Tag: vaccine manufacturers

Understanding the Vaccine Injury Table

The Vaccine Injury Table was created by the National Childhood Vaccine Injury Act of 1986.

“The Table makes it easier for some people to get compensation. The Table lists and explains injuries/conditions that are presumed to be caused by vaccines. It also lists time periods in which the first symptom of these injuries/conditions must occur after receiving the vaccine. If the first symptom of these injuries/conditions occurs within the listed time periods, it is presumed that the vaccine was the cause of the injury or condition unless another cause is found.”

What You Need to Know about the National Vaccine Injury Compensation Program

A table injury is an illness, disability, injury or condition covered by the National Vaccine Injury Compensation Program.

“For example, if you received the tetanus vaccine and had a severe allergic reaction (anaphylaxis) within 4 hours after receiving the vaccine, then it is presumed that the tetanus vaccine caused the injury if no other cause is found.”

What You Need to Know about the National Vaccine Injury Compensation Program

To quality as a table injury, the illness, disability, injury or condition has to occur within a specific “time period for first symptom or manifestation of onset or of significant aggravation after vaccine administration.”

Understanding the Vaccine Injury Table

So if there is a Vaccine Injury Table, then that proves that vaccine injuries are real, right?

The Vaccine Injury Table is easier to understand if you actually look at the table.
The Vaccine Injury Table is easier to understand if you actually look at the table.

Wait, does anyone dispute that vaccine injuries are real?

No one says that vaccines are 100% safe, so yes, of course, it is known that they have risks and cause adverse effects. While most of these adverse effects are usually mild, they can rarely be severe or even life threatening.

The idea the vaccine injuries are common is what is misunderstood and misrepresented by anti-vaccine folks.

It's no joke, studies have shown fewer side effects after the second dose of MMR!
It’s no joke, studies have shown fewer side effects after the second dose of MMR!

Consider the above post by Bob Sears…

Yes chronic arthritis after a rubella containing vaccine is a table injury, but it is very rare. Arthritis after the rubella vaccine is typically mild and temporary, lasting just a few days.

While rubella containing vaccines can cause arthritis, they do not cause lifelong rheumatoid arthritis. So even if you were to be one of the very rare people who developed chronic arthritis after a rubella containing vaccine, a table injury, it would still not be the same thing as rheumatoid arthritis.

“The association between rubella vaccination and chronic arthritis is less clear. Most recently published research, has shown no increased risk of chronic arthropathies among women receiving RA27/3 rubella vaccine and do not support the conclusion of the IOM (Slater et al., 1995; Frenkel et al., 1996; Ray et al., 1997). These studies have included a large retrospective cohort analysis which showed no evidence of any increased risk of new onset chronic arthropathies and a double-blind historical cohort study. One randomised placebo-controlled, double-blind study of rubella vaccination in sero-negative women demonstrated that the frequency of chronic (recurrent) arthralgia or arthritis was marginally increased (1.58 [1.01-2.45], p = 0.042) (Tingle et al., 1997). In 2011, the United States Institute of Medicine (IOM) reviewed available research and concluded that the evidence is inadequate to accept or reject a causal relationship between MMR vaccine and chronic arthralgia in women.”

Information Sheet Observed Rate of Vaccine Reactions Measles, Mumps and Rubella Vaccines

And it wouldn’t even be clear if your chronic arthritis was caused by the vaccine!

“The Table lists and explains injuries and/or conditions that are presumed to be caused by vaccines unless another cause is proven.”

What You Need to Know about the National Vaccine Injury Compensation Program

To be added to the Vaccine Injury Table, there only has to be scientific evidence that a condition could be caused by a vaccine.

“Where there is credible scientific and medical evidence both to support and to reject a proposed change (addition or deletion) to the Table, the change should, whenever possible, be made to the benefit of petitioners.”

Guiding Principles for Recommending Changes to the Vaccine Injury Table

That makes sense, as the NVICP is a “is a no-fault alternative to the traditional legal system for resolving vaccine injury petitions” for VICP-covered vaccines.

Vaccines Covered by the Vaccine Injury Table

Most routinely used vaccines are covered by the Vaccine Injury Table, including vaccines that protect against:

  • diphtheria, tetanus, and pertussis – DTaP, Tdap, Td
  • measles, mumps, and rubella – MMR, ProQuad
  • chickenpox – Varivax, ProQuad
  • polio – IPV, OPV
  • hepatitis B
  • hepatitis A
  • Hib
  • rotavirus
  • pneumococcal disease – Prevnar
  • influenza – seasonal flu vaccines
  • meningococcal disease – MCV4, MenB
  • human papillomavirus – HPV4, HPV9

In fact, “any new vaccine recommended by the Centers for Disease Control and Prevention for routine administration to children, after publication by the Secretary of a notice of coverage” is automatically included, at least for Shoulder Injury Related to Vaccine Administration and vasovagal syncope.

New vaccines are also covered if they are already “under a category of vaccines covered by the VICP.”

Immunizations given to pregnant women are also covered.

A few others, including vaccines that protect against pandemic flu, smallpox, and anthrax are covered by the Countermeasures Injury Compensation Program (CICP).

