This section highlights FDA-related milestones and regulatory updates for drugs developed by Moderna (MRNA).
Over the past two years, Moderna has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
COVID-19, mRNA-1010, mRNA-1018, mRNA-1083, mRNA-1283, mRNA-1287, and mRNA-1345. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
COVID-19 vaccine - FDA Regulatory Timeline and Events
COVID-19 vaccine is a drug developed by Moderna for the following indication: Covid-19.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- COVID-19 vaccine
- Announced Date:
- January 24, 2025
- Indication:
- Covid-19
Announcement
Moderna, Inc. announced that it has been awarded a tender for the supply of its mRNA COVID-19 vaccine in the European Union (EU), Norway and North Macedonia. Under the resulting agreement, 17 participating countries can access Moderna's mRNA COVID-19 vaccine for up to four years.
AI Summary
Moderna, Inc. has secured a tender to supply its mRNA COVID-19 vaccine in the European Union, Norway, and North Macedonia. The four-year agreement allows 17 participating countries to access the vaccine, providing them with the opportunity to diversify their supply of mRNA COVID-19 vaccines. This arrangement is expected to support national vaccination campaigns by ensuring steady vaccine availability.
The supply contract also includes options for pre-filled syringe formats, which are preferred by healthcare providers because they help reduce administration errors and save time. This added feature aims to boost vaccination campaign efficiency and enhance health security in the participating countries, reinforcing Moderna’s commitment to advancing mRNA medicine and contributing to global efforts to combat COVID-19.
Read Announcement- Drug:
- COVID-19 vaccine
- Announced Date:
- September 2, 2024
- Indication:
- Covid-19
Announcement
Moderna, Inc. announced that the Taiwan Food & Drug Administration (FDA) has approved an updated formulation of the COVID-19 mRNA vaccine Spikevax, targeting the SARS-CoV-2 variant JN.1., for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals six months of age and older.
AI Summary
Moderna announced that the Taiwan Food & Drug Administration has approved an updated formulation of its COVID-19 mRNA vaccine, Spikevax. This updated version is specially designed to target the SARS-CoV-2 variant JN.1 and is authorized for active immunization to prevent COVID-19 in individuals aged six months and older. The approval highlights Taiwan’s commitment to updating vaccine strategies to address evolving variants.
The updated Spikevax represents an important advancement in Moderna’s ongoing efforts to improve vaccine efficacy amid the changing landscape of COVID-19. By specifically addressing the JN.1 variant, Moderna aims to provide better protection and help reduce the spread of the virus. This development demonstrates the potential of mRNA technology in adapting to new challenges and enhancing public health protection through innovative vaccine formulations.
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mRNA-1010 - FDA Regulatory Timeline and Events
mRNA-1010 is a drug developed by Moderna for the following indication: Quadrivalent Seasonal Flu.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- mRNA-1010
- Announced Date:
- June 30, 2025
- Indication:
- Quadrivalent Seasonal Flu
Announcement
Moderna, Inc. announced positive results from a Phase 3 efficacy study (P304) evaluating the relative vaccine efficacy (rVE) against influenza illness of mRNA-1010, the Company's seasonal influenza (flu) vaccine candidate, compared to a licensed standard-dose seasonal influenza vaccine in adults aged 50 years and older. mRNA-1010 achieved the most stringent superiority criterion prespecified in the protocol, with an rVE of 26.6% (95% CI; 16.7%, 35.4%) in the overall study population.
AI Summary
Moderna announced that its Phase 3 study, P304, met the most stringent superiority criterion by showing that its mRNA-1010 flu vaccine achieved a relative vaccine efficacy (rVE) of 26.6% (95% CI: 16.7%, 35.4%) compared to a licensed standard-dose vaccine in adults aged 50 and older. The study demonstrated strong efficacy across multiple influenza strains, including A/H1N1, A/H3N2, and B/Victoria, with similar positive results seen in participants aged 65 and older.
The findings suggest that mRNA-1010 could offer a better match to circulating strains, an advantage that may be crucial for future influenza pandemics. Moderna plans to present these results at a forthcoming medical conference and will work with regulators as it prepares its submission for this vaccine candidate.
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mRNA-1018 - FDA Regulatory Timeline and Events
mRNA-1018 is a drug developed by Moderna for the following indication: pandemic influenza vaccine.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- mRNA-1018
- Announced Date:
- May 28, 2025
- Indication:
- pandemic influenza vaccine
Announcement
Moderna, Inc. announced positive interim data from a Phase 1/2 clinical study (NCT05972174) evaluating the safety and immunogenicity of its investigational pandemic influenza vaccine, mRNA-1018, in approximately 300 healthy adults aged 18 years and older.
