15 of those affected attend LeRoy Junior-Senior High School, leading some to wonder about possible environmental factors.  There is a 41-year-old toxic spill located a few miles from the school.

According to CNN:

“Whatever the cause, many experts in the medical community have expressed skepticism that these symptoms could be the result of toxins in the environment ... [W]henever there is a cluster of cases, it is necessary to thoroughly test for environmental or infectious causes.”

One possibility is an infectious disease.  One doctor who examined the teens in LeRoy found that they tested positive for strep and mycoplasma.

Obsessive-compulsive disease and tic symptoms, as well as Tourettes Syndrome, can be triggered by a bacterial pneumonia infection.  The CDC and individual states don't conduct surveillance for M. pneumonia, even though it is the most common cause of bacteria pneumonia in school-aged children.

And in fact, pneumonia vaccines don't even treat M. pneumonia; they are all S. pneumonia vaccines ... which could very well be the source of the problem.  When children are treated with S. pneumonia vaccines, it can result in an increase in other pneumonia serotypes.  It might be possible that the recent introduction of a new 13-valent vaccine is causing M. pneumonia to flourish.

Here’s some information about pneumonia infections and vaccines from the National Vaccine Information Center.  As you will see, the complications of M. pneumoniae can include nervous system disorders and tics.  And you will also see that pneumonia vaccines themselves can be just as dangerous.

Pneumococcal Disease (Pneumonia)

Quick Facts:

S. Pneumoniae (Pneumococcal infections)

• Streptococcus pneumonia (S. pneumoniae), also known as pneumococcus, is the most common cause of bacterial pneumonia and middle ear infection (otitis media) in the U.S., and the third most frequent cause of bacterial meningitis. The most common causes of viral pneumonia are influenza, parainfluenza and respiratory syncytial virus (RSV).[1]

• S. pneumoniae is found in the upper area of the throat behind the nose, and can be isolated in 5 to 10 percent of healthy adults and 20 to 40 percent of healthy children. It can cause serious illness, including inflammation of the brain, blood infections and pneumoniae.[2] It becomes pneumonia when it spreads to the lungs. The primary cause of death from S. pneumoniae is pneumonia.[3]

• S. pneumoniae is spread by direct or droplet transmission (such as coughing, sneezing or other contact with respiratory secretions) to people in close contact with an infected person. Crowded environments such as daycare centers, military barracks, prisons and homeless shelters, and poor ventilation can make transmission even more conducive.

• The CDC states that each year in the U.S. pneumococcus causes about 4000 cases of blood stream infections (bacteremia), meningitis, or other invasive disease in children younger than 5 years of age. Children under 2 years of age average more than 1 middle ear infection (otitis media) each year, many of which are caused by pneumococcus.[4]

• Symptoms for all forms of pneumococcal infections include sudden onset of fever and malaise. Other symptoms can include cough with sputum and other respiratory conditions such as shortness of breath or sneezing. Patients may feel unwell for several days with an unproductive cough and low-grade fever before the infection worsens. Symptoms of pneumococcal meningitis can include stiff neck, headache, lethargy, or seizures.[4] Symptoms of otitis media include a painful ear, red or swollen eardrum, fever, and irritability.[5]

Pneumococcal Vaccine

• There are two types of pneumococcal vaccines: Pneumococcal polysaccharide vaccine (PPSV) and Pneumococcal conjugate vaccine (PCV). The FDA has approved one PPSV: Merck’s Pneumovax 23; and two PCVs, Wyeth/Pfizer’s 7-valent PCV Prevnar; and Wyeth/Pfizer’s Prevnar 13.[6]

• The FDA recommends a 4-dose schedule of PCV13 to infants and children under 2 years of age, and a 1- or 2-dose schedule of PCV13 for children ages 2 through 18, depending on whether they have previously completely the infant schedule.[5]

• The PPSV23 vaccine is recommended for adults 65 years of age and older.[6] In an accelerated process, on December 30, 2011, the FDA expanded its approval of Prevnar 13 to include adults age 50 and older.[7]

• By 2008, eight years after it was introduced in the U.S., the pneumococcal vaccine was responsible for decreasing the rates of invasive pneumococcal disease in U.S. children age 5 and under to as much as one-fifth of what it was in 1998.[8] However, it was also responsible for increasing the rates of otitis media serotypes not included in the vaccine.[9]

NVIC “Quick Facts” is not a substitute for becoming fully informed about shingles and the shingles vaccine. NVIC recommends consumers read the more complete information following the "Quick Facts", as well as the  vaccine manufacturer product information inserts, and speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child.

Vaccine Reaction Symptoms & Ingredients

Our Ask 8, If You Vaccinate webpage contains vaccine reaction symptoms and more. Calculate vaccine ingredients for potential toxic exposures & print a vaccination plan with the Vaccine Ingredients Calculator. 

Food & Drug Administration (FDA)

Pneumococcal Vaccine, Polyvalent Merck & Co. Inc. Pneumovax 23 and Licensing Information

Pneumococcal 7-Valent Conjugate Vaccine (Diphtheria CRM₁₉₇Protein) Pfizer/ Pharmaceuticals Inc. Prevnar and Licensing Information

Pneumococcal 13-Valent Conjugate Vaccine (Diphtheria CRM₁₉₇Protein) Pfizer/Wyeth Pharmaceuticals Inc. Prevnar 13 and Licensing Information

Centers for Disease Control (CDC)

CDC on Pneumonia

CDC on Pneumococcal Vaccination

Pneumococcal Conjugate (PCV13) Vaccine Information Sheet

Pneumococcal Conjugate (PCV7) Vaccine Information Sheet

Pneumococcal Polysaccharide (PPSV23) Vaccine Information Sheet

Search for Vaccine Reactions

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Reporting a Vaccine Reaction

Since 1982 the NVIC has operated a Vaccine Reaction Registry, which has served as a watchdog on VAERS. Reporting vaccine reactions to VAERS is the law. If your doctor will not report a reaction, you have the right to report a suspected vaccine reaction to VAERS.

What is Pneumococcal Disease?

Pneumococcal disease (pneumonia) is an infection of the lungs that is usually caused by bacteria or viruses and, sometimes, fungi living in your nose, mouth, sinuses, or environment.[1]  A few strains that are untreatable by antibiotics have also developed as a result of overuse and inappropriate use of standard antibiotics. Antibiotic-resistant strains of pneumococcal diseases not included in pneumococcal vaccines also have developed as a result of the use of pneumococcal vaccines.

Influenza, parainfluenza, and respiratory syncytial viruses (RSV) are the most common viral causes of pneumonia.

Streptococcus pneumoniae (S. pneumoniae) are the most common bacterial cause of pneumonia. S. pneumoniae are bacteria that live in the nasopharynx, an area in the back of the nose, toward the base of the skull.[3] S. pneumoniae can cause infections in the middle ear, sinuses, trachea, bronchi, and lungs.

The term actually describes a group of illnesses all caused by S. pneumoniae, including pneumonia, bacteremia (bloodstream infection), sepsis (blood poisoning), sinusitis, meningitis (infection of tissues and fluids surrounding the brain and spinal cord), and acute otitis media (middle ear infections). These pneumococcal diseases are called “invasive” diseases because the germs invade parts of the body that are normally free from germs.[10] Less frequently it can also cause endocarditis, septic arthritis and peritonitis.[11]

The exact contribution of S. pneumoniae to childhood pneumonia is unknown, as it is often not possible to identify the causative organisms. In studies of children less than 5 years of age with community-acquired pneumonia, 30 percent of cases were classified as bacterial pneumonia, and 70 percent (21 percent of total community-acquired pneumonia) were found to be due to S. pneumoniae.[12]

According to Harrison’s Principles of Internal Medicine, 5 to 10 percent of healthy adults and 20 to 40 percent of healthy children are infected with S. pneumoniae at any given time, often without becoming sick or showing symptoms of infection. In an adult, these organisms can persist for 4 to 6 weeks, although it is possible for them to persist as long as 6 months. Respiratory syncytial virus (RSV) is the most common cause of pneumonia in children less than 1 year of age.[2]

Worldwide, pneumonia is the No. 1 killer of children under age 5. Strongly linked to malnutrition, poverty, and inadequate access to healthcare, 98 percent of pneumonia deaths are children living in mostly Third World Countries. According to the World Health Organization, 1.8 million children died in 2007 (latest year available) because of pneumonia, and 1.8 million will continue to die every year as long as global efforts to stem the disease are not met.[13]

In the U.S. in 2008 (latest data year available) there were 54,562 deaths due to pneumonia. The majority of these deaths (42,130) were persons aged 75 and older. For babies under 1 year of age, there were 210 deaths; for children ages 1 to 4, there were 118 deaths; for youths ages 5-14, there were 57 deaths. Together with influenza (1,722 deaths) pneumonia was the 8^th leading cause of death in the U.S. in 2008.[14]

NVIC Note: When reporting pneumonia and influenza deaths in the media, health officials often combine the two numbers, which can lead to confusion as to which ones are pneumonia and which ones are flu. For the purposes of this report, NVIC is using the CDC’s latest edition of the National Vital Statistics Report, which breaks the numbers down.

Pneumonia can be mild or severe. Symptoms of S. pneumoniae can mimic a cold or upper respiratory infection such as influenza, and can include sneezing, sore throat, and cough followed by a high fever. Chills and a cough with sputum—which is usually discolored and sometimes bloody—as well as fatigue, nausea, vomiting, rapid breathing or shortness of breath, and chest pain can also be symptoms of pneumonia.[3]

It is especially common for children to carry the bacteria in their throats without being ill from it. But once the droplets are in the lungs, white blood cells begin to attack the bacteria or offending organism, causing the lungs’ air sacs to fill with fluid, leading to difficulty breathing.

Often, the only signs of pneumonia in infants and younger children are fever and lethargy, even though they appear quite ill. Elderly persons can often have very few symptoms.[3]

Mycoplasma pneumoniae (M. pneumoniae) is the leading cause of bacterial pneumonia in school-age children.[15] Since the CDC and individual states do not conduct a surveillance system for M.  pneumoniae, the normal rate of infection for it is unknown. Some CDC reports suggest that M. pneumoniae accounts for 15 to 20 percent of community-acquired lower respiratory infection in adults.[16] With children, recent studies show that M. pneumoniae causes up to 40 percent of community-acquired pneumonia, and as many as 18 percent of cases requiring hospitalization.

