Chicago Tribune
05/29/2010

Several hundred dogs and cats in southeastern Wisconsin may need to be revaccinated after being given expired rabies vaccines.

Countryside Humane Society in Racine says hundreds of expired vaccines were administered from Dec. 10 to last week.

Countryside president Marilyn Benson says the agency learned of the expired vaccines Wednesday. She tells The Journal Times she’s not sure why expired vaccines were used.

Read the rest of the article.

WorldPoultry.net
05/25/2010

AviPro IBD Xtreme – Lohmann Animal Health’s vaccine against infectious bursal disease in poultry – is now available in 10,000 dose vials in the UK.

This will save a considerable volume of storage space in the fridge and make vaccination quicker and easier, says the company.

“This vaccine dissolves readily when reconstituted in water. Opening fewer vials makes the whole job more efficient,” commented Adam Goddard, Lohmann’s regional sales consultant in the UK. “Many integrators and independent broiler producers have individual houses holding 40,000 birds and farms with 300,000-400,000 birds. When vaccinating, this will mean using only 40 rather than 80 vials, compared with 5,000-dose vials, which is the largest size currently available.”

Read the rest of the article here.

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Dr. Sherri Tenpenny
Huffington Post
04/16/2010

Veterinarians and pediatricians have a great deal in common. Both are highly qualified medical professionals with similar years of education. Both often struggle to determine what is wrong with their patients since pets, like little people, cannot communicate what hurts. Their jobs are not easy, but the premise of their work is simple: Support the health of those in their care and abide by the oath: “First, do no harm.”

Wellness checkups for babies and pets are often synchronized with routine vaccination schedules. Before a shot is given, the consent of the caretaker is required. For human patients, this is where discussions with the doctor can turn dark. Parents are aware of others who have been discharged from a medical practice for questioning vaccines and are wary of bringing up their concerns. Their fears are not unfounded. According to a 2005 survey of the American Academy of Pediatrics (AAP), when faced with parents who refuse immunization, pediatricians reported that they always (4.8 percent) or at least sometimes (18.1 percent) tell parents that they will no longer serve as the child’s physician. Pet owners, on the other hand, have latitude to discuss their vaccination concerns. In many cases, refusing a vaccination has the full support of their vet.

When it comes to dogs, veterinarian professionals can tailor the vaccination schedule to the pet. The Canine Vaccine Guidelines and Recommendations offer suggestions about shots for puppies and adult dogs. Vaccines are categorized as core (recommended for all dogs); non-core (those that are optional); and not recommended (due to poor efficacy and unacceptable risk of side effects). The guidelines recognize vaccination as a medical procedure that needs to be individualized based on the animal’s geographic and lifestyle exposure. Veterinarian professional organizations allow flexibility and encourage doctors to extend vaccination intervals whenever necessary for the safety of the pet.

Most veterinarians agree house pets should be assessed yearly and vaccines – if given at all – should be tailored to an animal’s age, health, and lifestyle. For example, Dr. Matthew J. Toia, Chief Veterinarian Officer for PetLabsMD.com (“Pet-Labs”), a national direct to consumer animal health wellness testing laboratory staffed by licensed veterinarians and veterinary technicians, concurs. “An indoor cat with limited exposure to some diseases may never need some of the common vaccinations. For instance, Lyme’s disease, a regional illness for outside pets in endemic areas, is not necessary for unexposed animals in low risk regions of the country. Cats can forgo this vaccine without an issue.”

His comments are supported by two veterinary associations, the American Association of Feline Practitioners (AAFP) and the Academy of Feline Medicine (AFM). The Advisory Panel on Feline Vaccines (APFV) has guidelines for the selection and administration of vaccinations for cats. Feline shots fall into two basic categories: core vaccines (those recommended for most cats), and ancillary vaccines (those recommended for only a small percentage of cats.) Both of these organizations encourage cat owners to develop a good relationship with their veterinarian so their cat’s vaccination schedule can be openly discussed.

Veterinarians limit the number of vaccines given to puppies on a single visit. A study of more than 1,200 dogs found evidence that the risk of a vaccine-associated adverse event was significantly increased as the number of vaccine doses administered per office visit increased; each additional vaccine significantly increased risk of an adverse event by 27 percent in dogs under10 kg (22 lb) and 12 percent in dogs over 10 kg. Vets are cautious about giving multiple vaccines on one office visit.

