Announcements

Announcements

 

Paul G. Allen Frontiers Group [to 10 Oct 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
Press Release
The Paul G. Allen Frontiers Group Announces New Allen Distinguished Investigators
October 8, 2020
Collaborative projects funded by the awards will address important questions about neurodegenerative disease, nucleus biology, and protein turnover

News
Accelerating Frontier Science | The Paul G. Allen Frontiers Group
October 7, 2020
The Paul G. Allen Frontiers Group seeks pioneers and explorers willing to make big advancements, take risks, ask questions, be tenacious, and have curiosity to change the face of biology.

 

BARDA – U.S. Department of HHS [to 10 Oct 2020]
https://www.phe.gov/about/barda/Pages/default.aspx
BARDA News
October 9, 2020: Trump Administration Expands Collaboration with AstraZeneca to Develop and Manufacture an Investigational Monoclonal Antibody to Prevent COVID-19
To meet the Trump Administration’s Operation Warp Speed goals, the U.S. Department of Health and Human Services (HHS) and Department of Defense (DoD ) today announced an agreement with AstraZeneca for late-stage development and large-scale manufacturing of the company’s COVID-19 investigational product AZD7442, a cocktail of two monoclonal antibodies, that may help treat or prevent infection with SARS-CoV-2, the coronavirus that causes COVID-19.
The goal of AstraZeneca’s partnership with the U.S. Government is to develop a monoclonal antibody cocktail that can help prevent infection. An effective monoclonal antibody that can prevent COVID-19, particularly one that is long-lasting and delivered by intramuscular injection, may be of particular use in certain groups. This includes people who have compromised immune function, those who are over 80 years old, and people undergoing medical treatments that preclude them from receiving a COVID-19 vaccine. If the FDA authorizes use of AZD7442 for prevention of SARS-CoV-2, as outlined in agency guidance, the federal government will distribute the doses at no cost. As is customary with government-purchased medical products, healthcare professionals could charge for the cost of administering the product…

October 6, 2020: HHS funds development of needle-free vaccine administration technology
A patch that could administer vaccines without traditional needles will receive development support from the U.S. Department of Health and Human Services (HHS).
Under an approximately $22 million, 3-year agreement between the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, and Vaxxas – headquartered in Brisbane, Australia with offices in Cambridge, Massachusetts – the company will undertake U.S. and Australian Phase 1 clinical trials to evaluate the safety and efficacy of an easy-to-use, high-density micro-array patch (HD-MAP) and other development activities for the patch.
“Protecting health and saving lives in public health emergencies such as pandemics often requires rapid, widespread vaccination among large groups of people, which poses multiple logistics challenges,” said BARDA Acting Director Gary Disbrow, Ph.D. “Imagine placing a patch on your arm or leg instead of having to go to a clinic or doctor’s office to get a shot. Not only would needle-free technology simplify vaccination logistics and potentially lower costs, but a self-administered patch also may improve vaccination rates.”…

 

BMGF – Gates Foundation [to 10 Oct 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
Press Releases and Statements
No new digest content identified.

 

Bill & Melinda Gates Medical Research Institute [to 10 Oct 2020]
https://www.gatesmri.org/
The Bill & Melinda Gates Medical Research Institute is a non-profit biotech organization. Our mission is to develop products to fight malaria, tuberculosis, and diarrheal diseases—three major causes of mortality, poverty, and inequality in developing countries. The world has unprecedented scientific tools at its disposal; now is the time to use them to save the lives of the world’s poorest people
No new digest content identified.

 

CARB-X [to 10 Oct 2020]
https://carb-x.org/
News
10.04.2020  |
CARB-X is funding GangaGen Biotechnologies to develop a new drug to treat pneumonia caused by multidrug-resistant Klebsiella pneumoniae bacteria
CARB-X is awarding up to US$2.5 million to GangaGen Biotechnologies to develop novel antibacterial proteins, called klebicins, to treat pneumonia caused by Klebsiella pneumoniae.

