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Walgreens Receives BARDA Project NextGen Award to Conduct Novel COVID-19 Decentralized Clinical Study

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Walgreens has received a $25 million award from BARDA to conduct a Phase IV observational clinical study on COVID-19 vaccine data. The study aims to assess Correlates of Protection (CoP) and enhance U.S. public health preparedness. Walgreens will leverage its community pharmacy network to improve access and diversity in clinical trials.

Key points:

  • Study will enroll up to 4,000 participants across 20 retail pharmacy locations
  • Walgreens has administered over 90 million COVID-19 vaccinations to date
  • The project is part of HHS's $5 billion Project NextGen initiative
  • Walgreens will use its decentralized clinical trial platform for participant recruitment

Walgreens ha ricevuto un finanziamento di 25 milioni di dollari da BARDA per condurre uno studio clinico osservazionale di Fase IV sui dati dei vaccini COVID-19. Lo studio mira a valutare i Correlati di Protezione (CoP) e a potenziare la preparazione alla salute pubblica negli Stati Uniti. Walgreens utilizzerà la sua rete di farmacie comunitarie per migliorare l'accesso e la diversità negli studi clinici.

Punti chiave:

  • Lo studio arruolerà fino a 4.000 partecipanti in 20 sedi di farmacie al dettaglio
  • Walgreens ha somministrato oltre 90 milioni di vaccinazioni COVID-19 fino ad oggi
  • Il progetto fa parte dell'iniziativa Project NextGen da 5 miliardi di dollari del HHS
  • Walgreens utilizzerà la sua piattaforma di trial clinici decentralizzati per il reclutamento dei partecipanti

Walgreens ha recibido un premio de 25 millones de dólares de BARDA para llevar a cabo un estudio clínico observacional de Fase IV sobre los datos de la vacuna COVID-19. El estudio tiene como objetivo evaluar los Correlatos de Protección (CoP) y mejorar la preparación de la salud pública en EE. UU. Walgreens aprovechará su red de farmacias comunitarias para mejorar el acceso y la diversidad en los ensayos clínicos.

Puntos clave:

  • El estudio inscribirá hasta 4,000 participantes en 20 ubicaciones de farmacias minoristas
  • Walgreens ha administrado más de 90 millones de vacunas COVID-19 hasta la fecha
  • El proyecto es parte de la iniciativa Project NextGen de 5 mil millones de dólares del HHS
  • Walgreens utilizará su plataforma de ensayos clínicos descentralizados para el reclutamiento de participantes

Walgreens는 BARDA로부터 2,500만 달러의 지원금을 받아 COVID-19 백신 데이터를 바탕으로 IV상 관찰 임상 연구를 수행하게 됩니다. 이 연구는 보호 상관관계(CoP)를 평가하고 미국의 공공 건강 준비태세를 강화하는 것을 목표로 합니다. Walgreens는 지역 약국 네트워크를 활용하여 임상 시험에서 접근성과 다양성을 개선할 것입니다.

주요 사항:

  • 이 연구는 20개 소매 약국 위치에서 최대 4,000명의 참가자를 모집할 것입니다.
  • Walgreens는 현재까지 9천만 회 이상의 COVID-19 백신 접종을 실시했습니다.
  • 이 프로젝트는 HHS의 50억 달러 Project NextGen 이니셔티브의 일환입니다.
  • Walgreens는 참가자 모집을 위해 분산형 임상 시험 플랫폼을 사용할 것입니다.

Walgreens a reçu une bourse de 25 millions de dollars de BARDA pour réaliser une étude clinique observationnelle de Phase IV sur les données des vaccins COVID-19. L'étude a pour objectif d'évaluer les Correlats de Protection (CoP) et d'améliorer la préparation de la santé publique aux États-Unis. Walgreens va utiliser son réseau de pharmacies communautaires pour améliorer l'accès et la diversité des essais cliniques.