Vaccines Not Covered by the Vaccine Injury Table

What about vaccines that aren’t routine?

Other vaccines that are used in special situations, including vaccines that protect against rabies, yellow fever, Japanese encephalitis, cholera, and typhoid aren’t listed in the Vaccine Injury Table and aren’t covered by the National Vaccine Injury Compensation Program.

Have you seen any TV ads for lawsuits against the shingles vaccine, which isn't in the vaccine injury table.
Have you seen any TV ads for lawsuits against the first shingles vaccine?

Shingles vaccines and the older pneumococcal vaccine, Pneumovax, aren’t covered either.

And since they are not covered by the National Vaccine Injury Compensation Program, there are no restrictions on lawsuits against the manufacturers of these vaccines or the health providers who administer them.

So much for the idea that you can’t sue a vaccine manufacturer or that vaccine manufacturers have no liability for vaccines…

Why weren’t these vaccines covered?

Remember, the NVICP and Vaccine Injury Table were created by the National Childhood Vaccine Injury Act of 1986. The vaccines that aren’t covered are not on the routine childhood immunization schedule.

“There are no age restrictions on who may receive compensation in the VICP. Petitions may be filed on behalf of infants, children and adolescents, or by adults receiving VICP-covered vaccines.”

National Vaccine Injury Compensation Program Frequently Asked Questions

Still, since many of the covered vaccines can be given to adults, they are included, even if some of the vaccines adults routinely get aren’t covered.

Will they ever be covered?

“They found a low liability burden for these vaccines, that serious adverse events were rare, and that no consensus existed among stakeholders. After considering the staff report, NVAC chose, in 1996, not to advise the Department of Health and Human Services to include adult vaccines in VICP.”

Loyd-Puryear et al on Should the vaccine injury compensation program be expanded to cover adults?

Adding more adult vaccines to the Vaccine Injury Compensation Program (VICP) is something that has been looked at in the past, but it wasn’t thought to be necessary.

What to Know About the Vaccine Injury Table

The Vaccine Injury Table is a list of conditions set up to make it easier for people to get compensated from the National Vaccine Injury Compensation Program.

More on Understanding the Vaccine Injury Table

Are There Generic Vaccines?

We are used to drugs becoming generic once they have been around for a while, which may have you wondering if we have generic vaccines too.

“Who owns the patent on this vaccine?
Well, the people, I would say. There is no patent. Could you patent the sun?”

Jonas Salk

In addition to vaccines that don’t have patents, others have lost their patent protection, which typically lasts for only 20 years, so it seems like we could have generic vaccines.

Are There Generic Vaccines?

And we have.

Consider that once upon a time:

  • the Texas Department of Health Resources made up to 7 different vaccines
  • the University of Illinois made a BCG vaccine
  • the Michigan Department of Public Health made up to 8 different vaccines
  • Massachusetts Public Health Biological Laboratories (Mass Biologics) made several vaccines

These included many generic vaccines, including DPT and IPV.

In addition to Tenivac, made by Sanofi Pasteur, MassBiologics makes a generic Td vaccine.

In fact, the Massachusetts Public Health Biological Laboratories continues to make the last remaining generic vaccines, DT and Td.

Why Aren’t There More Generic Vaccines?

Couldn’t more pharmaceutical companies make vaccines, including more generic vaccines, so that they could be less expensive?

“In sum, although patent protection remains the major barrier to the production of affordable small-molecule generics, access to trade-secret–protected information and know-how present major additional obstacles to generic production of vaccines.”

Improving Global Access to New Vaccines: Intellectual Property, Technology Transfer, and Regulatory Pathways

Unfortunately, unlike drugs, patents aren’t the only issue when making a generic vaccine. You also need the expertise, investment, and studies to prove that your generic vaccine is as safe and effective as similar vaccines.

More on Generic Vaccines

About Those Lawsuits That Almost Put Vaccine Manufacturers out of Business

So you likely know that there were a bunch of lawsuits against manufacturers of the DPT vaccine in the early and mid 1980s.

“As the number of lawsuits grew to hundreds during the early 1980s, the pharmaceutical companies making vaccines saw their liability insurance bills soar. Worried not only about multimillion-dollar settlements, but also even the legal costs of defending themselves successfully, several companies simply stopped making vaccine.”

How a Media Scare On Vaccine Started a ‘near-Epidemic’

That’s why the National Vaccine Injury Compensation Act passed in 1986, creating the National Vaccine Injury Compensation Program and the Vaccine Court.

About Those Lawsuits That Almost Put Vaccine Manufacturers out of Business

But did those DPT vaccine lawsuits prove that vaccines aren’t safe?

Is that why vaccine manufacturers needed help to limit their liability?

“The total amount claimed in 1984 DTP vaccine suits ($1.3 billion) is more than 20 times the total value of 1984 sales of DTP vaccine at the market price of $2.80 per dose.”

Hinman on DTP Vaccine Litigation

Of course not!

While the older DPT vaccine did cause more local reactions, pain, and fever than the newer DTaP vaccine that replaced it, all of the serious reactions that triggered the lawsuits were later found to not be caused by the vaccine.

