Covaxeurope Put to the Test of Global Vaccine Solidarity
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Gavi's Vaccine Investment Strategy
Gavi’s Vaccine Investment Strategy Deepali Patel THIRD WHO CONSULTATION ON GLOBAL ACTION PLAN FOR INFLUENZA VACCINES (GAP III) Geneva, Switzerland, 15-16 November 2016 www.gavi.org Vaccine Investment Strategy (VIS) Evidence-based approach to identifying new vaccine priorities for Gavi support Strategic investment Conducted every 5 years decision-making (rather than first-come- first-serve) Transparent methodology Consultations and Predictability of Gavi independent expert advice programmes for long- term planning by Analytical review of governments, industry evidence and modelling and donors 2 VIS is aligned with Gavi’s strategic cycle and replenishment 2011-2015 Strategic 2016-2020 Strategic 2021-2025 period period 2008 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 RTS,S pilot funding decision VIS #1 VIS #2 VIS #3 MenA, YF mass campaigns, JE, HPV Cholera stockpile, Mid 2017 : vaccine ‘long list’ Rubella, Rabies/cholera studies, Oct 2017 : methodology Typhoid Malaria – deferred Jun 2018 : vaccine shortlist conjugate Dec 2018 : investment decisions 3 VIS process Develop Collect data Develop in-depth methodology and Apply decision investment decision framework for cases for framework with comparative shortlisted evaluation analysis vaccines criteria Phase I Narrow long list Phase II Recommend for Identify long list to higher priority Gavi Board of vaccines vaccines approval of selected vaccines Stakeholder consultations and independent expert review 4 Evaluation criteria (VIS #2 – 2013) Additional Health Implementation -
Yellow Fever 2016
Resident / Humanitarian Coordinator Report on the use of CERF funds RESIDENT / HUMANITARIAN COORDINATOR REPORT ON THE USE OF CERF FUNDS ANGOLA RAPID RESPONSE YELLOW FEVER 2016 RESIDENT/HUMANITARIAN COORDINATOR Pier Paolo Balladelli REPORTING PROCESS AND CONSULTATION SUMMARY a. Please indicate when the After Action Review (AAR) was conducted and who participated. Review agreed on 02/09/2016 and 07/09/2016. b. Please confirm that the Resident Coordinator and/or Humanitarian Coordinator (RC/HC) Report was discussed in the Humanitarian and/or UN Country Team and by cluster/sector coordinators as outlined in the guidelines. YES NO c. Was the final version of the RC/HC Report shared for review with in-country stakeholders as recommended in the guidelines (i.e. the CERF recipient agencies and their implementing partners, cluster/sector coordinators and members and relevant government counterparts)? YES NO Final version shared with UNICEF and UNDP, although this initiative was mainly implemented by WHO 2 I. HUMANITARIAN CONTEXT TABLE 1: EMERGENCY ALLOCATION OVERVIEW (US$) Total amount required for the humanitarian response: Source Amount CERF 3,000,000 Breakdown of total response COUNTRY-BASED POOL FUND (if applicable) 4,508,559 funding received by source OTHER (bilateral/multilateral) TOTAL 10,473,618 *The total amount does not match because this was considered an underfunded emergency. TABLE 2: CERF EMERGENCY FUNDING BY ALLOCATION AND PROJECT (US$) Allocation 1 – date of official submission: 06/04/2016- 05/10/2016 Agency Project code Cluster/Sector -
Hanna Nohynek @Hnohynek
Biosketch Hanna Nohynek @hnohynek Hanna Nohynek is Chief Physician and Deputy Head of the Infectious Diseases Control and Vaccines Unit of the Department of Health Security at the Finnish Institute for Health and Welfare. She serves as secretary of the Finnish NITAG (KRAR), and leads the subgroup on Strategic development of the influenza vaccination programme and the subgroup on the SARS-CoV-2 vaccination strategy. She practices clinical medicine at a travel health clinic in Aava, Helsinki. She was instrumental in designing the first THL (KTL) health advisory for refugees and asylum seekers in Finland, studying the narcolepsy signal post pandemic vaccination, designing the introduction of the HPV vaccine to the national immunization programme, and the introduction of the live attenuated influenza vaccine for children. Her present research interests are register-based vaccine impact studies, evidence based policy/decision making, vaccine