2026-04-14 21:46 CST

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New RNA / RNA-Particle Dog Vaccines: U.S. Regulatory and Study Information

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In the United States, veterinary biologics are licensed through the USDA APHIS Center for Veterinary Biologics. The CDC does not license dog vaccines. CDC involvement is related to rabies public-health guidance, exposure management, and certain dog importation and travel documentation requirements.

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The dog RNA-particle products identified in the public USDA records reviewed here are:

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Nobivac NXT Canine-1 Rabies
True product name: Rabies Vaccine, RNA Particle
Manufacturer: Intervet Inc. / Merck Animal Health
USDA product code: 1905D1

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Nobivac NXT Canine Flu H3N2
True product name: Canine Influenza Vaccine, H3, RNA Particle
Manufacturer: Intervet Inc. / Merck Animal Health
USDA product code: 15P5.R0

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The routine canine core puppy distemper/parvovirus combination products are still listed in USDA product records as modified live virus products rather than RNA-particle products. A current example is Nobivac Edge DAPPv, which USDA lists as Canine Distemper-Adenovirus Type 2-Parainfluenza-Parvovirus Vaccine, Modified Live Virus. UC Davis canine vaccination guidance also continues to describe the standard puppy core schedule around parvovirus, distemper, adenovirus, and rabies, with modified-live CPV, CDV, and CAV-2 vaccination starting at 6–8 weeks, repeated every 3–4 weeks, and the final puppy dose given no earlier than 16 weeks.

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AAHA’s 2025 review describes these newer companion-animal products as using self-amplifying RNA technology. The canine influenza product label states that Nobivac NXT Canine Flu H3N2 is a non-adjuvanted, freeze-dried injectable canine influenza virus H3N2 vaccine utilizing RNA particle technology and contains RNA particles coding for the H3 gene from canine influenza virus A/canine/Iowa/22619-4/2015(H3N2). The 2025 rabies study describes the dog rabies product as a non-adjuvanted, 0.5 mL vaccine based on Venezuelan equine encephalitis virus TC-83-derived RNA particle technology expressing the rabies glycoprotein.

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Dog Rabies RNA Product Timeline​

The USDA licensure summary for product code 1905D1 shows a dog 1-year revaccination interval approval date of June 18, 2019 and a dog 3-year revaccination interval approval date of May 10, 2024. The USDA licensure summary reviewed was compiled on May 10, 2024. The 2025 rabies study states that internal animal-study protocols tied to this product line were approved in 2016, 2017, and 2018, and that the field-safety protocol involving client-owned and purpose-bred dogs was approved in January 2020.

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Dog Rabies RNA Product Efficacy Data

For the dog 1-year interval, the USDA licensure summary lists 27 vaccinated dogs and 11 control dogs, all vaccinated at 12 weeks of age, with virulent rabies challenge at 392 days post-vaccination. The listed result was 0 of 27 vaccinated dogs affected and 9 of 11 controls affected.

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For the dog 3-year interval, the USDA licensure summary lists 27 vaccinated dogs and 13 control dogs, again vaccinated at 12 weeks of age, with virulent rabies challenge at 1106 days post-vaccination. The listed result was 0 of 27 vaccinated dogs affected and 11 of 13 controls affected.

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The 2025 rabies study reports the same general conclusion that a single 0.5 mL dose given at 12 weeks of age protected vaccinated dogs against virulent rabies challenge through a three-year interval in the challenge model used by the investigators. The study also reports a graded-dose dog study in which the vaccinated dogs maintained rabies-neutralizing antibody titers at or above 0.5 IU/mL through day 90 in that short-term comparison.

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Dog Rabies RNA Product Safety Data​

The USDA licensure summary includes a dog field-safety section with 622 dogs across 7 sites. Of those dogs, 206 were 12 weeks old, 21 ranged from 13 weeks to 1 year, and 395 ranged from 1 year to 16 years. Dogs were observed daily for 14 days after vaccination for adverse events.

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In that USDA dog field-safety section, adverse events listed as related to the test vaccine included:

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• Lethargy: 16 (2.6%)

• Anorexia: 8 (1.3%)

• Emesis: 7 (1.1%)

• Diarrhea: 4 (0.6%)

• Injection-site pain: 4 (0.6%)

• Nausea: 3 (0.5%)

• Aggression: 2 (0.3%)

• Hyperaesthesia: 2 (0.3%)

• Injection-site edema: 2 (0.3%)

• Lameness: 2 (0.3%)

• additional lower-frequency events including abnormal behavior, anxiety disorder, application-site self-trauma, enteritis, injection-site inflammation, injection-site pruritis, and injection-site stiffness. The USDA summary lists 57 related adverse events (9.2%) in that section and states that marked local reactions resolved within 1–5 days.