Most of the DPT lawsuits were thought to be frivolous.

That’s not surprising, as the same vaccine lawsuits that were succeeding in driving vaccine manufacturers out of business in the United States were failing in the UK and Canada!

This included the Loveday judgment in Great Britain’s High Court of Justice, Queen’s Bench Division and the Rothwell judgment in the Supreme Court of Ontario, Canada, both decided in 1988, with justices ruling that there was “insufficient evidence to demonstrate that pertussis vaccine can cause permanent brain damage in children.”

Similar cases were succeeding in the US though..

“The number (and dollar value) of suits increased in 1982, a year when broadcast and print media began to devote considerable attention to the alleged hazards associated with the use of pertussis-containing vaccines. Most of the media coverage has emphasized alleged risks of pertussis vaccines and has given relatively little attention to the benefits of their use.”

Hinman on DTP Vaccine Litigation

Most experts knew that most of the lawsuits were frivolous, but they weren’t able to stop the damage that was to come, as:

  • the DPT: Vaccine Roulette special aired on TV
  • Barbara Loe Fisher, believing that her child was damaged by the DPT vaccine, formed the Dissatisfied Parents Together organization and wrote the book DPT: A Shot in the Dark, which later influenced Bob Sears
  • there were temporary shortages of DTP vaccine in 1984, as “two of the three American manufacturers of the product decided to halt or restrict its sales.”

What else happened? I mean besides all of the studies proving the DPT vaccine was safe?

Parents who had been scared by the DPT controversy were ready and primed when Andy Wakefield showed up and told them that they had something new to worry about – the MMR vaccine and autism.

And of course, pertussis is now returning, as more parents are scared to vaccinate their kids and the newer DTaP vaccine isn’t as effective as DPT.

More on Those Lawsuits That Almost Put Vaccine Manufacturers out of Business

Vaccines In Development

Many of us have heard the myth that there are “300 new vaccines in the pipeline.”

It takes a long time to develop a new vaccine.
It takes a long time to develop a new vaccine.

Of course, no one really believes that means scientists are out there developing vaccines against 300 separate diseases or that it will mean that kids will some day get 300 more vaccines.

Vaccines In Development

So what does it mean?

Surprisingly, it doesn’t even mean 300 new vaccines are in the pipeline anymore. The latest, 2016 update of the Medicines in Development for Vaccines report from the Pharmaceutical Research and Manufacturers of America now states that there are “More Than 250 Vaccines in Development Pipeline.”

To understand what that means, you have to take a look at the vaccines being developed, which include:

  • 124 for infectious diseases
  • 105 for cancers
  • thirteen for allergies
  • eight for neurological disorders
  • seven for other conditions

And even of the 124 vaccines in development or testing for infectious diseases:

  • 36 are to prevent or treat HIV
  • 25 are to prevent influenza, including new nasal flu vaccines
  • 8 are for RSV
  • 8 are for Ebola

So when they talk about “300 vaccines in the pipeline,” remember that even when you consider that only 124 of them are for infectious diseases, of those, 77 are for just 4 different infectious diseases.

The other 47 vaccines in various stages of development include vaccines for CMV, tuberculosis, dengue, Zika, GBS, West Nile virus, Staph, herpes, hepatitis C, E. coli, pseudomonas, malaria, C. diff infections, Shigella, norovirus, anthrax, smallpox, and ricin.

Some others are for infections that you have likely never heard of, including viral hemorrhagic fever, Ross River virus infections, and Venezuelan equine encephalitis.

And unfortunately, very few of these infectious disease vaccines are in stage III trials, which means that very, very few are close to seeing the inside of a pediatrician’s office.

Potential New Vaccines

Which vaccines have the greatest potential to be protecting our kids soon?

A few vaccines have been recently approved, including:

  • Dengvaxia – a dengue fever vaccine developed by Sanofi Pasteur which has already been approved in Brazil, Mexico, the Philippines, El Salvador and Costa Rica (endemic areas)
  • Shingrix – a new shingles vaccine (adults only)
  • Vaxelis – a hexavelent vaccine (a combination vaccine, so technically not a new vaccine or at least it doesn’t mean that your child will get an additional shot, in fact, getting Vaxelis means getting fewer shots)

Based on which vaccines have completed phase III trials and have been submitted for registration to the FDA, the one likely candidate seems to be:

  • an Ebola vaccine from Merck (V920 has finished phase III trials as in under review)

Other vaccines in late development phases include:

  • an MMR vaccine from GSK (already available in other countries)
  • a 15-valent pneumococcal vaccine from Merck (V114, in Phase III trials – would compete with Prevnar 13)
  • Men Quad TT – a “second generation” meningococcal vaccine
  • Bexsero MenB vaccine for infants (in Phase III trials)
  • a Clostridium difficile infection vaccine for seniors by Pfizer (in Phase III trials)
  • a 20-valent pneumococcal vaccine from Pfizer, the makers of Prevnar (20vPnC, in Phase III trials)

And we may see the combination, pentavalent MenABCW-135Y meningococcal vaccine by 2021.

So much for 300 new vaccines…

For More Information on New Vaccines:

Updated May 26, 2019