Announcements

Announcements

 
 
Paul G. Allen Frontiers Group    [to 16 May 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
No new digest content identified.
 
 
BMGF – Gates Foundation  [to 16 May 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 16 May 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 16 May 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.
05.11.2020  |
CARB-X funds 60th project – $220M invested so far, plus millions more if milestones are met
CARB-X announced its 60th award today, representing more than $220 million invested since CARB-X was established in 2016 to support the early development of innovative products to fight drug resistance.
05.11.2020  |
CARB-X awards Day Zero Diagnostics $6.2M to develop a new test that would diagnose deadly superbug infections faster and determine what antibiotic would be most effective
CARB-X is awarding Day Zero Diagnostics, based in Boston, up to US$6.2 million in non-dilutive funding to develop a diagnostic system that could diagnose bacterial infections more quickly – within hours rather than days – and show physicians which antibiotics are most likely to effectively treat the infection. The innovative technology combines whole-genome sequencing and machine learning to identify the species of a pathogen and its drug-resistance profile without the need for culture, providing physicians with vital information to speed the appropriate treatment of serious drug-resistant bacterial infections in hours rather than days.
 
 
CEPI – Coalition for Epidemic Preparedness Innovations  [to 16 May 2020]
http://cepi.net/
Latest News
CEPI extends collaboration with Novavax to advance development and manufacture of COVID-19 vaccine
11 May 2020
 
 
Clinton Health Access Initiative, Inc. (CHAI)  [to 16 May 2020]
https://clintonhealthaccess.org/
News & Press Releases
No new digest content identified.
 
 
EDCTP    [to 16 May 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 16 May 2020]
http://www.vaccines.emory.edu/
[Undated]
No new digest content identified.
 
 
European Medicines Agency  [to 16 May 2020]
http://www.ema.europa.eu/ema/
News & Press Releases
EU actions to support availability of medicines during COVID-19 pandemic – update #6
Press release 15/05/2020
The EU Executive Steering Group on Shortages of Medicines Caused by Major Events held a virtual meeting on 13 May 2020. Participation to the meeting of the steering group was extended to all the heads of the national competent authorities (NCAs) of the EU Member States to discuss the measures taken by EU authorities to ensure the continued availability of medicines in Europe during the ongoing COVID-19 pandemic…

Press release: International coordination needed to encourage conduct of large, decision-relevant COVID-19 clinical trials
Last updated: 15/05/2020
[See Perspectives above for detail]
News: EMA recommends expanding remdesivir compassionate use to patients not on mechanical ventilation
Last updated: 11/05/2020
 
 
European Vaccine Initiative  [to 16 May 2020]
http://www.euvaccine.eu/news-events
Latest News
No new digest content identified.
 
 
FDA [to 16 May 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements
May 16, 2020 – Coronavirus (COVID-19) Update: FDA Authorizes First Standalone At-Home Sample Collection Kit That Can Be Used With Certain Authorized Tests
The U.S. Food and Drug Administration has authorized an at-home sample collection kit that can then be sent to specified laboratories for COVID-19 diagnostic testing. Specifically, the FDA issued an emergency use authorization (EUA) to Everlywell, Inc. for the Everlywell COVID-19 Test Home Collection Kit. Everlywell’s kit is authorized to be used by individuals at home who have been screened using an online questionnaire that is reviewed by a health care provider…

May 15, 2020 – Coronavirus (COVID-19) Update: Daily Roundup May 15, 2020

May 14, 2020 – Coronavirus (COVID-19) Update: Daily Roundup May 14, 2020

May 14, 2020 – Coronavirus (COVID-19) Update: FDA Informs Public About Possible Accuracy Concerns with Abbott ID NOW Point-of-Care Test

Today, the U.S. Food and Drug Administration is alerting the public to early data that suggest potential inaccurate results from using the Abbott ID NOW point-of-care test to diagnose COVID-19. Specifically, the test may return false negative results.