AI Summary
Moderna announced promising interim results from a Phase 1/2 study (NCT05972174) of its investigational mRNA-1018 vaccine, which is designed to combat the H5 avian influenza virus. The study involved approximately 300 healthy adults aged 18 and older, who received a two-dose regimen. By Day 43, nearly 98% of participants achieved protective antibody levels (HAI titers ≥1:40), marking a 44.5-fold increase from their baseline values. Pre-existing immunity was very low, with only about 2% of participants showing significant antibody levels before vaccination. The vaccine was well tolerated, with most side effects classified as Grade 1 or 2 and no major safety concerns observed. These interim results highlight the robust immune response elicited by mRNA-1018 and underscore the potential of mRNA technology for addressing emerging pandemic influenza threats.
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mRNA-1083 - FDA Regulatory Timeline and Events
mRNA-1083 is a drug developed by Moderna for the following indication: Combination vaccine against influenza and COVID-19.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- mRNA-1083
- Announced Date:
- May 21, 2025
- Indication:
- Combination vaccine against influenza and COVID-19.
Announcement
Moderna, Inc. announced that in consultation with the U.S. Food and Drug Administration (FDA), the Company has voluntarily withdrawn the pending Biologics License Application (BLA) for mRNA-1083, its flu/COVID combination vaccine candidate for adults aged 50 years and older.
AI Summary
Moderna announced that, in consultation with the U.S. Food and Drug Administration (FDA), it has voluntarily withdrawn the pending Biologics License Application (BLA) for its mRNA-1083 vaccine candidate. This vaccine, designed as a combination flu/COVID shot for adults aged 50 and older, is part of Moderna’s efforts to address simultaneous respiratory threats. The company plans to resubmit the BLA later this year, once it reviews the efficacy data from its ongoing Phase 3 trial of another vaccine candidate, mRNA-1010, which targets seasonal influenza. Moderna expects interim trial results from mRNA-1010 to emerge by summer, marking another step in its continued advancement of mRNA-based therapeutics.
The move demonstrates Moderna’s commitment to reliable data and regulatory guidance as it works to refine its vaccine portfolio. This careful approach is aimed at ensuring the safety and effectiveness of its products for public use.
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mRNA-1283 - FDA Regulatory Timeline and Events
mRNA-1283 is a drug developed by Moderna for the following indication: Next Generation COVID-19.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- mRNA-1283
- Announced Date:
- May 31, 2025
- Indication:
- Next Generation COVID-19
Announcement
Moderna, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved mNEXSPIKE® (mRNA-1283), a new vaccine against COVID-19, for use in all adults 65 and older, as well as individuals aged 12-64 years with at least one or more underlying risk factor as defined by the Centers for Disease Control and Prevention (CDC).[1]
AI Summary
Moderna, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its new COVID-19 vaccine, mNEXSPIKE® (mRNA-1283). This vaccine is now authorized for all adults aged 65 and older, as well as for individuals aged 12–64 who have at least one underlying risk factor as defined by the Centers for Disease Control and Prevention (CDC). The approval was based on a Phase 3 clinical trial involving about 11,400 participants. Findings from this trial showed that mRNA-1283 performed similarly to Moderna’s earlier vaccine, with a favorable safety profile and slightly higher vaccine efficacy, particularly among adults aged 65 and over. Moderna plans to offer mNEXSPIKE during the 2025-2026 respiratory virus season as an important new tool to protect high-risk populations against severe COVID-19 complications.
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mRNA-1287 - FDA Regulatory Timeline and Events
mRNA-1287 is a drug developed by Moderna for the following indication: Endemic HCoV.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- mRNA-1287
- Announced Date:
- September 12, 2024
- Indication:
- Endemic HCoV
Announcement
Moderna, Inc announced that Based on the company's strategic prioritization, five programs in its pipeline are discontinued: Endemic HCoV (mRNA-1287): The preclinical program will not advance into Phase 1. RSV infants (mRNA-1345): The company does not expect program to advance beyond the ongoing Phase 1 based on emerging clinical data. KRAS antigen-specific therapy (mRNA-5671): No further development plans. Triplet (mRNA-2752): The company has deprioritized further development based on emerging clinical data. Relaxin (mRNA-0184): The program is wrapping up Phase 1.