Points clés :

  • L'étude va inscrire jusqu'à 4 000 participants dans 20 pharmacies de détail
  • Walgreens a administré plus de 90 millions de vaccinations COVID-19 à ce jour
  • Le projet fait partie de l'initiative Project NextGen de 5 milliards de dollars du HHS
  • Walgreens utilisera sa plateforme d'essais cliniques décentralisés pour le recrutement des participants

Walgreens hat von BARDA einen Preis in Höhe von 25 Millionen Dollar erhalten, um eine Phase IV Beobachtungsstudie zu COVID-19 Impfdaten durchzuführen. Die Studie hat zum Ziel, die Korrelate des Schutzes (CoP) zu bewerten und die öffentliche Gesundheitsbereitschaft in den USA zu verbessern. Walgreens wird sein Netzwerk von Gemeindapotheken nutzen, um den Zugang und die Vielfalt in klinischen Studien zu verbessern.

Wichtige Punkte:

  • In der Studie sollen bis zu 4.000 Teilnehmer an 20 Einzelhandelsstandorten für Apotheken eingeschrieben werden
  • Walgreens hat bis heute über 90 Millionen COVID-19-Impfungen verabreicht
  • Das Projekt ist Teil der 5 Milliarden Dollar Project NextGen Initiative des HHS
  • Walgreens wird seine dezentrale Plattform für klinische Studien zur Rekrutierung von Teilnehmern nutzen
Positive
  • Received $25 million award for COVID-19 vaccine study
  • Potential to improve access and diversity in clinical trials
  • Leveraging extensive community pharmacy network for research
  • Administered over 90 million COVID-19 vaccinations to date
  • Only retail pharmacy with national decentralized clinical trial infrastructure
Negative
  • None.

The $25 million award to Walgreens for conducting a Phase IV observational clinical study is a significant development in medical research. This study will focus on Correlates of Protection (CoP), which are responses indicating how well a vaccinated person is protected from future infections. By leveraging Walgreens' extensive community pharmacy network, the study aims to enhance access to clinical research and ensure diverse participation. This initiative aligns with the broader goals of improving public health preparedness and advancing vaccine science. In the long-term, successful outcomes from this study could pave the way for better-informed vaccine strategies and policies, potentially reducing the impact of future pandemics.

From a business perspective, securing this BARDA award is a strategic win for Walgreens. The $25 million funding not only underscores the company's capability in handling large-scale health initiatives, but also enhances its reputation as a key player in decentralized clinical trials. This could lead to increased trust and preference among consumers and healthcare partners. Moreover, the focus on historically underrepresented communities could expand Walgreens' market reach and customer base. In the short term, investors might see this as a positive signal, potentially boosting stock prices. However, the long-term financial benefits will largely depend on the successful execution of the study and any subsequent partnerships or contracts.

Financially, the $25 million award, though not a game-changer in terms of revenue, adds a layer of diversification to Walgreens' income streams. This funding is part of the larger $5 billion Project NextGen initiative by HHS, indicating potential future opportunities for similar or larger awards. Additionally, the successful completion and positive outcomes of this study could enhance Walgreens' standing in the healthcare sector, possibly leading to increased partnerships and business ventures. For investors, this news is a positive indicator of Walgreens' strategic positioning and its ability to secure federal funds for critical health initiatives. It also demonstrates the company's role in the evolving landscape of healthcare services.

This study aims to enhance U.S. public health preparedness through Walgreens community pharmacy network, improving access and diversity in clinical trials via a $25m award

DEERFIELD, Ill.--(BUSINESS WIRE)-- Walgreens today announced it received a project award valued up to $25 million through the Rapid Response Partnership Vehicle (RRPV) to conduct a Phase IV observational clinical study focused on assessing Correlates of Protection (CoP), known as responses to a vaccine that predict how well a vaccinated person will be protected from future infections, using COVID-19 vaccine data. The RRPV is a Consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS). This partnership underscores a shared commitment to advancing public health through innovative research and leveraging Walgreens’ extensive community pharmacies to increase access and representation in clinical trials.

