Vaccinator's Manual SINOPHARM Vaccine - 28 FEBRUARY 2021
These WHO interim recommendations for use of the COVID-19 vaccine BIBP produced by Sinopharm were developed on the basis of advice issued by the Strategic Advisory Group of Experts on Immunization (SAGE) and the evidence summary included in the back
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ground document and annexes referenced below.
This document has been updated: version 15 March 2022.
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24 September 2021. The vaccine has been authorized by the Chinese National Regulatory Authority (NRA) – the National Medicinal Product Administration (NMPA) – as well as other regulatory authorities. Because WHO has granted Emergency Use Listing (EUL) for the COVID-19 Vaccine BIBP/
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Sinopharm, the Africa Union and Africa CDC’s Regulatory Taskforce has endorsed the Emergency Use Authorization for the vaccine (see scenario #1) and the specification is 0.5ml/dose, 1 dose/vial; or 2 doses/vial; or 5 doses/vial. As such, African Union Member States are recommended to waive any review processes and rely directly on the WHO EUL via the AVAREF managed pathway described in Scenario #1.
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O SAGE aplica os princípios da medicina baseada em evidências e estabeleceu um processo metodológico completo para emitir ou atualizar recomendações. Especificamente para vacinas contra a COVID-19, uma descrição detalhada dos processos metodológicos pode ser encontrada no esquema de evidênc
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ias do SAGE para vacinas contra a COVID-19. Esse esquema contém orientações sobre como levar em consideração os dados provenientes de ensaios clínicos em apoio à emissão de recomendações baseadas em evidências específicas para vacinas.
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PHARMA’S RESPONSE TO THE COVID-19 VACCINES CRISIS. Update Feb., 14, 2022. In September 2021, Amnesty International published A Double Dose of Inequality, which assessed the extent to which the pharmaceutical industry was restricting access to Covid-19 vaccines. This report updates that assessment
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of five leading vaccine manufacturers, AstraZeneca plc, BioNTech SE, Johnson & Johnson, Moderna Inc., and Pfizer Inc. It also includes for the first time an assessment of the two largest Chinese vaccine producers, China National Pharmaceutical Group Co., Ltd. (Sinopharm) and Sinovac Biotech Ltd. (Sinovac).
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24 September 2021. The vaccine has been authorized by the Chinese National Regulatory Authority (NRA) – the National Medicinal Product Administration (NMPA) – as well as other regulatory authorities. Because WHO has granted Emergency Use Listing (EUL) for the Sinovac COVID-19 vaccine (Vero Cell
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[Inactivated]) – CoronaVac, the Africa Union and Africa CDC’s Regulatory Taskforce has endorsed the Emergency Use Authorisation for the vaccine (see scenario #1). As such, African Union Member States are recommended to waive any review processes and rely directly on the WHO EUL via the AVAREF managed pathway described in Scenario #1
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Including Therapeutic Food, Dietary Vitamin and Mineral Supplementation - 2nd edition
Interim guidance, 26 October 2021
This interim guidance has been developed on the basis of the advice issued by the Strategic Advisory Group of Experts (SAGE) on Immunization at its meeting on 5 October 2021.
SAGE said moderately and severely immunocompromised persons should be offered an addition
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al dose of all WHO approved vaccines “since these individuals are less likely to respond adequately to vaccination following a standard primary vaccine series and are at high risk of severe COVID-19 disease.”
People aged 60 and older who received the Sinovac and Sinopharm vaccines should get a third dose too, the experts added, though use of other vaccines may also be considered depending on supply and access.
“When implementing this recommendation, countries should initially aim at maximizing 2-dose coverage in that population, and thereafter administer the third dose, starting in the oldest age groups”, they said.
SAGE has also reviewed a vaccine developed by Indian company Bharat Biotech and will issue a policy recommendation after WHO greenlights it for emergency use.
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En Paraguay, la vacunación contra COVID-19 inició el 22 de febrero de 2021. Se han autorizado un total de siete vacunas: Bharat-Covaxin, Moderna, Pfizer-BioNTech, AstraZeneca, Sinopharm, Sputnik V- Gamaleya y CoronaVac-Sinovac. Los grupos priorita
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rios de vacunación están definidos según el Plan Nacional de Vacunación contra COVID-19 en Paraguay
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Irresponsible pharmaceutical companies fuel the proliferation of superbugs through supply chain pollution, the European Public Health Alliance (EPHA) reports. The advocacy group uncovered lapses such as dirty production and inadequate waste disposal in the production of antimicrobials in China and I
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ndia, which supplies most of the antimicrobials consumed in Europe. In a briefing detailing the pollution, the EPHA urges major purchasers of antibiotics to blacklist irresponsible pharmaceutical companies, demand that the industry clean up its supply chain, introduce greater transparency on the origin of antibiotics, and review and revise procurement policies from an ethics perspective.
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Bisher hat die STIKO empfohlen, dass alle im Ausland mit einem nicht in der EU zugelassenen Impfstoff geimpften Personen eine erneute Impfserie mit einem in der EU zugelassenen Impfstoff erhalten sollen. Ziel der im Epidemiologischen Bulletin 13/2022 veröffentlichten aktualisierten COVID-19-Impfemp
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fehlung ist es, Personen, die eine COVID-19-Impfung mit einem der nicht in der EU zugelassenen Ganzvirusimpfstoffen (CoronaVac, Covilo und Covaxin) oder dem Vektor-basierten Impfstoff Sputnik V erhalten haben, mit einem Impfschutz auszustatten, der vergleichbar mit dem einer Grundimmunisierung plus Auffrischimpfung mit einem mRNA-Impfstoff ist.
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La dosis de refuerzo está indicada una vez transcurridos los 4 meses (120 días) de la última dosis del esquema inicial y será con vacuna de plataforma ARNm: Pfizer-BioNTech pediátrica a partir de los 5 años o Moderna para uso pediátrico a partir de los 6 años.
Frequently asked questions on COVID-19 vaccination. Version 6, 12 February 2022
As vacinas COVID-19 são eficazes contra novas variantes? O que significa para uma pessoa estar totalmente vacinada? Essa e outras dúvidas estão entre as dúvidas mais frequentes sobre a vacinação contra a COVID-19. Nesta sexta edição você encontrará respostas para essas e outras perguntas.
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Available in English, French, Spanish and Portuguese
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Los datos preliminares de eficacia se infirieron mediante un enfoque de “inmunogenicidad puente”, en el que los títulos neutralizantes obtenidos después de la vacuna en niños y niñas de 5 a 11 años se compararon con los títulos obtenidos en adolescentes de 16 a 25 años (en quienes se hab
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a evaluado la eficacia).Entre los participantes sin evidencia de infección previa por SARS-CoV-2, hubo 3 casos de COVID-19 entre los 1.305 receptores de vacuna a partir de los 7 días de la segunda dosis y 16 entre los 663 receptores de placebo.
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El siguiente manual se continuará actualizando, de ser necesario, a medida que se disponga de nueva información.
Overview
16 Dec 2021. This interim guidance pertains to heterologous primary and heterologous boosting schedules of Covid-19 vaccines. It focuses on heterologous schedules combining multiple vaccine platforms (e.g. a vectored vaccine followed by an mRNA vaccine).