safety, hesitancy, SARS-CoV-2, RSV, influenza and pneumococcus. She coordinates the work packages on field studies and communication for IMI DRIVE on brand specific influenza vaccine effectiveness (www.drive-eu.org). She has authored more than 130 original articles (including the first scientific report on the association between pandemic influenza vaccination and narcolepsy), and she teaches, giving over 30 invited lectures annually and guiding elective, graduate and PhD students (presently Raija Auvinen and Idil Hussein). She belongs to the external faculty of the University of Tampere MSc course on Global Health. She has served on expert committees evaluating HBV, PCV and rota virus vaccines in Finland, and as an advisor to the EU, IMI, IVI, WHO, GAVI, SIDA/SRC, and the Finnish MOFA. -
1 English Package Insert BCG VACCINE (Freeze-Dried)
English Package insert BCG VACCINE (Freeze-Dried) DESCRIPTION BCG Vaccine is a live freeze-dried vaccine derived from attenuated strain of Mycobacterium bovis, (Bacillus Calmette Guerin) used for the prevention of tuberculosis. It contains Sodium Glutamate as stabilizer. The vaccine meets requirements of WHO when tested by the methods outlined in WHO, TRS 979 (2013). COMPOSITION Live, attenuated BCG Vaccine (Bacillus Calmette Guerin strain) Each 0.1 ml contains between: 2x105 and 8 x 105 C.F.U. Reconstitute with Sodium Chloride Injection Dose: 0.05 ml, Intradermal for infants under one year old 0.1 ml, Intradermal for children over one year of age and adult. RECONSTITUTION BCG vaccine vial of 20 doses (0.05 ml) for infants under one year old/ 10 doses (0.1 ml) for children over one year of age and adult to be reconstituted by adding the entire content of the supplied container of diluents (Sodium Chloride Injection). Carefully invert the vial a few times to resuspend freeze-dried BCG. Gently swirl the vial of resuspended vaccine before drawing up each subsequent dose. The resulting suspension should be homogenous, slightly opaque and colourless. Reconsitute only with diluent provided by manufacture. Using an incorrect diluent any result in damage to the vaccine and / or serious reactions to those receiving the vaccine. Use immediately after reconstitution. If the vaccine is not used immediately then it should be stored in the dark at 2º to 8º C for no longer than 6 hours (1 immunisation session). Any opened vial remaining at the end of a vaccination session (within six hours of reconstitution) must be discard. -
DRAFT Landscape of COVID-19 Candidate Vaccines – 10 August 2020
DRAFT landscape of COVID-19 candidate vaccines – 10 August 2020 28 candidate vaccines in clinical evaluation COVID-19 Vaccine Number of Route of Clinical Stage Vaccine platform Type of candidate vaccine Timing of doses developer/manufacturer doses Administration Phase 1 Phase 1/2 Phase 2 Phase 3 PACTR202006922165132 Non-Replicating University of Oxford/AstraZeneca ChAdOx1-S 1 IM 2020-001072-15 2020-001228-32 ISRCTN89951424 Viral Vector Interim Report NCT04383574 Sinovac Inactivated Inactivated 2 0, 14 days IM NCT04456595 NCT04352608 Wuhan Institute of Biological Inactivated Inactivated 2 0,14 or 0,21 days IM ChiCTR2000031809 ChiCTR2000034780 Products/Sinopharm Beijing Institute of Biological Inactivated Inactivated 2 0,14 or 0,21 days IM ChiCTR2000032459 ChiCTR2000034780 Products/Sinopharm NCT04283461 NCT04405076 NCT04470427 Moderna/NIAID RNA LNP-encapsulated mRNA 2 0, 28 days IM Interim Report 2020-001038-36 BioNTech/Fosun Pharma/Pfizer RNA 3 LNP-mRNAs 2 0, 28 days IM NCT04368728 ChiCTR2000034825 CanSino Biological Inc./Beijing Institute Non-Replicating ChiCTR2000030906 ChiCTR2000031781 Adenovirus Type 5 Vector 1 IM of Biotechnology Viral Vector Study Report Study Report Anhui Zhifei Longcom Adjuvanted recombinant protein 0,28 or 0,28,56 Protein Subunit 2 or 3 IM NCT04445194 NCT04466085 Biopharmaceutical/Institute of (RBD-Dimer) days DISCLAIMER: These landscape documents have been prepared by the World Health Organization (WHO) for information purposes only concerning the 2019-2020 pandemic of the novel coronavirus. Inclusion of any particular product or entity in any of these landscape documents does not constitute, and shall not be deemed or construed as, any approval or endorsement by WHO of such product or entity (or any of its businesses or activities). -
