The US government will begin a coordinated wind-down of 22 mRNA vaccine-development projects, representing funding of $500 million. mRNA technology came into prominence as vaccines against COVID-19. What projects are affected?

By Patricia Van Arnum, Editorial Director, DCAT, pvanarnum@dcat.org

Change in US funding for mRNA vaccine projects
The US Department of Health and Human Services (HHS) announced this week (August 5, 2025) the beginning of a coordinated wind-down of its mRNA vaccine-development activities under the Biomedical Advanced Research and Development Authority (BARDA), including the cancellation and de-scoping of various contracts and solicitations. In all, BARDA is terminating funding for 22 mRNA vaccine-development projects worth about $500 million. BARDA is part of the Administration for Strategic Preparedness and Response within HHS.

Vaccines using mRNA technology came into prominence during the COVID-19 pandemic, with two major mRNA vaccines: Pfizer’s/BioNTech’s Comirnaty, which posted peak sales of $37.8 billion in 2022, and Moderna’s Spikevax, which posted peak sales in 2022 of $18.44 billion. The success of these mRNA vaccines transformed mRNA technology from a promising area of vaccine and therapeutic development to one with great commercial success, which was realized due to the pressing public health need to develop a COVID-19 vaccine.

Pfizer’s/BioNTech’s Comirnaty was granted full US Food and Drug Administration (FDA) approval in August 2021 for people ages 16 and older. Before that, it was the first COVID vaccine to receive FDA Emergency Use Authorization in December 2020. Moderna’s Spikevax gained full FDA approval for people 18 and older in January 2022 and was granted FDA Emergency Use Authorization in December 2020. The original COVID mRNA vaccines from both Pfizer/BioNTech and Moderna protected against the original SARS-CoV-2 virus, the virus that caused COVID-19. Both vaccines have been updated since over time to target new virus variants. The high revenue growth of these mRNA vaccines has also evolved since their peak sales in 2022 due to declining demand for COVID-19 vaccines and the shift from government-funded COVID vaccine programs to US commercial sales in September 2023 following a declaration  of the end of the COVID-19 public health emergency in May 2023. On a revenue basis, both Pfizer and Moderna have seen declining sales for their respective COVID vaccines, with Pfizer posting sales for its mRNA vaccine, Comirnaty, of $5.35 billion in 2024, and Moderna posting 2024 product sales, largely from its COVID vaccine, of $3.08 billion.

Shifting US policy on mRNA vaccines
The announcement by HHS of the wind-down of mRNA vaccine-development activities under BARDA reflects a shift in US government policy toward mRNA vaccines. Operation Warp Speed, a partnership between HHS, including the Centers for Disease Control and Prevention, the National Institutes of Health, and BARDA, and the US Department of Defense, was launched in 2020 to provide US government funding to help accelerate the development of a COVID-19 vaccine. mRNA technology was one platform technology supported through US government funding under Operation Warp Speed.

Now in 2025, HHS is shifting funding from mRNA vaccine projects. “We reviewed the science, listened to the experts, and acted,” said HHS Secretary Robert F. Kennedy, Jr., in an August 5, 2025, HHS press release in announcing the wind-down of the BARDA-supported mRNA technology programs. “BARDA is terminating 22 mRNA vaccine development investments because the data show these vaccines fail to protect effectively against upper respiratory infections like COVID and flu. We’re shifting that funding toward safer, broader vaccine platforms that remain effective even as viruses mutate.”

The wind-downs from HHS
The wind-down from HHS’ BARDA of mRNA vaccine development activities affect a range of programs including:

• Termination of contracts with Emory University and Tiba Biotech.
• De-scoping of mRNA-related work in existing contracts with Luminary Labs, ModeX, and Seqirus.
• Rejection or cancellation of multiple pre-award solicitations, including proposals from Pfizer, Sanofi Pasteur, CSL Seqirus, Gritstone, and others, as part of BARDA’s Rapid Response Partnership Vehicle and VITAL Hub. The Rapid Response Partnership Vehicle is a multi-purpose program designed to support medical countermeasures, such as vaccines, therapeutics, and medical technology products from early-stage development through advanced development, procurement, sustainment, and commercialization, including manufacturing infrastructure development. VITAL Hub is a BARDA Accelerator Network Hub supporting the development and acceleration of next-generation therapeutic and vaccine platforms and technologies to promote health security.
• Restructuring of collaborations with the US Department of Defense–Joint Program Executive Office affecting nucleic acid-based vaccine projects with AAHI, AstraZeneca, HDT Bio, and Moderna/UTMB.

While some final-stage contracts (e.g., Arcturus and Amplitude) will be allowed to run their course to preserve prior taxpayer investment, no new mRNA-based projects will be initiated, reports HHS. HHS has also instructed its partner, Global Health Investment Corporation, which manages BARDA Ventures, to cease all mRNA-based equity investments. In total, this affects 22 projects worth nearly $500 million. Other uses of mRNA technology within the department are not impacted by this announcement, according to HHS.

