
Asplenia Vaccination Guide
Stanford Health Care Vaccination Subcommitee Revision date 11/308/2018 Functional or Anatomical Asplenia Vaccine Guide I. PURPOSE To outline appropriate vaccines targeting encapsulated bacteria for functionally or anatomically asplenic patients. Routine vaccines that may also be indicated but not addressed here include influenza, Tdap, herpes zoster, HPV, MMR, and varicella.1,2,3 II. Background Functionally or anatomically asplenic patients should be vaccinated to decrease the risk of sepsis due to organisms such as Streptococcus pneumoniae, Haemophilus influenzae type B, and Neisseria meningitidis. Guidelines are based on CDC recommendations. For additional information, see https://www.cdc.gov/vaccines/schedules/hcp/imz/adult-conditions.html. III. Procedures/Guidelines1,2,3,6,7,8 The regimen consists of 4 vaccines initially, followed by repeat doses as specified: 1. Haemophilus b conjugate (Hib) vaccine (ACTHIB®) IM once if they have not previously received Hib vaccine 2. Pneumococcal conjugate 13-valent (PCV13) vaccine (PREVNAR 13®) IM once • 2nd dose: Pneumococcal polysaccharide 23-valent (PPSV23) vaccine (PNEUMOVAX 23®) SQ/IM once given ≥ 8 weeks later, then 3rd dose as PPSV23 > 5 years later.4 Note: The above is valid for those who have not received any pneumococcal vaccines previously, or those with unknown vaccination history. If already received prior doses of PPSV23: give PCV13 at least 1 year after last PPSV23 dose. 3. Meningococcal conjugate vaccine (MenACWY-CRM, MENVEO®) IM (repeat in ≥ 8 weeks, then every 5 years thereafter) 4. Meningococcal serogroup B vaccine (MenB, BEXSERO®) IM (repeat in ≥ 4 weeks) Timing of vaccination relative to splenectomy: 1. Should be given at least 14 days before splenectomy, if possible. -
Menhibrix® Meningococcal Groups C and Y and Haemophilus B Tetanus Toxoid Conjugate Vaccine
MenHibrix® Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine Age Indications for Menhibrix ® Vaccine Vaccine Administration Menhibrix® (GSK): for aged 6 weeks through 18 months at increased - Intramuscular (IM) injection in the anterolateral aspect of risk for meningococcal disease (see below) the thigh for most infants younger than 1 year of age In older children, in the deltoid muscle of the arm Indications for Use and Schedule - Indicated for active immunization to prevent invasive disease - 1-1.5 inch, 22-25 gauge needle - Use professional judgment in selecting caused by Neisseria meningitidis serogroups C and Y and needle length Haemophilus influenzae type b. Storage and Handling - Four doses (0.5 mL each) by intramuscular injection at 2, 4, 6, and 12 through 15 months of age. The first dose may be - Store in the refrigerator between given as early as 6 weeks of age. The fourth dose may be 35º-46º F (2º-8º C); Do NOT freeze Hib-MenCY-TT given as late as 18 months of age. - Protect vials from light. - Keep in the original box · Minimum interval - 8 weeks between doses - Administer vaccine immediately after drawn up in syringe MenHibrix will be supplied to select providers designated by the Georgia Immunization Office. HIGH- RISK INFANTS 6 WEEKS THROUGH 18 MONTHS OF AGE: Persons with persistent complement component pathway deficiencies Persons with anatomic or functional asplenia Complex congenital heart disease with asplenia Sickle cell disease Persons living in or traveling to countries in which N. meningitidis is hyper-endemic or epidemic. CONTRAINDICATIONS • An anaphylactic (severe allergic) reaction to a prior dose or a component of any meningococcal-, H. -
CDPH Letterhead