UNEP Mercury Treaty Protects Access to Thiomersal-Containing Vaccines
UNEP mercury treaty protects access to thiomersal-containing vaccines United Nations Environment Program has developed a treaty on mercury in an effort to protect human health and the environment by limiting mercury releases. In the course of the negotiations, a proposal was made to restrict vaccines that contain the preservative thiomersal under a section of the treaty that prohibits trade of mercury-added products. The implications of restricting thiomersal, an ethyl mercury-containing preservative, would be significant. According to SAGE, “Thiomersal-containing vaccines [are] safe, essential, and irreplaceable components of immunization programs, especially in developing countries, and…removal of these products would disproportionately jeopardize the health and lives of the most disadvantaged children worldwide.” The treaty annex that describes prohibited products specifically excludes “vaccines containing thiomersal as preservatives” under a short list of products the authors intended to emphasize were to be protected. Protecting access to vaccines came as the result of a strong partnership between WHO, UNICEF, GAVI, and civil society advocates and experts around the world to educate country delegates, who predominantly came from ministries of environment. This was also a wonderful partnership with animal health experts, who similarly rely on thiomersal for veterinary vaccines. By facilitating communication between ministries of health and ministries of environment, strong statements are made by delegates about the essential role of thiomersal-containing vaccines in protecting human health. PATH will be collecting and disseminating additional information about how the community came together around this issue and lessons learned in the coming months. . -
Editorial 10.5005/Ijmb-24-3-Iv
Editorial 10.5005/ijmb-24-3-iv COVID-19 Vaccines: Lets Go for It SARS CoV-2, also christened as COVID-19 is an acute respiratory illness caused by a novel coronavirus which originated from Wuhan China in 2019 and within a short span affected virtually each and every country around the globe, throwing healthcare preparedness and economy out of gear. The world was faced with a pandemic leading to overcrowded hospitals and overflowing mortuaries. Lockdowns imposed in countries jeopardized routine life never to normalize again. India has been among the top three countries with the maximum number of afflicted people. Thankfully , our statistics with respect to mortality is better as compared to the western world. The last year 2020 was completely COVIDISED if we may say so. The world economy is in doldrums and the health infrastructure is overstretched and fatigued. Everytime we feel that the disease is under control, the virus cleverly mutates to become more infective and develops increased ability to escape the immune surveillance. Efforts to develop a vaccine against this scourge were initiated at a war footing across the globe. A number of vaccines were approved for emergency use since the scientific committee didn’t have the time to wait further. In India, two vaccines- Covaxin and Covishield have been approved by the Government of India for mass vaccination. The mammoth program was initiated with first preference for the healthcare workers and frontline warriors. In the next phases, elderly population followed by the rest of the population in a phased manner was planned. It is really incredible and praiseworthy about the immaculate planning and implementation of the initiative in our country where the diversity is both a boon as well as bane. -
Cheat Sheet: COVID-19 Vaccine Pipeline
