Tag: development

Discontinued Vaccines

tripedia
The Tripedia DTaP vaccine was discontinued in 2013.

Most people know that the RotaShield rotavirus vaccine was discontinued in 1999 because it was found to be linked to intussusception.

It took eight years for a new rotavirus vaccine to be licensed.

Lymerix, a Lyme disease vaccine was discontinued in 2002. Unfortunately, we still don’t have a new replacement Lyme disease vaccine.

Vaccines That Have Been Discontinued

More commonly, a vaccine gets discontinued with little notice, as there are other options to keep kids vaccinated and protected.

Other vaccines that are no longer made, include:

  • Cervarix – an HPV vaccine that was discontinued in the US in 2016
  • Comvax –  a Hib/Hepatitis B combination – discontinued in 2014
  • Tetanus toxoid – discontinued 2013
  • Tripedia – a DTaP vaccine – discontinued 2011
  • TriHIBit – a DTaP/Hib combination
  • JE-VAX – discontinued 2005
  • Attenuvax – measles vaccine
  • Mumpsvax – mumps vaccine
  • Meruvax II – rubella vaccine
  • M-R-Vax – measles and rubella combo
  • M-M-Vax – measles and mumps combo
  • Biavax II – rubella and mumps combo
  • Heptavax-B – the original hepatitis B vaccine
  • HIB-Vax – the original Hib vaccine
  • Plague vaccine
  • Poliovax
  • Dryvax – smallpox vaccine
  • Measles-Smallpox combination vaccine
  • Diptussis – a diphtheria/pertussis combination (1949-55)
  • Quadrigen – a DTP/Polio combination (1959-68)
  • Streptococcus vaccine (1952-88)
  • Serobacterin – a pertussis vaccine (1945-54)
  • Rocky mountain spotted fever vaccine (1942-78)
  • Typhus vaccine (1941-79)
  • smallpox vaccine (1917-1976)

Most of these vaccines were discontinued because they simply became obsolete.

Orig. Title: SPvac806.8a
A smallpox vaccination kit included the diluent, a vial of Dryvax smallpox vaccine, and a bifurcated needle.

The Hib-Vax and Heptavax-B vaccines, for example, both use older technology, so these vaccines were discontinued when newer Hib and hepatitis B vaccines were introduced.

And some vaccines are discontinued  or are phased out when they get an update:

  • MMR -> MMR-II (1978)
  • Prevnar 7 -> Prevnar 13 (2010)
  • Gardasil -> Gardasil 9 (2014)

Still other vaccines, like Tripedia and TriHIBit, seemed to get discontinued as a business decision. Through mergers, Sanofi Pasteur, Ltd. ended up with two DTaP vaccines. They had their own Daptacel, but also had Tripedia, a vaccine they acquired from Pasteur Merieux. They ended up discontinuing Tripedia.

Merck also stopped making Comvax not because of “any  product safety or manufacturing issues,” but rather “as part of its ongoing effort to focus company resources on opportunities that provide the greatest value for customers, patients, and public health…”

Cervarix was discontinued because of low market demand. The competing HPV vaccine, Gardasil, had the much larger market share.

Vaccine Manufacturers and Discontinued Vaccines

And of course, some vaccine manufacturers simply stopped making vaccines.

The Texas Department of Health Resources once had a license to make vaccines, including DTP, diphtheria, DT, pertussis, tetanus, Td, and typhoid vaccines since 1950. They completely exited the vaccine market in 1979.

In the 1970s and 80s, dozens of vaccines were discontinued as Miles Inc., Eli Lilly, Parke Davis, and other companies stopped making vaccines.

While that is often downplayed these days, it is important to realize that we used to have much more competition among vaccine manufacturers. For example, in the early 1970s, the DTP vaccine was made by at least 11 different companies! We now have just two that make DTaP. And in many other cases, like for Prevnar, MMR-II, polio, and the chicken pox vaccine, there is just one manufacturer.