State of California—Health and Human Services Agency California Department of Public Health KAREN L. SMITH, MD, MPH EDMUND G. BROWN JR. Director and State Health Officer Governor January 25, 2017 IZB-FY-16-17-07 TO: California Vaccines for Children (VFC) Program Providers FROM: Sarah Royce, M.D., M.P.H, Chief Immunization Branch SUBJECT: HIBERIX™ (HAEMOPHILUS INFLUENZAE TYPE B (HIB) CONJUGATE VACCINE) AVAILABLE FOR BOTH PRIMARY SERIES AND BOOSTER DOSE This memo is divided into sections to enable you to quickly access the information you need: Section Page(s) Summary 1 Background and Composition 2 Recommendations for Vaccine Use 2 Eligible Groups 2 Licensed Dosing Schedule 2 Current ACIP Recommendations 3 Minimum Ages and Intervals 3 Contraindications 3 Precautions 3 Vaccine Information Statement 3 Administration 3 Storage and Handling 4 Administration with Other Vaccines 4 Potential Vaccine Adverse Events 4 Reporting of Adverse Events and Errors 4 How Supplied 4 Ordering and Billing 5 Documentation 6 California Vaccines for Children Program 850 Marina Bay Parkway, Building P, 2nd Floor, Richmond, CA 94804 Toll free (877) 243-8832 ● FAX (877) 329-9832 ● Internet Address: www.eziz.org Hiberix Page 2 of 6 January 25, 2017 SUMMARY On January 14, 2016, the United States Food and Drug Administration (FDA) expanded the licensure of Hiberix™ (GlaxoSmithKline Biologicals [GSK]). It is now licensed for the primary Hib vaccination series at 2, 4, and 6 months of age, in addition to the previous indication for the booster dose. Hiberix™ is a Haemophilus influenzae type b conjugate (tetanus toxoid conjugate) vaccine indicated for active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b for children 6 weeks through 4 years of age. -
An Overview of Nanocarrier-Based Adjuvants for Vaccine Delivery
pharmaceutics Review An Overview of Nanocarrier-Based Adjuvants for Vaccine Delivery Kailash C. Petkar 1,*,†, Suyash M. Patil 2,†, Sandip S. Chavhan 3 , Kan Kaneko 4, Krutika K. Sawant 3, Nitesh K. Kunda 2,* and Imran Y. Saleem 4,* 1 Department of Scientific and Industrial Research, Ministry of Science & Technology, Government of India, New Delhi 110016, India 2 Department of Pharmaceutical Sciences, College of Pharmacy and Health Sciences, St. John’s University, Jamaica, NY 11439, USA; [email protected] 3 Department of Pharmaceutics, Faculty of Pharmacy, The Maharaja Sayajirao University of Baroda, Kalabhavan, Vadodara 390001, India; [email protected] (S.S.C.); [email protected] (K.K.S.) 4 School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Liverpool L3 3AF, UK; [email protected] * Correspondence: [email protected] (K.C.P.); [email protected] (N.K.K.); [email protected] (I.Y.S.) † These authors contributed eqally to this work. Abstract: The development of vaccines is one of the most significant medical accomplishments which has helped to eradicate a large number of diseases. It has undergone an evolutionary process from live attenuated pathogen vaccine to killed whole organisms or inactivated toxins (toxoids), each of them having its own advantages and disadvantages. The crucial parameters in vaccination are the generation of memory response and protection against infection, while an important aspect is the effective delivery of antigen in an intelligent manner to evoke a robust immune response. In Citation: Petkar, K.C.; Patil, S.M.; Chavhan, S.S.; Kaneko, K.; Sawant, this regard, nanotechnology is greatly contributing to developing efficient vaccine adjuvants and K.K.; Kunda, N.K.; Saleem, I.Y. -
Gsk Vaccines in 2010
GSK VACCINES IN 2010 Thomas Breuer, MD, MSc Senior Vice President Head of Global Vaccines Development GSK Biologicals Vaccines business characteristics Few global players and high barriers to entry – Complex manufacturing – Large scale investment Long product life cycles – Complex intellectual property High probability of R&D success – 70% post-POC New technology/novel products Better pricing for newer vaccines – HPV vaccines (Cervarix, Gardasil) – Pneumococcal vaccines (Synflorix, Prevnar-13) Operating margin comparable to pharmaceutical products Heightened awareness New markets 2 Research & development timelines Identify Produce Pre-Clinical Proof of Registration/ Phase I Phase II Phase III File Antigens Antigens Testing Concept Post Marketing Research (inc. Immunology) Pre-Clinical Development (inc. Formulation