The other day, the FDA issued a letter warning veterinarians of adverse events related to administration of the monoclonal antibody therapy, Librela (bedinvetmab).

Source: https://www.wsj.com/health/pharma/fda-warns-about-dangers-of-dog-pain-drug-61b1dd63

Dear Veterinarian,

The U.S. Food and Drug Administration’s Center for Veterinary Medicine has completed an evaluation of adverse events reported in dogs of various ages treated with Librela (bedinvetmab injection). The adverse events identified and analyzed include: ataxia, seizures, other neurologic signs, including but not limited to, paresis, recumbency, urinary incontinence; polyuria, and polydipsia. In some cases, death (including euthanasia) was reported as an outcome of these adverse events. The FDA is making available reports containing summaries of clinical signs reported for Librela in the CVM FOIA Electronic Reading Room.

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As of April 18, 2024, the CVM’s database contained 3,674 cases linked to Librela, reported through March 31, 2024. A number of the most frequently reported adverse signs, including the most common one—ataxia, which has been observed in 17% of cases—are not currently listed on the product labeling. Other frequently reported but unlabeled signs include polydipsia, death, diarrhea, muscle weakness, convulsions, recumbency, and paresis.

Many dogs began showing concerning clinical signs after their initial Librela dose. Two-thirds of the cases assessed reported signs occurring within the first week of administration, with 30% of cases showing signs within the first day.

Based on the evaluation and analysis of these reports, the FDA has recommended adding a Post-Approval Experience section to the Librela label. However, the FDA Center for Veterinary Medicine does not currently have the authority to mandate safety-related labeling changes.

Zoetis still contends Librela is “safe and effective”

Source: https://todaysveterinarybusiness.com/zoetis-librela-fda-121624/

In a response by the drug maker to the FDA letter, Zoetis released the following:

“We continue to have the utmost confidence in the safety and efficacy of Librela. Since launching in Europe over three years ago, Librela has been used effectively with millions of dogs suffering from osteoarthritis pain. With more than 21 million doses distributed globally, no individual adverse event sign is reported at a rate higher than rare, as defined by the European Medicines Agency (EMA) as <10 per 10,000 treated animals; 1 dose = 1 treated animal).”

Zoetis stands firmly behind the safety of Librela and its ability to provide relief for dogs suffering from osteoarthritis pain.

In the analysis, 458 (12.6%) cases of death associated with Librela were reported to the FDA. As a pet owner, I believe the suffering or loss of even one pet is too many. The fact that such serious adverse events have been documented raises important questions about the safety of this drug, especially when we consider the emotional bond we share with our pets. No amount of treatment should come at the cost of a pet's life or well-being, and it is crucial for both veterinarians and pet owners to be fully informed about the potential risks.

Zoetis puts profits above pets

A Fortune 500 company, Zoetis generated revenue of $8.5 billion in 2023 with approximately 14,100 employees. The company reported revenue of $2.4 billion for the third quarter of 2024, an increase of 11% compared with the third quarter of 2023. Last week, the board approved a 16% payment increase. The dividend will be paid on Tuesday, March 4, 2025, to all holders of record of the Company’s common stock as of the close of business on Tuesday, January 21, 2025.

Revenue in the US segment was $1.3 billion, an increase of 15% compared with the third quarter of 2023. Sales of companion animal products increased 18%, driven by the company's monoclonal antibody (mAb) products for osteoarthritis (OA) pain, Librela ^® for dogs and Solensia ^® for cats.

However, shares of Zoetis (NYSE:ZTS) traded lower yesterday after the FDA notified veterinarians about adverse events linked to the company’s pain therapy, Librela (bedinvetmab injection).

Conclusion:

The FDA has raised a safety concern regarding the canine osteoarthritis drug, Librela, and has issued a warning letter to veterinarians about the adverse events associated with this monoclonal antibody treatment. The FDA has advised that pet owners be informed of the potential side effects that may occur after administering Librela, which should already be occurring for any drug being administered to a pet. While the FDA cannot mandate changes, it has recommended that the product’s label include a “Post Approval Experience” section detailing the adverse events identified during its evaluation.

Meanwhile, Zoetis continues to benefit from marketing Librela as a “miracle cure” for pain, tapping into the emotional connection pet owners have with their animals.

As consumers, it is crucial that we remain proactive in educating veterinary professionals about the risks associated with this and other commercially available treatments.

What should a veterinarian do if a patient treated with Librela has an adverse event?

If a dog under your care experiences an adverse event while receiving Librela, the FDA encourages you to report it to Zoetis, the drug sponsor, at 1-888‑963-8471. Drug sponsors are required to submit reports of adverse drug events to FDA. If you prefer to report directly to FDA, please see www.fda.gov/reportanimalae.

When reporting adverse events to the FDA and/or Zoetis, please include, if available, a full medical history, how many times the dog has received Librela, and the lot number on the vial used.