Other studies show that M. pneumoniae is also responsible for triggering wheezing in susceptible individuals and for exacerbating, or possibly causing, asthma.[17]

Persons of all ages are at risk of contracting M. pneumoniae, but it’s rarely seen in children less than 5 years old. Outbreaks can occur wherever crowded conditions exist, such as in school or military settings. Commonly referred to as “walking pneumonia,” an M. pneumoniae epidemic was declared in the Boston area in late 2011 after an outbreak was reported in several elementary schools.[18, 19] Previous M. pneumoniae epidemic outbreaks were reported in Ohio, Texas, and New York in 1993.[16]

Symptoms of M. pneumonia can take several days to develop, and can persist for weeks or months. The most common symptoms are sore throat, hoarseness, fever, cough that begins as nonproductive, but later may yield small to moderate amounts of non-bloody sputum, headache, chills, cold-like symptoms, myalgias, earache, and general malaise. Up to one-third of patients with M. pneumoniae may have ear symptoms including otitis externa, otitis media, and myringitis.[17]

With the most severe type of M. pneumoniae, tracheobronchitis accompanied by a variety of respiratory tract symptoms is common. Mild infections and asymptomatic conditions are most common in adults (about 20 percent).[16] However, bronchopneumonia involving one or more lobes of the lungs can develop in 3 to 10 percent of infected persons.

Complications of M. pneumoniae can include nervous system disorders such as encephalitis, cerebellar syndrome and polyradiculitis, cranial nerve palsies, asceptic meningitis or meningoencephalitis, acute disseminated encephalomyelitis, coma, optic neuritis, diplopia, mental confusion, and acute psychosis secondary to encephalitis. Ataxia, cranial nerve palsy, and Guillain-Barre Syndrome have also been reported.[20,21]

Additionally, a 2008 study showed that obsessive-compulsive disease and/or tic symptoms, as well as Tourettes Syndrome may also be triggered my M.  pneumoniae. These symptoms are more commonly classified as pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections, or PANDAS.[80]

Hospital-acquired pneumonia (also known as nosocomial pneumonia) is an infection of the lungs that occurs during a hospital stay. This type of pneumonia tends to be more serious because hospitalized persons are often sicker and unable to fight off germs.[22] Also, the types of germs in a hospital are often more dangerous than those acquired in the community, because the organisms tend to be more virulent and often drug resistant.[23] Hospital-acquired pneumonia occurs more often in patients who are on a respirator (ventilator) to help them breathe. When pneumonia occurs in this situation, it’s called ventilator-associated pneumonia.

Risk factors for getting hospital-acquired pneumonia are being on a breathing machine, aspirating food or other substances into the lungs, having chest surgery, being immunosuppressed, having long-term, chronic lung disease, not being fully alert, older age, and having a recent illness.

Community-acquired pneumonia is bacterial or viral pneumonia in people who have not recently been in the hospital or another health care facility such as a nursing home or rehabilitation center. [23,61]

Classic symptoms of typical community-acquired pneumonia are shaking chills, productive cough, fever, and pleuritic chest pain. Atypical symptoms can include gradual onset of mild fever, respiratory problems, and little or no sputum. Cough is typically productive in older children and adults, while a dry, nonproductive cough is more common in infants, young children and the elderly. Other symptoms can include a crackling sound in the lungs or bronchial tubes. [24,61]

Some patients with community-acquired pneumonia may actually have infection due to organisms such as H. influenza, Staphylococcus aureus (particularly in patients who take glucocorticoids), or C. pneumoniae, rather than classic S. pneumoniae. C. pneumoniae is the second most common cause of lung infections in people aged 5 to 35, and is commonly responsible for outbreaks of respiratory infections within families, college dorms, and military training camps.[2,61]

You can get aspiration pneumonia by breathing in or inhaling food, liquids, vomit, or fluids from your mouth into your lungs.[24]

Is Pneumococcal Disease Communicable?

Yes. Pneumococcal diseases are spread person-to-person through contact with persons who are ill, or through healthy persons who carry the bacteria in the back of the nose but are asymptomatic. Transmission is mostly through the spread of respiratory droplets or secretions (mucous) from the nose or mouth of an infected person.[10]

Day care centers are places where transmission can be prevalent, especially penicillin-resistant strains of pneumococcal serotypes. Other places where pneumococcal diseases can spread quite easily are nursing homes, military barracks, prisons, and shelters for the homeless. However, the risk of pneumococcal pneumonia is NOT increased by contact in schools or workplaces, including hospitals.[10]

While health officials have found that being an Alaska native, American Indian, or African-American puts you at higher risk of being susceptible to pneumococcal diseases, Harrison’s Principles of Internal Medicine notes that susceptibility patterns vary greatly between and even within individual communities, and the data are in a state of flux.

More importantly, Harrison’s also notes that the constant trend of all pneumococcal infections is toward more widespread antibiotic resistance.

History of Pneumococcal Disease in America

Pneumonia is a disease whose symptoms were recorded in the times of Hippocrates, as early as 460 B.C. Through the ages, surgeons and scientists referred to it as “acute fever, short rapid breaths,” and other symptoms we identify today with pneumonia.[25] It was Louis Pasteur who, in 1881, identified S. pneumoniae as the major cause of pneumonia in the U.S. Following this discovery, scientists worked at identifying individual serotypes of S. pneumoniae, and by 1940, over 80 had been documented.

Today there are at least 90 known serotypes. Pneumonia has remained as the eighth leading cause of death in the U.S. for the past several years.[14] In the 1930s, however, before antibiotics were widely available, pneumonia was the third leading cause of death in the U.S. The discovery of penicillin in the early 1900s helped bring the numbers down, but did not reduce the actual incidence of the disease, particularly in individuals whose immune systems are deficient.[25]

Today, just seven pneumoniae serotypes are responsible for 80 percent of infections in U.S. children aged 6 years and under. Worldwide, 10 of the most common serotypes are responsible for 62 percent of pneumococcal infections.[10] The CDC estimates that as many as 175,000 hospitalizations occur each year in the U.S. due to pneumococcal pneumonia, with 5 to 7 percent of that number dying. An estimated 50,000 cases of bacteremia occur each year in the U.S., with a case fatality rate of 20 percent, and as much as 60 percent in elderly adults. Between 3000 and 6000 cases of pneumococcal meningitis occur each year.[81]

Scientists began experimenting with rabbit serum in the 1890s in an attempt to discover a vaccine for pneumonia. In 1920, they found the rabbit antibodies could bind to polysaccharides of S. pneumoniae, and various forms of a polysaccharide vaccine soon were available in the U.S. through the 1940s. However, the discovery of penicillin in 1928 caused a lack of acceptance and market for the vaccine until 1977, when a 14-valent vaccine was licensed and approved by the FDA. [26]

A 23-valent pneumococcal vaccine was approved in 1983, but just prior to the FDA’s approval of a 7-valent vaccine in 2000, studies showed that the overall incidence of pneumococcal disease was still 23.2 cases per 100,000 people, for a total of 62,840 cases in 1998. The statistics also showed that disease rates were highest for children younger than 2 years of age and adults aged 65 or older, and that incidents among blacks were 2.6 times higher than among whites.[27]

By 2001, the pneumococcal disease rate in the U.S. had declined 69 percent overall among children under 2 years of age and 78 percent for vaccine and vaccine-related serotypes. The rate of pneumococcal meningitis also went down 59 percent. Interestingly, vaccine effectiveness seemed vary by state, with the largest decline (85 percent) in California. Researchers attributed the lower numbers to the new vaccine, the 7-valent, protein-polysaccharide conjugate, Prevnar.[28]

At the time, however, researchers also questioned whether an increase in disease caused by serotypes not included in the vaccine or not related to those in the vaccine might be possible, since this effect was seen in a different clinical trial, which evaluated Prevnar 7’s efficacy against otitis media. In that study, even though otitis media caused by the serotypes in the vaccine decreased, ear infections caused by non-vaccine serotypes increased by over a third. [29, 30]

By 2009, health officials had confirmed that non-vaccine serotypes were replacing the ones in the vaccine, and that they had caused invasive pneumonia in children to increase by 71 percent.[31,32] And worse, by January 2011, they also knew that the S. pneumoniae strain responsible for pneumonia not only was changing one of its DNA letters every 15 weeks – making it more resistant to antibiotics—but had already done so years before Prevnar even hit the market.[33]

Can Pneumococcal Disease Cause Injury and Death?

Yes. The primary cause of death from S. pneumoniae is pneumonia. But S. pneumoniae can also cause serious infections such as empyema, endocarditis, meningitis, bacteremia, peritonitis, septic arthritis, brain abscess, pancreatic and liver abscesses, aortitis, tubo-ovarian abscesses, necrotizing fasciitis, and sepsis.[3,35,41,42]

Complications of M. pneumoniae can include nervous system disorders such as encephalitis, cerebellar syndrome and polyradiculitis, cranial nerve palsies, asceptic meningitis or meningoencephalitis, acute disseminated encephalomyelitis, coma, optic neuritis, diplopia, mental confusion, and acute psychosis secondary to encephalitis. Ataxia, cranial nerve palsy, pericarditis, and Guillain-Barre Syndrome have also been reported.[21,35,41,42]

Additionally, a 2008 study showed that obsessive-compulsive disease and/or tic symptoms, as well as Tourettes Syndrome may also be triggered my M.  pneumoniae. These symptoms are more commonly classified as pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections, or PANDAS.[80]

M. pneumonia can also cause serious illness such as intravascular coagulation and a rare but severe complication called hemolytic anemia. Acute glomerulonephritis, renal failure, tubulointerstitial nephritis, and IgA nephropathy have also been reported as a consequence of M. pneumonia. Deaths from M. pneumoniae are reported primarily among the elderly and persons with sickle-cell disease.[16,34]

Who is at Highest Risk for Getting Pneumococcal Disease?

