Product TBL.Productname
Total Page:16
File Type:pdf, Size:1020Kb
Load more
Recommended publications
-
HPV Vaccine Safety - Vaccine Safety
CDC - HPV Vaccine Safety - Vaccine Safety Skip directly to search Skip directly to A to Z list Skip directly to navigation Skip directly to site content Skip directly to page options CDC Home CDC 24/7: Saving Lives. Protecting People.™ Search The CDC Vaccine Safety Vaccine Safety Vaccines Safety Basics Diphtheria, Tetanus, and Pertussis Vaccines: DTaP, Td, and Tdap Haemophilus Influenzae Type B (Hib) Hib Summary Human Papillomavirus (HPV) FAQs about HPV Vaccine Safety FAQ: Gardasil Vaccine recall JAMA Report Summary Information from FDA and CDC on Gardasil and its Safety (Archived) Measles, Mumps, Rubella (MMR) MMR Vaccine Safety Studies Measles, Mumps, Rubella, Varicella (MMRV) Information on the VSD MMRV Vaccine Safety Study MMRV Vaccine Safety Studies MMRV and Febrile Seizures Rotavirus Varicella Addressing Common Concerns Adjuvants Autism Vaccine not associated with autism CDC Statement: 2004 Pediatrics Paper CDC Statement on Pandemrix Fainting (Syncope) FAQs about Fainting (Syncope) After Vaccination Childhood Vaccines and Febrile Seizures Influenza Season 2012-2013 Influenza Season 2010-2011 GBS GBS and Menactra Meningococcal Vaccine FAQs about GBS and Menactra Meningococcal Vaccine IOM Assessment of Studies on Childhood Immunization Schedule IOM Report on Adverse Effects of Vaccines Pregnancy and Influenza Vaccine Safety Sudden Infant Death Syndrome (SIDS) Thimerosal http://www.cdc.gov/vaccinesafety/vaccines/HPV/index.html[10/13/2014 5:59:00 PM] CDC - HPV Vaccine Safety - Vaccine Safety CDC Study on Thimerosal and Risk of Autism -
COVID-19 and Cancer: from Basic Mechanisms to Vaccine Development Using Nanotechnology
International Immunopharmacology 90 (2021) 107247 Contents lists available at ScienceDirect International Immunopharmacology journal homepage: www.elsevier.com/locate/intimp Review COVID-19 and cancer: From basic mechanisms to vaccine development using nanotechnology Hyun Jee Han a,*, Chinekwu Nwagwu b, Obumneme Anyim c, Chinedu Ekweremadu d, San Kim e a University College London, Department of Neonatology, United Kingdom b Department of Pharmaceutics, University of Nigeria Nsukka, Nigeria c Department of Internal Medicine, University of Nigeria Teaching Hospital Ituku-Ozalla, Enugu, Nigeria d Department of Pharmaceutics and Pharmaceutical Technology Enugu State University of Science and Technology, Nigeria e Basildon and Thurrock University Hospital, United Kingdom ARTICLE INFO ABSTRACT Keywords: Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV- COVID-19 2), is a global pandemic which has induced unprecedented ramifications,severely affecting our society due to the Cancer long incubation time, unpredictably high prevalence and lack of effective vaccines. One of the interesting notions Vaccine development is that there is an association between COVID-19 and cancer. Cancer patients seem to exhibit exacerbated Pharmaceutics conditions and a higher mortality rate when exposed to the virus. Therefore, vaccines are the promising solution Nanotechnology to minimise the problem amongst cancer patients threatened by the new viral strains. However, there are still limitations to be considered, including the efficacy of COVID vaccines for immunocompromised individuals, possible interactions between the vaccine and cancer, and personalised medicine. Not only to eradicate the pandemic, but also to make it more effective for immunocompromised patients who are suffering from cancer, a successful vaccine platform is required through the implementation of nanotechnology which can also enable scalable manufacturing and worldwide distribution along with its faster and precise delivery. -
Vaccines for Preteens
| DISEASES and the VACCINES THAT PREVENT THEM | INFORMATION FOR PARENTS Vaccines for Preteens: What Parents Should Know Last updated JANUARY 2017 Why does my child need vaccines now? to get vaccinated. The best time to get the flu vaccine is as soon as it’s available in your community, ideally by October. Vaccines aren’t just for babies. Some of the vaccines that While it’s best to be vaccinated before flu begins causing babies get can wear off as kids get older. And as kids grow up illness in your community, flu vaccination can be beneficial as they may come in contact with different diseases than when long as flu viruses are circulating, even in January or later. they were babies. There are vaccines that can help protect your preteen or teen from these other illnesses. When should my child be vaccinated? What vaccines does my child need? A good time to get these vaccines is during a yearly health Tdap Vaccine checkup. Your preteen or teen can also get these vaccines at This vaccine helps protect against three serious diseases: a physical exam required for sports, school, or camp. It’s a tetanus, diphtheria, and pertussis (whooping cough). good idea to ask the doctor or nurse every year if there are any Preteens should get Tdap at age 11 or 12. If your teen didn’t vaccines that your child may need. get a Tdap shot as a preteen, ask their doctor or nurse about getting the shot now. What else should I know about these vaccines? These vaccines have all been studied very carefully and are Meningococcal Vaccine safe. -
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. -