Unlike their animal doctor counterparts, the American Academy of Pediatrics (AAP), endorses universal immunization and follows a one-size-fits-all vaccination schedule. The AAP not only assumes that all vaccines are necessary, pediatricians assume that children can all equally tolerate all vaccines given in the standard schedule. As many as six doses – and 18 vaccine antigens – can be given at the same time. The Advisory Committee of Immunization Practices (ACIP) recommends that if a dose is not administered “on time” at the routine two, four and six month checkups, the shot should be given at the next visit. Every dose is considered to be so essential that the ACIP has created a ‘catch up’ schedule for children who have missed even one shot.

Parents have become alarmed by the large number of injections given at one time. To by-pass their psychological concerns, manufacturers have created combination vaccines, such as Pediarix and Comvax, to trick parents into believing that their baby is “only” getting one shot at a time. Pediarix is actually three vaccines in one shot (DTaP, hepatitis B and polio) and Comvax combines the hepatitis B and HiB vaccine into one shot. The ACIP states that, “The use of combination vaccines is preferred over separate injections of its equivalent vaccine components”. The AAP backs up this recommendation, urging combination vaccines to “improve timely vaccination coverage.” Both ACIP and AAP overlook a potentially serious problem with combination shots: If a reaction occurs, it is impossible to determine which vaccine caused the side effect. Animal doctors have figured this out. The Association of Feline Practitioners (AAFP) recommends using single dose vaccines because “increasing the number of antigens in a vaccine also increases the probability associated adverse events.”

Most pediatricians seem to have a “vaccinate no matter what” approach to childhood immunizations rather than ensuring the safety and appropriateness of the individual child. The AAP encourages pediatricians to “work individually and collectively at local and national levels to ensure that all children receive all childhood immunizations on time.” This includes giving vaccines to children, even when they are sick. According to the most recent “General Recommendations for Vaccination”, published in 2006 by the Centers for Disease Control (CDC), there are few reasons for delaying vaccination. In fact, the guidelines state, “Among the most common conditions often inappropriately considered contraindications are diarrhea, minor upper-respiratory tract illnesses (including otitis media) with or without fever, mild-to-moderate local reactions to a previous dose of vaccine, current antimicrobial therapy, and the convalescent phase of an acute illness.” Pediatricians, at the behest of the CDC and the AAP, follow the CDC’s instructions to use of every encounter as an opportunity to vaccinate.

When animals are sick, most vets choose to err on the side of safety. Vaccines are delayed until the pet is healthy to minimize the risk of a reaction. According to PetEducation.com, the decision to vaccinate a sick animal should be made on an individual basis. The vet determines if a shot is appropriate by performing a physical examination and possibly obtaining laboratory tests to aid in the decision. Not so with children. According to the CDC, a routine physical exam and taking a temperature is no longer a prerequisite before vaccinating. If a child appears in the doctor’s office, vaccination should proceed.

Avoiding over-vaccination: Vaccine Titers
Many vets are concerned about the potential for side effects and complications from unnecessary shots and boosters. They order a blood test, called a titer, to determine the need for additional vaccinations. A vaccine titer is test that measures the level of an antibody in the blood, a component usually induced by vaccination. A titer is reported as a ratio of one to a number. The higher that number, the better. For example, a titer of 1:5 is a low titer, and generally implies a susceptibility to disease. A titer of 1:1,000,000 is a very high titer, and implies immunity. It is generally accept that a high titer indicates further vaccination is unnecessary.

While useful as a guide, titer levels have limitations. They only measure one component of the immune system so the level of full protection is unknown. Antibodies cannot be distinguished between those generated by vaccination from those developed after recovery from a disease. Except where vaccination is required by law, all animals can have serum antibody titers measured to determine the need for booster shots. Testing is especially important for pets that have previously experienced an adverse reaction. While not all vets agree with checking antibody titers, the test is available for pet owners who prefer not to follow the conventional practice of annual boosters.

While veterinary medical associations are advocates of vaccination, they insist that immunization is only one component of an individualized, health-care plan for pets. One organization that wants to assist owners in their quest for healthy pets is PetLabsMD.com, the first and only national company to offer consumer-direct laboratory testing. Pet owners can actively participate in the health and wellness for their pets. Tests can be ordered directly through the internet by owners at substantial savings. PetLabsMD.com offers hundreds of screening tests, from preventive profiles for cancer, to tests for infectious diseases, diabetes, nutritional deficiencies, and vaccination titers.