 

CEPI – Coalition for Epidemic Preparedness Innovations [to 10 Oct 2020]
http://cepi.net/
Latest News
No new digest content identified.

 

EDCTP [to 10 Oct 2020]
http://www.edctp.org/
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
Latest news
06 October 2020
EDCTP joins the GloPID-R funders network on (re-)emerging infectious diseases

 

Emory Vaccine Center [to 10 Oct 2020]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

 

European Medicines Agency [to 10 Oct 2020]
http://www.ema.europa.eu/ema/
News & Press Releases
News: EMA starts second rolling review of a COVID-19 vaccine
Last updated: 06/10/2020
EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on a vaccine for COVID-19 known as BNT162b2, which is being developed by BioNTech in collaboration with Pfizer.
The start of the rolling review means that the committee has started evaluating the first batch of data on the vaccine, which come from laboratory studies (non-clinical data). This does not mean that a conclusion can be reached yet on the vaccine’s safety and effectiveness, as much of the evidence is still to be submitted to the committee.
The CHMP’s decision to start the rolling review of BNT162b2 is based on preliminary results from non-clinical and early clinical studies in adults which suggest that the vaccine triggers the production of antibodies and T cells (cells of the immune system, the body’s natural defences) that target the virus.
Large-scale clinical trials involving several thousands of people are ongoing…

News: EU regulators fully uphold transparency and independence standards for COVID-19 treatments and vaccines
Last updated: 05/10/2020
[See COVID-19 above for detail]

 

European Vaccine Initiative [to 10 Oct 2020]
http://www.euvaccine.eu/
Latest News
No new digest content identified.

 

FDA [to 10 Oct 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements
October 9, 2020 – Coronavirus (COVID-19) Update: Daily Roundup October 9, 2020

October 8, 2020 – Coronavirus (COVID-19) Update: Daily Roundup October 8, 2020
:: Today, the FDA updated the dashboard on the Coronavirus Treatment Acceleration Program (CTAP) webpage. As of September 30, 2020, 550+ drug development programs were in planning stages, 350+ trials were reviewed by FDA and 5 COVID-19 treatments were currently authorized for emergency use.

October 8, 2020 – FDA awards six grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases
:: Today, the U.S. Food and Drug Administration announced that it has awarded six new clinical trial research grants to principal investigators from academia and industry totaling over $16 million over the next four years. These trial research grants, awarded through the Congressionally-funded Orphan Products Grants Program, enhance the development of medical products for patients with rare diseases.

October 8, 2020 – FDA Reaffirms Commitment to Safety, Security of its Public Health Laboratories

October 7, 2020 – Coronavirus (COVID-19) Update: Daily Roundup October 7, 2020
:: The FDA issued a letter to health care providers recommending that health care providers give clear, step-by-step instructions to patients who, in a health care setting, are self-collecting anterior nasal samples for SARS-CoV-2 testing. Without proper instructions, patients may not collect an adequate sample for testing, which may decrease the sensitivity of the test.

October 6, 2020 – Coronavirus (COVID-19) Update: Daily Roundup October 6, 2020
:: Today, the FDA issued guidance with recommendations for vaccine sponsors regarding the scientific data and information that would support issuance of an emergency use authorization (EUA) for investigational vaccines intended to prevent COVID-19.
:: Today, FDA launched a new webpage at www.fda.gov/covid19vaccines to highlight new information as it becomes available.
[See COVID-10 above for detail]

October 5, 2020 – Coronavirus (COVID-19) Update: Daily Roundup October 5, 2020

 

Fondation Merieux [to 10 Oct 2020]
http://www.fondation-merieux.org/
News, Events
No new digest content identified.