“We are still evaluating the information about inaccurate results and are in direct communications with Abbott about this important issue. We will continue to study the data available and are working with the company to create additional mechanisms for studying the test. This test can still be used and can correctly identify many positive cases in minutes. Negative results may need to be confirmed with a high-sensitivity authorized molecular test,” said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health…

May 13, 2020 – Coronavirus (COVID-19) Update: Daily Roundup May 13, 2020

May 12, 2020 – Coronavirus (COVID-19) Update: Daily Roundup May 12, 2020

May 11, 2020 – Coronavirus (COVID-19) Update: FDA Takes New Actions to Accelerate Development of Novel Prevention, Treatment Options for COVID-19

Today, the U.S. Food and Drug Administration took important actions to help accelerate the development of prevention and treatment options for COVID-19 by providing new guidance with recommendations for innovators and researchers conducting work in this area. These guidance documents aim to make the process for submitting applications to initiate studies for new drugs and biological products more efficient and outline recommendations for ways to design clinical trials to evaluate safety and effectiveness of these medical products for COVID-19…
 
 
Fondation Merieux  [to 16 May 2020]
http://www.fondation-merieux.org/
News, Events
No new digest content identified.
 
 
 
Gavi [to 16 May 2020]
https://www.gavi.org/
News releases
12 May 2020
Canada commits CAD 600 million to Gavi
11 May 2020
Spain pledges new support to Gavi
 
 
GHIT Fund   [to 16 May 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 16 May 2020]
https://www.theglobalfund.org/en/news/
Sourcing & Management of Health Products
COVID-19 Diagnostics Procurement through the Global Fund
15 May 2020
News
Global Fund Board Members Unite to Fight
15 May 2020
Voices
On the Front Lines: Responding to COVID-19
15 May 2020
Voices
Amid COVID-19, Communities Continue Fight against Other Pandemics
12 May 2020
Voices
Protecting Mothers and Babies from HIV during the COVID-19 Pandemic
12 May 2020
 
 
Hilleman Laboratories   [to 16 May 2020]
http://www.hillemanlabs.org/
No new digest content identified.
 
 
Human Vaccines Project   [to 16 May 2020]
http://www.humanvaccinesproject.org/media/press-releases/
HVP COVID Report   May 13, 2020
Human Challenges to Accelerate SARS-CoV-2 Vaccine Development
By Stanley A. Plotkin, MD
Emeritus Professor of Pediatrics
University of Pennsylvania
Vaxconsult
 
 
IAVI  [to 16 May 2020]
https://www.iavi.org/newsroom
Press Releases
No new digest content identified.
 
 
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/
Press Releases
Norway Renews its Support for IFFIm with US$400 Million Pledge
08 May 2020
The 10-year commitment to support Gavi vaccine programmes is part of Norway’s US$ 1 billion commitment to Gavi London, 8 May 2020 – Norway has committed an additional US$ 400 million over the next 10 years to the International Finance Facility for Immunisation (IFFIm), which leverages long-term donor financing.
 
 
IFRC   [to 16 May 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Global
International Nurses Day: Nurses deserve praise, thanks, protection amid COVID-19
Geneva, 11 May 2020 – Nurses and other health care workers on the frontlines of the fight against COVID-19 deserve to be recognized and commended for their lifesaving efforts and personal sacrifices amid increased medical risk – and in some places amid …
11 May 2020
 
 
IVAC  [to 16 May 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates
Commentary: The success of a Covid-19 vaccine will hinge on its delivery
May 2020
By Lois Privor-Dumm, Naor Bar Zeev, and Maria Deloria Knoll Originally published on STAT News
The lesson learned from a long history of using vaccines to fight massively disruptive diseases like smallpox and Ebola is that the vaccine itself is not enough. Like a good punch line, it’s all about the delivery. The smallpox vaccine […]
 
 
IVI   [to 16 May 2020]
http://www.ivi.int/
Selected IVI News & Announcements
No new digest content identified.
 