Young children are more likely to get pneumococcal diseases than older children or young adults. People most at risk of getting pneumonia are those with anatomic or functional asplenia (including sickle cell disease), patients taking immunosuppressive drugs, those with congenital and acquired immune deficiency (including HIV infections), children with cochlear implants, and those with chronic renal disease.[36]

Studies have also shown that having a vitamin D deficiency can make you more susceptible to getting pneumonia and having more complications from it, including death. For example, once infected, adult patients hospitalized with pneumonia are more likely to die if they are vitamin D deficient.[37] This association between vitamin D deficiency was not explained by patient age, sex, comorbidities, the severity of the systemic inflammatory response, or other known prognostic factors.

An earlier study (1999) in children also showed there is a strong association between pneumonia and nutritional rickets, which is a form of vitamin D deficiency. Other studies support the claim that vitamin D deficiency predisposes children to respiratory diseases.[38.39]

Numerous conditions such as having a prior cold or flu, or if you have been hospitalized for a surgery, especially chest or abdominal surgery, are risk factors for contracting pneumonia.[40] Also, people with recent viral infections, lung disease, heart disease, and swallowing problems, as well as alcoholics, drug users, those with cirrhosis of the liver, and those who have suffered a stroke or seizure are at higher risk for developing pneumonia than the general population.[3]

Overall malnutrition and illnesses that affect many organs or the whole body can also make you susceptible to getting pneumonia. Immunocompromised individuals with neutropenia, asplenia, sickle cell disease, disorders of complement and humoral immunity, human immunodeficiency virus (HIV) infections or chronic underlying disease also are more at risk. Children who have certain illnesses such as cerebral palsy, cystic fibrosis and chronic heart or lung conditions also are at higher risk.

Crowded conditions, group settings such as daycares, nursing homes and hospitals, and poor ventilation can contribute to transmission of S. pneumoniae. According to the CDC, children in an out-of-home day care are at an approximate two-fold increased risk of getting pneumonia. Also, being an Alaska native, African-American or American Indian puts you at an increased risk of invasive pneumonia, although health officials aren’t exactly sure why.[10]

Pregnant women also may be at risk. Other risk factors include being a smoker, having dementia or a neurological disease such as Parkinson’s, or living in a nursing facility.[23,41]

According to Harrison’s Principles of Internal Medicine, the risk of bacteremic pneumonia is relatively high among infants up to 2 years of age and low among teenagers and young adults. Rates begin increasing again at about age 55. Most cases of pneumococcal bacteremia in adults are due to pneumonia, with a mid-winter peak and a dip in summertime.[2]

Another risk for pneumonia is vaccination for rotavirus. According to a study published in 2008 by the FDA, an increase in both pneumonia cases and pneumonia deaths were observed with the rotavirus vaccine Rotarix.[92,95]

Who is at Highest Risk for Suffering Complications of Pneumococcal Disease?

Some people can be more susceptible to both getting pneumonia and having complications from it than others, such as an adult who smokes or drinks excessively, someone with an injury, someone undergoing chemotherapy, or someone taking medication that suppresses the immune system, such as prednisone.[43]

People with chronic illnesses such as heart, pulmonary, liver or renal disease, or people with weakened immune systems such as those living with HIV or anatomic asplenia (sickle cell disease) may also be more susceptible to contracting pneumonia and having serious complications from it. Children with cochlear implants or cerebrospinal (CSF) fluid leaks are more likely to get pneumococcal meningitis.[42.43,81]

Pneumococcal Prevention and Treatment Options

Treatment of pneumococcal diseases includes antibiotics, usually a broad-spectrum cephalosporin and/or vancomycin. Penicillin and other antibiotics are sometimes used; however, in some areas of the U.S., up to 40 percent of invasive pneumonia isolates are resistant to penicillin.[81]

The CDC and World Health Organization recommend pneumococcal and influenza vaccination as a method of preventing pneumococcal diseases, especially for children, the elderly, and people with diabetes, asthma, emphysema, HIV, cancer, or other long-term condition.[1,13,44] They also advocate Haemophilis influenza type b (Hib) vaccination as a preventative against Haemophilis-caused pneumonia.[42]

However, according to the National Institutes of Health and WHO’s UNICEF Global Plan for Prevention and Control of Pneumonia, other interventions can help prevent pneumonia too, particularly in babies and children.[13.42] Some of those strategies include:

• Exclusive breastfeeding for the first six months of life
• Replacing open-fire cook stoves – which increase risks of respiratory problems – with clean and vented stoves
• Improving overall nutrition of both mothers and young children, including adequate micronutrient consumption (vitamins, minerals)
• Preventing low birth weight
• Reducing indoor pollution of all types
• Zinc supplementation for children with diarrhea
• Practicing clean-living standards that reduce the spread of germs
• Promoting good hand washing habits, especially after going to the bathroom, blowing your nose, and diapering a baby, as well as before eating and before preparing foods
• Working to implement improved water and sanitation interventions in developing countries
• Prevention of HIV in children

The Society for Women’s Health Research (SWHR) offers additional advice on how to avoid getting sick and spreading germs and infections of any kind. While hand washing is the single most effective way to prevent the spread of infections, keeping your hands away from face, eyes, nose, and mouth can also limit the transfer of viruses, bacteria, and other harmful pathogens that can make you sick. In family, daycare, or school settings care should be taken not to share eating utensils or toys that may have been exposed to saliva or other bodily excretions.[45]

The CDC also has a webpage with guidelines on proper hygiene and cough etiquette that can help prevent the spread of respiratory infections in public or institutional settings. Help with hand washing in all types of settings, including cruise ships and day cares, is available at the CDC’s website here. Guidelines for preventing healthcare-associated pneumonia can be found here.[46,47,48]

NVIC note: Although the CDC advocates flu vaccination as one way of preventing pneumococcal disease, at least one study has shown that this method isn’t always effective. For example, in a study of immunocompetent elderly people aged 65-94, researchers found that influenza vaccination is not associated with reducing the risk of community-acquired pneumonia.[49]

Whether you choose to vaccinate or not, it is important to know that nutrition and exercise also play a part in prevention of pneumococcal diseases.

Vitamin D status is particularly important: clinical studies have shown that invasive pneumococcal disease, meningococcal disease, and group A streptococcal disease are more common when vitamin D levels are lowest. In Ethiopia, for example, it was found that 42 percent of children hospitalized for pneumonia had rickets, a form of severe vitamin D deficiency.[50] And in Kabul, Afghanistan, it was found that vitamin D3 supplementation, along with antibiotic treatment, can help control repeat pneumococcal infections.[51]

Even in the United States, many studies have shown that nutritional deficiencies can contribute to frequent respiratory tract infections.[57]

Other recent studies also have shown that regular moderate exercise can reduce the risk of catching cold-like symptoms and that physical fitness overall can reduce the frequency and severity of colds and respiratory infections.[52,53,54,55,56]

What is Pneumococcal Vaccine?

There are three pneumococcal vaccines approved in the U.S. for pneumococcal diseases. One is a polysaccharide; the other two are conjugate vaccines.[62]

The polysaccharide vaccine (Merck’s Pneumovax 23) is an inactivated-bacteria vaccine. It works by teaching your body to attack the bacteria if you are exposed to it.[58]

The conjugate vaccines (Wyeth/Pfizer’s 7-valent Prevnar and Prevnar 13) are killed or inactivated vaccines that use a protein or other small pieces taken from the bacteria to teach the immune system to recognize and fight active bacteria.[59]

Prevnar 7-valent is a Wyeth/Pfizer conjugate vaccine with an aluminum adjuvant. It contains the seven pneumococcal serotypes(4, 6B, 9V, 14, 18C, 19F, and 23F) responsible for 86 percent of bacteremia, 83 percent of meningitis, and 60 percent of acute otitis media in children aged 6 years and under. Before the introduction of Prevnar 13, the CDC recommended three doses of Prevnar be given at approximately two-month intervals, with a fourth dose at 12-15 months of age. It is injected directly into the muscle.[60]

According to the manufacturer’s product insert, the protein used to activate the pneumococcal bacteria is diphtheria CRM₁₉₇, a recombinant conjugate diphtheria toxin. The diphtheriae strain is grown in a casamino acids and yeast extract-based medium and purified through ultrafiltration, ammonium sulfate precipitation, and ion-exchange chromatography.[63] Prevnar also contains polysorbate 80, aluminum phosphate as an adjuvant, and no thimerosal.[81]

Although conjugate vaccines have a history of effectiveness, a recent study says there are still many unanswered questions about their use when multiple vaccines are being given, including their effectiveness in special populations.[65]

Efficacy for invasive pneumococcal diseases (IPD) relevant to the seven serotypes in this vaccine is estimated at 94 percent, and is credited with reducing invasive pneumococcal disease in U.S. children by 45 percent overall. Post-marketing surveillance, however, also showed that the incidence of IPD caused by one particular serotype, 19A, nearly tripled after the introduction of Prevnar 7. The rates of meningitis and invasive pneumonia caused by non-vaccine serotypes also increased for all age groups, and the rates of primary bacteremia did not change at al, indicating that non-vaccine strains were replacing those in the vaccine.[70]

According to the manufacturer’s product information insert, researchers already knew this would probably happen: clinical trials showed that while Prevnar-7’s efficacy against acute otitis media (AOM) was 51 percent in the protocol population and 44 percent in the intent-to-treat population, it also put children who received Prevnar-7 at an increased risk of otitis media due to pneumococcal serotypes not represented in the vaccine.[9,64]

The non-serotype disease increase was particularly noticeable in the most vulnerable populations, primarily in the elderly, HIV-positive adults, and children with underlying medical conditions. Almost immediately, one concern for health officials was that the serotypes most responsible for both vaccinated and unvaccinated populations were growing more and more resistant to antibiotics.[66,68,69]

But an even graver concern is that the rate of the complication known as pneumococcal empyema, an accumulation of dense pus between the outer surface of the lung and the chest wall, increased by 70 percent after the vaccine came into widespread use. The greatest increase was in children ages 2 to 4 – and once they were hospitalized, it was found that they were more likely to be so sick they needed surgery.[71,72]

The increased disease caused by non-serotypes was so great that some health officials declared it not cost-effective enough to give.[67]

The FDA’s answer to the problem was to recommend a different, newer vaccine, Prevnar 13, with six additional serotypes as a replacement for Prevnar 7.[73]

Possible adverse reactions with Prevnar-7 vaccination: According to the manufacturer, fever and, rarely, febrile seizures have been reported in children receiving Prevnar. For children who are at higher risk of seizures, the manufacturer suggests that fever-reducing drugs may be given.