Recommended Adult Immunization Schedule
Recommended Adult Immunization Schedule UNITED STATES for ages 19 years or older 2021 Recommended by the Advisory Committee on Immunization Practices How to use the adult immunization schedule (www.cdc.gov/vaccines/acip) and approved by the Centers for Disease Determine recommended Assess need for additional Review vaccine types, Control and Prevention (www.cdc.gov), American College of Physicians 1 vaccinations by age 2 recommended vaccinations 3 frequencies, and intervals (www.acponline.org), American Academy of Family Physicians (www.aafp. (Table 1) by medical condition and and considerations for org), American College of Obstetricians and Gynecologists (www.acog.org), other indications (Table 2) special situations (Notes) American College of Nurse-Midwives (www.midwife.org), and American Academy of Physician Assistants (www.aapa.org). Vaccines in the Adult Immunization Schedule* Report y Vaccines Abbreviations Trade names Suspected cases of reportable vaccine-preventable diseases or outbreaks to the local or state health department Haemophilus influenzae type b vaccine Hib ActHIB® y Clinically significant postvaccination reactions to the Vaccine Adverse Event Hiberix® Reporting System at www.vaers.hhs.gov or 800-822-7967 PedvaxHIB® Hepatitis A vaccine HepA Havrix® Injury claims Vaqta® All vaccines included in the adult immunization schedule except pneumococcal 23-valent polysaccharide (PPSV23) and zoster (RZV) vaccines are covered by the Hepatitis A and hepatitis B vaccine HepA-HepB Twinrix® Vaccine Injury Compensation Program. Information on how to file a vaccine injury Hepatitis B vaccine HepB Engerix-B® claim is available at www.hrsa.gov/vaccinecompensation. Recombivax HB® Heplisav-B® Questions or comments Contact www.cdc.gov/cdc-info or 800-CDC-INFO (800-232-4636), in English or Human papillomavirus vaccine HPV Gardasil 9® Spanish, 8 a.m.–8 p.m. -
3.2.3 Gardasil and Autoimmune Diseases
HPV vaccination and autoimmune disease CONFIDENTIAL Medicines Adverse Reactions Committee Meeting date 10 September 2015 Agenda item 3.2.3 Title Gardasil and autoimmune diseases Medsafe For advice/ Submitted by Paper type Pharmacovigilance Team For information Active constituent Medicines Sponsors Human papillomavirus type 6 L1 protein, type 11 Gardasil Bio CSL for MSD L1 protein, type 16 L1 protein and type 18 L1 protein Funding Fully funded for girls aged under 18 years or patients aged under 25 years old with confirmed HIV infection or in transplant patients. Previous MARC Gardasil has only been discussed previously in relation to CARM case meetings reports. International action The EMA have announced an investigation into HPV vaccine and complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS). This review will complete at the end of the year. Prescriber Update None Schedule Prescription medicine Usage data Over 200,000 girls and women have received at least one dose in NZ Worldwide cumulative exposure post-marketing, to the end of May 2015 was 63.6 million. Cumulative exposure in clinical trials was 29,932 Advice sought The Committee is asked to advise whether: − There is a safety concern relating to development of autoimmune conditions after HPV vaccination Medicines Adverse Reactions Committee: 10 September 2015 Page 1 of 46 HPV vaccination and autoimmune disease CONFIDENTIAL Table of Contents 1.0 PURPOSE ................................................................................................................................. -
COVID-19 Vaccine-Associated Anaphylaxis and Allergic Reactions: Consensus Statements of the KAAACI Urticaria/Angioedema/Anaphylaxis Working Group
Allergy Asthma Immunol Res. 2021 Jul;13(4):526-544 https://doi.org/10.4168/aair.2021.13.4.526 pISSN 2092-7355·eISSN 2092-7363 Review COVID-19 Vaccine-associated Anaphylaxis and Allergic Reactions: Consensus Statements of the KAAACI Urticaria/Angioedema/Anaphylaxis Working Group Mi-Ae Kim ,1† Yong Won Lee ,2† So Ri Kim ,3 Joo-Hee Kim ,4 Taek ki Min ,5 6 7 6 8 Received: May 10, 2021 Hae-Sim Park , Meeyong Shin , Young-Min Ye , Sooyoung Lee , 9 10,11 12* Accepted: Jun 2, 2021 Jeongmin Lee , Jeong-Hee Choi , Gwang Cheon Jang , Yoon-Seok Chang 13* Correspondence to Gwang Cheon Jang, MD, PhD 1Department of Pulmonology, Allergy and Critical Care Medicine, CHA Bundang Medical Center, CHA Department of Pediatrics, National Health University, Seongnam, Korea Insurance Service Ilsan Hospital, 100 Ilsan-ro, 2Division of Allergy and Clinical Immunology, Department of Internal Medicine, International St. Mary's Ilsandong-gu, Goyang 10444, Korea. Hospital, Catholic Kwandong University College of Medicine, Incheon, Korea 3 Tel: +82-31-900-0520 Division of Respiratory Medicine and Allergy, Department of Internal Medicine, Research Center for Fax: +82-31-900-0343 Pulmonary Disorders, Jeonbuk National University Medical School, Jeonju, Korea 4Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine Hallym University E-mail: [email protected] Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Korea 5 Yoon-Seok Chang, MD, PhD Department of Pediatrics, Soonchunhyang University Seoul Hospital, Soonchunhyang University -
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 -
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. -
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.