EDITED TRANSCRIPT PFE.N - Pfizer Inc Virtual Investor Day: Day 1
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Introduction of Inactivated Poliovirus Vaccine and Impact on Vaccine- Associated Paralytic Poliomyelitis — Beijing, China, 2014–2016
Morbidity and Mortality Weekly Report Introduction of Inactivated Poliovirus Vaccine and Impact on Vaccine- Associated Paralytic Poliomyelitis — Beijing, China, 2014–2016 Dan Zhao, MD1; Rui Ma, MD1; Tao Zhou, MD1; Fan Yang, MD1; Jin Wu, MD2; Hao Sun3; Fang Liu, MD4; Li Lu, MD1; Xiaomei Li1; Shuyan Zuo, MD5; Wei Yao6; JianYin6 When included in a sequential polio vaccination schedule, the risk for VAPP associated with subsequent OPV doses. inactivated polio vaccine (IPV) reduces the risk for vaccine- Countries that have previously introduced at least 1 IPV dose associated paralytic poliomyelitis (VAPP), a rare adverse event before vaccination with OPV have rapidly eliminated VAPP associated with receipt of oral poliovirus vaccine (OPV). (1). IPV has been available in China’s private sector since During January 2014, the World Health Organization (WHO) 2009. After completion of immunogenicity studies (3–5), recommended introduction of at least 1 IPV dose into routine Beijing introduced IPV into the public sector EPI program in immunization schedules in OPV-using countries (1). The December 2014 as part of a sequential schedule that included Polio Eradication and Endgame Strategic Plan 2013–2018 1 dose of IPV at age 2 months, followed by 3 doses of trivalent recommended completion of IPV introduction in 2015 and OPV at ages 3, 4, and 48 months. After the global synchronized globally synchronized withdrawal of OPV type 2 in 2016 (2). withdrawal of all Sabin type 2 vaccines in April 2016, trivalent Introduction of 1 dose of IPV into Beijing’s Expanded Program OPV was replaced with bivalent OPV, which contains types 1 on Immunization (EPI) on December 5, 2014 represented and 3 oral polio vaccine viruses. -
Valuing the Cost of Improving Chilean Primary Vaccination: a Cost Minimization Analysis of a Hexavalent Vaccine
Olivera et al. BMC Health Services Research (2020) 20:295 https://doi.org/10.1186/s12913-020-05115-7 RESEARCH ARTICLE Open Access Valuing the cost of improving Chilean primary vaccination: a cost minimization analysis of a hexavalent vaccine Ignacio Olivera1, Carlos Grau1, Hugo Dibarboure2, Juan Pablo Torres3, Gustavo Mieres1, Luis Lazarov1, Fabián P. Alvarez4 and Juan Guillermo López Yescas5* Abstract Background: The phased withdrawal of oral polio vaccine (OPV) and the introduction of inactivated poliovirus vaccine (IPV) is central to the polio ‘end-game’ strategy. Methods: We analyzed the cost implications in Chile of a switch from the vaccination scheme consisting of a pentavalent vaccine with whole-cell pertussis component (wP) plus IPV/OPV vaccines to a scheme with a hexavalent vaccine with acellular pertussis component (aP) and IPV (Hexaxim®) from a societal perspective. Cost data were collected from a variety of sources including national estimates and previous vaccine studies. All costs were expressed in 2017 prices (US$ 1.00 = $Ch 666.26). Results: The overall costs associated with the vaccination scheme (4 doses of pentavalent vaccine plus 1 dose IPV and 3 doses OPV) from a societal perspective was estimated to be US$ 12.70 million, of which US$ 8.84 million were associated with the management of adverse events related to wP. In comparison, the cost associated with the 4-dose scheme with a hexavalent vaccine (based upon the PAHO reference price) was US$ 19.76 million. The cost of switching to the hexavalent vaccine would be an additional US$ 6.45 million. Overall, depending on the scenario, the costs of switching to the hexavalent scheme would range from an additional US$ 2.62 million to US$ 6.45 million compared with the current vaccination scheme. -
The Hepatitis B Vaccine Is the Most Widely Used Vaccine in the World, with Over 1 Billion Doses Given
