A November 2007 report entitled, "Pipeline and Commercial Insight: Pediatric and Adolescent Vaccines," authored by vaccine analyst, Hedwig Kresse, for the independent market analyst Datamonitor discusses the future outlook for vaccine profits.
The report provides an assessment of products and a patient-based forecast of market size and coverage rates to the year 2016, and predicts that the introduction of high price vaccines will induce rapid growth in the pediatric and adolescent vaccines market.
The report predicts that due to the "promising commercial potential" of new, high-price vaccines, the pediatric and adolescent market will quadruple from approximately $4.3 billion in 2006, to over $16 billion by 2016, across the US, the EU-five including France, Germany, Italy, Spain, and the UK, and Japan.
The crucial factor for success in the pediatric market, the report notes, is the introduction of a product into national vaccination schedules. "Along with reimbursement, this virtually guarantees the rapid uptake and continuously high coverage rates in the target population," Ms Kresse states.
As an example, she cites Wyeth's Prevnar, as the first premium price vaccine launched in the US in 2000 for vaccinating infants against pneumonia and meningitis.
Since then, Prevnar has been added to the childhood vaccination schedules in the US and EU-five despite its high price of nearly $320 for the 4-dose regimen. In 2006, Global sales reached almost $2 billion, making Prevnar the first vaccine to attain blockbuster status, according to the report. By 2016, Datamonitor expects the total value of the infant market for pneumococcal vaccines to increase to $2.3 billion.
In June 2006, Merck's Gardasil was approved for cervical cancer. Because it was the first vaccine offered as a preventive measure for a form of cancer, its approval generated tremendous public attention along with pressure for healthcare authorities to make the vaccine available to teenage girls at a cost of $360 for 3 doses.
"Although most cases of cervical cancer in the developed world can be prevented through the existing pap smear screening programs, the expensive HPV vaccination has been recommended and is reimbursed for teenage girls across the US and Europe," Ms Kresse reports.
She notes that this decision is driven more by public pressure and excitement about the opportunity to vaccinate against cancer rather than by real need. The widespread publicity has led to a good uptake in the target group of adolescent girls, which is usually hard to reach for vaccination, Ms Kresse points out to investors.
Datamonitor sees a huge commercial opportunity in HPV vaccines, with annual sales of $1.4 billion in teenage girls for the seven major markets by 2016 and a cumulative catch-up opportunity in women aged 13-26 that could add up to over $17 billion until 2016.
But Ms Kresse warns investors that the "lack of medical need" for rotavirus vaccines such as RotaTeq will limit their uptake in most markets. RotaTeq is advertised to combat diarrhea that usually affects infants under the age of two, and was introduced by Merck in the US in 2006, at a price of $200 for the three-dose regimen.
According to Ms Kresse, many countries, but not the US, have refused to add the vaccine to their schedules due to cost-benefit reasons. "In the developed world, rotavirus diarrhea is rarely severe for small infants and quick and efficacious treatment is already available," she writes. "Consequently, healthcare authorities see no need to widely introduce a very expensive vaccine."
Datamonitor estimates that annual sales will remain limited to approximately $1 billion across the 7 major markets by 2016 and predicts that the US will account for the majority of sales, being the only country to have recommended the rotavirus vaccine for all infants.
Wyeth's Prevnar vaccine came on the market in 2000 and is recommended for children under 2. The vaccine was hailed as a breakthrough and had sales of more than $1.5 billion in 2006. Prevnar is given as four shots to children between 2 and 15 months.
On September 18, 2007, NewsMax reported that the vaccine has dramatically curbed pneumonia and other serious illnesses in children but is also having an unfortunate effect: "promoting new superbugs that cause ear infections."
According to NewsMax, doctors reported finding the first such germ that is resistant to all drugs approved to treat childhood ear infections and 9 toddlers in Rochester, N.Y., have had the bug and that it also may be turning up elsewhere.
It is a strain of strep bacteria not included in the pneumococcal vaccine. Prevnar prevents seven strains responsible for most cases of pneumonia, meningitis and bloodstream infections. But dozens more strains exist and some have become resistant to antibiotics since the vaccine combats the more common strains.
If the new strains continue to spread, "it tells us the vaccine is becoming less effective" and needs to be revised, Dr Dennis Maki, infectious diseases chief at the University of Wisconsin-Madison Hospitals and Clinics, told NewsMax.
A new study in the November 8, 2007 New England Journal of Medicine by researchers at Oregon Health & Science University, supported by the United States Public Health Service, suggests that the schedule for vaccinating and revaccinating against diseases should be reevaluated and adjusted.
The study found that in many cases, the established duration of immunity for vaccines is greatly underestimated, which means that people are getting booster shots when their immunity levels do not require it and those antibody responses caused by viruses such as measles mumps, and rubella remained at protective levels for several decades and in most cases, for life.
