Tag: legal cases

History of Vaccine Manufacturers

Currently, the main manufacturers of vaccines used in the United States include:

  1. Emergent Biosolutions – Anthrax vaccine
  2. GSK Vaccines – Bexsero, Boostrix, Cervarix, Energix-B, Fluarix, Havrix, Hiberix, Infanrix, Kinrix, Menveo, Pediarix, Rabavert, Rotarix
  3. Mass Biologics (Massachusetts Public Health Biological Laboratories) – made the first DTP vaccine and continues making a generic Td vaccine
  4. MedImmune (owned by AstraZenaca) – FluMist
  5. Merck – Gardasil, MMR-II, PedvaxHIB, Pneumovax23, ProQuad, Recombivax HB, RotaTeq, Vaqta, Varivax, Zostavax
  6. PaxVax – Vivotif typhoid vaccine
  7. Pfizer – Prevnar, Trumenba
  8. Protein Sciences Corporation – Flublok
  9. Sanofi Pasteur – Adacel, Daptacel, Fluzone, Imovax Rabies, Pentacel, IPOL, Pentacel, Menactra, YF-Vax,
  10. Seqirus – Afluria, Fluad, Flucelvax, Fluvirin
  11. Valneva – Japanese encephalitis vaccine (IXIARO), Dukoral cholera vaccine

Of course, there used to be many more.

During the past fifty years, companies devoted solely or primarily to manufacturing vaccines (such as Lederle and Praxis) have been acquired by other pharmaceutical companies; the number of companies making vaccines has decreased from twenty-six in 1967 to seventeen in 1980 and to five in 2004 (GlaxoSmithKline, Sanofi-Aventis, Merck, Wyeth, and Chiron).

Paul Offit, MD

And then there were four…

21st Century Vaccine Industry Changes

Unlike changes in the 1970s, the latest changes in the vaccine industry and among vaccine manufacturers don’t have a lot to do with companies being forced out of business because of lawsuits.

Mergers and consolidation seem to be fueling the changes.

For example, Novartis, recently considered one of the top five pharmaceutical corporations that make vaccines, sold off its vaccine business to CSL Limited and GSK.

CSL Limited then formed Seqirus to produce their flu vaccines.

In other changes:

  • Pfizer acquired Wyeth in 2008
  • Chiron Corp became Novartis Vaccines in 2006
  • Aventis Pasteur and Sanofi merged to become Sanofi Pasteur in 2004
  • SmithKline Beecham and Glaxo Wellcome merged to become GlaxoSmithKline in 2000

But you don’t really get how big these mergers are until you understand that:

  • Pasteur Merieux and Aventis merged to become Aventis Pasteur in 1999
  • Wyeth acquired Lederle Laboratories/Praxis in 1994
  • Lederle Laboratories and Praxis  merged in 1989
  • Connaught Laboratories was purchased by the French Merieux Institute, forming Pasteur Merieux in 1989

Still other vaccine manufacturers simply stopped making vaccines.

Older Vaccine Manufacturers

What ever happened to these vaccine manufacturers?

eli-lilly-vaccine
Eli Lilly used to make a Small Pox vaccine
  • Bionetics Research Inc.
  • Cutter Laboratories – made anthrax vaccine and the Salk polio vaccine that was involved in the Cutter incident. Was bought by Bayer in 1974, but they no longer make vaccines.
  • Dow Chemical (Pitman-Moore) – got out of the vaccine business in 1977-78 and stopped making 12 vaccines
  • Eli Lilly – got out of the vaccine business in 1976 and stopped making 14 vaccines
  • Evans Medical Ltd.
  • Mich (Michigan Department of Public Health) – once made 8 vaccines
  • Miles Inc. – exited the vaccine market in 1970 and stopped making 11 vaccines
  • North American Vaccine, Inc. – was purchased by Baxter International Inc. in 2000, a company that sold off its remaining vaccine business in 2000, including vaccines for meningitis C and tick borne encephalitis. North American Vaccine, Inc. once sold a DTaP vaccine – Certiva.
  • Organon Teknika Corporation
  • Parke-Davis – purchased by Warner-Lampert in 1970, but had sold off their flu vaccine division as King Pharmaceuticals, stopping production of 16 other vaccines. King Pharmaceuticals later changed its name to Parkdale Pharmaceuticals and stopped making vaccines in 2002.
  • Richardson-Merrill – got out of the vaccine business in 1976-78 and stopped making 14 vaccines
  • Sclavo
  • Solvay Pharmaceuticals – purchased by Abbott Laboratories in 2010, but Solvay’s flu vaccine business was sold off and their Influvac vaccine is no longer used in the United States
  • Squibb & Sons – now known as Bristol-Myers Squibb, since their 1989 merger, Squibb used to make vaccines, including Maurice Hilleman‘s first Japanese B encephalitis vaccine
  • Texas Department of Health Resources – exited the vaccine market in 1979 and stopped making 7 vaccines
  • University of Illinois – once made the BCG vaccine