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Just like human medications, veterinary drugs must pass through rigorous testing and evaluation before receiving FDA approval. This includes clinical trials designed to assess safety and effectiveness in target animal populations.

Or do they?

I previously wrote about the recently approved monoclonal antibody therapy, Librela (bedinvetmab), for treatment of osteoarthritis in dogs (Solensia for cats).

This particular drug has been touted for its effectiveness in 2 clinical studies conducted in the US and European Union (EU) with a total of 559 dogs for reducing pain associated with osteoarthritis (OA).

The graphs on the professional website are misleading regarding the efficacy of Librela.

This graph for the US field study is from the Librela (bedinvetmab) website under the “Efficacy” section. There is also a graph from the European clinical study on the website.

Source: https://www.librelavetteam.com/

Each graph presents the “% Success Rate Measured by CBPI” for both the Librela-treated group and a placebo group at various timepoints (7, 14, 28, 42, 56, and 84 days post treatment). According to the graphs on the website, a p-value 0.05 was marked on Days 42, 56, and 84 in the US field study and on Days 7, 14, 28, 42, 56 and 84 in the EU field study. A p-value is generally understood in the scientific community to indicate statistical significance if it is less than 0.05.

**Canine Brief Pain Inventory (CBPI), an owner-completed questionnaire designed to quantify the severity of OA pain and the impact of that pain on the activity of dogs.

The drug showed no significant difference as compared to placebo at the 28 day primary effectiveness study endpoint in the US field study.

Not only that but data on the graphs is false and misleading in that it erroneously concludes an effect at later time points when in fact there is no effect due to statistical Type I error. When multiple endpoints are tested statistically, the Type I error rate may be inflated.

This can be a difficult concept to understand. This video attempts to explain in simple terms what a Type 1 error is in statistics.

The bottom line is a Type 1 error is considered a false positive. This means that it is the probability of erroneously concluding an effect when the truth is that there is no effect. In this case this statistics wrongly concluded that the drug was more effective in reducing OA pain than the placebo when in fact there was no difference at any time point.

Neither the US nor the EU study was designed to make statistical conclusions regarding effectiveness at study days other than the primary endpoint on day 28. Adjustments were not made in the study to account for the potential inflation of Type I error rate, leading to false interpretation of effectiveness of the drug at later time points.

Therefore, the inclusion of a p-value (i.e., p 0.05) on the graphs on the website for the secondary time points creates a misleading impression about the efficacy of Librela, undermining the ability of the reader to understand the study results presented.

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The Librela website was found to be in violation of the Federal Food, Drug and Cosmetic Act (FD&C Act).

The FDA notified Zoetis, the company that produces Librela, on November 20, 2023 that the Librela website makes false and misleading claims and representations about the efficacy of Librela.

Source: https://www.fda.gov/media/174818/download

I am not aware of any response by Zoetis to this letter from the FDA. Clearly, the website has not been updated or changed to reflect the concerns outlined by the FDA in this letter.

The ADUFA authorizes the FDA to collect fees for certain animal drug applications.

Congress first passed and signed into law the Animal Drug User Fee Act (ADUFA) in 2003. It has since been reauthorized in 2008, 2013, 2018 and 2023.

This act, similar to PDUFA for human drugs, authorizes the FDA to collect fees for certain animal drug applications and supplements, products, establishments, and sponsors of animal drug applications and/or investigational animal drug submissions. These fees are used to fund more expedient approval of drugs.

Source: https://www.fda.gov/animal-veterinary/cvm-updates/fda-announces-fy-2025-animal-drug-user-fee-rates-adufa-and-agdufa

This allows the pharmaceutical industry to exert significant influence on the drug development and approval processes. Companies may push for approvals based on limited data, hoping that post-market surveillance will reveal more about a drug's effectiveness.

For 2023, the year Librela was approved for use, the revenue from sponsor fees were approximated to be 27 percent of total fee revenue for the FDA. The target revenue amounts for each fee category for FY 2023, were as follows: for application fees, the target revenue amount was $6,428,800; for product fees, the target revenue amount was $8,678,880; for establishment fees, the target revenue amount was $8,357,440 and for sponsor fees, the target revenue amount was $8,678,880.

The Animal Drug User Fee Act (ADUFA) base fee revenue for fiscal year (FY) 2023 was $29,931,240.

How can an agency regulate an industry that is paying much of its operating expenses? I have previously written about regulatory capture and how this is a serious conflict of interest.

Please share this letter to help educate veterinary professionals about Librela.

What can you do? Please print and share this letter so we can help educate veterinary professionals about the dangers of this antibody therapy.

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A concerning trend has emerged surrounding an FDA-approved drug that, despite its official approval, has been linked to serious health issues and even fatalities in pets. It’s crucial for pet owners to be informed and vigilant about the medications administered to their furry companions.

This particular drug, originally intended to treat osteoarthritis in animals, has been touted for its effectiveness. However, reports have surfaced of severe side effects and adverse reactions in many pets, raising alarms among veterinarians and pet owners alike.

