Dentons Flashpoint Daily Global Situation Report
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What Do We Know About India's Covaxin Vaccine?
FEATURE Tamil Nadu, India COVID-19 VACCINES [email protected] BMJ: first published as 10.1136/bmj.n997 on 20 April 2021. Downloaded from Cite this as: BMJ 2021;373:n997 http://dx.doi.org/10.1136/bmj.n997 What do we know about India’s Covaxin vaccine? Published: 20 April 2021 India has rapidly approved and rolled out Covaxin, its own covid-19 vaccine. Kamala Thiagarajan examines what we know so far. Kamala Thiagarajan freelance journalist Who developed Covaxin? cheapest purchased by any country in the world at 206 rupees per shot for the 5.5 million doses the Covaxin was developed by Indian pharmaceutical government currently has on order. The government company Bharat Biotech in collaboration with the has capped the price of the vaccine sold in the private Indian Council of Medical Research, a government market, with private hospitals able to charge up to funded biomedical research institute, and its 250 rupees.13 subsidiary the National Institute of Virology. Covaxin does not require storage at sub-zero Bharat Biotech has brought to market 16 original temperatures, which would be hard to maintain in vaccines, including for rotavirus, hepatitis B, Zika India’s climate and with the frequent power cuts in virus, and chikungunya.1 The company reportedly rural areas. Covaxin is available in multi-dose vials spent $60-$70m (£43-£50m; €50-€58m) developing and is stable at the 2-8°C that ordinary refrigeration Covaxin.2 can achieve. How does Covaxin work? Bharat Biotech says it has a stockpile of 20 million The vaccine is similar to CoronaVac (the Chinese doses of Covaxin for India and is in the process of vaccine developed by Sinovac)3 in that it uses a manufacturing 700 million doses at its four facilities complete infective SARS-CoV-2 viral particle in two cities by the end of the year. -
COVID-19 Vaccines Update Supplement Week Of: 5Th April, 2021
CARPHA UPDATE FOR Incident Manager / SITUATION REPORT COVID-19 Vaccines Update Supplement Week of: 5th April, 2021 I. Overview of Development and Regulatory Approvals: • 85 candidate vaccines are in clinical development: 16 in Phase 3 trials, and 4 in Phase 4 trials – see Figure in CARPHA COVID-19 Vaccine Regulatory Tracker (Phases tab). • 13 vaccines have received regulatory approvals in various countries, and 16 vaccines are at various stages of engagement with WHO for emergency use listing (EUL). • 4 vaccines have been approved by WHO for Emergency Use Listing: Pfizer-BioNTech’s vaccine: COMIRNATY®, AstraZeneca-SK Bio, AstraZeneca-SII (Covishield), and Janssen-Cilag. • 4 additional vaccines are expected to be approved by WHO in April – Tables 1 and 3. • There are 3 additional vaccines being considered by WHO but these are at the stage of submitting expressions of interest: Bharat Biotech, Clover Biopharmaceuticals-GSK + Dynavax, and BioCubaFarma (Cuba). • The WHO Strategic Advisory Group of Experts on Immunization (SAGE) interim recommendations and background documents are available for vaccines by: Moderna, Pfizer-BioNTech, AstraZeneca-Oxford and Janssen-Cilag at SAGE Interim Guidance. The recommendations provide guidance on the use the vaccines, including use in various groups. • Reports of rare clotting events among vaccinees continue to be assessed by various regulators. The EU's European Medicines Agency (EMA) has stated that there was no evidence to support decisions by regulators to restrict the use of Oxford-AstraZeneca vaccines in some age groups. The WHO maintains that the benefit-risk balance of the vaccine remains favorable. • CARPHA has shared its COVID-19 vaccine regulatory tracker with Member States for viewing as updates are made. -
V.3 1/25/2021 COVID-19 Vaccine FAQ Sheet
COVID-19 Vaccine FAQ Sheet (updated 1/25/2021) The AST has received queries from transplant professionals and the community regarding the COVID-19 vaccine. The following FAQ was developed to relay information on the current state of knowledge. This document is subject to change and will be updated frequently as new information or data becomes available. What kinds of vaccines are available or under development to prevent COVID-19? There are currently several vaccine candidates in use or under development. In the United States, the Government is supporting six separate vaccine candidates. Several other vaccines are also undergoing development outside of the United States government sponsorship and further information can be found here: • NYTimes Coronavirus Vaccine Tracker: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine- tracker.html • Washington Post Vaccine Tracker: https://www.washingtonpost.com/graphics/2020/health/covid-vaccine-update- coronavirus/ The types of vaccines are as follows (January 25, 2021) 1: Table 1: Vaccines Under Development Vaccine Type Compound Name Clinical Trial Notes [Sponsor] Phase mRNA mRNA-1273 Phase 3 Emergency use in [Moderna] U.S., E.U., other countries Approved in Canada BNT162b2 [Pfizer] Phase 2/3 Emergency use in U.S., E.U., other countries Also approved in Canada and other countries Replication- AZD1222 Phase 2/3 Emergency use in defective [AstraZeneca] Britain, India, other adenoviral vector countries (not U.S.) Ad26.COV2.S Phase 3 [Janssen] v.3 1/25/2021 Recombinant- NVX-CoV2373 Phase 3 subunit-adjuvanted [Novavax] protein Recombinant SARS- Phase 1/2 CoV-2 Protein Antigen + AS03 Adjuvant [Sanofi Pasteur/GSK] Inactivated CoVaxin [Bharat Phase 3 Emergency Use in coronavirus Biotech] India BBIBP-CorV Phase 3 Approved China, [Sinopharm] Bahrain, UAE; Emergency use elsewhere (not U.S.) Both of the mRNA SARS-CoV-2 vaccines (Moderna, Pfizer) have been approved by Emergency Use Authorization by the U.S. -
COVID-19 Vaccination Programme: Information for Healthcare Practitioners
COVID-19 vaccination programme Information for healthcare practitioners Republished 6 August 2021 Version 3.10 1 COVID-19 vaccination programme: Information for healthcare practitioners Document information This document was originally published provisionally, ahead of authorisation of any COVID-19 vaccine in the UK, to provide information to those involved in the COVID-19 national vaccination programme before it began in December 2020. Following authorisation for temporary supply by the UK Department of Health and Social Care and the Medicines and Healthcare products Regulatory Agency being given to the COVID-19 Vaccine Pfizer BioNTech on 2 December 2020, the COVID-19 Vaccine AstraZeneca on 30 December 2020 and the COVID-19 Vaccine Moderna on 8 January 2021, this document has been updated to provide specific information about the storage and preparation of these vaccines. Information about any other COVID-19 vaccines which are given regulatory approval will be added when this occurs. The information in this document was correct at time of publication. As COVID-19 is an evolving disease, much is still being learned about both the disease and the vaccines which have been developed to prevent it. For this reason, some information may change. Updates will be made to this document as new information becomes available. Please use the online version to ensure you are accessing the latest version. 2 COVID-19 vaccination programme: Information for healthcare practitioners Document revision information Version Details Date number 1.0 Document created 27 November 2020 2.0 Vaccine specific information about the COVID-19 mRNA 4 Vaccine BNT162b2 (Pfizer BioNTech) added December 2020 2.1 1. -
Bharat Biotech Inks Licensing Deal with Washington University School of Medicine in St
Bharat Biotech Inks Licensing Deal with Washington University School of Medicine in St. Louis to advance COVID-19 Intranasal Vaccine Technology Hyderabad, India, 23 September 2020: Vaccine Innovator, Bharat Biotech announces today, a licensing agreement with Washington University School of Medicine in St. Louis for a novel chimp- adenovirus, single dose intranasal vaccine for COVID-19. Bharat Biotech owns the rights to distribute the vaccine in all markets except USA, Japan and Europe. While the Phase I trials will take place in Saint Louis University’s Vaccine & Treatment Evaluation Unit, Bharat Biotech, upon obtaining the required regulatory approval, will pursue further stages of clinical trials in India and undertake large scale manufacture of the vaccine at its GMP facility located in Genome Valley, Hyderabad. We are proud to collaborate on this innovative vaccine. We envision that we will scale this vaccine to 1 billion doses, translating to 1 billion individuals vaccinated receiving a single-dose regimen. An intranasal vaccine will not only be simple to administer but reduce the use of medical consumables such as needles, syringes, etc., significantly impacting the overall cost of a vaccination drive. Our experience in viral vaccines, manufacturing capabilities, and distribution continue to be our strong suit in ensuring safe, efficacious, and affordable vaccines. It is prudent for Bharat to be involved in diverse but tenable projects to provide a much-needed vaccine against COVID-19 reaches all citizens of the world.” Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech, stated. This intranasal vaccine candidate has shown unprecedented levels of protection in mice studies; the technology and data having been recently published in the prestigious scientific journal Cell and in an editorial in Nature. -
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. -
National Emergency Management Organisation (Nemo) Ministry of National Security St
NATIONAL EMERGENCY MANAGEMENT ORGANISATION (NEMO) MINISTRY OF NATIONAL SECURITY ST. VINCENT AND THE GRENADINES WEST INDIES Tel: 784-456-2975, Fax: 784-457-1691, Email: [email protected] or [email protected] ______________________________________________________________________________ ___________________________________________________________________________________________________________________ HEALTH SERVICES SUBCOMMITTEE PROTOCOL FOR THE ENTRY OF FULLY VACCINATED TRAVELLERS TO ST. VINCENT AND THE GRENADINES – revised 10/08/2021 AIM: The safe entry of travellers to St. Vincent and the Grenadines in a manner that reduces the risk of the importation and subsequent transmission of COVID-19 in St. Vincent and the Grenadines. OBJECTIVES: 1. To establish the risk of the arriving traveller introducing new COVID-19 cases to SVG; 2. To minimize exposure of residents of SVG to new COVID-19 cases; 3. Early identification of potential exposure to COVID-19 and 4. Early containment of new COVID-19 cases. ESTABLISH RISK OF ARRIVING TRAVELLER: The arriving traveller will: 1. Complete the Pre-Arrival Form available at health.gov.vc And the Port Health Officer will: 1. Review Port Health form for each arriving passenger. 1 PHASED PROCESS OF ENTRY OF FULLY VACCINATED TRAVELERS TO ST. VINCENT AND THE GRENADINES: TESTING & QUARANTINE: PHASE #16 - Commencing Wednesday, August 11, 2021: 1. Where ‘Fully Vaccinated Travelers’ are those persons who: a. Have completed a vaccination regimen with one of the following COVID-19 vaccines recognized by the Ministry of Health, Wellness and the Environment of St Vincent and the Grenadines: i. AstraZeneca – Oxford AstraZeneca (Vaxzevria), COVISHIELD, AstraZeneca COVID-19 vaccine by SK Bioscience; ii. Pfizer-BioNTech COVID-19 vaccine; iii. Moderna COVID-19 vaccine; iv. -
Monday, September 14, 2020 Home-Delivered $1.90, Retail $2.20 Tears Flow
Nupepa o Te Tairawhiti THE GISBORNE HERALD RĀHINA, MAHURU 9, 2019 I MONDAY, SEPTEMBER 9, 2019 HOME-DELIVERED $1.70, RETAIL $2.00 TE NUPEPA O TE TAIRAWHITI RAHINA, MAHURU 14, 2020 I MONDAY, SEPTEMBER 14, 2020 HOME-DELIVERED $1.90, RETAIL $2.20 TEARS FLOW AT C COMPANY HOUSE PAGE 3 PUKANA: Kereru class students at Te TOLAGA BAY CIVIL DEFENCE PAGE 4 ‘All day, every day, te reo is our way’ Hapara School practise their te reo Maori every day. Te Wiki o te reo Maori VOLUNTEERS RECOGNISED is another week where the students UNHEARDOFSAVINGS! IT is Te Wiki o te reo Maori Ms Neilson said. what they teach us every embrace te ao Maori. The children are (Maori Language Week) but “Singing connects us morning so we will become pictured with teacher Tanya Neilson. te reo Maori is used at Te and brings us together better performers, therefore Picture by Liam Clayton. Hapara School every school and creates