Unlike other companies that merged or had their vaccine business sold off, these companies and their vaccines are gone. And some, like Bionetics Research Inc. and Organon Teknika Corporation were acquired by the same companies (ABL). They just don’t make vaccines anymore.

For More Information on Vaccine Manufacturers:

References on Vaccine Manufacturers:The Children’s Vaccine Initiative: Achieving the Vision. Historical Record of Vaccine Product License Holders in the United States
Pereira,Nuno Sousa. Vaccine Supply: Effects of Regulation and Competition. International Journal of the Economics of Business 18(2):239-271.October 2010

Mitochondrial disease and Vaccines

Mitochondrial disease is real.

Mitochondrial disease occurs when there is some failure in our mitochondria, which are classically thought of as the energy factories of our cells.

In addition to developmental delays, children with mitochondrial disease often have problems with their vision, hearing, muscle weakness, seizures, and dementia. Among the syndromes associated with mitochondrial disease include Kearns-Sayre syndrome (KSS), chronic progressive external ophthalmoplegia (CPEO), mitochondrial encephalomyopathy with lactic acidosis and stroke-like episodes (MELAS), myoclonic epilepsy with ragged-red fibers (MERRF), neurogenic weakness with ataxia and retinitis pigmentosa (NARP), or Leigh syndrome (LS), and mitochondrial recessive ataxia syndrome (MIRAS).

Mitochondrial disease does not cause autism.

It is possible for a child to have both a mitochondrial disease and autism though.

And according to the CDC, “As of now, there are no scientific studies that say vaccines cause or worsen mitochondrial diseases.”

What about Hannah Poling, the autistic child who was compensated by the Vaccine Court? Hannah Poling developed an encephalopathy, a table injury, for which she was compensated. Although she has a mitochondrial disorder, case was not about vaccines triggering or worsening that condition. Developing an encephalopathy within a short time of being vaccinated automatically made her eligible for compensation.

For more information:

NVICP

The National Vaccine Injury Compensation Program (NVICP) was created by the National Childhood Vaccine Injury Act of 1986 following years of often frivolous lawsuits against vaccine manufacturers and health professionals, even though similar lawsuits in the UK against vaccine manufacturers failed to find that the DPT vaccine caused vaccine injuries.

The NVICP was created as “a no-fault alternative to the traditional legal system for resolving vaccine injury petitions.”

Those who think they have suffered a vaccine injury can file a petition with the U.S. Court of Federal Claims – the Vaccine Court. A court-appointed special master eventually decides if the claim should be compensated or dismissed.

For more information:

 

Vaccine Court

The National Vaccine Injury Compensation Program (VICP) was created as “a no-fault alternative to the traditional legal system for resolving vaccine injury petitions.”

Those who think they have suffered a vaccine injury can file a petition with the U.S. Court of Federal Claims – the Vaccine Court. A court-appointed special master eventually decides if the claim should be compensated or dismissed.