I came across a post on Facebook in a grief support group for those who lost a beloved pet and it piqued my interest so I started to dive down this rabbit hole. At this point I should not be shocked by what I found but what I uncovered was utterly heartbreaking.

Posted October 20, 2024 to Grief and support for loss of a beloved pet

I started researching and came across many similar posts. There are hundreds of posts with very similar descriptions of pets that declined and eventually had to be euthanized or died after receiving a Librela injection.

Posted October 9, 2024 to Grief and support for loss of a beloved pet

This was a comment posted in response to the post about cancer: Yes: many reports in this group of sudden cancer diagnosis, tumors, etc. Librela blocks nerve growth factor, a protein critical to the functioning of every system and organ including the immune system. Disrupt the immune system and cancer can take over.

There is a Facebook group, LIBRELA (BERANSA, SOLENSIA)- The TRUTH, dedicated to this issue with over 30K followers

This is posted on the About page for the group

Within HOURS of receiving the injection, my dog developed LIFE-THREATENING symptoms that nearly killed him. They were so severe, and horrific to watch, and most LASTED FOR WEEKS, and some are now PERMANENT (like bladder and bowel incontinence, nerve damage, partial blindness, and seizures). So... THAT is why I created this group… To get to the TRUTH!

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What is Librela/Solensia?

Osteoarthritis (OA) is the most common form of arthritis in dogs; it is estimated that it affects at least 25 percent of dogs at some point in their lifetime. OA is a degenerative and painful condition of the joints in which the normal cartilage cushion in the joints breaks down. Eventually, the bones in the joint rub against each other, causing pain, decreased joint movement, and sometimes formation of bone spurs or other changes in and around the joint. OA continues to get worse over time.

Librela, approved in May 2023, is the first mAb the FDA has approved for use in dogs. Librela is a monthly injectable monoclonal antibody (mAb), bedinvetmab, therapy for dogs with osteoarthritis pain. (Note: Librela is sold by Zoetis, a spinoff from Pfizer) Solensia (frunevetmab) is the same type of mAb therapy approved for use in cats.

Antibodies are parts of your immune system. They seek out the antigens (foreign materials) and stick to them in order to destroy them. Monoclonal antibodies are proteins made in a laboratory produced using a biological manufacturing process involving live cells. Monoclonal antibodies are clones of a single antibody, meaning they are exact copies of one antibody. They are produced by cloning a unique white blood cell, and all subsequent antibodies are derived from that cell. (Note: the “mab” at the end of the name denotes it as a mAb) Monoclonal antibodies bind to specific targets in the body and are used for diagnosis, disease treatment and research.

Mechanism of action of Librela/Solensia

Bedinvetmab works by binding to canine nerve growth factor (NGF), a protein that's elevated in dogs with osteoarthritis.

The involvement of nerve-growth factor in pain sensation is mainly a result of its interaction with a cell receptor called tropomyosin receptor kinase A (TrkA). Normally when NGF binds to TrkA receptors it leads to the production of chemical transmitters (such as substance P) that are involved in pain sensation and the release of inflammatory substances from immune cells. 

The inability of bedinvetmab-bound nerve-growth factor to interact with TrkA receptors that are involved in pain sensation leads to a reduction in pain. Binding of the mAB to NGF thereby prevents the pain signal from reaching the brain and interacting with its receptors.

In essence this therapy is just masking the pain and not doing anything to actually mitigate the arthritic condition itself or the underlying inflammatory disease process causing the arthritis. The dog then feels no pain and continues normal activities which can exacerbate the condition thereby INCREASING joint damage.

As a side note, in some contexts, Trk A is oncogenic (cancer causing), in other contexts TrkA has the ability to induced terminal differentiation in cancer cells.

NGF serves many vital roles in the body

NGF, one of several naturally-occurring proteins in the body that are known as neurotrophins, is responsible for transmitting and modulating pain signals from the joints and it is also responsible for repairing and protecting the nerves throughout the body.

Nerve growth factor is synthesized and secreted by a variety of cells in the body, including those involved in immune functions and structural cells. NGF serves several important roles but overall it is a protein involved in embryo development and regulates the growth, maintenance, and survival of neurons in the central and peripheral nervous systems. It is also involved in a wide range of homeostatic functions, including wound and muscle repair and in pain sensation.

• NGF is a neurotrophic factor that helps neurons develop and survive, especially sensory neurons that transmit touch, temperature, and pain.

• NGF binds to receptors on the surface of neurons, which initiates signaling pathways that control the neuron's growth, differentiation, and survival.

• NGF plays a significant role in protecting neurons from damage and degeneration, which is particularly important in conditions like Alzheimer's disease and peripheral neuropathies.

• NGF promotes the regeneration of damaged neurons, aiding in the recovery from injuries and neurodegenerative diseases.

• NGF plays a critical role in the regulation of both innate and acquired immunity. In acquired immunity, NGF is produced by the Thymus as well as CD4+ T cell clones, inducing a cascade of maturation of T cells under infection.

• NGF may play a critical role in the maintenance and survival of pancreatic beta cells.

So why would anyone want to block NGF? Most doctors and veterinarians say that's a TERRIBLE idea!

What can you do if your pet took Librela/Solensia?

A class action lawsuit has recently been filed against the drug maker. The suit alleges misrepresentations about Librela by manufacturer Zoetis that the treatment is safe and effective for dogs.

Source: https://www.classaction.org/news/librela-lawsuit-says-zoetis-failed-to-warn-pet-owners-about-dangers-of-canine-osteoarthritis-drug

If your pet has experienced an adverse reaction to LIBRELA/BERANZA OR SOLENSIA contact Zoetis and report ALL of the side effects.

The most important thing you can do to get these drugs recalled and to hold Zoetis accountable is to report your pet’s adverse event and to update any previously filed reports if your beloved pet has since lost their life.

Call Zoetis to update them with your details using your case number. They are required to report to the FDA within 15 days of receiving a report. You can follow-up with the FDA to be sure they have, or report directly to FDA yourself.

Zoetis

Email: supportUS@zoetis.com

Phone: 1-888-963-8471 Option 2

https://www.zoetisus.com/product-support/vmips/contact-vmips

FDA

Email: AskCVM@fda.hhs.gov

Phone: 1-888-FDA-VETS (1-888-332-8387)

https://www.fda.gov/animal-veterinary/report-problem/how-report-animal-drug-and-device-side-effects-and-product-problems

According to the cases, FDA has received more than 3,800 reports of side effects concerning Librela through the end of last year. The European Database of Suspected Adverse Drug Reaction Reports presently contains nearly 20,000 reports of adverse events linked to Librela, the majority of which are classified as “systemic disorders,” the suit adds.

When will enough be enough?!

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Rabies Virus is the deadliest virus in the world.

Once symptoms appear, rabies virus infection is 100% lethal.

Source: https://www.labroots.com/trending/microbiology/5761/brief-history-rabies

Rabies is caused by the rabies virus. It’s a lyssavirus - a single-stranded, bullet-shaped, enveloped RNA virus.

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Background on Rabies

Rabies is a very serious disease that can result in inflammation of the brain and ultimately death. All warm-blooded mammals, including humans can get rabies. Transmission occurs when saliva containing the rabies virus is introduced into an opening in the skin, usually via the bite (or less likely a scratch) of a rabid animal. Wild animals that are most often associated with rabies include skunks, foxes, raccoons, coyotes and bats.

Rabies in dogs has been known since the fifth century B.C. and worldwide the dog has long been known to be a principal transmitter of rabies. In North America, however, bats (more on bats in upcoming blogs) are the most common carriers because pet owners are typically required to vaccinate their animals.

In the U.S., around 4,000 animal rabies cases are reported each year, with more than 90% occurring in wildlife like bats, raccoons, skunks, and foxes. Unvaccinated dogs who spend time outdoors, especially around wild animals, are at the greatest risk for contracting rabies. Dogs account for only about 1% of rabid animals reported each year with about 400 to 500 cases of rabies being reported in domestic pets each year.

A dog infected with rabies may exhibit the following signs:

• Fearfulness

• Aggression

• Excessive drooling/foaming at the mouth

• Difficulty swallowing

• Confusion/disorientation

• Difficulty moving/paralysis

• Dilated pupils or vacant stare

• Abnormal behavior (i.e. a wild animal who does not shy away from people)

The incubation period is related to the distance between the bite site and the brain, wound severity and amount of virus. Symptoms of rabies usually take 2-8 weeks to develop after the bite, but in some rare circumstances, it can take up to a year.

Early symptoms include:

• Fever (high temperature)

• Changes in behavior

• Howling or yelping

• Licking or chewing the bite wound

Rabies can then develop in one of two ways, ‘dumb rabies’ (most common) or ‘furious rabies’.

Source: https://www.pdsa.org.uk/pet-help-and-advice/pet-health-hub/conditions/rabies-in-dogs

There are no available tests for rabies in live patients, so vets have to diagnose it based on symptoms, travel history, and whether the dog was seen being bitten by another animal. Definitive diagnosis is done using a post-mortem antibody test. This means that the test can only be performed on animals after they have died or been euthanized.

The best, and the only way to prevent rabies in dogs is to vaccinate against it.

In several countries around the world, canine rabies was greatly reduced by mass immunization of dogs.

In the United States the canine strain of rabies was eliminated in 2007.

"The elimination of canine rabies in the United States represents one of the major public health success stories in the last 50 years," former CDC Director Dr. Julie Gerberding said in a statement.

The first rabies vaccine was developed by Pasteur in the early 1880s when he adapted “street” virus to rabbits by serial intracerebral passage (Pasteur, 1885). This was mainly used for humans.