Science) Clinical Development (inc. Post Marketing Surveillance) Transfer Process to Manufacturing Build Facility x x Up to $10-20M Up to $50-100M $500M - $1B x x x 1-10 yrs 2-3 yrs 2-4 yrs > 1 yr GSK vaccines business 2009 sales £3.7 billion (+30%) +19% CAGR excl. H1N1 Vaccines represent 13% since 2005 of total GSK sales Sale s (£m) 4000 3500 Recent approvals: 3000 US: Cervarix 2500 EU: Synflorix 2000 Pandemic: Pandemrix; Arepanrix 1500 1000 500 0 2005 2006 2007 2008 2009 Increased Emerging Market presence Growth rate is CER 5 GSK vaccines: fastest growing part of GSK in 2009 2009 Sales Share Growth (CER) Respiratory £ 6,977m 25% +5% Consumer £ 4,654m 16% +7% Anti-virals £ 4,150m 15% +12% Vaccines £ 3,706m 13% +30% CV & Urogenital -
Vaccinations for Pregnant Women the Table Below Shows Which Vaccinations You May Or May Not Need During Your Pregnancy
Vaccinations for Pregnant Women The table below shows which vaccinations you may or may not need during your pregnancy. Vaccine Do you need it during your pregnancy? Influenza Yes! You need a flu shot every fall (or even as late as winter or spring) for your protection and for the protection of your baby and others around you. It’s safe to get the vaccine at any time during your pregnancy. Tetanus, diphtheria, Yes! Women who are pregnant need a dose of Tdap vaccine (the adult whooping cough vaccine) during each pregnancy, prefer- whooping cough ably in the early part of the third trimester. It’s safe to be given during pregnancy and will help protect your baby from whooping (pertussis) cough in the first few months after birth when he or she is most vulnerable. After Tdap, you need a Tdap or Td booster dose every Tdap, Td 10 years. Consult your healthcare provider if you haven’t had at least 3 tetanus- and diphtheria-toxoid containing shots some- time in your life or if you have a deep or dirty wound. Human No. This vaccine is not recommended to be given during pregnancy, but if you inadvertently receive it, this is not a cause for papillomavirus concern. HPV vaccine is recommended for all people age 26 or younger, so if you are in this age group, make sure you are HPV vaccinated before or after your pregnancy. People age 27 through 45 may also be vaccinated against HPV after discussion with their healthcare provider. The vaccine is given in 2 or 3 doses (depending on the age at which the first dose is given) over a 6-month period. -
Global Advisory Committee on Vaccine Safety (GACVS)
Global Advisory Committee on Vaccine Safety (GACVS) Report on GACVS meeting June 2013 1 | GACVS June 2013 report Topics Discussed ! Pentavalent vaccine in 4 Asian Countries ! Zoster vaccine safety and varicella vaccine safety in immunocompromised populations ! Immunization during pregnancy ! Yellow fever vaccine safety during mass immunization campaigns in sub-Saharan Africa ! Safety profile: Japanese encephalitis vaccines ! Update: human papillomavirus vaccines ! Update: pandemic influenza vaccine (Pandemrix®) and narcolepsy 2 | GACVS June 2013 report Progressive pentavalent vaccine introduction in 4 Asian Countries ! Sri Lanka (Crucell, Jan 2008): – Within 3 months, 4 deaths and 24 suspected HHE: precautionary suspension of initial lot. – 1 death following immunization April 2009: vaccine suspended, DTwP and Hep B resumed. ! Bhutan (Panacea, Sep 2009) – 5 cases of encephalopathy and/or meningoencephalitis lead to suspended vaccination 23 Oct 2009. (Subsequently, 4 serious AEFI were identified and investigated). ! India (Serum Institute of India, Tamil Nadu and Kerala, Dec 2011; Goa, Pondicherry, Karnataka, Haryana, Jammu and Kashmir, Gujarat and Delhi from Q3 2012 – Q1 2013) – To date, 83 AEFI cases reported, some associated with mortality. ! Vietnam (Crucell, Jun 2010 - May 2013) – 43 serious AEFI investigated, including 27 with fatal outcome. – Following 9 deaths following vaccination reported Dec 2012 - March 2013: vaccine suspended. 3 | GACVS June 2013 report GACVS analysis of common features among countries experiencing significant vaccine safety concerns ! Vaccination programmes are well established and achieves high coverage ! Vaccine introduction was accompanied by thorough training of health-care staff on benefits and risks of vaccine ! Sri Lanka and Bhutan: discontinuation and resumption of pentavalent vaccine did not significantly modify pattern of serious AEFI with previously utilized vaccines ! Limitations in all 4 countries: – Incomplete clinical information complicated causality assessment. -