Most importantly, owners will have the added convenience of having their pets’ blood tests done in the privacy of their own homes, avoiding the added stress of taking a pet to the vet. PetLabsMD.com is expanding their nationwide network of veterinarians and veterinary technicians who will come directly to your home to draw the necessary samples. Pet owners without access to a holistic veterinarian can order important health tests directly from Pet-Labs.

Vets vs Peds: A Interesting Comparison
Unlike the AAP that routinely denies any connection between vaccines, adverse events and side effects, the Council on Biologic and Therapeutic Agents (COBTA) at the American Veterinary Medical Association concludes that vaccines can cause problems and should be individualized. The following is an excerpt of their policy:

“There are insufficient data available to scientifically determine a single best vaccination protocol regimen for application to all animals globally. Despite significant advances in our knowledge of antigens and antigen presentation, gaps still remain in our under-standing of the immune system’s acute and chronic reaction to multiple vaccinations. The body of knowledge surrounding the genetic variability within individual breeds or species and the resulting idiopathic responses to vaccination (including vaccine-associated adverse reactions), is increasing but remains too inconclusive to make specific recommendations appropriate for all patients. Consequently, COBTA believes that a customized approach to recommended vaccination protocols is the safest and most effective method to medically address the increasing diversity in patients presented for immunization.”

It appears that veterinarians are more prudent about vaccination than their pediatrician counterparts. A comparison of Vets to Peds can be summarized as follows:

* Veterinarians consider pets as individuals. Vaccines are customized to their needs and lifestyles. For example, dogs that have allergies are often vaccinated less, given smaller doses or not vaccinated at all. If any adverse reaction was experienced from a vaccine, vets are cautious about future vaccines. Unfortunately, the same level of individual tailoring and caution is not found in the pediatric community.
* To avoid over vaccinating, vets often request vaccine titers. Pediatricians do not offer vaccine titers for children; in fact, all vaccines are mandated for all kids, at the risk of expulsion from the medical practice for refusing.
* Veterinarians acknowledge that vaccines can cause serious adverse reactions, including well-documented cancers in cats: feline leukemia and feline sarcomas. Pediatricians rarely, if ever, acknowledge an association between vaccines and asthma, eczema, seizures, gastric reflux, strokes, cancer and autism. Parents are told a side effect is not caused by a recent vaccine; tens of thousands of dollars of medical tests and procedures are ordered to prove it.
* Most veterinarians seem to understand that a one-size-fits-all vaccine policy is not appropriate. Not so for people doctors.

It’s time for pediatricians, the AAP, the CDC, the ACIP and all others involved with human vaccination programs to acknowledge that vaccines have risks and can cause serious harm, including death. If animal doctors can work with owners to individualize vaccination schedules, to avoid over-vaccinating though vaccine titers, and to encourage participatory care, human doctors need to start doing the same. Parents need to demand care that is as good for their children as it is for their pets.

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Lynn McTaggart
WDDTY
03/29/2010

The US and UK governments and the press are exulting in the recent highly public hanging of Dr Andrew Wakefield, found guilty of misconduct by the British General Medical Council (GMC). Wakefield, you may recall, is the British gastroenterologist who first raised the alarm bells over the measles–mumps–rubella vaccine (MMR).

In the minds of many medicos and in the press, the MMR vaccine now stands fully vindicated. The scientist who claimed that the MMR vaccine causes autism has been discredited. Order has been restored.

In our Special Report this month, publisher Bryan Hubbard set out both to investigate the Wakefield decision and to uncover any evidence purporting to demonstrate the safety of the vaccine.

Wakefield never maintained that the MMR vaccine caused autism. All he did was raise a cautious alarm after finding that a number of children with autism were presenting with the same gut problems that seemed to have developed right after their MMR jabs.

Now, he and his colleagues in America have carried out a subsequent study on monkeys, which demonstrated that the hepatitis B vaccine can cause neurological damage and progressively severe chronic inflammation in gastrointestinal tissue—exactly what he originally discovered with the MMR vaccine and autistic children.

Despite being exhaustively peer-reviewed and accepted for publication, Wakefield’s monkey study was subsequently pulled as ‘not suitable’ for publication after the GMC delivered its verdict. The pulling of the study ultimately became the centrepiece of our story. The more that Bryan dug into this issue, the more layers of deceit he uncovered in the form of censorship, data-massaging and burying of damning data.