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Polio Pioneers

The Polio Pioneers have been described as “the largest clinical trial in history.”

It was led by Thomas Francis Jr.

The blinded trial involved 1.3 million children in elementary school, grades 1 to 3, who either got Salk‘s inactivated polio shot, a saline placebo, or were observed control subjects.

Randall Kerr is said to be the first Polio Pioneer, getting a polio shot (or a placebo), at Franklin Sherman Elementary School in Fairfax, Virginia on April 26, 1954.

Children lined up for their shots in 44 states, with very few failing to get all three shots over the course of the trial, which continued until July 10, 1954.Upon getting their third shot, kids got a Polio Pioneers button and card, which many still have today.

The results of the trial, that Salk’s vaccine work, was reported on April 12, 1955.

How did people react to the news?

salk-trial
The success of the Polio Pioneers trial made front headlines in major newspapers.

It is said the Salk’s mother wept when she heard the news.

Mrs. Roosevelt, who was observing the ten year anniversary of FDR’s death, said that she was “delighted” about the success of the Polio Pioneers trial.

Routine vaccination with the Salk polio vaccine began soon after, on April 25, 1955.

Polio Pioneer Reunions

Although more than a few Polio Pioneers have gone online to coment on their experiences, in 2003, Ben Wechsler got the idea for a big reunion.

A former Polio Pioneer who had become the director of the Pittsburgh East Rotary Club (a club that works to end polio around the world), he found a box of microfilm that Dr. Thomas Francis had left to the medical history library at the University of Michigan and found the names of all of the original Polio Pioneers.

He then set out to find them…

For More Information On The Polio Pioneers:

Jonas Salk

Dr. Jonas Salk developed the first polio vaccine in 1955, just before Albert Sabin developed his oral polio vaccine in 1961.

Approval of Salk’s vaccine followed national testing of the Polio Pioneers, one million children between the ages of six to nine years. Salk also gave his experimental vaccine to his children, his wife, and of course, to himself.

In 1955, he appeared on See It Now and told Edward R. Murrow:

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

Although he could not have patented his vaccine if he had wanted to, he was right that “there is no patent.” The National Foundation for Infantile Paralysis, which he was working for, didn’t patent the vaccine either.

In 1961, Sabin’s live, attenuated polio vaccine replaced Jonas Salk’s inactivated polio vaccine that had been in use since 1955. The United States switched back to IPV in 2000 because of concerns over VAPP.

In addition to his vaccine, his Salk Institute for Biological Studies continues to do research on aging and regenerative medicine, cancer biology, immune system biology, metabolism and diabetes, neuroscience and neurological disorders and plant biology.

For More Information On Jonas Salk:

Gregory A. Poland on Vaccines

Gregory Poland, MD is well known for many things that he has done in his long career as a pediatric infectious disease specialist and vaccinologist, including receiving the Charles Merieux Lifetime Achievement Award in Vaccinology from the National Foundation for Infectious Diseases in May 2006.

He has published over 350 peer-reviewed scientific journal articles and chapters in books and he is the Editor-in-Chief for the journal Vaccine.

As Director of Mayo Clinic’s Vaccine Research Group, Dr. Poland has a focus on “vaccinomics,” or the “development of personalized vaccines based on the increased understanding of immune response phenotype-genotype information,” working “to explain how vaccine-induced immune responses and vaccine-related adverse events may be genetically determined — and therefore predictable.”

He is sometimes known for being misquoted by anti-vaccine groups, who use his words out of context, sometimes even in testimony against state vaccine laws, because of his article highlighting some of the limitations of the measles vaccine.

Some pediatricians and vaccine hesitant parents may also know Dr. Poland for these quotes:

The way forward is clear. Because no credible evidence during the past 13 years supports the hypothesized connection between the MMR vaccine and autism disorders, it is bereft of credible evidence and must be discarded.