memories and incorporating the intrinsic day. memory space in our brains. link to culture and identity PAGES Each day the kereru “We know our students and the essential element 5-8,11, whanau class have the enjoy our morning sessions of whanaungatanga (the 12, 13, 16 same routine of performing and they could independently importance of people and a waiata (song), karakia run it on their own. connectedness),” said Ms (prayer) and haka and “We are a culturally diverse Neilson. HEARING• Mask refusal halts Fullers ferry trip practise use of te reo Maori whanau and celebrate and “The school’s focus this •NEW Political party leader’s Covid theories kupu (words) and commands respect all people.” year has been about creating raising fears for Maori health because that is a part of who Te Hapara has two kapa a sense of belonging and PBL they are as a class, says haka tutors — Papa Pura and we feel that through culture, • Expecting ugly GDP figures for quarter teacher Tanya Neilson. -
Periodic Update on AEFI
CONSOLIDATED REGIONAL AND GLOBAL INFORMATION ON ADVERSE EVENTS FOLLOWING IMMUNIZATION (AEFI) AGAINST COVID-19 AND OTHER UPDATES WASHINGTON, DC Updated: 31 March 2021 1 OFFICIAL REPORTS ON PHARMACOVIGILANCE PROGRAMS CANADA § As of 19 March 2021, 3,729,312 doses of the Pfizer-BioNTech, Moderna, and Covishield vaccines had been administered. § A total of 2,530 individual reports of one or more adverse events (0.068% of doses administered) were reported. Of these, 320 were considered serious events (0.009% of doses administered), with anaphylaxis being the most frequently reported. § There were a total of 7,397 adverse events following immunization (AEFI) (consisting of 2,530 reports of one or more events), mostly non-serious adverse events, such as injection-site reactions, partesia, itching, hives, headache, hyposthesia, and nausea. Only 0.8% of cases corresponded to anaphylaxis (59 cases, or 15.8 cases per million doses administered). § Most adverse events reported were among women, and in people between the ages of 18 and 49, these being the groups prioritized for vaccination § A total of 24 reported adverse events were identified as post-vaccination deaths. After medical review, it was determined that 13 of these deaths were not linked to administration of the COVID-19 vaccine, while the other 11 are still under investigation. Link: https://health-infobase.canada.ca/covid-19/vaccine-safety/ UNITED STATES § Nearly 126 million doses of the Pfizer-BioNTech and Moderna vaccines were administered between 14 December 2020 and 29 March 2021. § The Vaccine Adverse Event Reporting System (VAERS) received 2,509 reports of deaths (0.0019% of doses administered) that have not been linked to the vaccine. -
Summit of G20 Argentina
Boletín informativo del Ministerio de Relaciones Exteriores, Comercio Internacional y Culto de la República Argentina 1 July 20, 2021 SUMMIT OF G20 Solá: “We have the opportunity to create a better economy with less inequality” ARGENTINA - UNITED STATES Bilateral Meeting of Foreign Minister Solá and Secretary of State Antony Blinken Solá at G20 Summit: “We have the opportunity to create a better economy with less inequality” 2 “Today, more than ever, we must strengthen organizations at Palazzo Lanfranchi, the Minister international cooperation and solidarity to achieve highlighted the importance of “preparedness for inclusive and sustainable post-COVID-19 recovery,” and response to health emergencies, based on Foreign Minister Felipe Solá stated during the G20 international solidarity and cooperation” in order to Foreign Affairs and Development Ministerial “prevent future epidemics from becoming new Meeting, held on 29 June in Matera, Italy, one of the global catastrophes.” objectives of which was to discuss ways to strengthen “multilateralism and global governance” “We need a common global growth plan that allows in view of the urgent problems facing the for coordinated fiscal and monetary interventions in international community. order to avoid unequal and unbalanced recovery and that guarantees a more equal future,” Solá Solá referred to the serious social and economic stated during his first address, adding that “we have effects of the pandemic, and advocated “redoubling the opportunity to create a better economy that efforts to guarantee global mass vaccination and produces less carbon, creates less inequality, and promote voluntary licensing agreements that provides digital access and access to new enable the necessary transfer of knowledge and technologies for all. -