 
JEE Alliance  [to 16 May 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.
 
 
MSF/Médecins Sans Frontières  [to 16 May 2020]
http://www.msf.org/
Latest [Selected Announcements]
Sudan
MSF urges to respect medical action after violent incursion in Rokero, Centr…
Statement 15 May 2020

Coronavirus COVID-19 pandemic
COVID19 and lack of protective equipment threaten lifesaving care in KenyaProject Update 15 May 2020

Coronavirus COVID-19 pandemic
COVID-19 in West Africa: “Let’s prepare for a long-distance run”
Op-Ed 15 May 2020
Afghanistan
“They came to kill the mothers” in Kabul maternity hospital attack
Voices from the Field 14 May 2020
 
 
Afghanistan
Revolting attack on maternity ward kills pregnant women and babie…
Press Release 13 May 2020
 
 
Coronavirus COVID-19 pandemic
MSF supports the COVID-19 pandemic response in Guinea
Project Update 12 May 2020
 
 
National Vaccine Program Office – U.S. HHS  [to 16 May 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 16 May 2020]
http://www.nih.gov/news-events/news-releases
Selected News Releases
Investigational ChAdOx1 nCoV-19 vaccine protects monkeys against COVID-19 pneumonia
May 15, 2020 — Study provided data for clinical testing to commence.
NIH begins clinical trial of hydroxychloroquine and azithromycin to treat COVID-19
May 14, 2020 — Study enrolling adults with mild to moderate COVID-19 in the United States.
Coordinated strategy to accelerate multiple COVID-19 vaccine candidates is key, NIH experts say
May 11, 2020 — More than one effective vaccine approach likely will be required to successfully protect the global community from SARS-CoV-2.
[See Milestones above for detail]
 
 
PATH  [to 16 May 2020]
https://www.path.org/media-center/
Selected Announcements
No new digest content identified.
 
 
Sabin Vaccine Institute  [to 16 May 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
BARDA Provides the Sabin Vaccine Institute with an Additional $20 Million for Further Development of Ebola Sudan and Marburg Vaccines
Wednesday, May 13, 2020
Sabin and Partner ReiThera Initiate Manufacturing of Clinical Trial Material
WASHINGTON, D.C. and ROME, Italy, May 13, 2020 – The Sabin Vaccine Institute (Sabin) and its partner ReiThera Srl today announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, has exercised the first two options, valued at $20 million, under the 2019 contract to advance the development of vaccines against Ebola Sudan and Marburg viruses through Phase 2 clinical trials…
 
 
UNAIDS [to 16 May 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
16 May 2020
New videos highlight LGBTI issues in Brazil
14 May 2020
Let transgender people be in the picture
14 May 2020
Russian regional AIDS centres leading the fight against COVID-19
14 May 2020
Uniting behind a people’s vaccine against COVID-19
[See Milestones above for detail]
13 May 2020
COVID-19 in prisons—a ticking time bomb
13 May 2020
“We are human, so of course it was scary”
13 May 2020
Sex workers in Bangladesh: building resilience during the COVID-19 pandemic
12 May 2020
People with disabilities often left behind by HIV responses
12 May 2020
United Nations agencies coordinate their COVID-19 response in South Africa
11 May 2020
Dealing with COVID-19 in Cameroon
11 May 2020
HIV testing and support for homeless people in Belarus
 