 

Gavi [to 10 Oct 2020]
https://www.gavi.org/
News releases
8 October 2020
Japan pledges US$ 130 million to support global access to COVID-19 vaccines
:: Japanese Government pledges US$ 130 million in funding to the Gavi COVAX Advance Market Commitment (AMC), bringing the total raised to roughly US$ 1.8 billion
:: This brings Gavi even closer to its initial fundraising goal of US$ 2 billion by the end of 2020 to help accelerate and reserve COVID-19 vaccines for low- and middle-income countries, following a series of significant pledges in the past week
:: Seth Berkley: “This vital funding not only helps us ensure lower-income countries aren’t left at the back of the queue when safe and effective COVID-19 vaccines become available, it will also play a vital role in ending the acute phase of this pandemic worldwide”
:: Motegi Toshimitsu, Foreign Minister of Japan. “Japan will contribute more than US $ 130 million for the COVAX Advance Market Commitment (AMC), in order to enable lower income countries to reinforce equitable access to COVID-19 vaccines.”

6 October 2020
Countries pledge nearly US$ 1 billion to support equitable access to COVID-19 vaccines
:: The United Kingdom, Canada, Germany, Italy and Sweden pledge approximately US$ 960 million to Gavi’s COVID-19 Vaccines Advance Market Commitment (COVAX AMC)
:: This week’s announcements mean nearly US$ 1.7 billion has been raised towards the effort to ensure equitable access to COVID-19 vaccines for low- and middle-income countries, with at least US$ 300 million more urgently needed by end 2020
:: H.E. Issoufou Mahamadou: “I would like to reiterate my support to Gavi and applaud the COVAX initiative as a way to assure universal and fair access to the COVID-19 vaccine.”

 

GHIT Fund [to 10 Oct 2020]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that No new digest content identified.

 

Global Fund [to 10 Oct 2020]
https://www.theglobalfund.org/en/news/
News/Updates
Global Fund and Chevron: United Against HIV, TB and Malaria
05 October 2020
The Global Fund and Chevron Corporation have celebrated a 12-year partnership that served as an example of the private sector’s contribution to the fight against infectious diseases and to building resilient health systems.

 

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 10 Oct 2020]
https://www.glopid-r.org/news/
News
European & Developing Countries Clinical Trials Partnership (EDCTP) joins the GloPID-R network
06/10/2020
GloPID-R is delighted to announce that the European & Developing Countries Clinical Trials Partnership (EDCTP) is now a member of the GloPID-R network. The EDCTP will be represented by Pauline Beattie and joins WHO and CEPI as an observer organization.

 

Hilleman Laboratories [to 10 Oct 2020]
http://www.hillemanlabs.org/
No new digest content identified.

 

Human Vaccines Project [to 10 Oct 2020]
http://www.humanvaccinesproject.org/media/press-releases/
Press Release
‘Comet’ Supercomputer Calculations Boost Our Understanding of Immune System
Oct 08, 2020
SDSC assists Vanderbilt University Human Vaccines Project
While researchers around the world race to develop an effective and safe COVID-19 vaccine, a team from the San Diego Supercomputer Center (SDSC) at UC San Diego contributed to a study led by Vanderbilt Vaccine Center of Vanderbilt University Medical Center (VUMC) on T cell receptors, which play a vital role in alerting the adaptive immune system to mount an attack on invading foreign pathogens including the Coronavirus SARS-CoV-2.

 

IAVI [to 10 Oct 2020]
https://www.iavi.org/newsroom
FEATURES
October 8, 2020
What are monoclonal antibodies, and can they treat COVID-19?
Monoclonal antibodies have changed the way we treat many diseases. They are a promising treatment for COVID-19, and IAVI is committed to developing SARS-CoV-2 antibodies that will be globally accessible. 

 

 

International Coalition of Medicines Regulatory Authorities [ICMRA]
http://www.icmra.info/drupal/en/news
Selected Statements, Press Releases, Research
No new digest content identified.

 

 

International Generic and Biosimilar Medicines Association [IGBA]
https://www.igbamedicines.org/
News
No new digest content identified.

 

 

IFFIm
http://www.iffim.org/
Announcements
No new digest content identified.

 

IFRC [to 10 Oct 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Global
World Mental Health Day: New Red Cross survey shows COVID-19 affecting mental health of one in two people
Geneva, 8 October (ICRC/IFRC) – Half of all respondents – 51 percent – in a seven-country survey said that the COVID-19 pandemic has negatively affected their mental health, an International Committee of the Red Cross (ICRC) survey found. In a new repo …
8 October 2020

 

IRC International Rescue Committee [to 10 Oct 2020]
http://www.rescue.org/press-release-index
Media highlights [Selected]
Press Release
New IRC data: Nearly 500 children sent to Libyan detention centres in past 6 months; IRC calls for immediate closure of inhumane centres
October 8, 2020

Press Release
Twelve fold increase in Ethiopia COVID-19 cases, severe weather and locusts creating massive need in Ethiopia, warns IRC
October 7, 2020

 

IVAC [to 10 Oct 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
No new digest content identified.

 

IVI [to 10 Oct 2020]
http://www.ivi.int/
Selected IVI News, Announcements, Events
Event
Building Vaccine Diplomacy and Advocacy
IVI Virtual State Forum 2020
Tuesday, October 13, 2020
04:00 New York / 10:00 Geneva, Copenhagen, Oslo / 17:00 Seoul
Watch live: bit.ly/ivi-state-forum-2020
Registration Required

 

JEE Alliance [to 10 Oct 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

 

MSF/Médecins Sans Frontières [to 10 Oct 2020]
http://www.msf.org/
Latest [Selected Announcements]
Lebanon
“I needed to make myself useful to overcome the panic”
Voices from the Field 9 Oct 2020

Kenya
COVID-19 further fuels mental health crisis in Dadaab as durable soluti…
Project Update 9 Oct 2020

Greece
EU must stop trapping people in miserable conditions on the Greek isl…
Statement 8 Oct 2020

Coronavirus COVID-19 pandemic
MSF supports India and South Africa ask to waive COVID-19 patent rights
Press Release 7 Oct 2020
[See Week in Review above for detail]

Coronavirus COVID-19 pandemic
High COVID-19 rates found among people living in extreme hardship in and …
Press Release 6 Oct 2020

Refugees, IDPs and people on the move
Enough is enough: new pact, same misery for refugees
Op-Ed 5 Oct 2020

 

National Vaccine Program Office – U.S. HHS [to 10 Oct 2020]
https://www.hhs.gov/vaccines/about/index.html
No new digest content identified.

 

NIH [to 10 Oct 2020]
http://www.nih.gov/news-events/news-releases
Selected News Releases
NIH clinical trial testing hyperimmune intravenous immunoglobulin plus remdesivir to treat COVID-19 Begins
October 8, 2020 — The study is taking place in hospitalized adults in the United States, Mexico and 16 other countries.

NIH to launch the Serological Sciences Network for COVID-19, announce grant and contract awardees
October 8, 2020 — The initiative is aimed at quickly increasing the nation’s antibody testing capacity.

NIH RADx initiative advances six new COVID-19 testing technologies
October 6, 2020 — Addition of new, rapid point-of-care platforms will expand national testing options.

NIH to support 85 new grants featuring high-risk, high-reward research
October 6, 2020 — The 2020 Director’s Awards will feature highly innovative biomedical research by investigators at all career stages.

 

PATH [to 10 Oct 2020]
https://www.path.org/media-center/
Press Releases
No new digest content identified.

 

Sabin Vaccine Institute [to 10 Oct 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

 

UNAIDS [to 10 Oct 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
7 October 2020
Lessons from the Ashodaya PrEP project in India

6 October 2020
Faith communities discuss the way forward in the HIV response

5 October 2020
Tanzanian community-based organizations support women who use drugs

5 October 2020
Women living with HIV are more likely to access HIV testing and treatment

 

UNICEF [to 10 Oct 2020]
https://www.unicef.org/media/press-releases
Statement
10/09/2020
Statement by UNICEF Executive Director Henrietta Fore on awarding of Nobel Peace Prize to WFP

Press release
10/07/2020
One stillbirth occurs every 16 seconds, according to first ever joint UN estimates
COVID-19-related health service disruptions could worsen the situation, potentially adding nearly 200,000 more stillbirths over a 12-month period

Statement
10/06/2020
UNICEF Statement on the Nagorno-Karabakh conflict

Press release
10/06/2020
Unrelenting violence continues to impact children in Ituri, eastern DRC

Statement
10/05/2020
Teachers: Leading in crisis, reimagining the future
Joint statement from David Edwards, General Secretary, Education International, Guy Ryder, Director-General, International Labour Organization, Audrey Azoulay, Director-General of UNESCO and Henrietta Fore, Executive Director, UNICEF

Press release
10/05/2020
Education Cannot Wait, the Global Partnership for Education, UNESCO & UNICEF call for the resumption of salary payments for teachers for the coming school year in Yemen

Statement
10/05/2020
Statement by Henrietta Fore, UNICEF Executive Director, to UNHCR Executive Committee
[As delivered]

 

Unitaid [to 10 Oct 2020]
https://unitaid.org/
Featured News
No new digest content identified.

 

Vaccination Acceptance Research Network (VARN) [to 10 Oct 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

 

Vaccine Confidence Project [to 10 Oct 2020]
http://www.vaccineconfidence.org/
Research and Reports
No new digest content identified.

 

Vaccine Education Center – Children’s Hospital of Philadelphia [to 10 Oct 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
No new digest content identified.

 

Wellcome Trust [to 10 Oct 2020]
https://wellcome.ac.uk/news
Explainer | 5 October 2020
What are monoclonal antibodies – and can they treat Covid-19?
For more than 30 years, monoclonal antibodies have transformed the way we treat many diseases. Researchers think they are also one of the most promising treatments for Covid-19. Here’s why.

Explainer | 5 October 2020
How can we get effective treatments for Covid-19?
From repurposed drugs to new therapies – researchers are working at incredible speed to find the best ways to treat Covid-19 patients.

 

The Wistar Institute [to 10 Oct 2020]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.

 

WFPHA: World Federation of Public Health Associations [to 10 Oct 2020]
https://www.wfpha.org/
Latest News
No new digest content identified.

 

World Organisation for Animal Health (OIE) [to 10 Oct 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
Press Releases
No new digest content identified.

 

 

::::::

 

ARM [Alliance for Regenerative Medicine] [to 10 Oct 2020]
https://alliancerm.org/press-releases/
Press Releases
The Alliance for Regenerative Medicine Applauds the Award of the Nobel Prize to CRISPR Pioneers
October 7, 2020
Washington, DC

 

BIO [to 10 Oct 2020]
https://www.bio.org/press-releases
Press Releases
BIO’s Dr. McMurry-Heath Applauds FDA Release of Guidance for Covid-19 Vaccines
October 6, 2020
Dr. Michelle McMurry-Heath, the president and CEO of the Biotechnology Innovation Organization (BIO), today applauded the Food and Drug Administration (FDA) for publicly releasing new guidance related to the emergency use authorization of future Covid-19 vaccines…
“In the midst of a pandemic, transparency and collaboration are critical if we are going to quickly and safely eradicate this global health threat. That is why we recently called for the public release of any new FDA guidance concerning emergency use authorization for Covid-19 vaccines. The release of this information is vital for the scientists and researchers working on the frontlines combating this pandemic, as well as for building public confidence in the scientific solutions our industry is committed to delivering.
“We applaud the FDA for following their tried and true tradition of releasing their guidance in a public and transparent way. Science should stand on its own. While we are still reviewing the details, this is an important step forward in providing greater regulatory clarity for vaccine makers and in earning the American people’s trust in any future vaccines. We look forward to ongoing communication with the independent experts at the FDA to further clarify the steps needed to bring a safe and effective vaccine to the American public.”

 

DCVMN – Developing Country Vaccine Manufacturers Network [to 10 Oct 2020]
http://www.dcvmn.org/
News; Upcoming events
No new digest content identified.