 

The 2025 rabies study summarizes the same dog safety population and reports that 42 of 622 vaccinated dogs (6.8%) had an adverse event considered related to the vaccine. The most commonly reported events were lethargy (2.6%), loss of appetite (1.3%), and vomiting (1.1%). The paper states that two dogs had injection-site swelling and that both resolved within two days without treatment.

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Dog Influenza RNA Product Timeline​

USDA product code 15P5.R0 is listed as Canine Influenza Vaccine, H3, RNA Particle for dogs. Merck publicly announced USDA approval of Nobivac NXT Canine Flu H3N2 on June 25, 2024. The 2024 canine influenza study states that internal study protocols were approved in May 2023 and September 2023.

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Dog Influenza RNA Product Label Information​

The product label states that Nobivac NXT Canine Flu H3N2 is indicated for vaccination of healthy dogs 8 weeks of age or older against canine influenza virus H3N2. The primary series is two 0.5 mL doses given subcutaneously 3–4 weeks apart. The label states that the product is adjuvant-free, preservative-free, antibiotic-free, and thimerosal-free. The label also states that duration of immunity has not been established.

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Dog Influenza RNA Product Efficacy Data​

The 2024 influenza study reports a challenge study with 20 dogs assigned to the vaccinated group and 20 dogs assigned to the placebo group, with some analyzed outcomes reported as 19 vaccinated dogs and 20 placebo dogs. The study reports that vaccinated dogs had reduced viral shedding, reduced coughing, reduced clinical disease, reduced lung consolidation, and reduced suppurative pneumonia after virulent H3N2 challenge.

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The same study reports that 14 of 19 vaccinated dogs (74%) had no lung consolidation, compared with 2 of 20 placebo dogs (10%). It reports that 12 of 20 placebo dogs (60%) showed suppurative pneumonia, compared with 0 vaccinated dogs in that analysis. It also reports that 6 of 19 vaccinated dogs (32%) coughed only once or twice, while 19 of 20 placebo dogs (95%) had persistent coughing for 1–8 days, and that viral shedding subsided 2 days sooner in vaccinated dogs than in placebo dogs.

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Dog Influenza RNA Product Safety Data​

The 2024 influenza study reports a field-safety study enrolling 654 dogs from 5 geographic locations, with 644 dogs completing the study. The dogs ranged from 8 weeks to 15 years of age and included 210 purpose-bred beagles and 434 client-owned dogs. A total of 217 dogs (33%) were 8 weeks old at the time of vaccination. Each dog received two 0.5 mL doses, for a total of 1301 administrations, and dogs were observed daily for 14 days after each administration.

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The same study reports that 2.5% of the 1301 administrations caused adverse reactions, mainly mild and short in duration, with lethargy (1.6%) listed as the most common event. The published summaries also list diarrhea (0.3%), polydipsia (0.2%), and anorexia, injection-site edema, anaphylaxis, and injection-site pain (0.1% each). The study reports that 2 of the 1301 administrations caused a local reaction and that both resolved within 24 hours without treatment.

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Authors and Source Attribution for the Public Dog Studies​

The 2024 canine influenza study lists authors including Haley M. Classe, Jennifer C. Dant, Mark Mogler, Kenneth A. Stachura, Rhonda L. LaFleur, Zach Xu, and Ian Tarpey. The paper states that the datasets are unavailable because they are proprietary information of Merck Animal Health and that the research was sponsored by Merck Animal Health.

The 2025 rabies study lists authors including Ken Stachura, Randall Davis, Kari Carritt, Mark Mogler, Zach Xu, and Ian Tarpey.

AAHA’s review article on RNA vaccines in companion animals was written by Emily Singler, VMD.

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Where CDC Applies on the Dog Rabies Side

CDC guidance for veterinarians states that dogs, cats, and ferrets should be vaccinated for rabies according to local law. CDC states that an animal is considered immunized 28 days after an initial rabies vaccination and that animals with previous vaccination history are considered vaccinated immediately after a booster if there has been no lapse in vaccine coverage. CDC also provides veterinarian guidance for rabies exposure management and bite-related public-health handling.

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CDC is also relevant in dog importation and certain travel documentation settings. CDC importation guidance states that for a first rabies vaccination, some required documentation cannot be completed until 28 days after vaccination. For booster vaccinations, validity is immediate so long as there has been no lapse in coverage.

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Note

This page is provided as a factual reference only. It was created to place dated source material, regulatory information, published study data, and agency guidance in one location for review. No personal opinion, recommendation, endorsement, rejection, or protocol is being presented on this page. Readers should review the cited sources directly and draw their own conclusions.