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mRNA-1345 - FDA Regulatory Timeline and Events
mRNA-1345 is a drug developed by Moderna for the following indication: Respiratory Syncytial Virus (RSV).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- mRNA-1345
- Announced Date:
- June 12, 2025
- Indication:
- Respiratory Syncytial Virus (RSV)
Announcement
Moderna, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved mRESVIA® (mRNA-1345), the Company's respiratory syncytial virus (RSV) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18-59 years of age who are at increased risk for disease.
AI Summary
Moderna, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its mRESVIA® (mRNA-1345) vaccine for preventing lower respiratory tract disease caused by RSV in individuals aged 18-59 who are at increased risk. The FDA reviewed data from a Phase 3 study where mRESVIA demonstrated safety and strong immune responses in this younger at-risk population. The study showed that the vaccine triggered neutralizing antibodies against both RSV-A and RSV-B, meeting the non-inferiority criteria compared to responses observed in older adults.
This approval marks an important step for Moderna in expanding protection against RSV. The vaccine was generally well-tolerated with common side effects including injection site pain, fatigue, and headache. Moderna plans to offer mRESVIA to both younger adults at increased risk and older adults in time for the 2025-2026 respiratory virus season.
Read Announcement- Drug:
- mRNA-1345
- Announced Date:
- March 31, 2025
- Indication:
- Respiratory Syncytial Virus (RSV)
Announcement
Moderna, Inc. announced that the Australian Therapeutic Goods Administration (TGA) has granted approval for mRESVIA® (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to prevent lower respiratory tract disease caused by RSV infection in adults aged 60 years and older.
AI Summary
Moderna, Inc. announced that the Australian Therapeutic Goods Administration (TGA) has approved its mRNA respiratory syncytial virus (RSV) vaccine, mRESVIA® (mRNA-1345). The approval allows use of the vaccine to prevent lower respiratory tract disease caused by RSV infection in adults aged 60 years and older. This milestone marks mRESVIA as the first mRNA vaccine in Australia approved for a condition beyond COVID-19. The decision highlights Moderna’s commitment to protecting older adults from severe respiratory illnesses. The TGA’s approval was based on positive results from the Phase 3 ConquerRSV clinical trial, which involved approximately 37,000 adults aged 60 and older across 22 countries. Moderna plans to supply mRESVIA from its Melbourne facility, aiming to reduce the substantial health burden RSV poses for older Australians.
Read Announcement- Drug:
- mRNA-1345
- Announced Date:
- August 23, 2024
- Indication:
- Respiratory Syncytial Virus (RSV)
Announcement
Moderna, Inc. announced that the European Commission (EC) has granted marketing authorization for mRESVIA® (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.
AI Summary
Moderna, Inc. announced that the European Commission has granted marketing authorization for its mRNA respiratory syncytial virus (RSV) vaccine, mRESVIA® (mRNA-1345). This approval allows the vaccine to be marketed in all 27 EU member states, as well as in Iceland, Liechtenstein, and Norway. The vaccine is designed to protect adults aged 60 years and older from severe RSV infections that cause lower respiratory tract disease.
mRESVIA is notable for being the first mRNA vaccine approved in Europe for a disease other than COVID-19. Moderna’s innovative mRNA platform, already proven successful with COVID-19 vaccines, is now being used to tackle RSV. The vaccine is provided in a pre-filled syringe to simplify administration and help reduce preparation time and errors during vaccination.
Read Announcement- Drug:
- mRNA-1345
- Announced Date:
- June 28, 2024
- Indication:
- Respiratory Syncytial Virus (RSV)
Announcement
Moderna, Inc. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of marketing authorization in the European Union for mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.
AI Summary
Moderna, Inc. announced that the European Medicines Agency’s CHMP has given a positive opinion recommending marketing authorization in the European Union for its RSV vaccine, mRESVIA (mRNA-1345). This vaccine is aimed at protecting adults aged 60 and older from lower respiratory tract disease caused by RSV infection.
The CHMP's favorable review was based on positive data from a large Phase 3 trial involving about 37,000 participants. Moderna emphasized that mRESVIA is delivered in a pre-filled syringe, which simplifies vaccine administration and helps reduce potential errors. This innovation underlines the flexibility and power of Moderna's mRNA platform. The final decision now rests with the European Commission, which will decide on the EU-wide marketing authorization for mRESVIA.