Other reactions include tenderness at the injection site, pain at the injection site that interfered with limb movement, erythema, induration, irritability, drowsiness, restless sleep, decreased appetite, vomiting, diarrhea, and urticarial-like rash. In the vaccine trials, hypotonic-hyporesponsive episodes (HHL) also were reported in rare instances. Twelve deaths were reported during clinical trials; four attributed to Sudden Infant Death Syndrome (SIDS) and seven to other non-vaccine-related causes.

In post-marketing, there have been reports of injection site dermatitis, injection site urticarial, injection site pruritis, localized lymphadenopathy at the injection site, face edema, dyspnea, bronchospasm, anaphylactoid reactions including shock, angioneurotic edema, erythema multiforme, and other adverse events.[64]

Warnings and contraindications with Prevnar-7: According to the manufacturer, this vaccine should not be given to infants or children with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection unless the potential benefit clearly outweighs the risk of administration. While mild infections with or without a low-grade fever are not necessarily contraindications to getting this vaccine, the manufacturer recommends that the severity of the symptoms be taken into consideration before administering it.

Prevnar-7 should be given with caution to children on anticoagulant therapy. This vaccine has not been tested for any carcinogenic or mutagenic potential, or for impairment of fertility. It’s also not known whether it can cause fetal harm when given to a pregnant woman, or whether the antigens or antibodies are excreted in human milk. This vaccine is NOT recommended for nursing mothers. Safety and immunogenicity data are either limited or not available for children in specific high risk groups for invasive pneumococcal disease (eg, persons with sickle cell disease, asplenia, HIV-infected). Although the vaccine contains diphtheria toxin protein, it does not substitute for routine diphtheria vaccination.[64]

Prevnar 13 contains 13 pneumococcal serotypes; seven of which are in PCV7 (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and six additional serotypes (1, 3, 5, 6A, 7F, and 19A). It was licensed by the FDA for prevention of invasive pneumococcal disease caused by the vaccine’s 13 serotypes, and for otitis media caused by serotypes in the PCV7 vaccine.

Prevnar 13 (PCV13) contains CRM₁₉₇, a mutant protein of diphtheria toxin used to activate the pneumococcal bacteria. The diphtheriae strain is grown in a casamino acids and yeast extract-based medium and purified through ultrafiltration, ammonium sulfate precipitation, and ion-exchange chromatography.[63,75] Although conjugate vaccines have a history of effectiveness, a recent study indicates that there are still many unanswered questions about their use when multiple vaccines are being given, including their effectiveness in special populations.[65]

Each of the 13 serotypes in Prevnar 13 is grown in soy peptone broth. Each dose contains polysorbate 80 and a succinate buffer, with aluminum phosphate as the adjuvant. There is NO latex in the tip cap or rubber plunger of the prefilled syringe.

The FDA has approved Prevnar 13 for children ages 6 weeks through 5 years of age, for children aged 60-71 months with underlying medical conditions; and as a booster dose for children who received 1 or more doses of PCV7 previously, and for adults age 50 and older, even if they have previously received the conventional pneumococcal polysaccharide vaccine (PPSV). According to the manufacturer’s product insert, the indication for adults is based on immune responses (i.e. titers measured in the blood), as there have been no controlled trials in adults demonstrating a decrease in invasive pneumococcal disease or pneumococcal pneumonia after vaccination with Prevnar 13.[74,76]

The approval of Prevnar 13 for adults came on December 30, 2011 in an accelerated process, even though there have been no controlled trials in adults demonstrating a decrease in pneumococcal pneumonia or invasive pneumococcal disease after vaccination with Prevnar 13.[7,74,77]

At the request of FDA, Pfizer is currently conducting post-marketing studies called the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA) to determine whether Prevnar 13 is effective in preventing community-acquired pneumonia caused by the 13 serotypes in the vaccine.[77,78,79]

PCV13 is injected into the muscle as a 4-dose series at 2, 4, 6, and 12-15 months of age. If other vaccines are administered at the same time, they should always be administered with different syringes at different injection sites.

For children who are beyond the age of routine infant schedule, or those who have not received either Prevnar or Prevnar 13, a catch-up schedule is recommended of three doses between 7 and 11 months of age; two doses between 12 and 23 months of age and one dose at age 24 months through age 5, prior to the 6^th birthday.[74]

Children who have received one or more doses of Prevnar may complete the pneumococcal vaccination series with Prevnar 13. Children 15 months through 5 years of age who are completely vaccinated with Prevnar may receive one dose of Prevnar 13 to cover the six additional serotypes. Children who have received Pneumovax 23 previously also should receive the recommended PCV13 doses.[81]

Children 24 through 71 months of age with an underlying medical condition who received fewer than 3 doses of PCV7 before age 24 months should receive a series of 2 doses of PCV13 followed by 1 dose of Pneumovax 23 administered at least 8 weeks later. Children 24 through 71 months of age with an underlying medical condition who received any incomplete schedule of 3 doses of PCV7 before age 24 months should receive 1 dose of PCV13 followed by 1 dose of PPSV23 administered at least 8 weeks later.[81]

For adults age 50 and older, Prevnar 13 is administered as a single dose.

According to the CDC, immune responses to Prevnar 13 were compared to Prevnar 7 studies, which determined that Prevnar 13’s efficacy was similar to Prevnar 7’s, or about 97 percent effective in reducing invasive disease caused by the vaccine-relevant serotypes. Prevnar 13 was then licensed based upon the comparable studies.[81]

In another study of Prevnar 13, children 7-11 months, 12-23 months, and 24-71 months of age who had not received pneumococcal conjugate vaccine doses previously were administered 1, 2, or 3 doses of PCV13 according to age-appropriate vaccination schedules. These schedules resulted in antibody responses to each of the 13 serotypes that were comparable to those achieved after the 3-dose infant PCV13 series in the U.S. immunogenicity trial, except for serotype 1, for which IgG GMC was lower among children aged 24-71 months.[81]

However, according to the manufacturer, immune responses (efficacy) for Prevnar 13 among infants born prematurely have not been specifically studied. In clinical trials, antibody responses to Prevnar 13 were lower in persons over age 65 compared to those aged 50 to 59. Effectiveness of Prevnar 13 in children below the age of 6 weeks or on or after the 6^th birthday have not been established. Also, Individuals with impaired immune responsiveness due to the use of immunosuppressive therapy (including irradiation, corticosteroids, antimetabolites, alkylating agents, and cytotoxic agents) may not respond optimally to active immunization. Also, Prevnar 13 will not protect against disease caused by stains of S. pneumoniae not contained in the vaccine. The effectiveness of Prevnar 13 when given less than 5 years after the 23-valent pneumococcal polysaccharide vaccine is not known.[74,83]

Additionally, immune responses to Prevnar 13 in adults were reduced when given with injected seasonal flu vaccine.[83]

Possible Adverse Reactions to Prevnar 13:

The safety of Prevnar 13 was assessed in 13 studies in over 4700 healthy infants and toddlers who received at least 1 dose of Prevnar 13. The most commonly reported adverse reactions were injection-site reactions, fever, decreased appetite, irritability, gastroenteritis, pneumonia, and increased or decreased sleep. Local reactions included pain/tenderness, redness of the skin, induration, and swelling.[82,83]

In infants and toddlers, the most common side effects were irritability, injection site tenderness, decreased appetite, decreased sleep, increased sleep, fever, injection site redness, and injection site swelling.[83]

Monitoring done during the 2010-11 flu season showed that when flu vaccine and Prevnar 13 are given on the same day, there may be an increased risk of febrile seizures in children 12-23 months old.[82]

According to the manufacturer’s product insert, in clinical trials, solicited adverse reactions classified as serious included bronchiolitis, gastroenteritis, and pneumonia. There were three deaths during the trial, all attributed to sudden infant death syndrome (SIDS). There were four hypotonic-hyporesponsive episodes, all of which occurred when the trial subjects received whole cell pertussis vaccine at the same time.

Unsolicited reactions included crying, hypersensitivity (including face edema, dyspnea, and bronchospasm), seizures (including febrile seizures) and urticarial or urticarial-like rash. Other adverse events were reported within three days of children’s vaccination with Prevnar 13, but they were not included as reactions to the vaccine. Those events included emergency room visits or hospitalizations for bronchiolitis, UTI, acute gastroenteritis, asthma, aspiration, breath holding, influenza, inguinal hernia repair, viral syndrome, URI, croup, thrush, wheezing, choking, conjunctivitis, pharyngitis, colic, colitis, congestive heart failure, roseola and sepsis.

In adult studies, solicited adverse events were similar to children’s studies, and included redness, swelling and pain at the injection site, or limitation of arm movement, fatigue, headache, chills, rash, decreased appetite, or muscle and joint pain. An increase in some systemic reactions such as headache, chills, rash, decreased appetite, muscle and joint pain was noted with Prevnar 13 was administered concomitantly with a flu shot.

Unsolicited serious adverse events in the adult studies included 12 deaths that occurred from three to 309 days after vaccination. Two of the deaths were within 30 days, and one was due to cardiac failure three days after receiving Prevnar 13 and a flu shot together. The reported causes of the 10 reported deaths occurring more than 30 days after vaccination were cardiac disorders, neoplasms, Mycobacterium avium complex pulmonary infection, and septic shock.

Post-marketing adverse reports included injection-site dermatitis, pruritis, urticarial, and lymphadenopathy at the injection site. Other post-marketing reports included anaphylactic reactions, angioneurotic edema, erythema multiforme, and apnea.[74]

Warnings and Contraindications for Prevnar 13:

Safety of Prevnar 13 in children below the age of 6 weeks or on or after the 6^th birthday has not been established. There are no adequate or well-controlled studies in pregnant women who are administered Prevnar 13. This vaccine should be given during pregnancy only if clearly needed. It is not known whether Prevnar 13 is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Prevnar 13 is administered to a nursing woman.[74]

According to the manufacturer’s product insert, data on the safety and effectiveness of Prevnar 13 when administered to immunocompromised individuals (e.g., those with congenital or acquired splenic dysfunction, HIV infection, malignancy, hemotopoietic stem cell transplant, nephrotic syndrome) are not available. These individuals may have reduce antibody responses to this vaccine.

