USDA Approval Imminent For H5N1 Bird Flu Vaccine In Cattle

USDA Approval Imminent For H5N1 Bird Flu Vaccine In Cattle

Nicolas Hulscher, MPH

According to a Medgene press release:

Medgene’s H5N1 vaccine for dairy cattle has met all requirements of USDA’s platform technology guidelines and is in the final stages of review for conditional license approval.

Medgene has also just signed a distribution agreement with Elanco Animal Health, which includes “commercialization of a highly pathogenic avian influenza (HPAI) vaccine for use in dairy cattle.”

According to Mark Luecke, CEO of Medgene:

With our critically important H5N1 vaccine for dairy cattle in the final stages of approval, we’re excited to partner with Elanco to quickly bring this much needed solution to U.S. dairies.

Medgene CTO, Alan Young explains:

We have been working with USDA-CVB who has been reviewing the data for our H5N1 vaccine for several months. We believe our most recent data will completely satisfy the standard for ‘reasonable expectation of efficacy’ and conditional license approval. Vaccines need to be made available quickly to animal owners and veterinarians who need them, so the partnership with Elanco helps to make sure our H5N1 vaccines for dairy cattle can be distributed without delay once the USDA makes a final decision to vaccinate.

The Medgene H5N1 vaccine is a protein-based subunit vaccine developed using the company’s “prescription platform technology”. The production process involves a baculovirus expression system in insect cell culture, where only specific viral proteins, such as the hemagglutinin (HA) protein, are generated. The vaccine is created by inserting the H5N1 gene sequence into the platform vector, leading to the production of the target protein, which is then purified, inactivated, and combined with an adjuvant to enhance the immune response.

Mass vaccination of cattle against H5N1 using a non-sterilizing vaccine amid a widespread animal pandemic can lead to serious risks:

• Accelerated Viral Evolution: Non-sterilizing immunity allows the virus to replicate in vaccinated hosts, applying selective pressure that can lead to antigenic escape mutations.
• Increased Risk of Zoonotic Spillover: Mutations under immune pressure could enhance the virus’s ability to bind human receptors, raising the risk of cross-species transmission and human infection.
• Silent Reservoirs in Vaccinated Cattle: Subclinical infections in vaccinated cattle could create undetected viral reservoirs, allowing the virus to mutate and circulate without obvious signs of illness.
• Inadequate Testing of Rapidly Updated Vaccines: The prescription platform technology enables quick adaptation of the vaccine, but there is a risk that insufficient testing could fail to catch safety or efficacy issues in new formulations.

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