To continue pouring money into futile attempts to prove a connection to the MMR vaccine when multiple high-quality scientific studies across multiple countries and across many years have failed to show any hint of a connection, and in the face of biologic nonplausibility, is dangerous and reckless of lives, public funding, and ultimately public health.

At some point, a point I believe we have well passed, the small group of people who claim such connections, who have no new or credible data, and for which their assumptions and hypotheses have been discredited must simply be ignored by scientists and the public and, most importantly, by the media, no matter how passionate their beliefs to the contrary.

At this point, the antivaccine groups and conspiracy proponents promoting such an association should be ignored, much as thinking people simply ignore those who continue to insist that the earth is flat or that the US moon landing in 1969 did not really occur.

There is no law against being foolish, nor any vaccine against ignorance; however, in the meantime the health of millions of children in the United States and worldwide is being placed at unnecessary and real risk through continued deliberate misinformation and discredited unscientific beliefs, and that should be a crime.

Having given us all clear advice on how to deal with “antivaccine groups and conspiracy proponents,” hopefully he can now focus on vaccinology and vaccinomics.

For More Information On Gregory Poland:

 

Efficacy vs Effectiveness of Vaccines

According to the CDC:

Vaccine efficacy and vaccine effectiveness measure the proportionate reduction in cases among vaccinated persons.

But what’s the difference between vaccine efficacy and effectiveness?

Vaccine efficacy is used when a study is carried out under ideal conditions, for example, during a clinical trial.

Vaccine effectiveness is used when a study is carried out under typical field (that is, less than perfectly controlled) conditions.

Postlicensure studies can often help figure out vaccine effectiveness. For example, the study “Varicella Vaccine Effectiveness in the US Vaccination Program: A Review,” that appeared in The Journal of Infectious Diseases in 2008 “reviewed the results of postlicensure studies of varicella vaccine effectiveness and compared these results with those of prelicensure efficacy trials.”

That study of the chicken pox vaccine found that “the estimates of effectiveness are lower than the prelicensure efficacy,” although several studies found the vaccine “100% effective in preventing combined moderate and severe varicella.”

For More Information On Efficacy vs Effectiveness of Vaccines:

Effectiveness Rates of Vaccines

We know that vaccines work.

But how well do they work?

Taken together, you have to say that vaccines work very well.

Remember, according to the CDC:

Vaccine efficacy/effectiveness (VE) is measured by calculating the risk of disease among vaccinated and unvaccinated persons and determining the percentage reduction in risk of disease among vaccinated persons relative to unvaccinated persons. The greater the percentage reduction of illness in the vaccinated group, the greater the vaccine efficacy/effectiveness.

They aren’t perfect though and some vaccines do work better than others.

For example, the MMR vaccine provides 99% protection (two doses) against measles, while the seasonal flu vaccine can vary from 10% to 60%, depending  on how well the flu vaccine matches the flu virus strains that are getting people sick that year.

Fortunately, most vaccines have over 90 to 95% effectiveness.

The exceptions, in addition to flu vaccines, are the mumps and pertussis vaccines.

In addition to problems with waning immunity, they have lower rates of effectiveness than most other vaccines:

That’s probably why we are seeing more outbreaks of mumps and pertussis among vaccinated children and young adults, although intentionally unvaccinated children and adults are also contributing to most of those outbreaks.

For More Information On Efficacy Rates of Vaccines:

New Vaccines

Children and teens currently get 13 vaccines that protect them against 16 vaccine-preventable diseases, including DTaP, IPV (polio), hepatitis B, Hib, Prevnar 13, rotavirus, MMR, Varivax (chicken pox), hepatitis A, Tdap, HPV, MCV 4 (meningococcal vaccine), and influenza.

Although that is a big increase from the number of vaccines that they were getting in the 1960s and 1980s, it is also a big increase in the number of diseases that they are protected against.

Few vaccines have been added to the immunization schedule recently though, despite the fact that some folks claim that 300 new vaccines are in the pipeline and will soon be given to kids.

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