 
UNICEF  [to 16 May 2020]
https://www.unicef.org/media/press-releases
Selected Press releases/Announcements
Press release
Geneva Palais briefing note on UNICEF response to COVID-19 in Rohingya refugee camps as first coronavirus case confirmed
15/05/2020
Press release
Declining vaccination rates in the Democratic Republic of the Congo could lead to resurgence in deadly diseases
KINSHASA/GENEVA/NEW YORK, 15 May 2020 –The reduction in vaccination rates currently being reported in the Democratic Republic of the Congo (DRC) will leave children in the country at increased risk of contracting deadly diseases such as polio, measles and yellow fever, UNICEF warned today.
The decline in the first two months of the year was likely due to established challenges such as poor cold chain systems, low coverage and stock supply. However, the DRC’s Expanded Programme on Immunization (EPI) is now facing a new challenge which will almost certainly worsen the situation: COVID-19. Health workers conducting routine vaccinations do not have access to adequate equipment to protect themselves, caregivers and children from the coronavirus. Parents are reluctant to attend vaccination sessions for fear of exposing themselves and their children to COVID-19…
Statement
Joint statement on Libya
by OCHA, UNHCR, UNICEF, UNFPA, WFP, WHO, IOM
13/05/2020
Press release
Forced returns of migrants must be suspended in times of COVID-19
Statement by the United Nations Network on Migration
GENEVA, 14 May 2020 – The United Nations Network on Migration is concerned by reports of States in many regions using forced return of migrants as a measure in response to COVID-19.    The Network calls on States to suspend forced returns during the pandemic, in order to protect the health of migrants and communities, and uphold the human rights of all migrants, regardless of status. Successfully tackling the pandemic cannot be achieved without upholding human rights.
When temporary border closures and movement restrictions are deemed necessary to prevent the transmission of COVID-19, they must be implemented in a way that is non-discriminatory and proportionate to achieving the public health aim pursued. Such closures should incorporate health protocols and processes to guarantee fundamental rights at all times.
Keeping everyone safe means ensuring that no-one faces the risk of refoulement by being returned to places where their life, safety or human rights are threatened. It means that collective expulsions, such as arbitrary pushbacks of migrants and asylum-seekers at borders, must be halted; that protection needs must be individually assessed; and that the rule of law and due process must be observed. It also means prioritizing protection, including every child’s best interests. These are obligations in international law that can never be put on hold and are vital to any successful approach to combatting COVID-19 for the benefit of all…
Press release
As COVID-19 devastates already fragile health systems, over 6,000 additional children under five could die a day, without urgent action
UNICEF launches #Reimagine, a global campaign to prevent the pandemic from becoming a lasting crisis for children
12/05/2020
Press release
UNICEF appeals for $1.6 billion to meet growing needs of children impacted by COVID-19 pandemic
New funding request is $1 billion more than March appeal, as countries reel from socioeconomic impact of COVID-19
11/05/2020
Statement
In light of COVID-19 crisis, UN officials call for immediate release of all children in detention, including Palestinian children
Joint Press Statement from Jamie McGoldrick, Humanitarian Coordinator in the occupied Palestinian territory (oPt), Genevieve Boutin, UNICEF Special Representative in State of Palestine, and James Heenan, Head of the UN Human Rights Office in the oPt
 
 
Unitaid  [to 16 May 2020]
https://unitaid.org/
Featured News
14 May 2020 | Statements
Equitable global access to vaccines, treatments and diagnostics is key to tackling COVID-19 pandemic

Geneva – As governments, international organizations, pharmaceutical industry, academia and others focus their efforts on the COVID-19 coronavirus, it is clear that this global pandemic needs a global response. It is both a public health need and a moral duty to ensure that this response is grounded in solidarity to ensure that the vaccines, treatments and diagnostics being developed are accessible to all, everywhere and at the same time.

Heads of State and government, and the World Health Organization, have recognized and actively supported this need.

There is growing international backing for the proposal of the President of Costa Rica for voluntary pooling of knowledge, intellectual property and data necessary for COVID-19 detection, prevention, treatment and response. The pledging marathon co-hosted by the European Union and its partners on 4 May 2020 stressed the need for global development of innovative responses that are both universally available and affordable.