Inactivated virus vaccines for dogs prepared from infected brain suspensions became available in the 1920s. The development of live attenuated rabies virus, vaccines in low egg passage (LEP) and high egg passage (HEP) (Koprowski, 1954) led to effective vaccination of dogs (Tierkel et al., 1953; Sikes, 1975). However, on rare occasions the live attenuated vaccines caused rabies-like disease in dogs and are no longer available.

Greatly improved inactivated virus vaccines prepared from rabies virus grown in diploid cell culture are now commonly used in dogs.

Annual vaccination for rabies increases risk of adverse events for pets.

According to one study, the rabies vaccine had the highest rate of adverse events among individual vaccines. Rabies vaccines cause a multitude of adverse effects. These range from immediate reactions to long term, chronic illness, and even death. Anaphylactic (or allergic) reactions are amongst the most severe reactions that can be seen after vaccination. The signs may be facial swelling, itching, weakness, diarrhea, difficulty breathing, shock and death.

Documented reactions include:

• Behavior changes (aggression, separation anxiety)

• Obsessive behavior, self-mutilation, tail chewing

• Pica – eating wood, stones, earth, stool

• Destructive behavior, shredding bedding

• Seizures, epilepsy

• Fibrosarcomas at injection site

• Autoimmune diseases of bone marrow and blood cells, joints, eyes, skin, kidney, liver, bowel or central nervous system

• Muscular weakness and or atrophy

• Chronic digestive problems

One veterinarian recommends…

Animals that have had anaphylactic reactions should be treated beforehand with antihistamines if vaccination is mandatory. To further minimize the risk, avoid using vaccines with multiple antigens, use modified live instead of killed vaccines, make certain the vaccine is not injected into the vein, and use subcutaneous or intranasal vaccines instead of intramuscular ones if possible.

If multiple doses of vaccines are administered to small-breed dogs (<10 kg), this may increase the risk of adverse reactions. Therefore, it is best to give only one vaccine at a time.

Annual re-vaccination recommendation on the vaccine label is just that.

Some rabies vaccinations are licensed for one year, others are labeled for three years, but some states require annual vaccinations regardless of labeling. Actually, three-year rabies vaccinations are the same as one-year vaccinations. There is no additional volume or disease agent administered to trigger an immune response; the labeling is simply different for the vaccinations.

Although your pet may receive a vaccination labeled for one year and is technically protected for three years, she is not legally protected for three years in the eyes of the state. Therefore, protection based on vaccination is a legal definition and not based on actual immune status. The annual revaccination recommendation on the vaccine label is just that: a recommendation without the backing of long term duration of immunity studies.

Veterinary immunologist Dr. Ronald Schultz states: “There is no benefit from annual rabies vaccination and most one year rabies products are similar or identical to the 3-year products with regard to duration of immunity and effectiveness. However, if they are 1 year rabies vaccines, they must be legally given annually! Rabies vaccine is the only canine vaccine requiring a minimum duration of immunity study. However, revaccination annually does not necessarily improve immunity. However, annual vaccination does significantly increase the risk for an adverse reaction in the dog.”

Most of the inactivated rabies virus vaccines on the market today induce immunity in dogs that lasts for 3 years. Scientific data suggest that commercial rabies vaccines confer durations of immunity well beyond 3 years, and that vaccinating dogs against rabies triennially, as nearly all American states require, is unnecessary. From challenge trials, the duration of immunity for regular vaccines has been shown to be seven to nine years, if not longer.

In 1992, Aubert demonstrated in France that dogs remained immune to a rabies virus challenge 5 years after vaccination. The serological studies of Schultz and Schultz and Conklin showed that immunity to rabies virus was present 7 years after vaccination.

According to a study by the Rabies Challenge Fund, scientific data suggests that immunity to rabies in vaccinated dogs can last longer than three years. A prospective study of 65 research beagles kept in a rabies-free environment was undertaken to determine the duration of immunity after they received licensed rabies vaccines. The eventual goal was to extend mandated rabies booster intervals to 5 or 7 years and help reduce the risk of vaccine-associated adverse events.

The study demonstrated that i) duration of immunity to rabies in vaccinated dogs extends beyond 3 years; ii) immunologic memory exists even in vaccinated dogs with serum antibody titer < 0.1 IU/mL; and iii) non-adjuvanted recombinant rabies vaccine induces excellent antibody responses in previously vaccinated dogs 14 days after administration.

The bottom line was that protection from rabies persists without annual or triennial re-vaccination.

Recommendations based on available science-based evidence

Given all this information, vaccination especially re-vaccination should be based on risk versus benefit for companion animals. That being said because the outcome of contraction of rabies infection is particularly devastating, I believe the benefit of vaccination outweighs the risk of adverse effects. This is why I chose to give my new puppies the rabies vaccine however, I made sure to ask for the thimerosol-free (adjuvant-free) rabies vaccine to help reduce the chance of a adverse reaction.