He found dirty tricks at the heart of medicine that would have made Richard Nixon’s Watergate henchmen proud. He found journalism bought and paid for by drug companies.

But what has been most shocking to us as journalists is the misinformation spread about by our own colleagues in the press. Virtually no major newspaper, or TV or radio station (save the Huffington Post) has bothered to look beyond the official releases of the GMC or government agencies to learn the truth about MMR. Some journalists have even allowed themselves to get in bed with drug companies.

The safety of the vaccine is now beside the point. Wakefield’s error was to challenge medicine’s most sacred cow: vaccination is now in a sense a standard-bearer for a certain mindset. It represents the triumph of Science over the randomness of Nature. Most doctors look to vaccination as proof that medicine has conquered infectious disease.

Researchers, scientific publications, doctors, drug companies and even journalists are willing to do almost anything to maintain that assumption of a priori benefit. Vaccination is now performed for its own sake—whether or not it is necessary, beneficial or even safe. To attack anything about any jab has come to be viewed as treason.

What needs to be put on display is not an honest scientist like Wakefield, but the level of deceit that is now routine—among scientists, researchers and reporters—all in the name of the public ‘interest’

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HOLYOKE, Colo. — Jason Timmerman coaxed a balky calf into a chute on his feedlot one recent afternoon and jabbed a needle into its neck. He was injecting the animal with a new vaccine to make it immune to a dangerous form of the E. coli bacteria.

The calf and thousands of others are part of a large-scale test to see whether animal vaccines are an answer to one of the nation’s most persistent food-safety problems.

The test has been a long time coming. Bureaucratic delays in Washington stalled the arrival of the vaccines for years, even as people continued to become sick and die from eating tainted beef. And now, even if the vaccines prove successful in the ambitious tests that are just getting under way, they face an uncertain future as farmers and feedlot owners worry about who will pick up the extra cost.

“I hope it works,” Mr. Timmerman said. “It probably won’t be so good for my pocketbook directly, but it’ll probably be good for the industry.”

Scientists are fairly sure that vaccines like the one Mr. Timmerman gave his cattle will not, on their own, wipe out the dangerous strain of E. coli known as O157:H7. But if they prove effective, they could significantly reduce the amount of harmful bacteria that cattle carry into slaughterhouses, which means that safeguards already in place there would have a greater chance of eliminating the remaining germs from the beef supply.

While studies have shown varying degrees of effectiveness, many researchers believe E. coli vaccines can reduce the number of animals carrying the bacteria by 65 to 75 percent. That may be enough to prevent the surge of E. coli that typically occurs each summer, when the germ thrives and reports of illness increase.

The vaccines may also reduce the number of so-called supershedders, cattle that carry unusually high levels of E. coli, with the potential to overwhelm slaughterhouse safeguards.

“Anything we can do to reduce that inbound load will help us be more successful,” said Mike Chabot, general manager of a Cargill packing plant in Fort Morgan, Colo.

Food poisoning from toxic strains of E. coli, mostly the O157:H7 variety, has become a recurring problem. The strain is responsible for an estimated 73,000 illnesses and 61 deaths across the country each year.

Since January 2007, the industry has initiated 52 recalls of beef tainted with E. coli, compared with 20 in the three previous years. In one of the most recent cases, in October, a company in upstate New York recalled more than 500,000 pounds of ground beef after two people died and more than two dozen were sickened.

In an effort to counter the threat, two vaccines have been developed commercially. One, made by a Minnesota company called Epitopix, received preliminary approval from the Agriculture Department in March, meaning it can be sold while research continues. Dr. James D. Sandstrom, general manager of Epitopix, said that about 300,000 head of cattle will get the vaccine in the coming months as part of a series of large trials.

A second vaccine has been developed by Bioniche Life Sciences, a Canadian company. It was approved for use in Canada last year and is awaiting approval in the United States.

Both vaccines spent years tangled in Washington red tape, largely because they straddle the border between animal medicine and human health.

Many E. coli strains live in a cow’s digestive tract without making it sick. But several strains, notably O157:H7, can sicken people who eat it in ground beef or other foods.

Companies have been working on vaccines for close to a decade. The Agriculture Department received its first application for an O157:H7 vaccine in 2001. But by September 2003, the agency determined that it did not have jurisdiction. The agency said it had authority to approve vaccines only for animal health, and E. coli did not make cattle sick.