The Compelling Need for Game-Changing Influenza Vaccines
THE COMPELLING NEED FOR GAME-CHANGING INFLUENZA VACCINES AN ANALYSIS OF THE INFLUENZA VACCINE ENTERPRISE AND RECOMMENDATIONS FOR THE FUTURE OCTOBER 2012 The Compelling Need for Game-Changing Influenza Vaccines An Analysis of the Influenza Vaccine Enterprise and Recommendations for the Future Michael T. Osterholm, PhD, MPH Nicholas S. Kelley, PhD Jill M. Manske, PhD, MPH Katie S. Ballering, PhD Tabitha R. Leighton, MPH Kristine A. Moore, MD, MPH The Center for Infectious Disease Research and Policy (CIDRAP), founded in 2001, is a global leader in addressing public health preparedness and emerging infectious disease response. Part of the Academic Health Center at the University of Minnesota, CIDRAP works to prevent illness and death from targeted infectious disease threats through research and the translation of scientific information into real-world, practical applications, policies, and solutions. For more information, visit: www.cidrap.umn.edu. This report was made possible in part by a grant from the Alfred P. Sloan Foundation. This report is available at: www.cidrap.umn.edu This report was produced and designed by Betsy Seeler Design. © 2012 Regents of the University of Minnesota. All rights reserved. Contents Preface...............................................................................................................................................................2 Executive Summary..........................................................................................................................................5 Chapter.1. -
For the Use Only of a Registered Medical Practitioner Or a Hospital Or a Laboratory ENGERIX B Hepatitis B Vaccine
For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory ENGERIX® B Hepatitis B Vaccine (rDNA) IP (Genetically Engineered) 1. NAME OF THE MEDICINAL PRODUCT Hepatitis B Vaccine (rDNA) IP (Genetically Engineered) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ENGERIX B 20 mcg/1 ml (Adult) 1 dose (1 ml) contains : Equivalent to 20 mcg purified HBV surface antigen produced in Saccharomyces cerevisiae; Hydrated Aluminium Oxide IP equiv to 0.5 mg Aluminium ENGERIX B 10 mcg/0.5 ml (Paediatric) 1 dose (0.5 ml) contains: Equivalent to 10 mcg purified HBV surface antigen produced in Saccharomyces cerevisiae; Hydrated Aluminium Oxide IP equiv to 0.25 mg Aluminium For the full list of excipients, see section 6.1 List of excipients 3. PHARMACEUTICAL FORM Suspension for injection The suspension is turbid white. 4. CLINICAL PARTICULARS 4.1. Therapeutic indications ENGERIX B is indicated for active immunization against Hepatitis B Virus infection (HBV) caused by all known subtypes in subjects of all ages considered at risk of exposure to HBV. It can be expected that hepatitis D will also be prevented by immunization with ENGERIX B as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection. Immunization against hepatitis B is expected in the long term to reduce not only the incidence of this disease but also its chronic complication such as chronic active hepatitis B and hepatitis B associated cirrhosis. In areas of low prevalence of hepatitis B, immunization is particularly recommended for those belonging to groups identified at increased risk of infection (see below), however, universal immunization of all infants and adolescents will contribute to the control of hepatitis B on a population basis.