What about re-vaccination? A significant number of practitioners believe the annual revaccination recommendation on the vaccine label is evidence the product provides immunity for (only) one year. Again, this is simply not true. Some vets have suggested that giving a vaccine annually that has a duration of immunity of 3 or more years provides much better immunity than if the product is given only once during the three years. This is simply not true because many practitioners really don’t understand the principles of vaccinal immunity.

Again, re-vaccination should be about risk versus benefit. The role dogs play in our lives have changed dramatically over the last hundred years. They are no longer left outdoors to guard our homes and livestock, or used just for hunting, they have become part of our families and for some are our surrogate children. Therefore, are my little couch potato, pampered fur babies at risk of contraction of rabies virus? Are they outside all day? Do they have contact with wild animals? Did my 18 year old geriatric fur kid have any risk of contracting rabies?

I would contend that in these instances the risk far outweighs any benefit they may receive from annual vaccinations. If a vaccine is given that is not needed and it causes an adverse reaction that is unacceptable and very costly.

We need more reasonable regulations and protocols, based on science and not just fear.

Exemptions for rabies vaccination

Nineteen US States now allow medical exemptions in lieu of rabies vaccination. 

Alabama, California, Colorado, Connecticut, Delaware, Florida, Illinois, Maine, Massachusetts, Maryland, New Hampshire, New Jersey, Nevada, New York, Oregon, Pennsylvania, Vermont, Virginia, Wisconsin.

Each state’s law is different, but in most cases, it means your vet can write an exemption for a pet who isn’t healthy enough to be vaccinated.

One state (Hawaii) has no laws or regulations that require vaccination on a statewide basis. Nine states only require rabies vaccinations for IMPORTED animals above a certain age (usually 3 months old). 

If your state doesn’t already allow exemptions, think about whether you’d like to get involved and help make changes.

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Two types of vaccinations are recommended for dogs: core and noncore. Core vaccines are required for all dogs and puppies, while noncore vaccines are optional and depend on your dog's lifestyle and where you live. While it is suggested that some dogs do not need every vaccine and this decision is between you and your veterinarian (or is it? keep reading to find out). Some vaccines, like the rabies vaccine, are required by law in most states.

Source: https://www.akc.org/expert-advice/health/puppy-shots-complete-guide/

In addition, there is a 9-in-1 vaccine. Canine Spectra® 9 vaccine is designed for subcutaneous vaccinations of healthy dogs 6 weeks of age or older as an aid in the prevention of disease caused by Canine Distemper, infectious Canine Hepatitis, Canine Adenovirus Type 2 (CAV-2), Canine Parainfluenza, Canine Parvovirus Type 2b, Leptospira Canicola, Leptospira Grippotyphosa, Leptospira Icterohaemorrhagiae, Leptospira Pomona.

There is also a canine influenza vaccine, although not recommended for routine use. To be fully vaccinated against influenza, dogs should receive two initial sets of vaccinations followed by a yearly booster.

There is a difference of opinion about having your adult dog vaccinated every year. Some vets believe too many vaccinations in adult dogs pose health risks. But others disagree, saying that yearly vaccinations will prevent dangerous diseases such as distemper. However, recent research indicates that not all vaccines require yearly boosters.

COVID vaccine for dogs?! (Yes, I’m aware that’s a photo of a cat)

In 2020, the U.S. Department of Agriculture (USDA), which grants commercial licenses for pet vaccines, was not approving any for COVID-19. And why would they even need to?

Source: https://www.science.org/content/article/do-we-need-covid-19-vaccine-pets

"Cats and dogs don't play an important role in the maintenance or transmission of the disease to humans," says William Karesh, executive vice president for health and policy at EcoHealth Alliance (you may have heard of this organization in another context), a nonprofit that tracks emerging diseases in animals. As a result, he says, "There's no need for a vaccine from a public health standpoint."

The "data do not indicate that such a vaccine would have value," according to the agency. Although, "Companies are still free to do research and development on these vaccines," USDA spokesperson Joelle Hayden tells Science, "but without a license, they can't sell or distribute them."

However, a U.S. veterinary pharmaceutical company, Zoetis (just wait until you find out what company this one is associated with) was working on a COVID vaccine for mink and pets. Data presented by the company showed cats and dogs mounted a strong immune response to the viral molecule, or antigen, although it's not yet clear whether it was enough to protect them against infection.

Zoetis, decided to supply the vaccine to zoos* on an experimental basis, and committed to donating 26,000 doses — enough to vaccinate 13,000 animals. The development meant that many zoo-dwelling cats, like lions and tigers, were getting vaccinated. Why would zoo animals need to be vaccinated against SARS-CoV-2? They claim that zoo animals had a lot of exposure to people but I thought most zoos were closed during the pandemic.

*This is a topic I may explore in another post.