This political will is being translated into action through the Access to COVID-19 Tools (ACT) Accelerator. Unitaid is proud to be part of the partnership driving the work around development, manufacturing, procurement and deployment of treatments. Core to this work must be to find innovative solutions that are adapted and accessible to all, especially in low-resource settings…
 
 
Vaccination Acceptance Research Network (VARN)  [to 16 May 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.
 
 
Vaccine Confidence Project  [to 16 May 2020]
http://www.vaccineconfidence.org/
Latest News & Archive
Building trust, managing risk around vaccines: from trials to delivery
Course Dates: 20 – 23 July 2020
This 3.5-day course, developed by the Vaccine Confidence ProjectTM at LSHTM, will highlight the importance of maintaining and improving vaccine confidence and explore the diversity of concerns and perceptions about vaccines and how they have impacted vaccine uptake across multiple global settings.
 
 
Vaccine Education Center – Children’s Hospital of Philadelphia  [to 16 May 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
No new digest content identified.
 
 
Wellcome Trust  [to 16 May 2020]
https://wellcome.ac.uk/news
News | 14 May 2020
Julia Gillard appointed as next Chair of Wellcome
Julia Gillard, the former Prime Minister of Australia, has been appointed as the next Chair of Wellcome. She will will succeed Eliza Manningham-Buller, who is stepping down from the role in April 2021.

News | 12 May 2020
Wellcome Leap announces leadership team
Wellcome Leap, a not-for-profit organisation founded by Wellcome to accelerate innovations that benefit global health, will be led by Regina E. Dugan as CEO and Jay Flatley as Chair.
With initial funding of $300 million, Wellcome Leap will undertake bold, unconventional programmes and fund them at scale. These programmes will target complex human health challenges with the goal of achieving breakthrough scientific and technological solutions within a decade…
 
 
The Wistar Institute   [to 16 May 2020]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.
 
 
WFPHA: World Federation of Public Health Associations  [to 16 May 2020]
https://www.wfpha.org/
Latest News
No new digest content identified.
 
 
World Organisation for Animal Health (OIE)   [to 16 May 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
Press Releases
No new digest content identified.

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ARM [Alliance for Regenerative Medicine]  [to 16 May 2020]
https://alliancerm.org/press-releases/
Press Releases
No new digest content identified.
 
 
BIO    [to 16 May 2020]
https://www.bio.org/press-releases
Press Releases
Modernized Biotech Regulation Will Unleash Greater Innovation
May 14, 2020
The U.S. Department of Agriculture (USDA) released today a modernized, science-based regulatory system for plant biotechnology aimed at maintaining oversight while driving innovation. Now government and industry must do more to build an informed and…

BIO Appoints a Physician-Scientist as New President and CEO
May 14, 2020
Immunologist Michelle McMurry-Heath is Selected  for Her Global Leadership and Commitment to Innovation and Patients Former FDA Official Will Succeed Industry Leader Jim Greenwood  on June 1 as Leader of World’s Largest Biotechnology…
Dr. Moncef Slaoui “Excellent Choice” to Lead Operation Warp Speed
May 13, 2020
Following the announcement that Dr. Moncef Slaoui will lead the Trump Administration’s “Operation Warp Speed” initiative, BIO’s President and CEO, Jim Greenwood, issued the following statement:  “Dr. Moncef Slaoui is an excellent choice…
New Medicine Pipeline Tracker Illustrates Unprecedented Effort to Eradicate COVID-19
May 12, 2020
The Biotechnology Innovation Organization (BIO) today unveiled a first-of-its-kind, interactive tracker of the new treatments and vaccines in the COVID-19 pipeline. This online resource illustrates the unprecedented campaign being undertaken by…
 
 
DCVMN – Developing Country Vaccine Manufacturers Network  [to 16 May 2020]
http://www.dcvmn.org/
News
9 May 2020
DCVMN united with the EU at the Coronavirus Global Response international pledging event
Brussels, 04 May 2020 – Governments, global health organizations, and experienced partners joined hands…
 
 
IFPMA   [to 16 May 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
COVID-19 Biopharmaceutical Industry – Regulatory Guiding Principles
Published on: 14 May 2020
During these unprecedented times, it is essential that we all come together to contribute to the development of medicines and vaccines for treatment and prevention of COVID-19.