The research also reconfirmed a previous finding by Slifka and his colleagues: that the duration of immunity after smallpox vaccination is much longer than previously thought. In that earlier study published in the journal Nature Medicine in 2003, these OHSU researchers observed surprisingly long-lived antiviral antibody responses but they were unable to measure the slow rate of decline.
The study indicates that the duration of immunity after smallpox vaccination is maintained with a calculated half-life of 92 years and that a person who has received the primary series of tetanus vaccine is likely to be protected for 3 decades.
Experts say we have allowed ourselves and our children to be overdosed through a culture dominated by industry marketing influence which has now become dangerously out of control and detrimental to our children's health. "In the 21st century, it is unacceptable to be marketing medication to infants and children that may not work," Dr Steven Czinn, chair of the department of pediatrics at the University of Maryland School of Medicine, told Reuters on October 11, 2007.
In the November 19, 2007 Huffington Post article, "Over Medicated and Over-Vaccinated: The Unintended Consequence of Medicines Meant to Protect," Deirdre Imus asks, "Where are the conflict-free studies that prove giving infants and children 49 immunizations - most of them by age 5, are safe and effective?"
She points out that studies have provided evidence that the over-vaccination of dogs and cats can result in numerous maladies including cancer, skin and ear conditions, arthritis, allergies, diabetes, aggression, behavior problems and other immune system dysfunctions. "There is even a name for the conditions caused by animal over-vaccination, vaccinosis," she notes.
Ms Imus also points out that the mercury-containing preservative, thimerosal, used in vaccines for over 50 years was removed from animal vaccines in 1992.
"Unfortunately for the kids," she writes, "it remained in children's vaccines for another decade and remains in some vaccines like the influenza (25 micrograms) and tetanus vaccine (25 micrograms) today and in trace amounts (3 micrograms) in some immunizations."
She says most people do not realize is that any liquid waste containing more than 200 parts per billion (ppb) mercury must be deposited at a hazardous waste site and that drinking water cannot exceed 2 ppb mercury.
"But when the influenza vaccines arrive and are injected into pregnant woman and infants as young as six months, those vaccines contain 50,000 ppb mercury," Ms Imus notes.
This amount of mercury is 250 times higher than hazardous waste, she notes, and according to EPA guidelines, this amount can only be considered safe if a person weighs 550 pounds. "Even trace amounts of mercury in vaccines can be anywhere from 600 to 2000 ppb," she warns.
On November 13, 2006, PutChildrenFirst.org, a parent-led organization advocating vaccine safety, issued a press release to announce the results of a survey conducted October 27-30, 2006, by Zogby International of over 9,000 Americans to learn their plans for getting flu shots, their knowledge of its ingredients, and who they hold responsible for making sure vaccines are safe.
The survey showed that an overwhelming majority of Americans were unaware that most flu shots contain mercury and that they would refuse a shot with mercury. After learning that mercury is an ingredient, 74% of those polled said they were less likely to get a flu shot and 86% of parents said they were less likely to allow their child to get a shot.
Lisa Handley is a founding parent of PutChildrenFirst.org, whose son Jamison had an adverse reaction to a flu shot with mercury in 2003. "I know firsthand how life-changing a flu shot with mercury can be, since our son began his regression into autism after his flu shot," she states.
"With everything we know about the dangers of mercury and the havoc it can wreak on young, developing brains, there is no excuse for any vaccine to contain mercury," says Lyn Redwood, RN, MSN, President of SafeMinds, a nonprofit organization committed to ending mercury-induced neurological disorders.
"The survey reveals that Americans are overwhelmingly in the dark about what is in most flu shots," Ms Redwood stated in the press release.
"They do not want a known neurotoxin injected into their children, and they believe Congress and medical professionals must be more vigilant about keeping vaccines safe and mercury-free," she added.
PutChildrenFirst also advises that two recent studies in leading medical journals admitted that limited data exists to support the effectiveness of flu vaccines. One study, in the Journal of the American Medical Association, noted that, "there is scant data on the efficacy and effectiveness of influenza vaccine in young children," the release notes.
According to Ms Imus, we are beginning to see prescribed vaccines, like the whole cell DPT and Rotovirus, which are later found to be unsafe.
"While physicians warn the public about the over use of antibiotics," she points out, "it is the physicians themselves that over-prescribed these antibiotics for every ailment under the sun."
"And like antibiotics," she writes, "every time a new vaccine was developed, it quickly found its way onto the immunization schedule along with the recommended booster shots."
"We are now reaping the unintended consequences of the overuse of these medical interventions," she states. "Instead of being healthier, we have a nation of very sick children."
Forcing parents to inject poisonous concoctions into innocent, helpless children against their will is a gross violation of their most basic parental rights.
(Evelyn Pringle is an investigative journalist focused on exposing corruption in government and corporate America)