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mRNA-1769 - FDA Regulatory Timeline and Events
mRNA-1769 is a drug developed by Moderna for the following indication: Mpox Vaccine.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- mRNA-1769
- Announced Date:
- September 6, 2024
- Indication:
- Mpox Vaccine
Announcement
Moderna Inc announced that is developing mRNA-1769 as a mpox vaccine for use in adults. Currently, a Phase 1/2 trial evaluating the safety, tolerability, and immunogenicity of mRNA-1769 in Healthy Participants is underway.
AI Summary
Moderna Inc is developing mRNA-1769, a new mpox vaccine designed for use in adults. The company is currently testing the vaccine in a Phase 1/2 trial that focuses on its safety, tolerability, and ability to trigger an immune response in healthy participants. The trial, which began in 2023 with 351 subjects, aims to provide key data by 2025.
Early research on mRNA-1769, conducted in non-human primates, showed it performed better than the Bavarian Nordic Jynneos vaccine in preventing severe illness and reducing virus levels. These findings suggest that mRNA-1769 might offer improved protection against mpox while potentially addressing some of the limitations seen in older vaccines. Moderna’s work highlights the growing promise of mRNA technology in creating more effective vaccines for emerging diseases.
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mRNA-4157/V940 (KEYTRUDA) - FDA Regulatory Timeline and Events
mRNA-4157/V940 (KEYTRUDA) is a drug developed by Moderna for the following indication: Provide an additive benefit and enhance T cell-mediated destruction of tumor cells.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- mRNA-4157/V940 (KEYTRUDA)
- Announced Date:
- December 19, 2024
- Indication:
- Provide an additive benefit and enhance T cell-mediated destruction of tumor cells.
Announcement
Personalis, Inc announced agreements with long time collaborators Merck and Moderna that accelerate the advancement of the company's business strategy
AI Summary
Personalis, Inc. announced significant agreements with longstanding partners Merck and Moderna that boost the company’s business strategy. As part of the deals, Merck has made a $50 million investment by purchasing common stock in a private placement. This investment gives Merck a 16.5 percent beneficial ownership in Personalis, underlining the company’s essential role in Merck’s precision oncology efforts.
In addition, Personalis has secured a multi-year extension with Moderna. The extension involves using Personalis’ ImmunoID NeXT Platform® and related technologies in support of the investigational individualized neoantigen therapy V940/mRNA-4157. This collaboration is focused on advancing personalized cancer care. Personalis’ CEO, Chris Hall, highlighted the potential of individualized therapies to transform cancer treatment, emphasizing the importance of these agreements in paving the way for routine cancer patient treatment in the future.
Read Announcement- Drug:
- mRNA-4157/V940 (KEYTRUDA)
- Announced Date:
- June 3, 2024
- Indication:
- Provide an additive benefit and enhance T cell-mediated destruction of tumor cells.
Announcement
Moderna, announced the first presentation of results from a planned analysis from the Phase 2b randomized KEYNOTE-942/mRNA-4157-P201 study, a clinical trial evaluating mRNA-4157 (V940), an investigational individualized neoantigen therapy (INT), in combination with KEYTRUDA, Merck's anti-PD-1 therapy, in patients with resected high-risk melanoma (stage III/IV) following complete resection (n=157).
AI Summary
Moderna announced promising results from a planned analysis of the Phase 2b KEYNOTE-942/mRNA-4157-P201 study. This clinical trial evaluated mRNA-4157 (V940), an investigational individualized neoantigen therapy, in combination with Merck’s anti-PD-1 therapy KEYTRUDA in patients with resected high‐risk stage III/IV melanoma. At a median follow-up of approximately 35 months, the combination reduced the risk of recurrence or death by 49% compared to treatment with KEYTRUDA alone. The study also showed a 62% reduction in the risk of distant metastasis or death. Notably, the 2.5-year recurrence-free survival rate was 74.8% for the combination therapy, versus 55.6% for KEYTRUDA monotherapy. These encouraging results were presented during a rapid oral abstract session at the 2024 ASCO Annual Meeting, supporting further clinical development of this novel treatment approach.
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Nova 301 - FDA Regulatory Timeline and Events
Nova 301 is a drug developed by Moderna for the following indication: for multiple norovirus genotypes.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Nova 301
- Announced Date:
- September 30, 2024
- Indication:
- for multiple norovirus genotypes.
Announcement
Moderna, Inc. announced that the first participant in the U.S. has been dosed in the Nova 301 Trial, a pivotal Phase 3 randomized clinical trial evaluating the efficacy, safety, and immunogenicity of an investigational norovirus vaccine, mRNA-1403. Global recruitment for the Nova 301 trial has also begun.
