BARDA Stakeholder Portal
aspr U.S. Department of Health & Human Services
  Administration for Strategic Preparedness and Response
US Flag An official website of the United States government Here’s how you know
×

Official websites use .gov

See More

A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS

A lock or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites

Project NextGen: Next Generation Medical Countermeasures

Enhancing our preparedness for COVID-19 strains and variants

BARDA, in collaboration with the National Institute of Allergy and Infectious Diseases, is supporting the development of next generation medical countermeasures, including vaccines and therapeutics, to protect Americans from public health security threats such as coronaviruses.

While existing vaccines against COVID-19 are still very effective at preventing serious illness and death, they are less capable of reducing infection and transmission over time. New variants, waning immunity, and resistance to previously authorized therapeutics will continue to challenge our healthcare systems in the coming years, creating a critical need to develop novel vaccines and therapeutics.

Through Project NextGen, the U.S. government will leverage public-private partnerships to develop new vaccines, therapeutics, and technologies to better address current SARS-CoV-2 viral strains and prepare for future ones.

Robert Johnson, Ph.D., Director of Medical Countermeasures, provides a brief introduction to the Project NextGen Initiative.

BARDA’s Project NextGen Focus Areas

  • Better Protection and Longer Lasting Vaccines: Vaccines that provide broader protection against variants of concern and a longer duration of protection.
  • Vaccines that are Easier to Administer and Reduce Spread of the Virus: Including mucosal vaccines such as those delivered intranasally, which could have the potential to dramatically reduce infection and transmission, in addition to preventing serious illness and death.
  • Pan-Coronavirus Protection: Pan-coronavirus vaccines which protects against several different coronaviruses.
  • Modernized, More Resilient Treatment: New and more durable monoclonal antibodies that are resilient against new variants as they arise.
  • Innovative Solutions for Faster, Lower Cost, Rapidly Deployable Technologies: Advancing new technologies that will improve access and enable faster, lower cost, rapid, and flexible production of vaccines and therapeutics.

PROGRAM AREAS OF ADVANCED RESEARCH AND DEVELOPMENT

Select a program area to learn more:

Strengthen
Treat
Enable

Dan Wolfe, Ph.D., Vaccines Branch Chief for the division of Chemical, Biological, Radiological, and Nuclear medical countermeasures at BARDA provides a brief introduction to the Project NextGen Strengthen program

Strengthen

Our goal is to support clinical development for next generation vaccines that have potential to expand the breadth of coverage against existing and future variants, extend the duration of protection, and offer better protection in the prevention of illness and transmission over the current state of vaccine technologies.

We will support a robust pipeline of next generation vaccine candidates by conducting Phase I/IIa safety and immunogenicity trials using existing NIAID infrastructure and network sites and Phase IIb efficacy trials.

STRATEGY

De-risk key development efforts for many vaccine candidates rather than focusing on funding entire development plans for just a small subset of candidates

Diversify portfolio to include a range of platforms that increase access

Expedite progress to see potential efficacy signals compared to licensed/authorized vaccines

Improve efficacy using mucosal administration, non-spike antigens, and/or multi-receptor binding domain-based approaches

Ramya Natarajan, Ph.D., a health scientist at BARDA, provides a brief introduction to the Project NextGen Treat Program

Treat

Our goal is to advance next generation therapeutics. Our initial focus is on enhanced monoclonal antibodies to protect vulnerable populations and partnering with companies to generate clinical data to support FDA licensure or emergency use authorization of next generation therapeutics that are resistant to future SARS-CoV-2 variants.

STRATEGY

De-risk candidate therapeutics through Phase 3 clinical development through fixed price and/or cost-plus incentive contracts utilizing cost sharing, successful trials will de-risk further advanced development

Prioritizing development of mAbs for those vulnerable individuals for whom vaccines are not effective.

Incentivize developers to accelerate development timelines

Target highly conserved monoclonals to increase durability and ensure commercial sustainability of these products

Kimberly Hofmeyer, Ph.D., Deputy Director for Project NextGen at BARDA, provides a brief introduction to the Project NextGen Enable program

Enable

Our goals are to advance next generation vaccine and therapeutics technologies and innovative cGMP manufacturing of vaccines that decrease costs, speed production, increase efficacy, and improve access.

STRATEGY

BARDA will invest in technologies that lower production cost, scale and complexity to enable sustainment and access.

BARDA will invest in MCM enhancement technologies that enable increased uptake by all populations

The earlier an MCM arrives, the more lives are saved. BARDA will invest in technologies to increase speed of MCM development and production

An effective MCM gains public trust and saves the most lives. BARDA will invest in MCM technologies that increase efficacy

Opportunities

BARDA is seeking information and submissions regarding COVID-19 vaccines and therapeutics.
We will continue to update our Broad Agency Announcement and EZ-BAA with Project NextGen partnership opportunities and encourage you to check out our Project NextGen website for more information. Review our current partnership opportunities:

Calendar EVENTS Control

On July 20, BARDA hosted the Project NextGen: Enablers for Innovative COVID-19 Vaccine Manufacturing virtual workshop to engage with the vaccine development and manufacturing communities. The goal of the workshop was to gather feedback and identify opportunities that address vaccine manufacturing challenges and gaps to meet the goals of Project NextGen. The event featured speakers from NIIMBL, BIO, and FDA CBER and a panel discussion that also included BARDA Subject Matter Experts. Topics included upstream and downstream processing, formulation and analytical support. Over 400 individuals from across the industry attended the workshop.

Project NextGen
Watch the entire workshop
Laptop SUBMIT A TECHWATCH MEETING REQUEST Control

Submit a TechWatch meeting request for next generation medical countermeasures to address COVID-19.

Prior to submitting to the Broad Agency Announcement (BAA), we encourage interested parties to request a TechWatch meeting for the opportunity to receive feedback from BARDA staff. Submission of a TechWatch Meeting Request does not guarantee a meeting or funding. Additional dates will be added pending future Area of Interest (AOI) openings.

LEARN ABOUT TECHWATCH
Bull Horn FUNDING OPPORTUNITIES Control

The Rapid Response Partnership Vehicle (RRPV) supports BARDA to accelerate the advanced development of MedicalCountermeasure (MCM) products and technology development to address evolving needs including pandemic influenza, emerging infectious diseases, and other biological threats.

EXPLORE RRPV OPPORTUNITIES

The Patch Forward Prize, part of Project NextGen, is a $50 million competition to advance microneedle patch-based RNA vaccines for COVID-19, seasonal influenza, and pandemic influenza. BARDA calls on vaccine developers and patch makers to partner and accelerate new vaccine technologies.

EXPLORE PATCH FORWARD PRIZE

HIGHLIGHTED PROJECT NEXTGEN POSTS