From 2006 to 2014, National Vaccine Injury Compensation Program claims have included:

  • 2,265 claims that were compensated
  • 1,850 compensated claims that were settled and which “cannot be characterized as a decision by HHS or by the Court that the vaccine caused an injury.”
  • only 193 claims that were compensated by court decision and for which “the evidence is legally sufficient to show that the vaccine more likely than not caused (or significantly aggravated) the injury; or the injury is listed on, and meets all of the requirements of, the Vaccine Injury Table, and HHS has not proven that a factor unrelated to the vaccine more likely than not caused or significantly aggravated the injury.”
  • only 223 claims that were compensated by concession and for which “it is more likely than not that the vaccine caused the injury or the evidence supports fulfillment of the criteria of the Vaccine Injury Table.”
  • 1,329 claims that were dismissed
  • $1,513,056,840 that was paid

During this same time, over 2.5 billion doses of vaccines were given!

Since the National Vaccine Injury Compensation Program began, in 1988, almost $3.5 billion dollars have been paid out for 4,899 compensated awards.

Again, “over 80 percent of all compensations awarded by the VICP comes as a result of a negotiated settlement between the parties in which the HHS has not concluded, based upon review of the evidence, that the alleged vaccine(s) caused the alleged injury.”

Although $3.5 billion sounds like a lot, the most important thing to remember is that the small number of real vaccine injuries are dwarfed by the billions of doses of vaccines given and deaths from vaccine-preventable disease prevented.

For more information:

Package Inserts for Vaccines

The package inserts for vaccines are not as useful as many parents believe, especially if you are trying to do research about vaccines.

No, it is not because your pediatrician won’t let you read them, after all, package inserts for each and every vaccine are easy to find.

And it certainly isn’t because package inserts are hiding information that would keep you from getting your kids vaccinated if you were more aware of it.

Again, vaccine package inserts are easy to find.

It is that some of the information in the vaccine package insert is not what you think it is. For example, in addition to Data from Clinical Studies, the Adverse Reactions section includes side effects that are voluntarily reported and for which “it may not be possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.”

What does that mean?

Just because a side effect is in the package insert, depending on the section, it doesn’t automatically mean that it was caused by the vaccine. That is why autism and SIDS are listed as adverse events for the Tripedia vaccine.

Adverse  events  reported  during  post-approval  use  of  Tripedia  vaccine  include  idiopathic  thrombocytopenic  purpura,  SIDS, anaphylactic reaction, cellulitis, autism, convulsion/grand mal convulsion, encephalopathy, hypotonia, neuropathy, somnolence and  apnea.  Events  were  included  in  this  list  because  of  the  seriousness  or  frequency  of  reporting.  Because  these  events  are reported  voluntarily  from  a  population  of  uncertain  size,  it  is  not  always  possible  to  reliably  estimate  their  frequencies  or  to establish a causal relationship to components of Tripedia vaccine.

In fact, many studies have shown that there is no causal relation between vaccines and autism or vaccines and SIDS.

Package inserts are useful, but you should understand why and how they were written if you are going to add them to your vaccine research.

For more information:

Medical Exemptions for Vaccines

All fifty states allow doctors to write medical exemptions to state mandates to getting vaccines for school or daycare.

While medical exemptions should be very clear cut, they seem to generate controversy, just like personal belief and religious exemptions.

Why?

In the real world, there should be very few reasons to get a medical exemption for vaccines. They should mostly include the vaccine contraindications and precautions that are listed for each vaccine.

They typically wouldn’t include having undergone MTHFR genetic testing, having a history of eczema, or a cousin with autism, etc.

For more information:

Personal Belief Exemptions to Vaccines

Twenty states allow personal belief exemptions, also called a philosophical exemption, to getting vaccinated to attend daycare and school.

In most other states, a religious exemption can be used, or abused, as a personal belief exemption.

Only three states, California, Mississippi, and West Virginia, do not allow non-medical exemptions to vaccines.

These exemptions are for state vaccine mandates to attend school and daycare.

What is a personal belief or philosophical exemption? Does it have to do with the strength of your convictions? Usually not. In Texas, for example, parents can “choose an exemption from immunization requirements for reasons of conscience,” but they don’t have to list any of those reasons.

For more information: