Announcements
Paul G. Allen Frontiers Group [to 21 Mar 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
Press Release
No new digest content identified.
BMGF – Gates Foundation [to 21 Mar 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
No new digest content identified.
Bill & Melinda Gates Medical Research Institute [to 21 Mar 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 21 Mar 2020]
https://carb-x.org/
CARB-X is a non-profit public-private partnership dedicated to accelerating antibacterial research to tackle the global rising threat of drug-resistant bacteria.
No new digest content identified.
CEPI – Coalition for Epidemic Preparedness Innovations [to 21 Mar 2020]
http://cepi.net/
Latest News
CEPI collaborates with the Institut Pasteur in a consortium to develop COVID-19 vaccine
Led by the Institut Pasteur and including Themis and the University of Pittsburgh, the consortium becomes CEPI’s eighth COVID-19 vaccine development programme.
News 19 Mar 2020
CEPI partners with University of Hong Kong to develop COVID-19 vaccine
Partnership becomes seventh COVID-19 vaccine development project that CEPI has signed since Jan 23, 2020.
News 18 Mar 2020
Clinton Health Access Initiative, Inc. (CHAI) [to 21 Mar 2020]
https://clintonhealthaccess.org/
News & Press Releases
No new digest content identified.
EDCTP [to 21 Mar 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
No new digest content identified.
Emory Vaccine Center [to 21 Mar 2020]
http://www.vaccines.emory.edu/
No new digest content identified.
European Medicines Agency [to 21 Mar 2020]
http://www.ema.europa.eu/ema/
News & Press Releases
Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic
Press release 20/03/2020
The European Commission, the European Medicines Agency (EMA) and national Head of Medicines Agencies (HMA) have published new recommendations for sponsors on how to manage the conduct of clinical trials in the context of the coronavirus disease (COVID-19) pandemic. The impact of the pandemic on European health systems and more broadly on society, will make it necessary for sponsors to adjust how they manage clinical trials and the people who participate in these trials.
The guidance provides concrete information on changes and protocol deviations which may be needed in the conduct of clinical trials to deal with extraordinary situations, e.g. if trial participants need to be in self-isolation or quarantine, access to public places (including hospitals) is limited due to the risk of spreading infections, and healthcare professionals are being reallocated…
Press release:
Call to pool research resources into large multi-centre, multi-arm clinical trials to generate sound evidence on COVID-19 treatments
Last updated: 19/03/2020
EMA’s Human Medicines Committee (CHMP) has published a statement urging the EU research community to prioritise large randomised controlled studies because they are most likely to generate the conclusive evidence needed to enable rapid development and approval of potential treatments of COVID-19. The statement promotes a harmonised approach to data collection and a robust methodology for COVID-19 clinical trials across the EU to make best use of the available supply of investigational agents. It emphasises the need to include all EU countries in these trials.
News:
First regulatory workshop on COVID-19 facilitates global collaboration on vaccine development
Last updated: 18/03/2020
Today, the first global regulatory workshop on COVID-19 was convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). The virtual meeting brought together delegates from 17 different countries, representing more than 20 medicines regulatory authorities globally, as well as experts from the World Health Organization and the European Commission, to discuss the development of vaccines against COVID-19. The event was co-chaired by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA)…
European Vaccine Initiative [to 21 Mar 2020]
http://www.euvaccine.eu/news-events
Latest News
Vaccine development services: COVID19 vaccine projects encouraged to apply
16 March 2020
Researchers developing vaccine candidates against COVID19 can benefit from TRANSVAC2 services
FDA [to 21 Mar 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements
March 20, 2020 – Coronavirus (COVID-19) Update: FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits
March 20, 2020 – Coronavirus (COVID-19) Update: FDA allows expanded use of devices to monitor patients’ vital signs remotely
March 20, 2020 – Coronavirus (COVID-19) Update: FDA provides guidance on production of alcohol-based hand sanitizer to help boost supply, protect public health
March 19, 2020 – Coronavirus (COVID-19) Update: FDA Continues to Facilitate Development of Treatments
March 19, 2020 – Coronavirus (COVID-19) Update: Blood Donations
March 19, 2020 – FDA Approves New Treatment for Pediatric Patients with Any Strain of Hepatitis C
March 18, 2020 – Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections
March 18, 2020 – Coronavirus (COVID-19) Update: FDA Issues Guidance for Conducting Clinical Trials
The U.S. Food and Drug Administration today issued a guidance for industry, investigators and institutional review boards conducting clinical trials during the coronavirus (COVID-19) pandemic…
March 17, 2020 – Coronavirus (COVID-19) Update: FDA Issues Temporary Policy for FSMA Onsite Audit Requirements
Fondation Merieux [to 21 Mar 2020]
http://www.fondation-merieux.org/
News, Events
No new digest content identified.
