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-* December, 2021 release of emails from ICAN FOIA.((December, 2021 | [[Informed Consent Action Network]] | [[https://www.icandecide.org/wp-content/uploads/2021/12/Dec-Returned-Consults-Combined.pdf]]))
-Summary
-  * January, 2022 release of emails from ICAN FOIA.((January, 2022 | [[Informed Consent Action Network]] | [[https://www.icandecide.org/wp-content/uploads/2022/01/NIH-FOIA-53963-09.15.2021-Returned-Consults_Redacted.pdf]]))
-Summary Overview - Total 54 pages most deal with media inquiries items of note are official talking points which are significant claiming safety of spike protein and efficacy of COVID vaccines and development timeline. There is also a talking point section that references lock-downs and testing as successful in China. March 2, 2020 p49 more granular data notes low risk to children and comparison to flu transmission.
-p 10
-Key messages/talking points-
-Reporter questions- Can you tell me generally who is working on a vaccine? What are the steps required to create such a vaccine? Will it help that folks have already worked on vaccines related to other
-coronaviruses? What is the typical time frame for creation of a vaccine?
-==Statement attributed to NIAID== The NIAID Vaccine Research Center is developing an mRNA (messenger RNA) vaccine for the virus that causes COVID-19. NIAID Director Dr. Anthony S. Fauci is overseeing the NIH response to the COVID-19 outbreak. Dr. Barney Graham, deputy director of the [[NIAID Vaccine Research Center]] and chief of the Viral Pathogenesis Laboratory, is leading efforts to develop and test the mRNA vaccine candidate to prevent acquisition of SARS-CoV-2, and Dr. Kizzmekia Corbett is the scientific lead on this project in his lab.
-mRNA vaccines direct the body's cells to express a protein to elicit a broad immune response including
-high levels of neutralizing antibodies. The expressed [[spike protein]] is designed based on knowledge of the
-virus structure and stabilization through protein engineering, but the platform does not contain live or
-inactivated virus. The mRNA vaccine platform is well suited for responding to emerging outbreaks as drug
-product can be produced more quickly than with many other vaccine platforms. In this particular case,
-extensive vaccine research on the coronaviruses that cause SARS and MERS conducted over the past
-several years by the VRC in collaboration with Moderna allow for a rapid response to the virus that
-causes COVID-19.
-NIAID and its ongoing industry partner Moderna anticipate the vaccine will be ready for the first stage of
-clinical testing in about a month or so. In a Phase 1 clinical trial, a vaccine is given to healthy volunteers to test if it is safe and induces an immune response.
-You can learn more about the subsequent steps for clinical research on vaccines from this FDA webpage
-((https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/vaccine-product-approval-process))
-It is important to note that a COVID-19 vaccine will not be widely available to the public
-for at least a year and likely longer. Clinical testing to establish a vaccine's safety and efficacy takes time
-Key messages/talking points-
-Reporter questions- Can you tell me generally who is working on a vaccine? What are the steps
-required to create such a vaccine? Will it help that folks have already worked on vaccines related to other
-coronaviruses? What is the typical timeframe for creation of a vaccine?
-==Statement attributed to NIAID== The NIAID Vaccine Research Center is developing an mRNA (messenger RNA) vaccine for the virus that causes COVID-19. NIAID Director Dr. Anthony S. Fauci is overseeing the NIH response to the COVID-19 outbreak. Dr. Barney Graham, deputy director of the NIAID Vaccine Research Center and chief of the Viral Pathogenesis Laboratory, is leading efforts to develop and test the mRNA vaccine candidate to prevent acquisition of SARS-CoV-2, and Dr. Kizzmekia Corbett is the scientific lead on this project in his lab.
-mRNA vaccines direct the body's cells to express a protein to elicit a broad immune response including
-high levels of neutralizing antibodies. The expressed spike protein is designed based on knowledge of the
-virus structure and stabilization through protein engineering, but the platform does not contain live or
-inactivated virus. The mRNA vaccine platform is well suited for responding to emerging outbreaks as drug
-product can be produced more quickly than with many other vaccine platforms. In this particular case,
-extensive vaccine research on the coronaviruses that cause SARS and MERS conducted over the past several years by the VRC in collaboration with Moderna allow for a rapid response to the virus that causes COVID-19.
-NIAID and its ongoing industry partner Moderna anticipate the vaccine will be ready for the first stage of
-clinical testing in about a month or so. In a Phase 1 clinical trial, a vaccine is given to healthy volunteers to test if it is safe and induces an immune response.
-You can learn more about the subsequent steps for clinical research on vaccines from this FDA webpage-
-((https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/vaccine-product-approval-process)) It is important to note that a COVID-19 vaccine will not be widely available to the public
-for at least a year and likely longer. Clinical testing to establish a vaccine's safety and efficacy takes time.
