100 research outputs found
Interim recommendations for use of the inactivated COVID-19 vaccine, CoronaVac, developed by Sinovac
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 extraordinary meeting on 29 April 2021.
Declarations of interests were collected from all external contributors and assessed for any conflicts of interest. Summaries of the reported interests can be found on the SAGE meeting website and SAGE Working Group website.
The guidance is based on the evidence in the background document on the Sinovac-CoronaVac (COVID-19) vaccine and the
annexes which include the GRADE and Evidence to Recommendation tables. Both these documents are available on the SAGE
COVID-19 webpage: https://www.who.int/groups/strategic-advisory-group-of-experts-on-immunization/covid-19-materials. These interim recommendations refer to the inactivated vaccine against COVID-19 developed by Sinovac. The trade name of the vaccine is CoronaVac. In the subsequent text the vaccine will be referred to as Sinovac-CoronaVa
AZD1222 vaccine against COVID-19 developed by Oxford University and Astra Zeneca: Background paper
WHO SAGE values framework for the allocation and prioritization of COVID-19 vaccination
This Values Framework offers guidance globally on the allocation of COVID-19 vaccines between countries, and to offer guidance nationally on the prioritization of groups for vaccination within countries while supply is limited. The Framework is intended to be helpful to policy makers and expert advisors at the global, regional and national level as they make allocation and prioritization decisions about COVID-19 vaccines
Background document on the mRNA vaccine BNT162b2 (Pfizer-BioNTech) against COVID-19
Background document to the WHO Interim recommendations for use of the Pfizer–BioNTech COVID-19 vaccine, BNT162b2, under Emergency
Use Listin
Interim recommendations for use of the Pfizer–BioNTech COVID-19 vaccine, BNT162b2, under Emergency Use Listing
Critical Evidence Questions For COVID-19 Vaccines Policy Making.
This document lists areas of evidence that would assist SAGE to formulate policy recommendations for consideration by WHO regarding the use of COVID-19 vaccines as they become available. It is not intended as alternative to the lists of requirements for licensure as formulated by regulatory bodies nor does it replace or provide an alternative to the WHO Target Product Profile. Rather it reflects the evidence-needs for COVID-19 vaccine policy making, based on the current scientific thinking, to assist SAGE in deciding upon the optimal use given the limited vaccine supply in order to maximise impact on the pandemic in different populations and epidemiologic setting
Interim recommendations for use of the AZD1222 (ChAdOx1-S [recombinant]) vaccine against COVID-19 developed by Oxford University and AstraZeneca
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 extraordinary meeting on 8 February 2021 (1).
Declarations of interests were collected from all external contributors and assessed for any conflicts of interest. Summaries of the
reported interests can be found on the SAGE meeting website and SAGE Working Group website.
These interim recommendations apply to AZD1222 (ChAdOx1-S [recombinant]) vaccine against COVID-19 developed by Oxford
University (United Kingdom) and AstraZeneca as well as to ChAdOx1-S [recombinant] vaccines against COVID-19 produced by
other manufacturers that rely on the AstraZeneca core clinical data, following demonstrated equivalence in their regulatory review
and once emergency use listing (EUL) has been obtained from WHO.
The guidance is based on the evidence summarized in the Background document on AZD1222 vaccine against COVID-19 developed
by Oxford University and AstraZeneca and the Background paper on COVID-19 disease and vaccines
WHO SAGE roadmap for prioritizing uses of COVID-19 vaccines in the context of limited supply
An approach to inform planning and subsequent recommendations based upon epidemiologic setting and vaccine supply scenario
Background document to the WHO Interim recommendations for use of Ad26.COV2.S (COVID-19) vaccine
This background document was prepared by the Strategic Advisory Group of Experts (SAGE) on Immunization Working Group on COVID-19 Vaccines to inform the discussions of SAGE at its 15 March 2021 meeting, which resulted in the issuance of the WHO interim recommendations for use of the Ad26.COV2.S (COVID-19) vaccine.
Both the recommendations and the background document are available on the SAGE COVID-19 webpage:
https://www.who.int/groups/strategic-advisory-group-of-experts-on-immunization/covid-19-materials.
Declarations of interests were collected from all external contributors and assessed for any conflicts of interest. Summaries
of the reported interests can be found on the SAGE meeting webpage and SAGE Covid-19 Working Group webpage.
Context
The Janssen vaccine is a recombinant vector vaccine that uses a human adenovirus to express the SARS-CoV-2 spike protein and is based on the Ad26 vector platform. The adenoviruses are a group of viruses that cause infections in the respiratory and gastrointestinal tracts; the adenovirus vector used in the experimental vaccine has been modified, so that
it can no longer replicate in humans and cause illness. In developing the vaccine, Janssen employed the same vector used in the first dose of its prime–boost vaccine regimen against Ebola virus disease (Ad26 ZEBOV and MVN-BN-Filo). As of 31 December 2020, Ad26-based vaccines have been used to vaccinate 193 831 participants in clinical studies and
vaccination programmes. These more than 193 000 participants included people from different age groups (elderly, adults, children and infants), individuals positive for human immunodeficiency virus (HIV), and pregnant and breastfeeding women, and the data show a favourable safety profile. Ad26-based vaccines elicit strong humoral immune responses with both neutralizing activity and non-neutralizing antibody functionalities, and cellular immune responses involving both
CD8+ T cells and CD4+ T-cells, the latter with a predominantly Th1 phenotype, irrespective of the transgene encoded immunogens (1-4). Overall, these vaccines have been shown to have an acceptable clinical safety profile to date.Data taken into consideration are those included in the US Food and Drug Administration Vaccines and Related
Biological Products Advisory Committee (VRBPAC) meeting documentation, available under the following links:
www.fda.gov/media/146217/download and www.fda.gov/media/146218/download
SPI-B/EMG : MHCLG Housing Impacts Paper - 10 September 2020
SPI-B/EMG paper prepared in response to a Ministry of Housing, Communities and Local Government (MHCLG) commission for advice on the role of housing in transmission. It was considered at SAGE 56 on 10 September 2020. It should be viewed in context: the paper was the best assessment of the evidence at the time of writing. The picture is developing rapidly and, as new evidence or data emerges, SAGE updates its advice accordingly. Therefore, some of the information in this paper may have been superseded and the author’s opinion or conclusion may since have developed. These documents are released as pre-print publications that have provided the government with rapid evidence during an emergency. These documents have not been peer-reviewed and there is no restriction on authors submitting and publishing this evidence in peer-reviewed journal
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