Gavi [to 21 Mar 2020]
https://www.gavi.org/
Stories
21 March 2020
Gavi Board calls for bold engagement to respond to COVID-19
Geneva, 21 March 2020 – With the COVID-19 pandemic already affecting 47 Gavi-supported countries, Gavi, the Vaccine Alliance has already taken new steps to help strengthen the preparedness of health systems in lower-income countries with the full support of its Board.
Gavi will also be working closely with WHO, CEPI, World Bank, UNICEF and other partners to create the optimal conditions for the acceleration of priority candidate vaccines with a focus on access including assuring adequate scale up of production and delivery to be sure the vaccine gets to where it is needed to stem the pandemic.
“We have already seen the impact COVID-19 can have on health systems in wealthier countries; in countries with already fragile health systems it could be catastrophic,” said Dr Ngozi Okonjo-Iweala, Chair of the Gavi Board during a meeting on Thursday. “As has become brutally clear in recent months, this disease doesn’t respect borders, which is why it will take a truly global response to defeat it. Gavi is making funding immediately available for lower-income countries to respond to the crisis. Routine immunisation against other deadly diseases like measles, yellow fever and diphtheria also must continue – we cannot have two global outbreaks on our hands.”…
GHIT Fund [to 21 Mar 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 21 Mar 2020]
https://www.theglobalfund.org/en/news/
News & Stories
Funding Model
Building High-Quality Grants
20 March 2020
News
Global Fund Supports 11 Countries in Response to COVID-19
20 March 2020
GENEVA – The Global Fund announced today that 11 countries have so far used financial assistance from the Global Fund in response to the COVID-19 pandemic.
Working within its mandate to fight HIV, tuberculosis and malaria and to strengthen systems for health, the Global Fund issued new guidelines earlier this month to provide flexibility for countries to use up to 5% of approved grants to fight COVID-19 and to mitigate the potential consequences of the pandemic on existing programs to fight HIV, TB and malaria…
Sourcing & Management of Health Products
COVID-19 Procurement and Supply Update for Global Fund Principal Recipients
19 March 2020
Video
COVID-19 Pandemic: Statement from Executive Director Peter Sands
19 March 2020
Hilleman Laboratories [to 21 Mar 2020]
http://www.hillemanlabs.org/
No new digest content identified.
Human Vaccines Project [to 21 Mar 2020]
http://www.humanvaccinesproject.org/media/press-releases/
Press Releases
No new digest content identified.
IAVI [to 21 Mar 2020]
https://www.iavi.org/newsroom
Press Releases
March 5, 2020
IAVI and Batavia Biosciences Announce Collaboration on VSV-vector Based Epidemic Preparedness Vaccines
Mutual expertise drives innovations to address supply issues for vaccines for outbreak pathogens
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
COVID-19: Critical to keep the supply chain of essential medicines manufacturing operating at full capacity (March 2020)
IGBA, the International Generic and Biosimilar medicines Association (IGBA), representing global manufacturers of generic and biosimilar medicines, today calls upon the global policy leaders and governments to do everything in their power to keep the manufacturing operations and the supply chain of essential medicines operating at full capacity. This will allow our companies to continue to produce much needed critical medicines. While we support the need to protect healthcare workers and to provide hospitals with essential materials, putting unreasonable restrictions on exports of essential medical supplies or medicines will do more harm than good at this time of urgent need.
IFFIm
http://www.iffim.org/
No new digest content identified.
IFRC [to 21 Mar 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
No new digest content identified.
IVAC [to 21 Mar 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates
COVID-19 Questions Answered: IVAC-Affiliated Experts Give Their Take on the Challenges with Infection Control
March 2020
As coronavirus-related facts change by the day or hour, International Vaccine Access Center experts in epidemiology, vaccine development, economics, policy, and behavioral science are called upon to analyze current events and predict what’s ahead. Here is a round robin on the latest with the pandemic and what our people are doing to support a rapid […]
IVI [to 21 Mar 2020]
http://www.ivi.int/
Selected IVI News & Announcements
IVI at work on COVID-19
[undated]
As COVID-19 continues to disrupt communities around the world, IVI remains committed to our mission to protect the world’s most vulnerable people from vaccine-preventable diseases by developing safe, effective, and affordable vaccines for global health. We do this for diseases like cholera and typhoid, as well as emerging infectious diseases.
