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Landscape overview: Moderna and Pfizer lead the race in mRNA flu vaccines, with plans for regulatory filings in 2024-2025

By Brian Buntz | April 4, 2023

Influenza virus. 3D illustration showing surface glycoprotein spikes hemagglutinin purple and neuraminidase orange

[Image courtesy of Adobe Stock]

mRNA technology helped propel the development of some of the most successful drugs in pharma history — notably, the Comirnaty COVID-19 from Pfizer/BioNTech generated almost $56 billion in 2022 while Moderna’s Spikevax vaccine raked in $18.4 billion. But demand for COVID-19 vaccines continues to cool. In 2023, Comirnaty brought in $15 billion between its two developers.

Flu vaccines and oncology are two potential areas that could fuel mRNA in the future. CureVac, in collaboration with GSK, recently announced promising phase 2 interim data from their seasonal influenza vaccine development program. The multivalent vaccine candidate, which encodes antigens matched to all four WHO-recommended flu strains, boosted antibody titers at all dose levels and across all age groups. The candidate showed strong performance against influenza A strains, with geometric mean titers numerically beating those elicited by licensed comparator vaccines. While the vaccine’s response against influenza B strains was lower than comparators, CureVac intends to optimize the vaccine to enhance immune responses against these strains in an additional phase 2 study.

Moderna and Pfizer are further along. The former is advancing its mRNA flu vaccine candidate mRNA-1010, which is being studied against high dose Fluzone HD in a fully enrolled phase 3 study. The company intends to file for regulatory approval in 2024. It is also developing a vaccine candidate, mRNA-1083, against flu and COVID-19. It is targeting regulatory approval for the combination vaccine in 2025. 

In October 2023, Pfizer announced that its mRNA flu vaccine candidate met both primary endpoints in a phase 3 trial involving participants aged 18 to 64 years old. Yet the vaccine demonstrated non-inferiority and superiority to a licensed flu vaccine. Yet the vaccine missed a secondary endpoint related to immunogenicity for influenza B strains.

One possibility is that mRNA-based flu vaccines will tend to generate more side effects than traditional flu vaccines. In a phase 3 study, for instance, Moderna’s experimental mRNA flu vaccine generated a stronger immune response than a currently marketed traditional vaccine, but the safety findings were similar to previous mRNA vaccine studies, with muscle pain, headache, fatigue, pain and swelling topping the list of the most common reactions.

An analysis of patient-reported outcomes during the last flu season found that simultaneous administration of a COVID-19 mRNA booster and a flu vaccine resulted in a roughly 10% increased risk of mild systemic reactions compared to receiving the COVID-19 booster alone.

Sanofi has acknowledged the promise and perils of mRNA flu vaccines

Sanofi, a prominent flu vaccine maker, has acknowledged both the challenges and the potential of mRNA technology for flu. In a presentation earlier in 2023, the company shared market research noting that health care professionals will likely be reluctant to adopt mRNA-based flu vaccines with storage requirements more stringent than standard refrigeration. Additional market research notes that just under 70% of health care providers and patients would be unlikely to use mRNA vaccines with triple the severe side effect burden compared to a standard dose of traditional flu vaccine. A 2022 study of more than 35,000 adults from nine countries found that the novelty of mRNA vaccine technology increased hesitancy compared to conventional vaccines. Since then, demand for mRNA-based COVID vaccines has continued to steeply drop.

HCPs and consumers are unlikely to use vaccines with3x severe side effect burden compared to Standard Dose

Graphic showing health care providers (HCPs) and consumers’ reluctance toward vaccines with three times as many severe side effects compared to the standard of care flu vaccine. Source: Sanofi Company Presentation.

Despite challenges, Sanofi still lists an mRNA vaccine candidate on its pipeline page. Sanofi announced positive interim data from an early phase 1/2 study of its mRNA flu vaccine in September 2021. The SP0273 vaccine demonstrated favorable reactogenicity compared to other mRNA candidates in adults aged 18-64. Sanofi’s SP0273 vaccine also showed favorable reactogenicity compared to other mRNA candidates in the same age group (18 to 64 years old).

In addition to mRNA-based vaccine designs, Novavax was developing a next-generation flu vaccine, qNIV (NanoFlu), using a different approach. The company’s quadrivalent nanoparticle vaccine, which targets seasonal flu using recombinant technology, successfully completed two phase 3 studies. The company, however, now only cites three products on its website — its authorized COVID-19 vaccine, a joint COVID/flu vaccine in phase 2 and a preclinical malaria vaccine.