Apnea has been observed in some premature infants who receive this vaccine. Decisions on whether a premature infant should get Prevnar 13 should be made based on consideration of the child’s medical status and the potential benefits and possible risks of vaccination.[74]

Prevnar 13 should not be given to anyone with a history of severe allergic reaction to any component of the vaccine, or to any diphtheria toxoid-containing vaccine.[83]

Pneumovax 23 (PPSV23) is a Merck & Co. purified capsular polysaccharide antigen indicated for vaccination against pneumococcal disease caused by serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33. It was the first pneumococcal vaccine approved in the U.S. for adults, and is administered as a single dose. In 1988 the ACIP recommended booster doses every six years for patients at highest risk of disease. In 1997, the ACIP changed that recommendation to 1 repeat dose 5 years after the initial dose for patients at highest risk of disease. However, routine revaccination of immunocompetent with Pneumovax 23 is not recommended.[26,81,84]

Pneumovax 23 is approved for adults age 50 and older, and for persons age 2 and older who are at increased risk for pneumococcal disease. It is not approved for children younger than 2 because children of this age do not have an effective immune response to capsular types included in this vaccine. It is injected into the muscle.[86]

This vaccine is also recommended for persons aged 2 to 64 with long-term health problems such as:

• Weakened immune systems, e.g., persons with HIV, leukemia/lymphoma/Hodgkin’s Disease, organ transplant, cancer treatment
• Lack of spleen or non-functionalo splenia such as sickle cell disease
• Diabetes
• Chronic liver or kidney disease
• Other conditions that increase the risk of pneumococcal pneumonia

Additionally, this vaccine is recommended for persons aged 19 to 64 with asthma or who are smokers, and for nursing home residents.[88]

Pneumovax 23 is a clear colorless solution containing phenol as a preservative and saline in addition to the 23 pneumococcal strains. It works by inducing type-specific antibodies that enhance opsonization, phagocytosis, and killing of pneumococci by leukocytes and other phagocytic cells.[84]

Effectiveness at preventing disease with Pneumovax 23 varies. According to the manufacturer, it has a 57 percent overall effectiveness against invasive infections caused by serotypes in the vaccine.[87] By patient condition, reported effectiveness in clinical trials was:

• 65% Chronic pulmonary disease
• 69% Congestive heart failure
• 73% Coronary vascular disease
• 75% Immunocompetent patients aged 65 and older
• 84% Diabetes

Cautioning that effectiveness cannot be confirmed for certain groups of immunocompromised patients, Merck said in an efficacy report that it had not been able to recruit sufficient numbers of unvaccinated patients from each disease group to study effectiveness in them. [87]

According to the manufacturer’s product insert, children younger than 2 do not have an effective enough immune response for this vaccine to be of use for them. Also, in a randomized clinical study, it was found that persons receiving Zostavax, a vaccine for shingles, concurrently with Pneumovax 23 had a reduced immune response to the Zostavax.[84]

The most common adverse reactions to Pneumovax 23 in clinical trials included injection site pain/soreness tenderness, swelling/induration at injection site, headache, injection-site erythema, asthenia, fatigue, and myalgia. Fever, diarrhea, chills, dyspepsia, nausea, back and neck pain, upper respiratory infection, and pharyngitis were also reported occasionally.

Serious adverse experiences within 14 days after Pneumovax 23 included angina pectoris, heart failure, chest pain, ulcerative colitis, depression, and headache/tremor/stiffness/sweating. Other serious adverse experiences included cerebrovascular accident, lumbar radiculopathy, and pancreatitis/myocardial infarction resulting in death. Also, the rate of vaccine-related systemic adverse reactions was higher following revaccination (37.5 percent) than following initial vaccination in subjects aged 65 or older.[84]

Additional adverse reactions reported in post-marketing included cellulitis, malaise, fever in excess of 102 degrees F, decreased limb mobility, peripheral edema in the injected extremity, nausea, vomiting, lymphadentitis, lymphadenopathy, thrombocytopenia in patients with stabilize idiopathic thrombocytopenic purpura, hemolytic anemia in patients who have had other hematologic disorders, leudocytosis, anaphylactoid reactions, serum sickness, angioneurotic edema, arthralgia, arthritis, paresthesia, radiculoneuropathy, Guillain-Barre syndrome, febrile convulsion, rash, urticarial, and cellulitis-like reactions.[84]

Warnings and contraindications for Pneumovax 23

Persons who have experienced previous allergic reactions to any components in this vaccine should not get this vaccine. Vaccination should also be deferred in persons with a moderate or severe acute illness.[87]

It is not known whether Pneumovax 23 can cause fetal harm when administered to a pregnant women or can affect reproduction capacity. It should be given to pregnant women only if clearly needed. It also is not known whether this drug is excreted in human milk. Therefore, caution should be exercised when Pneumovax 23 is administered to a nursing woman.[84]

Pneumovax 23 should not be given to children less than 2 years of age. Persons who are immunocompromised, including those receiving immunosuppressive therapy, may have a diminished immune response to this vaccine.[84]

Since elderly individuals may not tolerate medical interventions as well as younger individuals, the manufacturer warns that a higher frequency and/or a greater severity of reactions in some older individuals cannot be ruled out. The manufacturer also urges caution and appropriate care in administering this vaccine to individuals with severely compromised cardiovascular and/or pulmonary function in whom a systemic reaction would pose a significant risk.[87]

NVIC note: After reviewing reports of increased systemic and local site reactions following some second doses of Pneumovax 23, Australian health officials announced on Jan. 12, 2012 that they are now recommending a second dose of this vaccine only for specific risk groups, where the benefits of the vaccine outweigh the risk of the adverse reactions, and only if at least 5 years have passed since the first vaccination. Australian officials also said that a second dose of Pneumovax 23 should NOT be routinely given to Australian citizens with healthy immune systems.[90,91]

Pneumococcal Vaccines and Advance Market Commitments

Another pneumococcal vaccine, GlaxoSmithKline’s Synflorix, is approved for use in many Third World countries. It contains 10 serotypes, including three of the most prevalent in the developing world. Synflorix was the first pneumococcal vaccine to receive WHO “prequalification” for global use for participation in the global Advance Market Commitment (AMC) plan. In December 2011, Pfizer/Wyeth’s Prev(e)nar 13 was the second pneumococcal vaccine approved for Third World use under AMC’s.[89,90]

The AMC announcement came in conjunction with the FDA’s approval of Prevnar 13 for use in adults age 50 and older. In addition to the U.S., the European Union, Australia, Mexico, and more than 10 other countries also approved Prevnar 13 for adults. Boosted by a grant from the Bill and Malinda Gates Foundation, Pfizer agreed to supply the vaccine to needy countries at a 90 percent discount. [93]

AMC’s are legally binding agreements that developed countries make with vaccine makers to purchase vaccines that are needed in developing countries; the vaccine makers then promise to not only develop the vaccine, but to either sell it at reduced prices or donate it to designated countries. According to WHO, the purpose of an AMC is to provide incentives to vaccine manufacturers to invest in the necessary research and manufacturing capacity needed to bring a vaccine for the developing world to market.[96]

World health officials said the reason for choosing pneumococcal vaccines as the first AMC was because of the cost-effectiveness the vaccine would have relative to the cost of disease and lives saved. More than 1.5 million children, mostly in Third World countries, die every year from pneumonia, more than any other disease. Having the pneumococcal vaccine available at a discount price not only could save as many as 603,000 lives each year, but would be the most cost effective way of saving their lives, health officials said.[94,97]

However, in a strongly worded critique published in Economic & Political Weekly in November 2011, a member of India’s National Technical Advisory Group on Immunization, Jacob Puliyel, disagreed with its use as an AMC there. “This AMC “looks like a policy not to have a policy, but to utilize vaccines indiscriminately,” Puliyel said. In India, the pneumococcal vaccine costs considerably more than it does to simply treat the disease, and prevents only 4 cases of pneumococcal infections out of every 1,000 children, he said. Claiming that everyone but the pharmaceutical companies was paying for the vaccine, Puliyel said the Indian government needed to re-evaluate this vaccine’s cost effectiveness before making further commitments to administer it on a widespread basis. “If we are being asked to make long-term advance market commitments before evaluating the utility or even the market value of a vaccine, this policy needs a careful scrutiny,” he said.[98,99]

History of Pneumococcal Vaccine Use in America

Scientists began working on a vaccine for select strains of pneumoniae as early as 1911, and a hexavalent (6 serotypes) was available from E.R. Squibb in 1954. However, interest in a vaccine was low at that time because of the introduction of penicillin in the 1940s. A14-valent pneumococcal vaccine was first licensed in the U.S. in 1977. Twenty-three years later, in 2000, 7-valent Prevnar was licensed. The 23-valent polysaccharide vaccine for adults and select populations, Pneumovax 23, was licensed in 1983. Prevnar 13 was introduced in 2000, as a primary replacement for Prevnar 7, due to an increase in pneumococcal diseases not covered by the original vaccine.[26]

According to the CDC, besides the pneumococcal vaccines, there are several other vaccines that target bacteria or viruses that can cause pneumonia. These vaccines include: Haemophilus influenza type b (Hib); pertussis (whooping cough); varicella chickenpox); measles; and influenza.[1]

Prior to Prevnar 7 being introduced in the U.S. in 2000, studies from 1998 showed that the overall incidence of pneumococcal disease was 23.2 cases per 100,000 people, or a total of 62, 840 cases. Disease rates were higher for children younger than 2 years of age and adults aged 65 or older.[5]

Subsequent studies showed that the vaccine was highly effective in reducing the number of severe lung, blood and brain infections in infants and children, including pneumococcal pneumonia, sepsis and meningitis. But at the same time, a serious and sometimes fatal complication known as pneumococcal empyema increased—and the children who were hospitalized for this condition were often so sick they needed to be hospitalized. By 2009, health officials had also found that non-vaccine serotypes had rapidly replaced the vaccine-related ones, causing an increase in non-vaccine pneumococcal disease in both children and adults.[72,100,101,102]

As a result, Prevnar 13 was adopted in 2000.[74]

Then, in December 2011 in an accelerated process, the FDA approved it for people ages 50 years and older. And in January 2012, the Centers for Medicare and Medicaid Services announced that they are requiring hospitals to offer the pneumococcal vaccine to all patients 65 years old and older, and to patients between the ages of 6 and 64 if they have diabetes, nephritic syndrome, end stage renal disease (ESRD), congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), spleen removed or not functioning, HIV, or asthma. [78,103,104]

How Effective Is Pneumococcal Vaccine?