Here’s how we’re accelerating vaccines against COVID-19:
:: Development of an international standard laboratory vaccine effectiveness evaluation platform for multiple vaccine development groups:
. VSV-receptor binding domain vaccine with Sumagen, a Korean biotech company
. COVID DNA vaccine in a consortium of 6 organizations led by Genexine with IVI, Binex, GenNBio, Korea Advanced Institute of Science and Technology, Pohang University of Science and Technology) with plans to start clinical trials in July 2020
:: Progress with CEPI for IVI as a clinical partner for CEPI-supported vaccine candidates
:: In the process of obtaining funding for enhanced COVID-19 surveillance at existing IVI work sites that conduct febrile surveillance for typhoid in Ghana, the Democratic Republic of Congo, Nigeria, Madagascar, Burkina Faso, Mozambique and Ethiopia.
JEE Alliance [to 21 Mar 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.
MSF/Médecins Sans Frontières [to 21 Mar 2020]
http://www.msf.org/
Latest [Selected Announcements]
Burkina Faso
Four questions on the unprecedented humanitarian emergency…
Interview 20 Mar 2020
Coronavirus disease COVID-19
“Our priority is to protect hospital staff” where COVID-19 began in Italy
Project Update 20 Mar 2020
Coronavirus disease COVID-19
Vulnerable communities are bracing for impact of COVID-19
Op-Ed 20 Mar 2020
Coronavirus disease COVID-19
As COVID-19 continues to spread, MSF prepares for action in France
Press Release 18 Mar 2020
Syria
People in northwest Syria continue to struggle despite truce
Project Update 17 Mar 2020
South Sudan
Huge numbers of wounded and displaced as violence continues in J…
Press Release 17 Mar 2020
Coronavirus disease COVID-19
Help and solidarity needed in Europe to protect medical staff fr…
Press Release 16 Mar 2020
Coronavirus disease COVID-19
Challenges in supporting COVID-19 response
Interview 16 Mar 2020
National Vaccine Program Office – U.S. HHS [to 21 Mar 2020]
https://www.hhs.gov/vaccines/about/index.html
NVAC 2020 Meetings
June 9-10, 2020 NVAC Meeting
September 23-24, 2020 Meeting (Virtual)
NIH [to 21 Mar 2020]
http://www.nih.gov/news-events/news-releases
Selected News Releases
NIH shifts non-mission-critical laboratory operations to minimal maintenance phase
March 20, 2020 — Only mission-critical functions within NIH research laboratories will be supported.
New coronavirus stable for hours on surfaces
March 17, 2020 — SARS-CoV-2 stability similar to original SARS virus.
NIH clinical trial of investigational vaccine for COVID-19 begins
March 16, 2020 — Study enrolling Seattle-based healthy adult volunteers.
[See Milestones above for detail]
NIH Reports First Known Employee with COVID-19 Infection
March 15, 2020 — Individual is self-quarantined and staff who work in close proximity have been notified, asked to self-quarantine, and will be screened for COVID-19.
PATH [to 21 Mar 2020]
https://www.path.org/media-center/
Selected Announcements
No new digest content identified.
Sabin Vaccine Institute [to 21 Mar 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.
UNAIDS [to 21 Mar 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
20 March 2020
Chains of solidarity and kindness during the COVID-19 outbreak
UNICEF [to 21 Mar 2020]
https://www.unicef.org/media/press-releases
Press release
World Poetry Day: Young people in war zones across the world share heart-wrenching poems calling for peace
As the world battles COVID-19, peace in countries affected by conflict is critical, warns UNICEF
21/03/2020
Statement
COVID-19 does not discriminate; nor should our response
Statement by the United Nations Network on Migration
20/03/2020
Press release
COVID-19: Children at heightened risk of abuse, neglect, exploitation and violence amidst intensifying containment measures
Newly released technical guidance aims to help authorities strengthen protection measures for children during pandemic
NEW YORK, 20 March 2020 – Hundreds of millions of children around the world will likely face increasing threats to their safety and wellbeing – including mistreatment, gender-based violence, exploitation, social exclusion and separation from caregivers – because of actions taken to contain the spread of the COVID-19 pandemic. UNICEF is urging governments to ensure the safety and wellbeing of children amidst the intensifying socioeconomic fallout from the disease. The UN children’s agency, together with its partners at the Alliance for Child Protection in Humanitarian Action, has released a set of guidance to support authorities and organizations involved in the response.