The cost question

Traditional flu vaccines tend to be inexpensive — generally in the low tens of dollars per dose. As STAT News has pointed out, pundits believe it is unlikely that mRNA-based flu vaccines would cost less than traditional flu vaccines. Given that likelihood, mRNA flu shot makers will need to show their vaccines are substantially more effective than current options. To win a preferential recommendation from the CDC’s vaccine advisory committee and charge premium prices, they would likely need to demonstrate at least twice the benefit of standard flu shots, Dr. Arnold Monto, an influential influenza epidemiologist at University of Michigan School of Public Health, told STAT.

mRNA flu vaccine overview (does not include all hybrid flu/COVID vaccines)

Company/Organization Vaccine Name/ID Description/Details Phase & Study Details Strains Covered (if specified)
Moderna mRNA-1010 An mRNA-based flu vaccine designed to elicit a robust immune response against flu strains.
  • Phase 3 (P303) clinical study interim analysis announced on September 13, 2023.
  • In March 2024, Moderna announced that in the most recent Phase 3 trial (P303), mRNA-1010 met all immunogenicity primary endpoints.
  • It intends to file for approval in 2024.
A/H1N1, A/H3N2, B/Yamagata, B/Victoria
National Institutes of Health (NIH) H1ssF-3928 mRNA-LNP An experimental universal influenza vaccine developed by NIAID’s Vaccine Research Center.
  • Started clinical trial on May 15, 2023, at Duke University.
  • Phase 1 trial with enrollment of up to 50 volunteers aged 18-49.
  • The NIH-backed research offers hope for a “universal flu vaccine” that can protect against all 20 known influenza virus subtypes.
  • Doses: 10, 25, or 50 µg
  • Optimum dosage evaluation with 10 more participants.
  • Uses hemagglutinin (HA) for broader immunity.
  • Part of the Collaborative Influenza Vaccine Innovation Centers (CIVICs) program.
Universal
Novavax COVID-19-Influenza Combination Vaccine Combination vaccine targeting SARS-CoV-2 and influenza using Novavax’s recombinant nanoparticle technology and Matrix-M adjuvant.
  • Novavax continues to share updates about its influenza and COVID-19-Influenza Combination (CIC) vaccine candidates.
  • The company is planning a phase 3 trial in the second half of 2024.
  • Novavax will also present new data on its updated XBB.1.5 COVID-19 vaccine, which showed robust neutralizing antibody titers for the XBB.1.5 and JN.1 subvariants in participants who previously received an mRNA vaccine.
  • The safety and reactogenicity profile of the updated vaccine was consistent with its prototype vaccine (NVX-CoV2373).
  • Influenza A/H1N1
  • Influenza A/H3N2
  • Influenza B/Victoria
  • Influenza B/Yamagata
  • SARS-CoV-2 (Prototype and XBB.1.5)
CureVac (with GSK) Multivalent, modified mRNA seasonal flu vaccine candidate mRNA-based seasonal flu vaccine candidate based on an advanced mRNA backbone.
  • On April 4, 2024, CureVac announced promising interim data from the ongoing phase 2 part of the combined phase 1/2 study of their seasonal influenza vaccine candidate, in collaboration with GSK.
  • Phase 2 dosing began in Q4 2023 for older adults (65-85 years).
  • Phase 1 safety data for 270 adults (18-50) showed no concerns.
  • Collaboration with GSK started in July 2020.
Broad coverage against WHO-recommended flu strains
Pfizer (in collaboration with BioNTech) Quadrivalent modRNA influenza vaccine/COVID vaccine mRNA-based influenza/COVID vaccine candidate with potential for rapid manufacturing, flexibility, and improved flu strain match.
  • In October 2023, Pfizer and BioNTech announced positive topline results from a Phase 1 study of the PF-07926307 vaccine.
  • Won Fast Track status
  • The lead formulations demonstrated robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains. The safety profile was consistent with the companies’ COVID-19 vaccine.
  • Study informed by data from the ongoing Phase 2 trial which demonstrated a promising safety and immunogenicity profile.
Strains recommended by WHO for the Northern Hemisphere
Sanofi and Translate Bio MRT5400 & MRT5401 Experimental mRNA-based influenza vaccine.
  • Early-stage human testing showed a strong immune response against A strains but was ineffective against the less prevalent B strains.
  • No significant public updates since 2021.
  • Sanofi is working on the next generation of mRNA technology to overcome current challenges.
  • Focus on a better immune response against B strains, improved lipid encapsulation of mRNA molecules, and longer stability at regular fridge temperatures.
Initial prototypes were more successful for A strains than B strains.
University of Pennsylvania Multivalent mRNA vaccine Experimental mRNA-based universal influenza vaccine targeting 20 strains.
  • Preclinical animal studies highlighted in 2023 in JAMA in mice and ferrets showed the vaccine induced antibodies against all 20 targeted influenza A and B strains.
  • Vaccinated animals had better protection against matched and mismatched virus strains compared to single-strain vaccines.
  • The multivalent vaccine boosted existing immunity to common strains while inducing new antibodies against other strains.
  • Results suggest broad protection via neutralizing antibodies for matched strains and other mechanisms like antibody-mediated cell toxicity for mismatched strains.
Universal

Filed Under: clinical trials, Drug Discovery, Infectious Disease
Tagged With: Biopharma trends, CureVac, flu vaccine development, GSK, influenza vaccine, Moderna, mRNA technology, next-gen vaccines, NIH, Pfizer, pharmaceutical giants, R&D innovation
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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