According to the CDC, in a large clinical trial, PCV7 was shown to reduce invasive disease caused by vaccine serotypes by 97 percent, and reduce invasive disease caused by all serotypes, including serotypes not in the vaccine, by 89 percent.  Children who received PCV7 had 7 percent fewer episodes of acute otitis media and underwent 20 percent fewer tympanostomy tube placements than did unvac­cinated children. There was evidence that PCV7 reduces naso­pharyngeal carriage of pneumococcal serotypes included in the vaccine. PCV13 was licensed in the United States based upon studies that compared the serologic response of children who received PCV13 to those who received PCV7. These studies showed that PCV13 induced levels of antibodies that were comparable to those induced by PCV7 and shown to be protective against invasive disease. [8]

Other clinical studies show that after 3 doses, 90 percent of healthy infants who received 7-valent Prevnar had antibodies to the vaccine’s seven serotypes. Initially, the vaccine appeared to reduce invasive pneumococcal disease by as much as 97 percent, but the duration of protection against those seven serotypes was unknown. A few years after the introduction of the vaccine, it was discovered that serotypes not included in Prevnar were quickly replacing the 7 vaccine serotypes.[105,106,107]

Additionally, it was found that non-vaccine serotypes were causing an increase in antibiotic-resistant cases of severe ear infections. But even though the estimates of the vaccine's efficacy against ear infections — 57 percent efficacy against serotype-specific pneumococcal otitis media and 6 percent efficacy against acute otitis media from any cause — were lower than the estimated efficacy of other childhood vaccines, health officials still said they believe that the vaccine’s overall effectiveness was “substantial.”[9]

Effectiveness of Prevnar 13 was measured in a randomized, double-blind trials that found antibody levels for the new vaccine were comparable to Prevnar 7, although immune responses varied, depending on the pneumococcal serotype. After a 4^th dose was added to the Prevnar 13 schedule, studies showed that immune response was from 97 to 100 percent in healthy children. In children with underlying medical conditions, they found limited and inconclusive data available on the efficacy and effectiveness of Pneumovax 23. [76]

Children with impaired immune responsiveness, whether due to the use of immunosuppressive therapy (including irradiation, corticosteroids, antimetabolites, alkylating agents, and cytotoxic agents), a genetic defect, HIV infection, or other causes, may have reduced antibody response to active immunization.[64,74]

Although vaccination is the CDC’s preferred method of pneumococcal disease prevention, some studies have shown that vaccination isn’t always effective. In fact, a 2009 analysis of 22 clinical trials concluded that, in adults, pneumococcal vaccination does not appear to be effective in preventing pneumonia, even in populations for whom the vaccine is currently recommended.[8,114]

A 2009 patent application for a potential Novartis pneumococcal vaccine adjuvanted with M59 (squalene, Polysorbate 80, sorbitan trioleate 85, and citrate buffer) repeated these findings, asserting that clinical trials with Pneumovax 23 in Germany did not show any protective effectiveness against pneumococcal pneumonia. And in laying the groundwork for the need for the new adjuvant, the patent applicant even goes so far to say, “Nonetheless, the pneumococcus vaccine is recommended in industrialized countries by the respective national ministries, medical associations and advising committees for the elderly, immunosuppressed adults and also children with chronic illnesses, among others (STIKO vaccine recommendations).”[109]

But according to the FDA, clinical trials with PPV23 showed that it had an aggregate effectiveness of 50 to 80 percent for the prevention of invasive pneumonia in elderly individuals.[111]

The manufacturer, Merck, also reports efficacy numbers in its product insert.[84] Merck says:

• The levels of antibodies that correlate with protection against pneumococcal disease have not been clearly defined.
• Persons who are immuncompromised, including persons receiving immunosuppressive therapy, may have a diminished immune response to Pneumovax 23.
• A retrospective cohort analysis study based on the U.S. Centers for Disease Control and Prevention pneumococcal surveillance system, showed 57% overall protective effectiveness against invasive infections caused by serotypes included in Pneumovax 23 in persons aged 65 and older.
• Pneumovax 23 shows a 65 to 84% effectiveness among specific patient groups (e.g., persons with diabetes mellitus, coronary vascular disease, congestive heart failure, chronic pulmonary disease, and anatomic asplenia)
• It also shows a 75% effectiveness in healthy persons aged 65 or older

Merck also says that Vaccine effectiveness could not be confirmed for certain groups of immunocompromised patients.

A study in Spain on individuals living with HIV found that introduction of the 7-valent pneumococcal conjugate vaccine preceded a sharp drop (81 percent) in incidence of invasive pneumonia among HIV-positive adults in Spain. However, HIV-positive people who did get invasive pneumonia had higher rates of respiratory failure, more frequent intensive care unit admission (nearly three times as likely), and were three times more likely to need mechanical ventilation. The study authors said that “widespread use of highly active antiretroviral therapy, polysaccharide vaccine, and 7-valent pneumococcal conjugate vaccine has contributed to these [observed] changes.”[112]

The World Health Organization also hesitates to call Pneumovax 23 a total success in stemming the rates of pneumonia worldwide. In a public statement in March 2008, the WHO wrote:

“Despite the existence of multiple studies conducted over more than 30 years, the efficacy and effectiveness of PPV23 in children and adults remain poorly defined and the subject of controversy. Numerous problems contribute to the difficulty of measuring the efficacy and effectiveness of this vaccine, including the rarity of the most specific outcome, i.e., S. pneumoniae infection; the non-specificity of the diagnostic criteria for more common outcomes, e.g., pneumococcal pneumonia; and the likelihood/biological plausibility that efficacy and effectiveness vary with the presence and severity of various underlying conditions associated with an increased risk of pneumococcal infection.”

WHO also noted, “Furthermore, there have been very few studies of the efficacy or effectiveness of PPV23 in children.” Commenting that observational studies did show some effectiveness of this particular vaccine, WHO said the organization would not advise against its use, so long as it didn’t “detract from achieving high levels of coverage with PCV7 among infants.”

Can Pneumococcal Vaccine Cause Injury and Death?

With any vaccine, it is possible to suffer reactions that cause injury and death, including allergic reactions to components in the vaccine, whether they are active or inactive. That’s why the manufacturer instructs physicians to determine whether you or your child is a good candidate for a vaccine in advance to administering it. As a precaution, the manufacturers also advise that your physician have epinephrine and other life-saving agents readily available before administering the vaccine.[64,74,84]

NVIC is proud to host MedAlerts, a powerful database search engine that offers an alternative to searching for adverse vaccine events through the U.S. Government’s official search engine, Vaccine Adverse Events Reporting System (VAERS). MedAlerts examines symptoms, reactions, vaccines, dates, places, and more. MedAlerts contains the same information as the government’s website, but offers a better user interface, more powerful search capabilities, and more extensive reporting.

According to MedAlerts, data from VAERS as of November 14, 2011 showed more than 50,000 reports of adverse events in connection with the three pneumococcal vaccines. Some of these events may include multiple symptoms. Of this number, 264 were  deaths.

There also have been reported deaths in clinical trials of pneumococcal vaccines. Children in groups who got the pneumococcal vaccine suffered more seizures, irritability, high fevers and other reactions. There were 12 deaths in the Prevnar group, including 5 Sudden Infant Death Syndrome (SIDS) deaths.[64]

In January 2012, GlaxoSmithKline was fined 400,000 pesos ($93,000) by an Argentine judge for allegedly being responsible for the deaths of 14 babies who were in GSK pneumococcal vaccine clinical trials in Argentina and Panama. The judge agreed with Argentina’s National Administration of Medicine, Food and Technology that GSK conducted illegal lab trials in 2007 and 2008 with its pneumococcal vaccine Synflorix.

Two of the trial’s investigators were also charged and fined $70,000 each. According to the Buenos Aires Herald, the charges included preying on illiterate parents by forcing them to sign 28-page consent agreements, experimenting with human beings, falsifying parental authorizations so babies could participate in vaccine-trials, and refusing to release parents and their children from the trials when they tried to exit them early. GSK officials responded that none of the deaths was related to the trials because all of the dead children had been given placebos, and that they planned to appeal the judgment.[115]

In November 2009, Netherlands officials announced they were suspending use of an entire batch of Prevnar after three babies died following administration of the PCV. The vaccine’s maker, Pfizer, denied that the vaccine was connected to the deaths.[116]

And in India in 2008, clinical trials for Prevnar 13 were stopped when a baby in the trials died after receiving the vaccine. Since the baby had a pre-existing cardiac abnormality, officials claimed that trial criteria protocol had not been followed in allowing the baby to be part of the trial. Subsequently, Indian health officials canceled all further trials.[117]

A transient increase in HIV replication has also been reported following Pneumovax 23 vaccine. No clinical or immunologic dete­rioration has been reported in these persons.[8]

Who is at highest risk for complications from pneumococcal vaccine?

A child who is sick or has been recently sick may be at increased risk for having a  serious vaccine reaction. Ask your doctor to give your child a physical exam to make sure your child is healthy before vaccination.

Through monitoring vaccine administration during the 2010-11 flu season, the CDC found that there may be an increased risk of febrile seizures in children 12 to 23 months old who get the flu and pneumococcal vaccines on the same day.[10]

Infants born prematurely who receive Prevnar 13 may experience sleep apnea.

Also, according to the manufacturer’s product information sheet, elderly individuals may experience more severe adverse reactions than younger persons. Some individuals with underlying medical conditions of varying severity may experience local reactions and fevers associated with clinical deterioriation requiring hospital care.[84]

Who should not get pneumococcal vaccine?

Anyone who has experienced a hypersensitivity to any components in any pneumococcal vaccine, including diphtheria toxoid, should not get this vaccine.

Prevnar 7 is for pediatric use only. Prevnar should be given with caution to children on anticoagulant therapy.[64]

Prevnar 13 should be administered to premature infants only after weighing the risks versus the benefits of vaccinating for pneumonia, and only after considering the child’s medical status.[74]

Pneumovax 23 is not approved for children less than 2 years of age. Pregnant women should only get this vaccine if clearly needed.

Women who are at high risk of pneumococcal disease and who are candidates for pneumococcal vaccine should be vaccinated before preg­nancy, if possible.[8]

Questions to Ask Doctors about Pneumococcal Vaccine

Before you vaccinate, NVIC suggests reviewing our If You Vaccinate, Ask  8! here to familiarize yourself with important information that can help you make a choice on whether and when you want you or your child to get the pneumococcal vaccine.

Other questions you should ask your doctor:

• What are the benefits and risks of this vaccine?
• What side effects may I expect to see?
• How do I recognize an unusual or dangerous side effect?
• What should I do if my child appears very ill or has a high fever after vaccination?
• Do you offer a modified vaccine schedule (if you’re interested in spreading out the number of vaccines your child is getting at one time)?

Why NVIC is Opposed to a Pneumococcal Vaccine Mandate:

Flawed Clinical Trials Did Not Prove Safety: Wyeth Lederle and Kaiser Permanente compared one experimental vaccine (pneumococcal) against another (meningococcal), which seriously compromised the scientific validity of the trial. Children in groups who got the pneumococcal vaccine suffered more seizures, irritability, high fevers and other reactions. There were 12 deaths in the Prevnar group, including 5 Sudden Infant Death Syndrome (SIDS) deaths. And in a follow-up observational study of the VAERS reports on Prevnar through February, 2002, there were 608 serious adverse events already reported, including 117 deaths.[64,123]

No Long Term Studies: There are no long term studies to evaluate whether pneumococcal vaccines given alone or in combination with other vaccines is associated with chronic illness or disability, such as the development of diabetes, asthma, seizure disorders, learning disabilities, ADHD, or autism.

Vaccine Components Not Thoroughly Evaluated: Each 0.5ml dose of Prevnar 7 and Prevnar 13 contains 0.125 mg. of aluminum, a metal that is neurotoxic. Additionally, Prevnar 13 contains Polysorbate 80, which can cause severe nonimmunologic anaphylactoid reactions.[118]

The vaccine manufacturers also state that this vaccine “has not been evaluated for any carcinogenic or mutagenic potential, or impairment of fertility."[64,74,84]

Efficacy Low for Preventing Ear Infections: Despite the suggestion by the manufacturer and Kaiser Pemanente officials in pre-licensure press releases that Prevnar vaccine is an ear infection vaccine, the vaccine was never licensed by the FDA to prevent ear infections. Clinical trials showed that the vaccine when introduced  decreased a child's chance of getting an ear infection by only 7 percent. And later studies showed that because of serotype replacement, it not only actually increased incidences of acute otitis media, but also increased antibiotic-resistant pneumococcal strains.[76,105,106,107]

Voluntary Use of the Vaccine Is High: Wyeth Lederle, the CDC and AAP have done an excellent job promoting the mass use of this vaccine by children. Prevnar topped the sales charts as the No. 1 best-selling new pharmaceutical among all pharmaceuticals brought on the market in the year 2000, generating $461 million in sales. By 2009, when Pfizer acquired Wyeth, Prevnar sales were $3.7 billion a year. And now, with the introduction of Prevnar 13,sales of the new vaccine are expected to $6 billion a year by 2015.[121,122]

Read NVIC's written statement to the National Vaccine Advisory Committee opposing any mandate that doesn't provide medical, religious and personal belief exemptions for health care workers.

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Additional Bibliography/Sources/Reading Material:

Medical Literature

Pilishvili T, Lexau C, Farley M, Hadler J, et.al. Sustained Reductions in Invasive Pneumococcal Disease in the Era  of Conjugate Vaccine. 2010. J Infect Dis. (2010) 201(1):32-41. Online. (accessed Jan 2012). http://jid.oxfordjournals.org/content/201/1/32.full.pdf+html?sid=443796ad-d47e-4c38-bdf7-5ddd42c0728b

World Health Organization e-Library of Evidence for Nutrition Actions (eLENA). Vitamin D Supplementation to Improve Treatment Outcomes Among Children Diagnosed with Respiratory Infections. April 2011. Online. (accessed Jan 2012). http://www.who.int/elena/titles/bbc/vitamind_pneumonia_children/en/index.html

Niederman M. In the clinic. Community-acquired pneumonia. Ann Intern Med. 2009;151(7).

Centers for Disease Control and Prevention. Pneumococcal Polysaccharide Vaccine Information Sheet. What You Need To Know. April 2009. (accessed Jan. 2012).  http://www.cdc.gov/vaccines/pubs/vis/downloads/vis-ppv.pdf

O'Brien KL, Wolfson LJ, Watt JP, Henkle E  et al. Burden of disease caused by Streptococcus Pneumoniae in Children Younger than 5 Years: Global Estimates. Lancet. 2009 Sep 12;374(9693):893-902. Online. (accessed Jan 2012). http://www.ncbi.nlm.nih.gov/pubmed/19748398

Dagan R. Serotype Replacement in Perspective. Vaccine. 2009 Aug 21;27 Suppl 3:C22-4. Epub 2009 June 21. Online. (accessed Jan 2012). http://www.ncbi.nlm.nih.gov/pubmed/19545935

Van der Poll T, Opal SM. Pathogenesis, treatment, and prevention of pneumococcal pneumonia. Lancet. 2009;374:1543-1556. Online. (accessed Jan 2012). http://www.sciencedirect.com/science/article/pii/S0140673609611144

Walker VP, Modlin RL. The vitamin D connection to pediatric infections and immune function. Pediatric Research, 2009; 65(5 Pt 2):106R-113R. Online. (accessed Jan 2012). http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2925470/

Eskola J, Kilpi T, Palmu A, Jukka J, et al. Efficacy of a Pneumococcal Conjugate Vaccine against Otitis Media. N Eng J Med. Feb. 8, 2001;344:403-409. Online. (accessed Jan 2012) http://www.nejm.org/doi/full/10.1056/NEJM200102083440602#t=citedby

Hausdorff WP, Bryant J, Paradiso PR, et al. Which pneumococcal serogroups cause the most invasive disease: implications for conjugate vaccine formulation and use, part I. Clin Infect Dis 2000;30:100–21. Online. (accessed Jan 2012). http://cid.oxfordjournals.org/content/30/1/100.abstract?ijkey=eadccbb61f0ff43bf98cc20a3a6d45719606d30f&keytype2=tf_ipsecsha

Rehman PK. Sub-clinical rickets and recurrent infection. Journal of Tropical Pediatrics, 1994; 40: 58.

Alexander ER, Foy HM, Kenny GE, et al. 1966. Pneumonia due to Mycoplasma pneumoniae. Its incidence in the membership of a co-operative medical group. N. Engl. J. Med. 275:131–136.

J Bryce, C Boschi-Pinto, K Shibuya, RE Black. WHO estimates of the causes of death in children. Lancet 2005; 365: 1147-52. Online. (accessed Jan 2012). http://www.sciencedirect.com/science/article/pii/S0140673605718778

Media Articles

ShareCare.com. Who Should Not Take Diphtheria CRM197 Protein Conjugate? Jan. 2012. Online. (accessed Jan 2012). http://www.sharecare.com/question/who-not-take-diphtheria-crm-protein

Gbenga-Mustapha O. Pneumonia Kills 177,000 Children Yearly. The Nation. Jan. 17, 2012. Online. (accessed Jan 2012). http://www.thenationonlineng.net/2011/index.php/health/33455-pneumonia-kills-177-000-children-yearly.html

World Pharma News. Prevent Pneumococcal Disease in Infants and Young Children in the World’s Poorest Countries. Dec. 19, 2011.  Online. (accessed Jan. 11, 2012) http://www.worldpharmanews.com/pfizer/1912-prevent-pneumococcal-disease-in-infants-and-young-children-in-the-worlds-poorest-countries

National Institutes of Health. NIH Research Matters. Wood Cooking Stoves Combat Pneumonia. Dec. 5, 2011. Online. (accessed Dec 2011). http://www.nih.gov/researchmatters/december2011/12052011stoves.htm

NIH News. Press Release. Wood Stove Intervention Can Reduce Childhood Pneumonia. Nov. 14, 2011. Online. (accessed Dec 2011). http://www.nih.gov/news/health/nov2011/niehs-14.htm

Matthew Herper. What Bill Gates Says About Drug Companies. Forbes. Nov. 10, 2011. Online. (accessed Jan 2012). http://www.forbes.com/sites/matthewherper/2011/11/10/what-bill-gates-says-about-drug-companies-2/

Wikipedia.org. List of Micronutrients. Aug. 23. 2011. Online.  http://en.wikipedia.org/wiki/List_of_micronutrients

FT Cutts, SMA Zaman, G Enwere, S Jaffar, OS Levine, JB Okoko, et al. Efficacy of nine-valent pneumococcal conjugate vaccine against pneumonia and invasive pneumococcal disease in the Gambia: randomized, double-blind, placebo-controlled trial. Lancet 2005; 365: 1139-46.

