Tag: vaccine manufacturers

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