Cheat Sheet: COVID-19 vaccine pipeline Primary sponsor(s) Description Platform Funders Status Considerations Read more Pfizer / BioNTech Comirnaty mRNA Pfizer ($500M) Ph. I/II ongoing: 456/Germany Efficacy: Interim analysis shows that the candidate was safe and well-tolerated with New York Times mRNA that encodes for USG ($1.9M) Ph. II planned: 960/China an efficacy rate of 95%. SARS-CoV-2 spike protein. Warp Speed Finalist Ph. II/III ongoing: 44K US +5 Manufacturing/delivery: mRNA vaccines are relatively easy to scale and Authorization: EUA in EU, US, +9; WHO manufacture. Emergency Validation Platform history: No previous mRNA vaccines licensed for use. Approval: Bahrain, New Zealand, Saudi Arabia, Switzerland Moderna mRNA-1273 mRNA USG ($2.48B) Ph. I ongoing: 155/US Efficacy: Interim analysis shows that the candidate was safe and well-tolerated Moderna Synthetic messenger RNA CEPI/GAVI (Undisclosed) Ph. II/III ongoing: 3000 (12 to 17 years)/ US with an efficacy rate of 94.5%. Statement that encodes for SARS- Warp Speed Finalist Ph. III ongoing: 30,000/US Manufacturing/delivery: mRNA vaccines are relatively easy to scale and CoV-2 spike protein. COVAX Portfolio Authorization: EUA in Canada, EU, manufacture (potential for 1B doses by 2022); likely to require two doses, but a AVAC Israel, US third may be necessary. Webinar Approval: Switzerland Platform history: No previous mRNA vaccines licensed for use. U. of Oxford AZD1222 Viral USG ($1.2B) Ph. II ongoing: 300 vols (6-17 years)/ UK Efficacy: Ph. III interim analysis shows vaccine was safe and well-tolerated, efficacy Science AstraZeneca Chimpanzee Adeno vector vector CEPI/GAVI ($750M) Ph. -
Yellow Fever Vaccine
Yellow Fever Vaccine: Current Supply Outlook UNICEF Supply Division May 2016 0 Yellow Fever Vaccine - Current Supply Outlook May 2016 This update provides revised information on yellow fever vaccine supply availability and increased demand. Despite slight improvements in availability and the return of two manufacturers from temporary suspension, a constrained yellow fever vaccine market will persist through 2017, exacerbated by current emergency outbreak response requirements. 1. Summary Yellow fever vaccine (YFV) supply through UNICEF remains constrained due to limited production capacity. Despite the return of two manufacturers from temporary suspension, the high demand currently generated from the yellow fever (YF) outbreak in Angola, in addition to potential increased outbreak response requirements in other geographic regions, outweigh supply. The demand in response to the current YF outbreak in Angola could negatively impact the supply availability for some routine immunization programme activities. UNICEF anticipates a constrained global production capacity to persist through 2017. UNICEF has long-term arrangements (LTAs) with four YFV suppliers to cover emergency stockpile, routine immunization, and preventative campaign requirements. During 2015, UNICEF increased total aggregate awards to suppliers to reach approximately 98 million doses for 2016- 2017. However, whereas supply can meet emergency stockpile and routine requirements, it is insufficient to meet all preventive campaign demands, which increased the total demand through UNICEF to 109 million doses. The weighted average price (WAP) per dose for YFV increased 7% a year on average since 2001, from US$ 0.39 to reach US$ 1.04 in 2015. Given the continued supply constraints, UNICEF anticipates a YFV WAP per dose of US$1.10 in the near-term. -
An Overview of COVID Vaccine Clinical Trial Results & Some Challenges
An overview of COVID vaccine clinical trial results & some challenges DCVMN Webinar December 8th, 2020 Access to COVID-19 tools ACCESSACCESS TO TOCOVID-19 COVID-19 TOOLS TOOLS (ACT) (ACT) ACCELERATOR ACCELERATOR (ACT) accelerator A GlobalA GlobalCollaboration Collaboration to Accelerate tothe AccelerateDevelopment, the Production Development, and Equitable Production Access to New and Equitable AccessCOVID-19 to New diagnostics, COVID-19 therapeutics diagnostics, and vaccines therapeutics and vaccines VACCINES DIAGNOSTICS THERAPEUTICS (COVAX) Development & Manufacturing Led by CEPI, with industry Procurement and delivery at scale Led by Gavi Policy and allocation Led by WHO Key players SOURCE: (ACT) ACCELERATOR Commitment and Call to Action 24th April 2020 ACT-A / COVAX governance COVAX COORDINATION MEETING CEPI Board Co-Chair: Jane Halton Co-Chair: Dr. Ngozi Gavi Board Workstream leads + DCVMN and IFPMA-selected Reps As needed – R&D&M Chair; COVAX IPG Chair Development & Manufacturing Procurement and delivery Policy and allocation (COVAX) at scale Led by (with industry) Led by Led by R&D&M Investment