In a matter of months, COVID-19 has upended the lives of children and families across the globe. School closures and movement restrictions are disrupting children’s routines and support systems. They are also adding new stressors on caregivers who may have to forgo work.
Stigma related to COVID-19 has left some children more vulnerable to violence and psychosocial distress. At the same time, control measures that do not account for the gender-specific needs and vulnerabilities of women and girls may also increase their risk of sexual exploitation, abuse and child marriage. Recent anecdotal evidence from China, for instance, points to a significant rise in cases of domestic violence against women and girls.
“In many ways, the disease is now reaching children and families far beyond those it directly infects,” said Cornelius Williams, UNICEF Chief of Child Protection. “Schools are closing. Parents are struggling to care for their children and make ends meet. The protection risks for children are mounting. This guidance provides governments and protection authorities with an outline of practical measures that can be taken to keep children safe during these uncertain times.”
Increased rates of abuse and exploitation of children have occurred during previous public health emergencies. School closures during the outbreak of Ebola virus disease in West Africa from 2014 to 2016, for example, contributed to spikes in child labor, neglect, sexual abuse and teenage pregnancies. In Sierra Leone, cases of teenage pregnancy more than doubled to 14,000 from before the outbreak.
As part of the guidance, the Alliance is recommending that governments and protection authorities take concrete steps to ensure protection of children is integral to all COVID-19 prevention and control measures, including:
:: Train health, education and child services staff on COVID-19 related child protection risks, including on the prevention of sexual exploitation and abuse and how to safely report concerns;
:: Train first responders on how to manage disclosure of gender-based violence (GBV Pocket Guide), and collaborate with healthcare services to support GBV survivors;
Increase information sharing on referral and other support services available for children;
:: Engage children, particularly adolescents, in assessing how COVID-19 affects them differently to inform programming and advocacy;
:: Provide targeted support to interim care centres and families, including child-headed households and foster families, to emotionally support children and engage in appropriate self-care;
:: Provide financial and material assistance to families whose income generating opportunities have been affected; and
:: Put in place concrete measures to prevent child-family separation, and ensure support for children left alone without adequate care due to the hospitalization or death of a parent or caregiver; and
:: Ensure the protection of all children is given the utmost consideration in disease control measures.
Statement
Statement by UNICEF Executive Director Henrietta Fore on the COVID-19 pandemic
NEW YORK, 18 March 2020 – “One week since COVID-19 was declared a pandemic, the number of cases continues to soar around the world. Hundreds of millions of children are not in school. Parents and caregivers are working remotely whenever they can. Borders have been closed. Lives have been upended.
“These are uncharted waters for all of us. At UNICEF, we are fighting a new virus, debunking myths and battling misinformation, all while looking after the well-being of our staff and our own families.
“Our life-saving work to provide children with health, education, nutrition and protection has never been more critical. With millions of children uprooted, affected by wars, dying from preventable causes, out of school, or missing out on essential vaccines, the need for support has never been greater.
“UNICEF is working to help prevent the spread of the virus among communities in the affected countries. We are sharing accurate information on how to keep families safe, providing hygiene and medical kits to schools and health clinics, and mitigating the impact of the outbreak on children’s access to health, education and social services.
“Now more than ever, we count on our donors to continue supporting our mission for those with nothing and no one – despite these difficult times.
Press release
One year after Cyclone Idai, 2.5 million people in Mozambique remain in need of humanitarian assistance
UNICEF prepares for more frequent and ferocious disasters as a result of the climate crisis
17/03/2020
Press release
Almost 5 million children born into war in Syria, 1 million born as refugees in neighbouring countries
Over 9,000 children killed or injured in the conflict, according to verified data, with an average of one child killed every 10 hours since monitoring began
15/03/2020
Vaccination Acceptance Research Network (VARN) [to 21 Mar 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.
Vaccine Confidence Project [to 21 Mar 2020]
http://www.vaccineconfidence.org/
Latest News & Archive
No new digest content identified.
Vaccine Education Center – Children’s Hospital of Philadelphia [to 21 Mar 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
Coronavirus Updates
Frequently Asked Questions about Coronavirus Disease 2019 (COVID-19)
Last Updated: March 19, 2020
Get some fast facts about the coronavirus from CHOP and the CDC. The CDC will provide updated information as it becomes available.
Wellcome Trust [to 21 Mar 2020]
https://wellcome.ac.uk/news
Opinion | 18 March 2020
Urgent investment needed for diagnostics, treatments and vaccines to end the COVID-19 pandemic
Alex Harris, Head of Global Policy Policy and Advocacy team, Wellcome
Now is not the time to make cautious investments: now is the time for courageous action to tackle coronavirus (COVID-19).
The Wistar Institute [to 21 Mar 2020]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.
WFPHA: World Federation of Public Health Associations [to 21 Mar 2020]
https://www.wfpha.org/
Latest News
No new digest content identified.
World Organisation for Animal Health (OIE) [to 21 Mar 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
Press Releases
COVID-19 and veterinary activities designated as essential
OIE/WVA Joint Statement
In the framework of the COVID-19 pandemic, the World Organisation for Animal Health (OIE) and the World Veterinary Association (WVA) jointly draw attention to the roles and responsibilities of the veterinary profession for public health. They highlight the specific veterinary activities which are key to ensure a continuum in food safety, disease prevention and emergency management.
Paris, 18 March 2020 – To effectively tackle the challenges posed by the COVID-19 pandemic, many governments around the world have taken restrictive measures to close non-essential businesses. These decisions raise questions regarding potential adaptations that need to be implemented by the veterinary profession.
In this context, the World Organisation for Animal Health (OIE) and the World Veterinary Association (WVA) advocate for the specific activities of Veterinary Services to be considered as essential businesses.
Maintaining the activities that are crucial to public health
Veterinarians are an integral part of the global health community. Beyond the activities linked to the health and welfare of animals, they have a key role in disease prevention and management, including those transmissible to humans, and to ensure food safety for the populations.
In the current situation, it is crucial that, amongst their numerous activities, they can sustain those necessary to ensure that:
:: national and regional veterinary regulatory and inspection services can oversee the integrity of public health
:: only healthy animals and their by-products enter the food supply to guarantee food safety for the populations,
:: emergency situations can be addressed,
:: preventative measures, such as vaccination against diseases with a significant public health or economic impact, are maintained.
:: priority research activities continue.
Supporting veterinary activities in the current context
When conducting their work, veterinarians have the responsibility to safeguard their health, the health of those they work with, and their clients’ health. Hence, they must ensure that appropriate levels of biosecurity are implemented, that their personnel are protected with the necessary equipment, and that animal owners are informed of precautionary measures in place. It is the responsibility of each individual to ensure that appropriate behaviours are respected in the framework of these activities, to avoid further spread of COVID-19.
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ARM [Alliance for Regenerative Medicine] [to 21 Mar 2020]
https://alliancerm.org/press-releases/
Press Releases
No new digest content identified.
BIO [to 21 Mar 2020]
https://www.bio.org/press-releases
Press Releases
America’s Biopharmaceutical Companies Working Around the Clock to Beat Coronavirus
March 20, 2020
Companies are Coming Together to Achieve Shared Goal of Eradicating the Virus
Press Release
Media Advisory: World’s Largest Biopharmaceutical Organization to Host Two-Day Virtual Summit on Coronavirus
March 19, 2020
The two-day summit will take place on Tuesday, March 24 and Wednesday, March 25, and will be led by BIO President and CEO Jim Greenwood and Dr. George Scangos, President and CEO of Vir Biotechnology. BIO Board Chairman Dr. Jeremy Levin, CEO of Ovid Therapeutics, appointed Dr. Scangos to oversee the BIO Coronavirus Collaboration Initiative, which is intended to help connect innovators with partners across both the industry and inside the federal government to combat the coronavirus.
The summit will include leaders from biotech and pharmaceutical companies, global academic experts in virology and immunology, and non-governmental organizations. Those invited to participate include Ambassador Deborah Birx, Dr. Robert Kadlec, and other senior leaders from key government offices, including the U.S. Department of Defense, U.S. Department of Health & Human Services, the Centers for Disease Control and Prevention, National Institutes of Health, and the Food and Drug Administration. Information regarding confirmed guests will be provided at a later date….
CLICK HERE TO REGISTER
WHO: BIO, Industry Leaders, Senior Government Officials, and Scientific Experts
WHAT: Virtual Summit to Foster Public-Private Collaboration to Address the Coronavirus
WHEN: Tuesday, March 24 and Wednesday, March 25
WHERE: Virtual Meeting, registration required
DCVMN – Developing Country Vaccine Manufacturers Network [to 21 Mar 2020]
http://www.dcvmn.org/
News
No new digest content identified.