The Food and Drug Administration determined that it did not have jurisdiction, either. While it regulated many animal medicines as well as drugs aimed at human health, it was not responsible under federal law for animal vaccines.

“It was in both agencies’ netherworld, where neither agency felt they were authorized by law to approve that product,” said Chuck Lambert, a former deputy under secretary for marketing and regulatory programs at the Agriculture Department.

Finally, in March 2005, the Agriculture Department reversed course and said it would take applications. But even as it agreed to review the vaccines, the agency set a high bar for approval.

Officials determined that the vaccines must show at least a 90 percent reduction in the number of cattle carrying the bacteria. And among cattle that still harbored E. coli after being vaccinated, the agency insisted on a 99.9 percent reduction in the number of bacteria shed by the animals.

That was more than the vaccines could achieve — and more than the agency demanded of many other vaccines.

“It was a very high, unrealistic target,” said Dr. David R. Smith, a professor of epidemiology at the University of Nebraska at Lincoln, who has done research on the Bioniche vaccine. Dr. James A. Roth, the director of the Center for Food Security and Public Health at Iowa State University, said that many widely used vaccines, including many for common bovine respiratory ailments, were successful in preventing disease less than 80 percent of the time.

The E. coli vaccines were stuck in limbo. Then, in 2007, the number of E. coli-related beef recalls jumped sharply, alarming food safety advocates and some in the beef industry, who pushed for additional tools.

“I was looking for anything that could help us because people were getting sick and people were dying,” said Dr. Richard Raymond, the Agriculture Department’s under secretary for food safety from 2005 to 2008.

In early 2008, the department told the two vaccine companies that it would relax its requirements. This March, the agency approved sale of the Epitopix vaccine.

“The federal government was slow,” Dr. Raymond said. He called the 18-month lag while the Agriculture Department and the F.D.A. hashed out the jurisdictional dispute “pure wasted time.”

But Dr. John Clifford, the Agriculture Department’s head veterinarian, said the government had acted expeditiously in working through complex regulatory challenges. The two federal agencies “did not slow down the companies’ development of this product,” Dr. Clifford said.

The Agriculture Department said in a statement that it holds all vaccine manufacturers to a high standard and works with them to ensure they meet its requirements.

Dr. Kent McClure, general counsel of the Animal Health Institute, a pharmaceutical industry group, said that while the review took longer than the industry would have liked, the new legal clarity could pave the way for other food safety vaccines.

One possibility, he said, was a vaccine for campylobacter, a bacterium that infects poultry without making them sick, but which causes millions of cases of food poisoning each year.

Today another roadblock stands in the way of the E. coli vaccines: who will pay for them.

Epitopix said it had not yet set a price for its vaccine. In Canada, Bioniche charges about $3 a dose. The vaccines require two or three doses to be effective, meaning the cost could approach $10 an animal.

Farmers and feedlot owners fear that they will be stuck with the vaccine cost and that it will cut into already tight margins. Mr. Timmerman, the feedlot owner, said that in a good year his profit is $25 to $35 an animal.

“The incentive for the vaccine is it’s going to benefit the packer who is vulnerable to recalls and lawsuits,” said Ronald F. Eustis, executive director of the Minnesota Beef Promotion and Research Council, a trade group that represents farmers and feedlot owners. “Unless the farmer, the producers, the rancher is somehow compensated, he’s going to be reluctant to lay out the cash.”

The large-scale study that includes Mr. Timmerman’s calves is being coordinated and paid for by Cargill, the food giant that is the biggest producer of ground beef in the country.

It will include close to 100,000 cattle, with the animals going next summer at Cargill’s Fort Morgan slaughterhouse. Tests will be done on the meat, in particular the smaller pieces, known as trim, that go into ground beef. Researchers will look to see if it contains less E. coli than trim from unvaccinated cattle.

E. coli contamination generally starts when bacteria in feces on a cow’s hide are transferred to the carcass. Cargill has added many steps to keep carcasses clean, including steam pasteurization and hot water washes. But regular tests at the plant still turn up occasional traces of E. coli in trim, underscoring the need for additional steps, like a vaccine.

“It’s definitely a piece of the solution,” said James L. Marsden, a professor of food safety at Kansas State University. “When you combine it with other pieces you may be looking at a real solution, a total solution.”