Committee COVAX Independent Product Group Technical Review Group Portfolio Group Vaccine Teams SWAT teams RAG 3 COVAX SWAT teams are being set up as a joint platform to accelerate COVID- 19 Vaccine development and manufacturing by addressing common challenges together Timely and targeted Multilateral Knowledge-based Resource-efficient Addresses specific cross- Establishes a dialogue Identifies and collates Coordinates between developer technical and global joint effort most relevant materials different organizations/ challenges as they are across different COVID-19 and insights across the initiatives to limit raised and/or identified vaccines organizations broader COVID-19 duplications and ensure on an ongoing basis (incl. -
Edical Sciences Esearch (IJAMSCR)
Dr. N. Sriram et al / Int. J. of Allied Med. Sci. and C lin. Research Vol-9(1) 2021 [ 1-10] International Journal of Allied Medical Sciences and Clinical Research (IJAMSCR) ISSN: 2347 -6567 IJAMSCR |Volume 9 | Issue 1 | Jan - Mar - 2021 www.ijamscr.com Review article Medical research Development of new covid -19 vaccines from india : A systematic review 1Dr. N. Sriram, 2S. Kameshwaran , 3Asokkumar DS , 4N. Elavarasan, 5M. Sarbudeen 1Department of Pharmaceutics, Hits College of Pharmacy, Bogaram, Ghatkesar, Hyderabad, Telangana, India 2-5 Excel college of Pharmacy, Komarapalayam, Namakkal, Tamilnadu – 637303. *Corresponding Author :Dr. N. Sriram email: [email protected] ABSTRACT Extreme acute respiratory syndrome Coronavirus 2 (SARS -CoV-2) is an extremely pathogenic new virus that has triggered the current worldwide coronavirus disease pandemic (COVID -19). Currently, substantial effort has been made to produce successful and safe medicines and SARS-CoV-2 vaccines. To avoid more morbidity and death, a successful vaccine is important. Though some regions which deploy COVID -19 vaccines on the basis of protection and immunogenicity data alone, the aim of vaccine research is to obtain d irect proof of vaccine effectiveness in protecting humans against SARS-CoV -2 and COVID-19 infections in order to selectively increase the production of effective vaccines. A SARS-CoV-2 candidate vaccine can function against infection, illness, or transmiss ion and a vaccine that is capable of minimising all of these components may lead to disease control. In this study, we discussed the Bharat Biotech and Covishield Serum Institute of India's Covaxin - India's First Indigenous Covid -19 Vaccine. -
Human Papillomavirus Vaccine
Human Papillomavirus Vaccine: Supply and Demand Update UNICEF Supply Division October 2020 0 Human Papillomavirus Vaccine Supply and Demand Update - October 2020 This update provides information on human papillomavirus vaccine, including supply, demand, and pricing trends. It highlights continued supply constraints foreseen over 2020 and 2021, which also affects countries procuring through UNICEF. UNICEF requests self-financing middle-income countries to consolidate credible multi-year demand and to submit multi-year commitments through UNICEF. 1. Summary • UNICEF’s strategic plan for 2018-2021 seeks to ensure that at least 24 countries nationally introduce human papillomavirus (HPV) vaccine into their immunization programmes.1 As of to date, 20 countries supplied through UNICEF, of which 15 supported by Gavi, the Vaccine Alliance (Gavi) and five countries having transitioned from Gavi support and self-finance their procurement, have introduced HPV vaccines since 2013. Fourteen middle-income countries (MICs) are also procuring HPV vaccines through UNICEF. From 2013 to 2019, UNICEF’s total HPV vaccine procurement reached 30.9 million doses in support of girls. There is currently no gender-neutral programmes in countries supplied through UNICEF. Of the 30.9 million doses, UNICEF procured 28.3 million doses (91 per cent) for countries supported by Gavi, including those that transitioned from Gavi support and still access Gavi prices, and 2.6 million doses (9 per cent) on behalf of self-financing MICs. • In December 2016, Gavi revised its programme strategy to support full-scale national HPV vaccine introductions with multi-age cohort (MAC) vaccinations. This substantially increased HPV vaccine demand through UNICEF from 2017.