Rockoff J. Wall Street Journal. Japan Clears Suspended Vaccines. March 25, 2011. Online. (accessed Jan 2012). http://online.wsj.com/article/SB10001424052748704604704576221623126167378.html

Lah K. CNNHealth. Japan Suspends 2 Vaccines While Authorities Investigate Infant Deaths. March 8, 2011. Online. (accessed Jan 2012). http://www.cnn.com/2011/HEALTH/03/08/japan.vaccines/index.html

Geneva: UNICEF/ WHO. Pneumonia, the Forgotten Killer of Children. 2006. Online. (accessed Jan 2012). http://whqlibdoc.who.int/publications/2006/9280640489_eng.pdf

NVIC Press Releases/Statements/Commentaries

Palevsky L.Aluminum and Vaccine Ingredients: What Do We Know? What Don’t We Know? NVIC.org. 2012. Online. http://www.nvic.org/Doctors-Corner/Aluminum-and-Vaccine-Ingredients.aspx

Fisher BL. Doctors Denying Vaccine Risks: An American Tragedy. April  21, 2011. Online. http://www.nvic.org/NVIC-Vaccine-News/April-2011/Doctors-Denying-Vaccine-Risks--An-American-Tragedy.aspx

Fisher BL. No Pharma Liability? No Vaccine Mandates. March 2, 2011. Online. http://www.nvic.org/NVIC-Vaccine-News/March-2011/No-Pharma-Liability--No-Vaccine-Mandates-.aspx

Fisher BL. New Vaccine Science Can Help Bridge the Divide. Jan. 16, 2011. Online. http://www.nvic.org/NVIC-Vaccine-News/January-2011/New-Vaccine-Science-Can-Help-Bridge-the-Divide.aspx

Fisher BL. Plug into new NVIC Advocacy Portal & Protect Vaccine Exemptions. Nov. 2, 2010. Online. http://www.nvic.org/NVIC-Vaccine-News/November-2010/New-NVIC-Advocacy-Portal.aspx

Other Institutions/Organizations

Staff. The History of Vaccines Blog. Approval of Conjugate Pneumococcal Vaccine for Adults. Jan. 10, 2012. Online. (accessed Jan 2012). http://www.historyofvaccines.org/content/blog/approval-conjugate-pneumococcal-vaccine-adults

Bridges CB. Adult Immunization in the United States, 2012. pp.15-18. Update. Jan. 5, 2012. PDF. Online. (accessed Jan 2012). http://www.womeningovernment.org/files/file/CarolynBridges.pdf

Mercola J. UK Scraps Pneumonia Vaccines Because They ‘Don’t Work’. June 20, 2011. Online. (accessed Dec 2011). http://articles.mercola.com/sites/articles/archive/2011/06/20/uk-scraps-pneumonia-vaccines-because-they-dont-work.aspx

Mercola J. Nearly 250,000 Deaths from ONE Common Mistake: Here’s How to Protect Yourself. Feb. 4, 2011. Online. (accessed Jan 2012) http://articles.mercola.com/sites/articles/archive/2011/02/04/death-by-medicine-an-update.aspx

Fisher, Barbara L. Mercola.com. The ‘Vaccine Shock’ of the Year. June 1, 2010. http://articles.mercola.com/sites/articles/archive/2010/06/01/barbara-loe-fisher-may-21-interview.aspx

Narcolepsy is a disabling neurological disorder characterized by excessive daytime sleepiness.  It is often accompanied by causing muscle weakness.

The Herald reports:

“The parents have asked that a centre of excellence be established and that where family doctors see children with day-time sleepiness who had been vaccinated with pandemrix, they should refer these children to the centre.”

Dr. Robet Lustig, arguably the number one enemy of the sugar lobby, has published a well written article in the prestigious scientific journal Nature arguing that sugar is a poison.  He believes that the negative health effects of sugar consumption can no longer be ignored, any more than the health effects of tobacco and alcohol can be ignored.

According to Dr. Lustig, via the website Diet Doctor:

“The problem with sugar isn’t just weight gain ... A growing body of scientific evidence is showing that fructose can trigger processes that lead to liver toxicity and a host of other chronic diseases. A little is not a problem, but a lot kills -- slowly.”

Lustig goes on to argue that sugar used to be available to our ancestors only as fruit or honey -- and then only for a few months of the year.

Experiments showed that fructose activates the same proteins in pancreatic cells that your tongue uses to taste sweets. When these cells are exposed to both glucose and fructose, they secrete more insulin than they do when exposed to glucose alone.

According to Science News:

“Most sugars join the [metabolic assembly line] at a point where a supervisory enzyme can control the flow of goods. But fructose comes in farther down, where it can lead to an overproduction of fat. And because fructose ... doesn’t stimulate the same insulin response that glucose does, the hormone isn’t doing the other regulatory things it usually does, like moderating appetite.”

U.S. farmers have been subsidized in one form or another for more than 200 years.   In 1862, the practice was expanded when congress passed the Homestead Act, known as the Morrill Act, which granted 160 acres of government land to those who wanted to begin farming or ranching.

Between World Wars I and II, several commodity crops received government subsidies to ensure that farmers would produce enough staple crops for the population. At that time, the major subsidized crops were corn, cotton, wheat, oats, sugar, and tobacco.

According to the Organic Consumers Association:

“Our current farm subsidy programs are modern vestiges of earlier government initiatives to provide commodity crops in times of national crisis.  However, as the video ... will show, this system is being abused by Big Ag and is contributing terribly to the climate crisis.”

Bear in mind that researchers recently pointed out that there is a major discrepancy in claims regarding the safety and efficacy of HPV vaccines for girls.  One major concern is the claim that HPV vaccines are an important tool in preventing cervical cancer. But the efficacy of the vaccines in preventing cervical cancer has not been demonstrated because the study periods have been too short.

In fact, even persistent HPV infections do not generally lead to cervical cancer in the long term; most HPV infections resolve spontaneously within 2 years.

According to Medscape:

“HPV vaccines must maintain a near 100% efficacy for a full 15 years, at a minimum, for cervical cancer to be prevented ... So far, Merck has not conducted any studies, nor are any planned, to evaluate the long-term immunogenicity and efficacy of needed booster shots ... Reported serious adverse reactions associated with HPV ... include death, convulsions, paraesthesia, paralysis, Guillain–Barré syndrome, transverse myelitis, facial palsy, chronic fatigue syndrome, anaphylaxis, autoimmune disorders, deep vein thrombosis, pancreatitis, and pulmonary embolism.”

To emphasize the above:  Merck has stated that they do NOT intend to evaluate ANY long term efficacy of cancer prevention.  There IS NO EVIDENCE that that their product prevents cervical cancer.

It has long been known that mesenchymal stem cells (MSCs) in skeletal muscle are an important part of the muscle repair process.  The scientists discovered that MSCs in muscle are very responsive to mechanical strain.

According to Fight Aging:

“They witnessed MSC accumulation in muscle of mice after vigorous exercise ... Preliminary data suggest MSCs become deficient in muscle with age. The team hopes to develop a combinatorial therapy that utilizes molecular and stem-cell-based strategies to prevent age-related muscle loss.”

Average telomere length, although it declines with age, is somewhat dynamic in response to circumstances.  Recent research found that the white blood cell telomere length in women who were moderately or highly active had a 0.07 standard deviation increase.

According to Fight Aging:

“Greater moderate- or vigorous-intensity activity was also associated with increased [telomere length ... Associations remained after adjustment for body mass index ... Although associations were modest, these findings suggest that even moderate amounts of activity may be associated with longer telomeres, warranting further investigation in large prospective studies.”

In the morning, your body's metabolism is at its most active and you are better able to work off the extra calories throughout the day.  And a dessert item at breakfast can help you control cravings throughout the rest of the day.

According to Jezebel:

“Over the course of a 32 week-long study ..., participants who added dessert to their breakfast -- cookies, cake, or chocolate -- lost an average of 40 lbs. more than a group that avoided such foods. What's more, they kept off the pounds longer.”

Dr. Berwick said that the five primary causes of the wasteful spending were overtreatment of patients, failure to coordinate care, administrative complexity, burdensome regulations, and fraud.

According to the New York Times:

“If his estimate is right, Medicare and Medicaid could save $150 billion to $250 billion a year by eliminating waste".

There is also an association between pork consumption and liver cancer.  Research has also found a significant correlation between pork and multiple sclerosis.

According to Perfect Health Diet:

“What can be behind those relationships? The relatively high omega-6 fat content of pork may be a contributing factor, but it can’t be the whole story. It seems there is something else in pork that makes pork consumption risky.”

Repeat surgery rates can vary from doctor to doctor by anywhere from zero to 70 percent.  The additional operations are performed when pathology reports suggest that cancer cells have been left behind, but surgeons differ as to how such reports should be interpreted.

According to the New York Times:

“Nearly half of the repeat operations were done in women whose pathology reports did not indicate that any stray cancer cells had been left behind, meaning that the operations probably did not help the patients. In more disturbing findings, 14 percent of patients who did have evidence of cancer left behind did not have another operation, for unknown reasons.”

The researchers performed gene expression profiling in the livers of mice fed diets supplemented with either fish or krill oil. They found that the krill oil downregulated the activity of pathways involved in hepatic glucose production and lipid and cholesterol synthesis.  Krill oil supplementation also increased the activity of the mitochondrial respiratory chain.

According to the study, as reprinted on the website Green Med Info:

“Surprisingly ... [fish oil] modulated fewer pathways than a [krill oil]-supplemented diet and did not modulate key metabolic pathways regulated by [krill oil], including glucose metabolism, lipid metabolism and the mitochondrial respiratory chain. Moreover, [fish oil]  upregulated the cholesterol synthesis pathway, which was the opposite effect of krill-supplementation.”

The state passed a law requiring students in grades 7 to 12 to get vaccinated, but many parents chose to opt out of the program.

The Los Angeles Times reports:

“[D]eaths ... can be prevented if cases are identified and treated quickly ... Pertussis is a bacterial disease that infects the respiratory system. It can be particularly dangerous for infants”.

It’s a good time to reflect back on the SCARE that was created over people not getting pertussis vaccines.  Now it’s been revealed that those vaccines require six follow-up booster shots just to continue to work ... if they work at all.  More likely than not, the vaccine provides NO protection in any case, as the strain that is causing the damage is not actually in the vaccine.  

Previous research has already shown very serious long-term health consequences of diet soda consumption, primarily due to highly toxic additives and artificial sweeteners such as sodium benzoate, aspartame (NutraSweet), acesulfame potassium (Ace-K), sucralose (Splenda) and high-fructose corn syrup.

According to the study:

"Daily diet soft drink consumption was associated with several vascular risk factors and with an increased risk for vascular events. Further research is needed before any conclusions can be made regarding the potential health consequences of diet soft drink consumption."

If you want to decrease your risk of stroke, however, one of the best things you can do is get some sunshine.  A research team recently used NASA satellite data to determine how sunlight corresponded with stroke risk, and found that people who got less than the midpoint level of sun exposure were at a 60% increased risk for stroke.  The connection is most like the “sunshine vitamin”, vitamin D, which is produced when your body is exposed to sunlight.  Vitamin D has been associated with a lower risk of stroke and heart attack risk in previous research.