Veterinary vaccines are a multi-billion dollar business

The global veterinary vaccines market size was valued at USD 10.38 billion in 2023. The market is projected to grow from USD 10.94 billion in 2024 to USD 18.45 billion by 2032, exhibiting a compound annual growth rate of 6.7% during the forecast period.

North America dominated the global market with a share of 45.38% in 2023.

Zoetis has quickly risen to prominence as a key player in the global animal health sector. Zoetis, the largest animal vaccine company generated some 8.5 billion U.S. dollars in revenue in 2023, up 6% compared to the 8.1 billion dollars in the preceding year.

Source: https://www.proclinical.com/blogs/2024-6/global-top-10-animal-health-companies-in-2024

Zoetis provides vaccines, pharmaceuticals, diagnostics, and genetics designed for both livestock and companion animals. Zoetis was established in 2013 through a spin-off from top pharma company Pfizer's animal health division. Pfizer spun off its 83% interest in Zoetis on May 16, 2013, making Zoetis a fully independent company on February 1, 2013. The spinoff was considered a success, with Zoetis' share price increasing by more than 74% after going public. 

Corruption extends to the companion animal and livestock industry

Though the FDA regulates human vaccines, the USDA regulates veterinary vaccines, in part, because the first animal vaccines were for livestock. The USDA has retained oversight of veterinary biologics (e.g., vaccines), which now includes vaccines for companion animals such as cats and dogs. It is no secret that conflicts of interest are riddled throughout the government, including the FDA and USDA. It is well known that the FDA has a “revolving door” with the same pharmaceutical companies that the agency regulates.

Read more about the FDA “revolving door” here: https://childrenshealthdefense.org/defender/revolving-door-fda-staff-leave-pharma-jobs-work-behind-scenes-influence-agency/

Both the FDA and USDA are often staffed by former lobbyists of the meat and poultry industries, and some who are even particularly high-level appointees who had contributed heavily to political campaigns of members of Congress. There is even a website where you can search people who have been through the “revolving door” of lobby groups and government agencies.

A recent report discovered that the USDA has shifted from being a people's agency to an agency for corporate agriculture. The report commissioned by the Agribusiness Accountability Initiative, a network of family farm and public interest groups identified five areas as being influenced by the ties USDA officials have with corporations: biotech foods, mad cow disease, captive supply in meatpacking, concentrated animal feeding operations and meat inspection policies.

Given all this, it is not difficult to believe that the corruption extends to animal health companies in that there are ties between USDA officials and leading animal health companies.

Vaccines required for dog grooming

In my experience the corruption with veterinary vaccines extends to the level of veterinary clinics and veterinarians. Sharing here this anecdote from my own experience with this issue.

While living in Georgia I would take Allie to get groomed at a animal hospital, Companion Animal Hospital. They did a great job with grooming and it was close to my house.

Allie sleeping in her favorite spot.

After years of getting her groomed there, I was told they were requiring all pets to have the canine influenza vaccine in order to be dropped off for grooming going forward. As an expert in the field of influenza and working at the University of Georgia at a Center of Excellence for influenza I found this requirement to be quite odd.

Canine influenza virus (CIV) was first observed in racing greyhounds in Florida in 2004. However, serum collected from racing Greyhounds between 1984 and 2004 and tested for canine influenza virus (CIV) in 2007 had positive tests going as far back as 1999. Dogs housed in groups or exposed to transient populations of other dogs, such as dogs at the racetrack, shelter, or dog daycare environments, were at the greatest risk of exposure to CIV. Merck Animal Health launched the first canine influenza vaccine – NOBIVAC^® Canine Flu H3N8 – in 2009. I knew that canine influenza was not a widespread issue in the US and there had not been any confirmed cases in pet dogs in Georgia at the time. Canine influenza H3N2 didn’t emerge as an epidemic in the U.S. until 2015.

So why would my little couch potato dog need to get a flu shot to be groomed? She didn’t fit into any of the high risk categories and was at the clinic only an hour or two every few months. Come to find out one of the veterinarians who worked at the animal hospital at the time played a role in the development the canine flu shot. And now it made sense.

Luckily, they weren’t the only game in town. I found another groomer and Allie never received a canine influenza shot.

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Veterinary vaccine hesitancy on the rise

Negative attitudes toward human vaccines may “spill over” to increase vaccine hesitancy for companion animals (pets). While vaccine hesitancy isn’t a new concept, the pandemic seems to have further impacted how segments of the population feel about vaccines not only for themselves, but also for their dogs.

A recent survey in the US showed that 52% of dog owners exhibited some degree of canine vaccine hesitancy. Canine vaccine hesitancy refers to doubt about safety, efficacy, and/or importance of canine vaccination.

Authors of the survey wrote, “We find that attitudinal measures of human and pet vaccine hesitancy are closely related to each other. Moreover, they are strong predictors of vaccine behavior. Measures of vaccine hesitancy are also strong predictors of support for vaccination mandates.”