AI Summary
Moderna, Inc. announced a significant step forward in its efforts to fight norovirus with the initiation of the Nova 301 Trial. The first participant in the U.S. has now been dosed in this pivotal Phase 3 randomized clinical trial, which is designed to evaluate the efficacy, safety, and immunogenicity of their investigational norovirus vaccine, mRNA‑1403. Global recruitment for the trial is underway as the study aims to enroll roughly 25,000 participants 18 years and older, with a particular focus on adults aged 60 and above who are at higher risk of severe illness. This trial represents an important milestone in potentially developing a new mRNA‑based vaccine to prevent norovirus infections, a virus known to affect millions worldwide and place a significant burden on healthcare systems.
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SPIKEVAX (COVID-19 Vaccine, mRNA) - FDA Regulatory Timeline and Events
SPIKEVAX (COVID-19 Vaccine, mRNA) is a drug developed by Moderna for the following indication: COVID-19 in individuals 18 years of age and older.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SPIKEVAX (COVID-19 Vaccine, mRNA)
- Announced Date:
- August 23, 2024
- Indication:
- COVID-19 in individuals 18 years of age and older
Announcement
Moderna, Inc announced that it has received approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for a partial change application for an updated formulation of its COVID-19 mRNA vaccine Spikevax, targeting the SARS-CoV-2 variant JN.1.
AI Summary
Moderna, Inc. announced that its updated COVID-19 mRNA vaccine, Spikevax, targeting the SARS-CoV-2 variant JN.1 has received approval from Japan’s Ministry of Health, Labour and Welfare. This approval came through a partial change application aimed at updating the vaccine formulation to better match the circulating strains of the virus, particularly the Omicron subvariants.
Moderna’s CEO, Stéphane Bancel, highlighted the importance of using the latest vaccine updates to offer improved protection against COVID-19. With COVID-19 vaccinations increasingly viewed as a routine measure similar to seasonal flu shots, this updated formulation is set to be administered alongside the flu vaccine. The decision supports efforts to protect high-risk populations and aligns with recent public health recommendations.
Read Announcement- Drug:
- SPIKEVAX (COVID-19 Vaccine, mRNA)
- Announced Date:
- June 7, 2024
- Indication:
- COVID-19 in individuals 18 years of age and older
Announcement
Moderna Inc announced that it has submitted an FDA application for review of its Spikevax 2024-2025 formula, which targets the SARS-CoV-2 variant JN.1.
AI Summary
Moderna Inc. has submitted an FDA application for its new COVID-19 vaccine candidate, the Spikevax 2024-2025 formula, which specifically targets the SARS-CoV-2 variant JN.1. The company is moving forward with manufacturing, and doses could be ready to ship as early as August if regulatory approval is obtained. The submission follows the FDA’s guidance to update COVID-19 vaccines with a monovalent composition focusing on the JN.1 variant, an approach that is also supported by global health agencies.
CEO Stéphane Bancel emphasized the importance of staying up to date with COVID-19 vaccines, especially during the upcoming respiratory illness season. Moderna is working to provide enhanced protection and is submitting data to regulators worldwide to support the registration and timely supply of the new formula for the 2024-2025 vaccination campaign.
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V940-001 - FDA Regulatory Timeline and Events
V940-001 is a drug developed by Moderna for the following indication: for Adjuvant Treatment of Patients with Resected High-Risk (Stage IIB-IV) Melanoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- V940-001
- Announced Date:
- May 15, 2024
- Indication:
- for Adjuvant Treatment of Patients with Resected High-Risk (Stage IIB-IV) Melanoma
Announcement
Merck announced First presentation of Phase 2b three-year follow-up data evaluating mRNA-4157 (V940), an investigational individualized neoantigen therapy, in combination with KEYTRUDA® (pembrolizumab) in patients with high-risk stage III/IV melanoma following complete resection
AI Summary
Merck recently shared promising results from its Phase 2b clinical trial involving mRNA-4157 (V940), an investigational individualized neoantigen therapy. In this study, the therapy was combined with KEYTRUDA® (pembrolizumab) and given to patients with high-risk stage III/IV melanoma who had completed tumor resection. The three-year follow-up data marks the first detailed clinical presentation of this regimen. The study aims to improve immune system responses by targeting unique tumor mutations, which could help prevent cancer recurrence and extend patient survival. Merck’s findings show encouraging longer-term outcomes and support further investigation into this innovative treatment strategy. By focusing on a combination of immunotherapy treatments, the research team hopes to offer a new option for patients facing advanced melanoma, paving the way for additional research and potentially improved quality of life for these individuals.
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