-p 15.. March 13, 2020
-This reporter is working on a story about the Covid-19 vaccine trial involving NIAID and Moderna; she is
-under the impression that a vaccine could be available in April. NIAID would send her the following-
-NIAID scientists collaborated with the biotechnology company Moderna, Inc., to develop an investigational mRNA (messenger RNA) vaccine to prevent coronavirus disease 2019 (COVID-19). A Phase 1 clinical trial of the vaccine will be held at the [[Kaiser Permanente]] Washington Health Research Institute in Seattle, a NIAID-supported Vaccine and Treatment Evaluation Unit (VTEU). The trial does not have a firm start date.
-This phase 1 trial will determine, in a small number of people (usually less than 50), vaccine safety and
-whether the vaccine induces the desired protective response; this typically takes about three months.
-If the vaccine shows promise, the next step in the development process is a Phase 2 study, the goal of
-which is to understand if the vaccine can protect people from infection with the virus that causes COVI D-
-. This requires enrolling hundreds of people in endemic regions. Although NIAID is on track to quickly
-advance to clinical trials, it is important to note that a COVID-19 vaccine will not be widely available to the public for at least a year and likely longer. Clinical testing to establish a vaccine's safety and efficacy takes time.
-p 21 March 2, 2020
-Additional/background information- Dr. Lane was publicly named by the WHO in a press conference last week as part of the WHO-led mission to China. We referred reporters requesting to speak to him to the WHO's report from that mission, but these specific reporters pushed back asking to speak with Dr. Lane about what he saw and t he task force's findings. Dr. Lane would respond with the following-
-==Main Talking Points==
-I appreciated the opportunity to be part of the China-WHO joint mission on COIVD-19.The joint mission focused on key questions related to the natural history of and severity of COVID-19, the transmission dynamics of virus in different settings and the impact of the ongoing response.
-While our itinerary was tightly controlled we visited multiple public health, healthcare and community
-venues and felt those we spoke with spoke fairly freely and in depth. The outbreak in China has been steadily declining since February 2 (see graphs below). NIH-000044
-This decline is likely due to the strong top-down leadership and aggressive public health measures put in
-place by the government of China shortly after recognition of the problem coupled with the rapid
-identification of the causative agent and deployment of diagnostic tests.
-There has been a whole-of-China approach in response to the outbreak including closing of wet markets,
-limitations on travel, universal temperature monitoring and hand washing, cancellation of mass gathering activities, closing of schools, extensive contact tracing, medical isolation of close contacts, mass public education, identification of designated hospitals to care for COVID-19 patients and expansion of healthcare capacity.
-The rapid implementation of these measures by [[China]] likely slowed the global spread and provided
-additional time to develop containment strategies (including the development of countermeasures). A substantial array of studies of COVID-19 are ongoing. These include studies of pathogenesis, development of improved diagnostics, clinical trials of investigational therapeutics and development of vaccines
-==More Granular Details==
-Among close contacts, approximately 1-5% w ere found to be infected with the virus, indicating it is less infectious than flu. Following the earliest days of the outbreak and following the deployment of adequate supplies of personal protective equipment there have been very few cases in health care workers- many of which were acquired in the community, not in the health care setting.
-Relatively few reported cases (2.4%) are in children and the disease appears to be milder in children. Symptoms are non-specific and range from no symptoms to severe pneumonia and death. Fever(87.9%) and cough {67.7%) are the most common. Sore throat {13 .9%) and nasal congestion (4.8%) are less common.
-Most people (80%) will have mild disease and recover; 13% have severe disease and 6% are critical. The overall case fatality rate is 3.8% and has been dropping over the course of the outbreak. The
-highest mortality rates are in those over 80 {21.9%)
-p49 list of vaccine corp invitation is REDACTED
-==More Granular Details==
-Among close contacts, approximately 1-5% w ere found to be infected with the virus, indicating it is less
-infectious than flu. Following the earliest days of the outbreak and following the deployment of adequate supplies of personal protective equipment there have been very few cases in health care workers- many of which were acquired in the community, not in the health care setting.
-Relatively few reported cases (2.4%) are in children and the disease appears to be milder in children.
-Symptoms are non-specific and range from no symptoms to severe pneumonia and death. Fever (87.9%) and cough (67.7%) are the most common. Sore throat (13 .9%) and nasal congestion (4.8%) are
-less common.
-Most people (80%) will have mild disease and recover; 13% have severe disease and 6% are critical.
-The overall case fat ality rate is 3.8% and has been dropping over the course of the outbreak. The
-highest mortality rates are in those over 80 (21.9%)