Ongoing mRNA vaccine development
Meanwhile, on a private-sector basis, mRNA vaccine-development projects continue. Last month (July 2025), the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended marketing authorization for Pfizer’s/BioNTech’s LP.8.1-adapted monovalent COVID-19 vaccine, Comirnaty LP.8.1, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. SARS-CoV-2 is the virus that caused COVID-19, which was the basis for the global pandemic that began in late 2019. The adaptation is based on the recommendation from the EMA’s Emergency Task Force (ETF) to update COVID-19 vaccines to target the LP.8.1 variant for the 2025–2026 season. The ETF stated that “targeting LP.8.1 will help maintain the effectiveness of the vaccines as SARS-CoV-2 continues to evolve.”

The CHMP’s recommendation will be reviewed by the European Commission, which is expected to make its final decision soon (as reported on July 25, 2025). Pfizer reports that it and BioNTech have already initiated manufacturing of the LP.8.1-adapted monovalent COVID-19 vaccine at risk to ensure supply readiness ahead of the upcoming fall and winter season, when the demand for COVID-19 vaccination is expected to increase. The updated vaccine will be available to ship to applicable European member states immediately following the EC decision.

Pfizer reports that the CHMP’s recommendation is based on the cumulative body of evidence previously submitted by Pfizer and BioNTech that includes clinical, non-clinical, and real-world data supporting the safety and efficacy of Pfizer and BioNTech COVID-19 vaccines. This application included non-clinical and manufacturing data showing that the LP.8.1-adapted monovalent COVID-19 vaccine generates overall improved immune responses against multiple circulating SARS-CoV-2 lineages, including XFG, NB.1.8.1, LF.7, and other currently circulating contemporary sublineages, compared to the companies’ JN.1 and KP.2-adapted monovalent COVID-19 vaccines, according to information from Pfizer. Pfizer reports that it and BioNTech have also submitted data for the updated COVID-19 vaccine to regulatory authorities around the world and they are continuing to monitor the evolving epidemiology of COVID-19 in preparation to meet global public health needs.

The COVID-19 vaccines by Pfizer and BioNTech are based on BioNTech’s proprietary mRNA technology and were developed by both companies. BioNTech is the marketing authorization Holder for Comirnaty and its adapted vaccines in the US, the European Union, the UK, and other countries, and the holder of emergency use authorizations or equivalents in the US jointly with Pfizer) and other countries. To date (as reported on July 25, 2025), over a billion adults and children around the world have received the Pfizer-BioNTech COVID-19 vaccine, which Pfizer reports continues to demonstrate a favorable safety and efficacy profile supported by real-world evidence, clinical, non-clinical, pharmacovigilance, and manufacturing data

Upon authorization by the European Commission, Pfizer’s/BioNTech’s LP.8.1-adapted COVID-19 vaccine will be available for individuals 6 months of age and older. Doses will be ready to ship to applicable EU member states immediately upon authorization by the European Commission, according to information from Pfizer.

Moderna provided an updates in its second-quarter 2025 results that were released earlier this month (August 2025) on its COVID and other mRNA vaccine development projects. In early August (August 2025) as part of its second-quarter 2025 earnings, Moderna reported $114 million in Spikevax sales, its mRNA COVID-19 vaccine, which included $88 million of US sales and $26 million of international sales. Moderna recently announced FDA approval for the supplemental biologics license application (sBLA) for Spikevax in children 6 months through 11 years of age who are at increased risk for COVID-19 disease. The company’s COVID-19 vaccine (mRNA-1273) was previously available for pediatric populations under Emergency Use Authorization, Additionally, the company announced it has received final approval from the European Medicines Agency for Spikevax targeting the LP.8.1 variant in individuals six months of age and older. Moderna also announced FDA approval for mNEXSPIKE (mRNA-1283), a next-generation vaccine against COVID-19, for use in all adults aged 65 and older, as well as individuals aged 12-64 years with at least one underlying risk factor.

With respect to other mRNA respiratory projects, in June (June 2024), Moderna announced positive Phase III efficacy results for its seasonal flu vaccine (mRNA-1010). The company is submitting mRNA-1010 data for publication, presenting data at medical conferences,  and preparing to file for FDA approval. In May 2025, the company announced that in consultation with the FDA, it had voluntarily withdrawn the pending biologics license application (BLA) for mRNA-1083, a seasonal flu + COVID vaccine, with the plan to resubmit after vaccine efficacy data from the Phase III trial of its investigational seasonal flu vaccine (mRNA-1010) are available. The company says it is engaging with regulators on data requirements for resubmitting the BLA for mRNA-1083.