As a leading community pharmacy and front door to the U.S. healthcare system, Walgreens played a pivotal role in the distribution of COVID-19 vaccines and testing throughout the pandemic. Walgreens has administered over 90 million COVID-19 vaccinations to date, showcasing its capacity to handle large-scale health initiatives. Building on this experience, through this collaboration, the BARDA-funded study will utilize select Walgreens community pharmacies as clinical trial sites to assess the effectiveness of FDA-authorized COVID-19 vaccines. This initiative aims to enhance access to clinical research across diverse patient populations, particularly in communities historically underrepresented in clinical trials.

“We are honored to be selected by BARDA and its RRPV for this important study as this is a step forward to utilize public and private partnerships to bring clinical trials into more communities across the country,” said Ramita Tandon, chief clinical trials officer at Walgreens. “With our experience in immunizations and trusted relationship with millions of patients and customers, Walgreens is uniquely positioned to support this critical research. As the only retail pharmacy with a national decentralized clinical trial infrastructure and dedicated clinical research staff, we are committed to helping enhance public health preparedness.”

Walgreens will employ a comprehensive approach to participant recruitment, which will leverage its physical footprint in addition to its compliant and secure decentralized clinical trial platform to reach patients where it’s most convenient for them. The study will enroll up to 4,000 participants across 20 retail pharmacy locations nationwide, ensuring a diverse and representative study population.

Funding for this award was received under Project NextGen, a $5 billion initiative by HHS to advance a pipeline of new, innovative vaccines and therapeutics providing broader and more durable protection for COVID-19 than the first-generation COVID vaccines and medicines. BARDA is supporting the development of new vaccines, therapeutics, and enabling technologies to better address the waning immunity and resistance to current and future SARS-CoV2 viral strains.

This project is being funded with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction (OT) number: 75A50123D00005.

About Walgreens:

Walgreens (http://www.walgreens.com) is included in the U.S. Retail Pharmacy and U.S. Healthcare segments of Walgreens Boots Alliance, Inc. (Nasdaq: WBA), an integrated healthcare, pharmacy and retail leader. True to its purpose of “more joyful lives through better health,” Walgreens has a more than 120-year heritage of caring for communities and providing trusted pharmacy services, and today is playing a greater role as an independent partner of choice offering healthcare services that improve care, lower costs, and help patients. Operating nearly 9,000 retail locations across the U.S. and Puerto Rico, Walgreens is proud to serve nearly 9 million customers and patients daily. The company’s pharmacists are playing a more critical role in healthcare than ever before, providing a wide range of pharmacy and healthcare services, including those that drive equitable access to care for some of the nation’s most underserved populations. Walgreens offers customers and patients a true omnichannel experience, with fully integrated physical and digital platforms designed to deliver high-quality products and healthcare services. Within the U.S. Healthcare segment, Walgreens portfolio also includes businesses in primary care, multi-specialty, post-acute care, urgent care, specialty pharmacy services, population health and provider enablement.

Walgreens

Carmen Lopez

media@walgreens.com

Source: Walgreens

FAQ

What is the purpose of Walgreens' BARDA-funded COVID-19 study (WBA)?

The study aims to assess Correlates of Protection (CoP) for COVID-19 vaccines, enhancing U.S. public health preparedness and improving access and diversity in clinical trials through Walgreens' community pharmacy network.

How many participants will Walgreens (WBA) enroll in the COVID-19 vaccine study?

Walgreens plans to enroll up to 4,000 participants across 20 retail pharmacy locations nationwide for the BARDA-funded COVID-19 vaccine study.

What is the value of the BARDA award received by Walgreens (WBA) for the COVID-19 study?

Walgreens received a project award valued up to $25 million through the Rapid Response Partnership Vehicle (RRPV) to conduct the Phase IV observational clinical study on COVID-19 vaccine data.

How many COVID-19 vaccinations has Walgreens (WBA) administered to date?

Walgreens has administered over 90 million COVID-19 vaccinations to date, demonstrating its capacity to handle large-scale health initiatives.

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