IFPMA [to 21 Mar 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
Global Biopharmaceutical Industry pulling out all the stops to address Coronavirus public health crisis
19 March 2020, Geneva – The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), representing the world’s leading biopharmaceutical companies, today confirmed that having already mobilized on an unprecedented scale to respond to the COVID-19 pandemic, they commit to do more. The biopharmaceutical industry commits to accelerate its effort to use its skills, technology and resources to bring safe, effective diagnostics, treatments and vaccines to patients around the world as a matter of urgency…
…Among the commitments are to:
:: use industry’s expertise and know-how to speed up the development of safe and effective vaccines, partnering with others to make it possible;
:: use industry’s medical expertise to support global healthcare systems to manage the unprecedented increase in pressure they face;
:: share tools and insights to test potential therapies and vaccines as well as developing and scaling up capacity ofdiagnostics for testing for COVID-19 patients as much as possible;
:: increase industry’s manufacturing capabilities and willingly share available capacity to ramp up production once a successful vaccine or treatment is developed;
:: work to secure continuity of supply for all essential medicines, vaccines and diagnostics for patients with other life-threatening diseases, calling on governments to implement policies and decisions that facilitate access for those in need…
Pharma industry and patient groups collaborate on a NEW guidance note on best practices for interaction
16 March 2020
…The Note for Guidance aims to complement the 2019 IFPMA Code of Practice which covers the promotion of pharmaceutical products and interactions with Healthcare Professionals (HCPs), medical institutions and patient organizations. The new advisory note sets out principles of interaction on how to protect the independence, privacy and integrity of patients, caregivers and patient organizations when they receive financial and non-financial support from companies and associations. It provides best practice on what should be included in agreements and puts great emphasis on advising pharmaceutical companies and associations to carefully consider how and when to engage with patients and caregivers as individuals, as advisors, or as guest speakers at events and congresses…
PhRMA [to 21 Mar 2020]
http://www.phrma.org/
Selected Press Releases, Statements
America’s Biopharmaceutical Companies Working Around the Clock to Beat Coronavirus
Companies are Coming Together to Achieve Shared Goal of Eradicating the Virus
March 20, 2020
Washington, D.C. (March 20, 2020) — Today, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) underscored the industry’s commitment to finding solutions to prevent, diagnose and treat those with COVID-19, a disease caused by a novel strain of coronavirus. The decades-long investments biopharmaceutical companies have made in new technologies, research and treatments have prepared the industry to act swiftly to respond to the public health crisis.
America’s biopharmaceutical companies are working around the clock to:
:: Work with government agencies and diagnostic partners to increase COVID-19 testing capability and capacity.
:: Screen vast global libraries of medicines to identify potential treatments and have numerous clinical trials underway to test existing therapies.
:: Research and develop new therapies and treatments for those infected with the virus.
:: Use investments in new technologies to speed the development of safe and effective vaccines.
“I’m confident our industry will achieve its shared goal to beat coronavirus, and our commitment underscores how we are uniquely positioned to do so,” said Stephen J. Ubl, president and chief executive officer of PhRMA. “We have deep scientific knowledge gained from decades of experience with similar viruses; the industry has invested billions in technologies that have dramatically shortened the time it takes to decode viruses and develop a potential vaccine; and our companies alone have the ability to manufacture and broadly disseminate vaccines or treatments.”…
Industry Watch [to 21 Mar 2020]
:: Pfizer Announces Top-Line Results from Phase 3 Study of 20-Valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults Aged 18 Years or Older
20-valent pneumococcal conjugate vaccine demonstrated comparable safety and immunogenicity profile to licensed pneumococcal vaccines
March 18, 2020
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced top-line results from one of its Phase 3 studies (NCT03760146), which evaluated the safety and immunogenicity of its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate in adults 18 years of age or older not previously vaccinated against pneumococcal disease. The primary immunogenicity objectives of non-inferiority for the 20 serotypes included in 20vPnC in adults 60 years of age and older at one month after vaccination were met for all serotypes in common with licensed Prevnar 13® (pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) and six of the seven additional serotypes when compared to a licensed pneumococcal polysaccharide vaccine (PPSV23); one of the new seven serotypes missed noninferiority criteria by a small margin.1 Secondary immunogenicity objectives for adults 18-59 years old compared to those 60-64 years old met non-inferiority for all 20 serotypes. The safety objectives were met in adults 18 years of age or older demonstrating that the safety and tolerability of 20vPnC were comparable to licensed pneumococcal vaccines. Based on prior discussions with regulators, these data are expected to meet licensure criteria…
vaccines and global health :: ethics and policy 