Medgene Labs Receives Emergency Use Authorization for RHDV2 Vaccine

Rabbit Hemorrhagic Disease has quickly spread across the United States. Working with the USDA, Medgene Labs responds with a vaccine developed on its prescription platform technology.   

 

Medgene Labs, a vaccine and immunological services provider based in Brookings, SD, has received emergency use authorization for their experimental Rabbit Hemorrhagic Disease Virus 2 (RHDV2) vaccine from the USDA Center for Veterinary Biologics (CVB).

 

Rabbit Hemorrhagic Disease is a highly contagious, fatal disease in rabbits and is currently classified as a reportable foreign animal disease in the United States. Animal health officials detected RHDV2 in the U.S. for the third time since 2018 in February 2020. Since that time, it has been spreading to multiple states across the country.

 

Medgene Labs has been working closely with the USDA to provide a U.S.-based vaccine option, given vaccines imported from other countries require infecting rabbits in the manufacturing process. As part of the emergency use authorization process, efficacy has been demonstrated and safety studies are underway. The results of these studies supported USDA’s decision to grant Emergency Use Authorization for the vaccine while further work is ongoing for a full product license.

 

“We are excited to extend the use of our platform technology and achieve emergency use authorization for our RHDV2 vaccine from the USDA. We have worked closely with their team since the major outbreak to reach this milestone. We are dedicated to helping rabbit owners and veterinarians combat this devastating foreign animal disease,” stated Chief Executive Officer, Mark Luecke.

 

Medgene Labs’ RHDV2 vaccine is an inactivated or killed recombinant subunit protein vaccine that builds immunity to RHDV2-specific antigenic proteins in the rabbit. The immune system sees the RHDV2 protein and learns to protect the rabbit from the virus. Production of the vaccine does not require the use of animals or live virus in the production facility. Because the vaccine only uses protein sequences from the RHDV2 virus to build immunity, it is impossible for a rabbit that receives the vaccine to shed any virus or infect other rabbits.

 

The vaccine is administered through a subcutaneous injection and is comprised of a 2-dose regimen with the second dose being delivered 21 days following the initial dose.

 

Medgene Labs is currently working with the USDA and state veterinarians to provide access to the vaccine nationwide. With Emergency Use Authorization, there are specific steps and documentation required to distribute the vaccine. The company is prepared to start receiving orders during the first week of October 2021 and has launched a web page to provide more information and answer frequently asked questions.

 

You can learn more by visiting www.medgenelabs.com/rhdv2 or by calling the company’s customer service line (605) 697-2600.

 


About Medgene Labs

 

Medgene Labs is the world’s leading Immunological Services ProviderTM. As an Immunological Services Provider, Medgene Labs monitors the production environment for new viruses, continuously updates its virus sequence and vaccine construct bank to rapidly address health risks, and serologically monitors animals for vaccine effectiveness. Medgene Labs provides these immunological services to its ISPRIME® community of animal owners and their veterinarians in support of delivering consistent and reliable health management tools. 

Additional information regarding Prescription Platform Vaccines can be found in Veterinary Services Memorandum Nos. 800.213 and 800.214. 

13 comments

  1. Your work on this recombinant vaccine for our precious rabbit campanions means the world to so many people. Not only are you saving our companions’ lives, but you cared enough to not require rabbits to die to save other rabbits.

  2. Does Medgene have the immediate ability to fulfill the current demand for RHDV2 vaccine in the US? I am concerned, given that the CA announcement stated that there would be no further permits for imported vaccine granted. This is also the time of year we usually see new cases in new areas…
    I’d also like to see protection against RHDV1, which has been known to appear in the US sporadically in past years; is there a plan to expand the coverage of the vaccine?

    1. Pamela,
      Thank you for your interest in our RHDV2 vaccine. We believe we have appropriate inventory to meet the current demand for the vaccine. Our goal is to eventually have the vaccine against both RHDV2 and RHDV1. However, it will likely be 2023 before this is possible.

      Medgene Labs, LLC

  3. Thank you for this article. I understand the vaccine comes in a vial of 25 doses – how long after the vial is opened does the vaccine remain viable/useable? Thank you.

    1. The USDA requires the label to state “use entire contents once opened”. This is due to sterility concerns and not stability. The product is stable once opened and kept refrigerated. However, we cannot guarantee sterility of the product once a needle enters the vial. Therefore, the phrasing on the label is required.

    1. Full safety testing is pending completion and approval by the USDA. However, observations recorded thus far include minimal injection site swelling in a small portion of vaccinated rabbits. Further information will be posted on our website upon review and approval by the USDA.

  4. Is the vaccine safe for pregnant does, or those who are bred within 14 days of the second dose?

  5. If a rabbit is currently vaccinated for RHDV2, using one of the imported vaccines, will it still require 2 doses when the rabbit comes due for a booster a year after the initial imported dose?

    We do not have data to support using our vaccine as a booster to the imported vaccine. Our recommendation is to proceed with the vaccine label regimen of two doses, administered 21 days apart. This will ensure proper protection.

    Also, how long does your vaccine protect a rabbit once it’s administered (is it a year like imported vaccines)?

    We anticipate one annual booster vaccination after the two initial doses. However, duration of immunity studies will be conducted to confirm this booster schedule is appropriate.

    If a 25 dose vial is meant to be disposed of “after opening”…do you have any intentions of doing single dose vials?

    We are working to offer alternative vial sizes. We will be able to offer 10-dose vials later this month and are evaluating options to acquire the appropriate equipment and supplies to offer smaller dose vials at some point in the future.

    Have you done stability testing on this product, even if you can’t guarantee sterility?

    Stability testing has been initiated and is ongoing for the intended 2-year expiration.

  6. If the vaccines from overseas have been used there for years and are the ones that have been being used here in the U.S. up until now, why isn’t that overseas vaccine just made legal in the U.S. ???? Doesnt make sense to have to use an experimental vaccine now when there is already one that works and has been used for years.

    1. Each country has certain regulations for validating and approving veterinary biologics. Further, the requirements for vaccine approval in one country do not always meet the requirements of another country. This is the case for the imported vaccines, as they have not undergone the necessary testing to meet US requirements.

      The Medgene RHDV2 vaccine has been reviewed by USDA-CVB and approved as efficacious, according to US standards. The final safety data is pending review and approval. We anticipate a conditional license in early 2022. At that time, the vaccine will no longer be considered experimental.

Leave a comment

Your email address will not be published. Required fields are marked *