Hepatitis B Vaccine Protect Yourself and Those You Love What is Hepatitis B? Hepatitis B is the most common serious liver infection in the world. It is caused by the hepatitis B virus (HBV), which attacks liver cells and can lead to liver failure, cirrhosis (scarring), or liver cancer later in life. The virus is transmitted through direct contact with infected blood and bodily fluids, and from an infected woman to her newborn at birth. Is there a safe vaccine for hepatitis B? YES! The good news is that there is a safe and effective vaccine for hepatitis B. The vaccine is a series, typically given as three shots over a six-month period that will provide a lifetime of protection. You cannot get hepatitis B from the vaccine – there is no human blood or live virus in the vaccine. The hepatitis B vaccine is the most widely used vaccine in the world, with over 1 billion doses given. The hepatitis B vaccine is the first "anti-cancer" vaccine because it can help prevent liver cancer! Who should be vaccinated against hepatitis B? The World Health Organization (WHO) and the U.S. Centers for Disease Control and Prevention (CDC) recommend the hepatitis B vaccine for all newborns and children up to 18 years of age, and all high-risk adults. All infants should receive the first dose of the vaccine in the delivery room or in the first 24 hours of life, preferably within 12 hours. (CDC recommends the first dose within 12 hours vs. the WHO recommendation of 24 hours.) The HBV vaccine is recommended to anyone who is at high risk of infection. -
SARS-Cov-2 Protein Subunit Vaccination Elicits Potent Neutralizing Antibody Responses
bioRxiv preprint doi: https://doi.org/10.1101/2020.07.31.228486; this version posted July 31, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. It is made available under aCC-BY 4.0 International license. SARS-CoV-2 protein subunit vaccination elicits potent neutralizing antibody responses Marco Mandolesi1,*, Daniel J. Sheward1,2,*, , Leo Hanke1, Junjie Ma1, Pradeepa Pushparaj1, Laura Perez Vidakovics1, Changil Kim1, Karin Loré3, Xaquin Castro Dopico1, Jonathan M. Coquet1, Gerald McInerney1, Gunilla B. Karlsson Hedestam1,†, , and Ben Murrell1,†, 1Department of Microbiology, Tumor and Cell Biology, Karolinska Institutet, Stockholm, Sweden 2Division of Medical Virology, Institute of Infectious Diseases and Molecular Medicine, University of Cape Town, South Africa 3Department of Medicine, Solna, Karolinska Institutet, Stockholm, Sweden *These authors contributed equally †These authors contributed equally The outbreak and spread of SARS-CoV-2 (Severe Acute Res- Results piratory Syndrome coronavirus 2), the cause of coronavirus dis- ease 2019 (COVID-19), is a current global health emergency and To evaluate the use and immunogenicity of recombinant a prophylactic vaccine is needed urgently. The spike glycopro- protein subunit vaccines for SARS-CoV-2 we immunized tein of SARS-CoV-2 mediates entry into host cells, and thus is a C57BL/6J mice (N=24) with either the spike ectodomain or target for neutralizing antibodies and vaccine design. Here we RBD, expressed in 293-F cells. The RBD domain was ex- show that adjuvanted protein immunization with SARS-CoV-2 pressed as an Fc-fusion protein, which was cleaved and the 1 spike trimers, stabilized in prefusion conformation , results in RBD subsequently purified by size-exclusion chromatogra- potent antibody responses in mice and rhesus macaques with phy. -
(DTP-Hep B-Hib) Vaccine Into the EPI Programme
EPIDEMIOLOGICAL UNIT Department of Health Services Ministry of Health Care and Nutrition 231, de Saram Place, Colombo 01000, Sri Lanka Telephone: (+94-11-) 2681548, 2695112, Fax: (+94-11-) 2696583, E-mail: [email protected], [email protected] My No: EPI/81/VII/2007 22nd October 2007 Provincial /Regional Directors of Health Services, Directors of Teaching Hospitals/Specialized Campaigns, M. SS /D.M.OO of Provincial /Base Hospitals, Heads of Decentralized Units and, Medical Officers of Health Introduction of combined pentavalent (DTP-Hep B- Hib) Vaccine into the EPI A decision has been taken to introduce Hib (Haemophilus Influenzae B) vaccine into the EPI programme in Sri Lanka from year 2008. This decision is based on the recommendation by the National Advisory Committee on Communicable Diseases. The Hib vaccine will be in the form of a combined pentavalent (DTP-HepB-Hib) vaccine, which would include DTP and Hep B and therefore would replace both DTP and Hepatitis B in the present schedule. Background The bacterium, Haemophilus influenzae type B (Hib), is an important cause of infections in infants and young children; severe disease in adults due to Hib is uncommon. Where it has been studied carefully, Hib is the leading cause of acute bacterial meningitis in infants and children less than five years old, accounting for one-third to one-half of all cases of bacterial meningitis in this age group. Bacterial meningitis is fatal unless treated immediately with antibiotics. Even with proper treatment 3-25% of affected children may die. Permanent disability with sequelae that include deafness, learning disabilities, and difficulties in movement is not uncommon among those who survive the infection. -
Pentavalent and Hexavalent Vaccines
Pentavalent and Hexavalent Vaccines Cold Chain Equipment Database ID 3_7 Year 2004 The freeze indicator is used to warn of freezing and is packed with vaccines that are sensitive to freezing temperatures: DTP, TT, DT, Td (freezing point of -6.5°C), hepatitis B (-0.5°C), liquid Hib and their combinations (DTP-HepB, and DTP-HepB+Hib vaccines) and JE. Every refrigerator storing vaccines should have a freeze indicator (Freeze Watch™). It is strongly recommended that one freeze indicator be placed in each cold box during vaccine transport and distribution. This is critical in places subject to low temperatures. Immunization in practice: a practical resource guide for Health workers – 2004 update_____Module 3: The cold chain WHO/IVB/04.06 Page 13 Vaccine Handling Database ID 81_1 Year 2006 The recommended conditions for storing vaccines used in immunization programmes are shown in Appendix 81_1. This diagram also indicates the maximum times and temperatures in each case. At the higher levels of the cold chain, i.e., at national (primary), and regional or province level, OPV must be kept frozen between - 15oC and -25oC. Freeze-dried vaccines (i.e., BCG, measles, MMR and yellow fever) may also be kept frozen at -15oC to -25oC if cold chain space permits, but this is neither essential nor recommended. At other levels of the cold chain (intermediate vaccine stores and health facilities), these vaccines should be stored between +2oC and +8oC. All other vaccines should be stored at between +2oC and +8oC at all levels of the cold chain. Liquid formulations of vaccines containing diphtheria, pertussis, tetanus, hepatitis B, Haemophilus influenzae type b, IPV and their combinations should not be frozen. -
Recent Zoonotic and Vector-Borne Viral Threats NIAID Vaccine
4/1/2020 PROTOTYPE PATHOGEN APPROACH TO PANDEMIC PREPAREDNESS HIV→PNEUMOVIRUS→PARAMYXOVIRUS→CORONAVIRUS ADVAC Alumni 2 April 2020 Barney S. Graham, MD, PhD Deputy Director Vaccine Research Center, NIAID, NIH 1 Recent Zoonotic and Vector-borne Viral Threats • Hanta virus • Nipah/Hendra • West Nile virus • SARS • Influenza • Chikungunya • Ebola • MERS • Zika • EV‐D68 • SARS‐CoV‐2 2 NIAID Vaccine Research Center Basic Research Process Development Nucleic acid Vectors VLPs • AIDS/HIV • Influenza Proteins and cGMP Manufacturing nanoparticles • Ebola/Marburg • RSV • Malaria Monoclonal antibodies • Tuberculosis • EID GLP Analysis • West Nile virus, Zika • Chikungunya • W/E/V equine encephalitis viruses • MERS‐CoV, SARS, and other CoV • Nipah and other paramyxoviruses • EV‐D68 and other picornaviruses Clinical Trials • Smallpox 3 1 4/1/2020 Public health burden of re-emerging & emerging viruses Traditional Approaches • Licensed vaccines/antibiotics Vaccine • Passive surveillance Challenges • Contact tracing • Quarantine • Vaccines for unmet needs • Emerging viruses • Improving licensed vaccines 4 4 New Technologies are Transforming Vaccinology • Structure-based vaccine design Structural analysis of antigenic sites on viral • Single-cell sorting, sequencing, and bioinformatics surface glycoproteins – Rapid isolation of human mAbs Isolation of human monoclonal – Definition of antibody lineages antibodies from single B cells – Analysis of immune responses • Protein engineering of self-assembling nanoparticles • Rapid DNA synthesis • Recombinant -
Proposed Minutes
Approved 07/19/2021 MINUTES ST. CLAIR SHORES CITY COUNCIL MEETING JUNE 21, 2021 Regular Meeting of the City Council, held in the Council Chambers, located at 27600 Jefferson Avenue., St. Clair Shores, Michigan. Present: Mayor Kip C. Walby, Council Members Peter Accica, John Caron, Ron Frederick, David Rubello, Candice Rusie and Chris Vitale Also Present: City Manager Matthew Coppler, City Clerk Mary Kotowski, Deputy City Clerk Abby Hauff, Directors Henry Bowman, Chris Rayes and Laura Stowell and City Attorney Robert Ihrie 1. CALL TO ORDER, ROLL CALL AND PLEDGE OF ALLEGIANCE Mayor Walby called the meeting to order at 7:00 p.m. Ms. Kotowski, City Clerk, called the roll, and a quorum was present. The Pledge of Allegiance was recited. Mayor Walby introduced Abby Hauff, the new Deputy City Clerk, and she said a few words. 2. PROCLAMATIONS & PRESENTATIONS a. Memorial Day Parade Trophy Presentation Cheryl Furdos, Memorial Day Parade Committee Chairperson, and Mayor Walby presented trophies to the following winners: The Best Color Guard - U.S. Air Force Honor Guard; The Best Special Entry - Eddie Munster and the Munster Koach; The Best Patriotic Float - Viviano Flower Shop; The Best Band - 338th Army Band; The Best School Band - Lakeview Marching Band; The Best Overall Float - SCS Baseball & Softball Association and Lac Ste. Claire Kiwanis, which was also the Mayor’s Choice; The Best Overall Entry - The Arsenal of Democracy Museum; and the Chairwoman’s Choice - Cub Scout Pack #2018. b. Dr. Jason McLellan Proclamation Mayor Walby presented the following proclamation to Mr. and Mrs. McLellan who were present on behalf of their son Dr. -
Kizzmekia S. Corbett
KIZZMEKIA S. CORBETT, PHD Senior Research Fellow National Institutes of Health | National Institute of Allergy and Infectious Diseases | Vaccine Research Center 40 Convent Drive, Building 40 - Room 2608, Bethesda MD 20892 [email protected] | phone: 301.761.7610 | fax: 301.480.2771 EDUCATION Doctor of Philosophy in Microbiology and Immunology 2014 University of North Carolina at Chapel Hill (UNC) Director’s Scholar Bachelor of Science in Biological Sciences | Secondary Major in Sociology 2008 University of Maryland – Baltimore County (UMBC) Robert and Jane Meyerhoff Scholar RESEARCH EXPERIENCE Research Fellow 10/14 - present National Institutes of Health | Vaccine Research Center | PI: Barney S. Graham, MD PhD Research Interest: mechanisms of viral immunity to inform influenza and coronavirus vaccine development Graduate Research Assistant 08/09 – 10/14 University of North Carolina at Chapel Hill | Microbiology and Immunology | PI: Aravinda de Silva, MPH PhD Research Interest: human antibody responses to dengue virus infection Visiting Scholar 04/14 – 05/14 Genetech Research Institute | PI: Aruna Dharshan de Silva, PhD Research Interest: immunological relevance of dengue virion maturation Postbaccalaureate Research Fellow 05/08 – 08/09 National Institutes of Health | Vaccine Research Center | PI: Barney S. Graham, MD PhD Research Interest: novel vaccine platform design for respiratory syncytial virus antigens NIH Undergraduate Scholarship Program Summer Intern 06/07 – 08/07 National Institutes of Health | Vaccine Research Center -
Shaping the Market: Gavi's Model for Bringing the Power of Vaccines To
#GaviSeth Shaping the market: Gavi’s model for bringing the power of vaccines to the world’s poorest children Seth Berkley MD National Vaccine Advisory Committee 2 February 2015, Washington DC www.gavi.org The challenge: Reducing delays in launching new vaccines in poor countries 2 #vaccineswork Gavi: an innovative public-private partnership Building on the comparative advantages of both public and private partners 3 #vaccineswork Gavi-supported vaccination programmes: an overview Refers to the first Gavi-supported introduction of each vaccine. Vaccine Investment Strategy: Gavi’s approach to prioritsing new vaccines Category VIS Criteria • Cholera Impact on child mortality Health Impact on overall mortality • Dengue impact • Hepatitis A Impact on overall morbidity • Hepatitis B (birth dose) Epidemic potential Global or regional public health priority • Hepatitis E Herd immunity Additional • Influenza* impact Availability of alternative interventions considerations • Meningococcal CYW Socio-economic inequity • Malaria Gender inequity • Rabies Disease of regional importance • Yellow Fever** Capacity and supplier base • DTP booster GAVI market shaping potential Implementation Ease of supply chain integration • Enterovirus 71 feasibility • Mumps Ease of programmatic integration Vaccine efficacy and safety * Maternal vaccination Vaccine procurement cost Cost and value ** Additional mass campaigns In-country operational cost for money Procurement cost per event averted Gavi’s unusual development model Co-financing Market- shaping Donor base -
DNA-Launched RNA Replicon Vaccines Induce Potent Anti-SARS-Cov-2
www.nature.com/scientificreports OPEN DNA‑launched RNA replicon vaccines induce potent anti‑SARS‑CoV‑2 immune responses in mice Inga Szurgot*, Leo Hanke, Daniel J. Sheward, Laura Perez Vidakovics, Ben Murrell, Gerald M. McInerney & Peter Liljeström The outbreak of the SARS‑CoV‑2 virus and its rapid spread into a global pandemic made the urgent development of scalable vaccines to prevent coronavirus disease (COVID‑19) a global health and economic imperative. Here, we characterized and compared the immunogenicity of two alphavirus‑ based DNA‑launched self‑replicating (DREP) vaccine candidates encoding either SARS‑CoV‑2 spike glycoprotein (DREP‑S) or a spike ectodomain trimer stabilized in prefusion conformation (DREP‑Secto). We observed that the two DREP constructs were immunogenic in mice inducing both binding and neutralizing antibodies as well as T cell responses. Interestingly, the DREP coding for the unmodifed spike turned out to be more potent vaccine candidate, eliciting high titers of SARS‑CoV‑2 specifc IgG antibodies that were able to efciently neutralize pseudotyped virus after a single immunization. In addition, both DREP constructs were able to efciently prime responses that could be boosted with a heterologous spike protein immunization. These data provide important novel insights into SARS‑ CoV‑2 vaccine design using a rapid response DNA vaccine platform. Moreover, they encourage the use of mixed vaccine modalities as a strategy to combat SARS‑CoV‑2. Te severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged as the causative agent of COVID- 19 in late 20191,2. Te disease pathology ranges from asymptomatic infection to severe acute respiratory distress and death3,4. -
"What Worries Me Is That People Do Trust Vaccines"
Subscribe Past Issues Translate RSS "What Worries Me Is That People Do Trust Vaccines" Interview with Paul A. O¸t, M.D. Professor at the University of Pennsylvania Director Vaccine Education Center Children’s Hospital of Philadelphia Paul O¸t is a widely recognized expert on vaccines and immunology. He is a co-inventor of the rotavirus vaccine known as RotaTeq, manufactured by Merck & Co., and now sits on the US National Institutes of Health’s (NIH) public-private committee known as Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), which is advising on the clinical trials of COVID-19 vaccine candidates. We asked for his thoughts on the clinical trials of COVID-19 vaccine candidates prioritized by Operation Warp Speed. A slightly edited version of our conversation appears below. Are the vaccines that are being prioritized by Operation Warp Speed in the US the most likely to work or just the fastest to produce? I think they’re just the fastest to be produced because for the most part they are all genetic vaccines; mRNA or replication-defective simian or human adenoviruses where you can just sort of plug and play. You know the gene you’re interested in— it’s the gene that codes for the SARS-CoV-2 surface protein, the Spike protein—so you just plug it in. It’s much easier to make than an inactivated viral vaccine, a live- attenuated viral vaccine, or a puriÛed protein vaccine. There is nothing that says these vaccines will be more likely to be safe or e˛ective than existing vaccine strategies.