 

ICBA – International Council of Biotechnology Associations [to 10 Oct 2020]
https://internationalbiotech.org/
News
No new digest content identified.

 

IFPMA [to 10 Oct 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
IFPMA Statement for the Special session of the Executive Board on implementation of Resolution WHA73.1
06 October 2020
OVID-19 is a human, social, and economic tragedy that, as of September 2020, has cost more than a million lives globally and is estimated to contract global GDP by $US 7 trillion in 2020.

Since the early days of this pandemic, the R&D-based biopharmaceutical industry has responded through many initiatives aimed at providing and prioritizing delivery of critical products to tackle COVID-19, motivated by a strong sense of responsibility to act together, in partnership with WHO and governments, to support health systems across the world in a concerted and collective response. In this spirit, IFPMA is  proud to be a founding member of the ACT-A Accelerator.

The R&D-based biopharmaceutical industry firmly believes that a coordinated, inclusive, and multi-stakeholder action is necessary to mitigate the impact of this unprecedented global health emergency, ensuring that no one is left behind. The private sector has an essential role to play in combating this public health crisis through its expertise, innovation, and resources. In the endeavour of finding effective and safe treatments and vaccines at record speed, the private R&D business model, enabled by strong and effective intellectual property incentives, has significantly contributed to the discovery and development of treatments that are currently being tested.

IFPMA member companies are deeply aware that science and innovation are a key part of the equation but not the entire solution. We remain committed to the principle of equitable and affordable access to COVID-19-related health products and call upon governments to do their part in ensuring adequate resources are appropriately allocated to build resilient, and sustainable healthcare systems. Investing in health is critical to ensuring growth and prosperity. With COVID-19 having exposed major weaknesses in pandemic preparedness, we welcome the WHO’s decision to conduct an independent evaluation of the global COVID-19 response to identify lessons learned.

 

PhRMA [to 10 Oct 2020]
http://www.phrma.org/
Selected Press Releases, Statements
The latest: What they are saying: Intellectual property protections vital to incentivize ongoing COVID-19 research and development
October 7, 2020
America’s biopharmaceutical companies are committed to COVID-19 treatment and vaccine research and development (R&D). Reliable IP protections have helped drive innovation and enhance patient access to breakthrough therapies. Innovators are also relying on these strong protections to discover new medical advances that will keep patients healthy during this pandemic and after…Strong and reliable IP protections support America’s robust innovation ecosystem by promoting innovation and affordability for patients who rely on new treatments and cures, like those in development to treat COVID-19. America’s biopharmaceutical companies remain committed to ensuring that treatments and vaccines developed for COVID-19 are available to all who need them.

PhRMA Statement on U.S. Food and Drug Administration COVID-19 Emergency Use Authorization Vaccine Guidelines
October 6, 2020
Pharmaceutical Research and Manufacturers of America president and CEO, Stephen J. Ubl made the following statement about reporting around the U.S. Food and Drug Administration (FDA) drafting new guidelines to bring about greater clarity and continued scientific rigor to the review and potential approvals of COVID-19 vaccines for emergency use authorization:
“PhRMA represents an industry built on the bedrock of scientific rigor. Back in September, leading biopharmaceutical companies researching and developing potential vaccines for COVID-19 issued a pledge ‘to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines.’
“This commitment to supporting a sound, scientific and deliberative process for the development and review of COVID-19 vaccines has not wavered.
“PhRMA supports any efforts by FDA to provide clarifying guidance and we have engaged with the agency to support bringing greater transparency to the review process for COVID-19 vaccines. To help address this public health crisis, our companies have also taken unprecedented steps to share vaccine clinical trial protocols and data in real time. We welcome the agency’s efforts to instill confidence in the rigorous safety of these potential vaccines.
“Science is guiding every aspect of our work. We remain focused on ensuring the highest of standards of patient safety, research, clinical testing and manufacturing are upheld throughout the vaccine research and development process.”