The survey was conducted by Boston University School of Public Health and captured responses from 2,200 dog owners in the US between March 30 and April 10, 2023. Results show that nearly 40% of the responding dog owners believe canine vaccines are unsafe, while more than 20% consider them ineffective, and 30% think they are medically unnecessary.

I now count myself among those dog owners who now exhibit some degree of canine vaccine hesitancy. And my adult dog will not receive any more vaccines.

A well-cared for dog can live long and age well

One big reason for my hesitancy on getting the new pups vaccinated was based on my experience with my sweet fur kid, Allie, who we had to let go of last year. Admittedly she was just shy of 19 years old and had a long life full of love and adventure, but I wholeheartedly believe that the rabies vaccine was the reason for the rapid decline in her health.

This is Allie in July 2022 at 18 years of age just prior to leaving Hawaii.

Allie was 18 years old when we relocated from Hawaii to Texas in the fall of 2022. She was a sweet, sassy little shih tzu who had been well cared for since I adopted at ten months old. I spared no expense when it came to keeping her happy and healthy. Some might have called her spoiled, but I say she was well cared for because she deserved to be. She was little, but she took up a lot of space in my life.

As Allie aged, she had developed some minor health conditions that were pretty well under control with medications and a healthy diet. At some point, the vet had diagnosed her with kidney disease which we regularly monitored via blood work and blood pressure. When I was first told about her diagnosis I switched her to a homemade kidney diet and started giving her Kidney Gold by Pet Wellbeing. This is a great product that I fully endorse. After having her on it for only a few weeks her kidney function values dropped into the normal range and stayed there for years.

While her vision wasn’t great and she had arthritis, as she aged she was still spunky enough to wander around outside and play with the neighbor dogs a bit even at the tender age of 18 (which is about 90 in human years). People were always surprised when I would tell them how old she was because she looked so good for her age. In fact, she looked better than some dogs half her age.

The rabies vaccine may have injured my geriatric fur baby

One of the requirements for pets to return to the mainland was a rabies vaccine. I was very distressed about this because I didn’t want her to get any more vaccines. Several years prior, the vet had said that Allie should not receive any more vaccines due to her age and underlying medical conditions. Besides, not only had she previously been vaccinated multiple times for rabies, had a titer test to show she had immunity. Most importantly, we lived in Hawaii which has been rabies free since 1912 when it instituted it’s rabies quarantine program. There was no risk of her importing rabies into a place nor was she at risk for contracting rabies.

At her health check prior to flying out of Hawaii, the vet also voiced her concerns about giving Allie a rabies vaccine. She did not want to give it to her. I asked her if we could get an exemption. She said we would run the risk of her not be accepted into the mainland US. Apparently, the vet had another patient that had foregone the rabies vaccine upon flying to the mainland and when they landed the officials would not allow the pet to enter the state. She said this person was made to fly back to Hawaii. In fact, in some states if the dog is not vaccinated they can be held for an extended quarantine period or euthanized. It was a difficult choice. Despite my better judgement we got her vaccinated and I regret that decision to this day.

After getting vaccinated, Allie seemed lethargic. I could tell she wasn’t feeling well which I had hoped would resolve. After arriving in Texas we dealt with chronic ear infections that were quite severe. In fact, at one point her ear was bleeding which was cause for great concern. We had a hard time getting her stable. She was on several rounds of oral and topical antibiotics.

The decline in her health was very rapid. She had a growth in her mouth that grew very rapidly. I was certain it was cancerous but there was nothing we could do about it due to her advanced age. Within 6 months she was having trouble getting around and was no longer walking up the ramp to get on the couch. She was incontinent and I was up with her several times at night to take her outside. As things progressed we had to give her pain meds to keep her comfortable at night.

This was Allie in March 2023 still at 18 years of age.

I really wanted her to have another birthday. It just got to hard for her and for me. She was losing weight despite eating four meals a day. We knew it was time. I didn’t want her to suffer any more. So two weeks before what would have been her 19th birthday in September, we let her go. She was so sweet even at the end. When the vet gave her the sedative she started gently snoring. Even though I knew it was time, it was the hardest thing I have ever had to do. I miss her like crazy.

While I can’t prove that the rabies vaccine was responsible for the decline in her health, I fully believe it played a significant role. I believe the vaccine suppressed her immune system which caused the chronic infections and also lead to rapid growth of her tumor. Who knows how much longer she might have lived had she not be subjected to that vaccination.

This experience caused me to start digging into the veterinary vaccine industry. You will be surprised what I discovered. If you think that human vaccines were not as fully and robustly tested as we once thought, it’s even worse for vaccines for companion animals.

To get started watch this episode of VSRF live as Steve Kirsch discusses veterinary vaccines with an experienced veterinarian of 40 years, Dr. Jennifer Ramelmeier, who is familiar with the questionable if not downright cruel treatment of pets and other animals in the name of “health”.

Find the full discussion here: https://rumble.com/v4rb8vr-vsrf-live-124-save-our-pets.html

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