Safe Return Plan FINAL
Safe Return to In-Person Instruction and Continuity of Service Pursuant to the Federal American Rescue Plan Act Hazlet Township School District June 2021 Revision: August 2021 HAZLET TOWNSHIP PUBLIC SCHOOLS ADMINISTRATION 2021-2022 BOARD OF EDUCATION Board President Victor J. Iannello, Jr. Vice President Jodie Moreno Board Members David Asfour Edward Barrett John Granite Steven Grossman William Kolibas Laura O’Hara George Theis Student Member James Grebenstein CENTRAL OFFICE ADMINISTRATION Superintendent of Schools Scott Ridley, Ed.D. Assistant Superintendent of Schools Joseph J. Annibale School Business Administrator/Board Secretary Christopher J. Mullins DIRECTORS Director of Curriculum, Instruction & Testing Heather Schwarz Director of Special Services Jacqueline Hafner Director of School Counseling Services Julie Ciccarone Director of Athletics John DeGenito SUPERVISORS Supervisor of Language Arts Suzanne Capraro Supervisor of Mathematics Jennifer Martins Supervisor of Science Michael Miller Supervisor of Special Services Chantal Molino Supervisor of Buildings & Grounds Charles Hildner Network Administrator Joseph Emerson District Affirmative Action Officer Andrew Piotrowski, Ed.D. Title IX Coordinator Suzanne Capraro BUILDING PRINCIPALS Sycamore Drive ECLC Gina Dorozynski Lillian Drive School Kathleen Matsutani Middle Road School Katherine Egan Raritan Valley School John Verderosa Beers Street School Ian Collis Cove Road School Dara Van Pelt Hazlet Middle School Christine McCoid, Ed.D. Raritan High School Andrew Piotrowski, Ed.D. Hazlet Township School District Date: June 15, 2021 Revised: August, 2021 1. Maintaining Health and Safety For each mitigation strategy listed below (A–H), please describe how the LEA will maintain the health and safety of students, educators, and other staff and the extent to which it has adopted policies, and a description of any such policies, on each of the following safety recommendations established by the CDC. -
COVID-19 Vaccines BJC and WUSM Employees
COVID-19 vaccines BJC and WUSM employees FAQs – updated September 10, 2021 Updates to this document have been made in red. The content in this document is intended for BJC/Washington University School of Medicine (WUSM) employees only, not for the general public. Click the topic below to go directly to the section: • Vaccine requirement and distribution – BJC/WUSM employees and contingent workers • Vaccine safety • Vaccine effectiveness • Vaccine distribution - public • Questions prior to receiving the vaccine • After I get the vaccine • More about the vaccines Vaccine requirement and distribution – BJC/WUSM employees and contingent workers 1. Which vaccine was officially approved by the FDA, and how is this different than the emergency use authorization the FDA granted the vaccine previously? On August 23, 2021, the Pfizer COVID-19 vaccine officially received full FDA approval. It is the first COVID-19 vaccine to receive this approval. This action by the FDA may influence some unvaccinated citizens to get vaccinated, as it is additional validation that the vaccine is safe and effective in preventing severe COVID-19 infection. For BJC, the FDA action does not change our requirement that all team members be vaccinated. 2. What is the deadline for employees to be vaccinated? September 15 is now the deadline for receiving a dose of any COVID-19 vaccine: first doses of a two-dose series or the single-dose Johnson & Johnson/Janssen vaccine. At this point, employees with a single dose of a two-dose vaccine will be “conditionally compliant” with the expectation 1 COVID-19 vaccine rollout to BJC and WUSM employees FAQs CS_586771 6/24/21 that they complete the series within 30 days.