Many activities, undertaken by governments, national regulatory authorities (NRAs), academia, global health stakeholders and the biopharmaceutical industry, are helping to identify, research, develop and manufacture at scale these vital technologies under immense time pressure.

While resources are being committed to address the pandemic, other equally important efforts must continue for the benefit of patients globally beyond COVID-19. Access to existing medicines and vaccines for treatment and prevention of other conditions, like diabetes, cancer and measles, must continue. Clinical research into new options and treatments for serious and life-threatening diseases and unmet medical needs should be preserved.

Despite the huge impact caused by COVID-19, the R&D-based biopharmaceutical industry must maintain and indeed increase the supply of medicines and vaccines to the best of our ability to patients at a time when ‘normal’ production, supply chains and business operations are adversely impacted and massively challenged.

With a need for increased speed and a ‘new’ normal comes unprecedented pressure on biopharmaceutical manufacturing, which we are committed to meeting whilst not affecting patient safety and quality.

Therefore, we would like to reiterate our continued commitments to:
:: Working in partnership and collaboration with NRAs to define the best science-based regulatory strategies for ensuring the availability of COVID-19 medicines and vaccines – Implementing new principles (e.g. regulatory reliance and mutual recognition) and enhancing existing approaches for clinical research, pharmaceutical production and advancement of new COVID-19 medicines and vaccines are critical for global public health.

:: Progressing research into new treatments and prevention of other conditions – We are committed to adhering to the best principles for conducting clinical research and ensuring the continuation of ongoing clinical trials for promising, non-COVID-19 treatments.

:: Maintaining supply of medicines and vaccines – Enabling continuity of manufacturing and availability of product supply is imperative for public health. Globally integrated supply chains, which ensure quality, safety and innovative approaches for distribution across the health sector, may be critically impacted by operational disruptions. We work to find solutions that address potential bottlenecks and barriers thereby avoiding disruptions that could jeopardize access to treatments.

:: Ensuring all our medicines and vaccines continue to meet appropriate standards for quality and safety – Patient safety and product quality are key priorities for the biopharmaceutical industry and are intrinsic to what we do. We routinely engage with regulatory and standard-setting bodies in the development and implementation of guidelines for the quality and safety of medicines and vaccines. We also monitor the use of our medicines and vaccines with patients to safeguard and promote public health.
 
 
PhRMA    [to 16 May 2020]
http://www.phrma.org/
Selected Press Releases, Statements
No new digest content identified.
 
 
Industry Watch   [to 16 May 2020]
:: Pfizer Announces Positive Top-Line Results From Phase 3 Lot Consistency Study of 20-Valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naive Adults 18 Through 49 Years of Age
20-valent pneumococcal conjugate vaccine elicits consistent immune response across three different lots
May 14, 2020   NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced top-line results from a second Phase 3 study (NCT03828617), which described the safety and evaluated the consistency of immune responses elicited across three different lots of its 20-valent pneumococcal polysaccharide conjugate vaccine (20vPnC) candidate in adults 18 through 49 years of age not previously vaccinated against pneumococcal disease. Responses elicited by 20vPnC for all 20 serotypes were equivalent across all three lots, meeting the primary immunogenicity objective of the study. In this study the 20vPnC safety profile was similar to the Prevnar 13® (pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) control group. This clinical lot consistency study is expected to satisfy licensure requirements for manufacturing consistency by the U.S. Food and Drug Administration, and other countries’ regulatory agencies.
“We are excited by the progress of our adult development program for 20vPnC as this is the second phase 3 trial for this investigational vaccine for which we have positive topline data,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer…