10 Things You Need to Know About DNA & RNA Vaccines for Livestock

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by The Sharp Edge, Corey’s Digs:

1. What are the different terms used for DNA or RNA-based veterinary biologics?

Not all genetic technologies used in veterinary medicine fall under the categories of “mRNA vaccines” or “mRNA gene therapies.”  There are other terms to look out for when it comes to genetic technologies for veterinary medicine.  These terms also include:

  • “RNA Particle Technology”
  • “RNA Particle Platform”
  • “DNA Vaccine”
  • “DNA Immunostimulant”
  • “Prescription Platform Product”

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2. How do DNA or RNA-based veterinary biologics work?

With SEQUIVITY’s RNA Particle Technology, a “gene of interest provides instructions” to the immune cells which “translate the sequence into proteins” that “act as antigens.” This triggers an immune response.

As for AgriLab’s ExactVac DNA technology, “the vaccine is produced by splicing a gene for a specific antigen” into “a bacterial plasmid” which “is then multiplied, purified and administered” for “delivery into target cells, where antigens produced by the plasmid elicit an immune response.”

Bayer’s Zelnate DNA immunostimulant is “made up of a special type of immunostimulatory DNA surrounded by a lipid carrier or liposome” which is then “engulfed by the animal’s immune cell” where the “liposome breaks down exposing the DNA” and the “pathogen-associated molecular pattern” of the DNA “attaches to the immune cell’s toll-like receptors triggering activation of the immune cell.”

3. Which agency approves veterinary biologics?

The USDA’s Animal and Plant Health Inspection Service (APHIS) and their Center for Veterinary Biologics is responsible for approving veterinary biological products including vaccines and DNA or RNA-based biologics. Here are the lists of the currently licensed veterinary biological products and biologics for aquatic animals.

4. Which DNA or RNA-based biologics have been approved for food animals?

There are several DNA and RNA-based genetic technologies that have received USDA approval or conditional approval for use on chickens, cows, fish, and pigs as outlined below.

Chickens
  • In September 2015, Harrisvaccines received a USDA conditional license for an RNA-based avian influenza vaccine. Harrisvaccines “employs their unique SirraVaxSM RNA Particle (RP) technology platform” which can be updated to match current and future avian flu strains. In October 2015, Harrisvaccines was awarded a USDA stockpile contract of 48 million doses of their “pioneering RNA particle vaccine.”  In November 2015, Merck acquired Harrisvaccines.
  • In November 2017, AgriLabs received USDA conditional approval for “the first DNA vaccine ever licensed for chickens” for avian flu using “AgriLabs’ ExactVac DNA technology with ENABL adjuvant.”  In January 2018, Huvepharma acquired AgriLabs.  Huvepharma’s DNA-based avian influenza vaccine has a conditional license on APHIS’s most recent list of approved veterinary biological products.
Cows
Fish
  • Elanco’s Apex IHN DNA vaccine for salmonids against Infectious Hematopoietic Necrosis Virus (IHNV) has received USDA approval and is on APHIS’s most recent list of licensed biologics for aquatic animals.  Elanco’s DNA technology uses “relevant genetic components of the virus” that are inserted into a plasmid and injected into the muscle, after which the plasmid “instructs cells to produce antigens, which initiate an immune response.”
Pigs
5. Is there ongoing research into DNA or RNA-based veterinary biologics?

There are a number of ongoing studies on DNA and RNA-based genetic technologies for veterinary medicine, as outlined below.

6. Is it possible for mRNA vaccines in livestock to contaminate meat, dairy or egg products?

According to a recent Epoch Times report, a 2014 USDA presentation on Vaccination for Contagious Diseases states that food animals receiving vaccines are subject to “mandatory withdrawal periods prior to slaughter for human consumption. Animals may not be sent to market until the withdrawal time has elapsed. During the mandatory withdrawal time vaccinated animals or products from vaccinated animals may not enter the food chain.  The withdrawal time is determined by the country in which the vaccine is licensed and stated in the product license.”  As the Epoch Times report notes, the USDA recognizes that there must be a waiting time between vaccination and slaughter for human consumption due to risks of contaminating the food supply.  The USDA presentation does not, however, acknowledge DNA or RNA-based biologics, but the same standard of waiting times likely applies, as evidenced by Merck’s RNA vaccine for pigs, which states “Do not vaccinate within 21 days before slaughter.”  However, Dr. Peter McCullough notes that mRNA technology “is far more durable than we ever could’ve imagined.  It lasts in the human body for months unchanged.”  Therefore, even with standard wait times, Dr. McCullough believes it is conceivable that mRNA technology administered to food animals could contaminate the food supply.

With that said, the Epoch Times report found “zero peer-reviewed studies looking into the transmissibility of mRNA vaccines from livestock to humans via either milk or meat.”  Dr. Peter McCullough has warned that developers of novel vaccine technologies for veterinary medicine are “blinded with infatuation for molecular biology and have lost sight of biological product safety in the food supply” adding that they have failed to acknowledge the “possibility of collateral impact to humans.”  In addition, Dr. McCullough has raised concerns regarding transmissibility based on a recent study which loaded cow’s milk with mRNA, and by consuming the milk, mice were successfully administered a Covid vaccine.  Dr. McCullough points out the “considerable ethical issues” this research presents, with a large segment of the public having “strong objections to mRNA in the food supply, particularly if it was done surreptitiously or with minimal labelling/warnings.”

7. Are there labeling requirements for meats, dairy or eggs that may have been contaminated by DNA or RNA-based veterinary biologics?

The required labeling for meat, dairy and egg products is not transparent about possible exposure to DNA or RNA-based veterinary biologics.  The USDA does, however, require “Bioengineered” labeling for foods that “contain detectable genetic material that has been modified through certain lab techniques and cannot be created through conventional breeding or found in nature.”  It is unclear whether the USDA’s testing process for “detectable genetic material” is capable of picking up traces of genetic material from biologics used in veterinary medicine.

Moreover, the USDA’s “Organic” labeling does appear to permit vaccines for livestock used for meat, dairy and eggs, though the requirements state that animals must not be given hormones or antibiotics.  A 2013 Agricultural Marketing Service document states that “organic livestock must be: – Produced without genetic engineering.”  However, the same document goes on to say that “Only a few drugs, such as vaccines, are allowed” for organically raised livestock.

Furthermore, in many cases, labeling is not clear about the country from which meats originate. Country of Origin Labeling (COOL) requirements were dropped for beef and pork in 2016.  COOL requirements remain in place for lamb, goat, chicken, and fish.  Additionally, USDA regulations on meat, poultry and eggs have enabled “Product of USA” labeling for animals born and raised in other countries and only processed in the U.S.  However, in March 2023, the USDA proposed a new rule to restrict labeling for “Product of USA” or “Made in the USA” to be used on “meat, poultry and egg products only when they are derived from animals born, raised, slaughtered and processed in the United States.”

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