Prevnar Vaccination

The New Pneumonia Jab

PREVNAR VACCINE (FOR PNEUMONIA AND PNEUMOCOCCAL MENINGITIS)

This vaccine is for use against pneumonia and pneumococcal Meningitis and has previously been in use in the United States.

THE DISEASE

The annual incidence for pneumonia in the US is approximately 10 cases per 100,000 people. Incidence for pneumococcal meningitis in young children is approximately 7 cases per 100,000. The death rate for the diseases is 8%, with 25% suffering neurological problems (the data sheet failed to say whether this was permanent or temporary). (1).

WHAT ARE THE RISK FACTORS FOR THE DISEASE?

Children who aren’t breast fed get more pneumonia and meningitis. Bottle sharing also heightens the risk. Those in organised day care centres are at greater risk, those with a history of middle ear infections and those with a history of prior antibiotic use. It should be noted there are antibiotics in vaccines.

The reason for introducing vaccination is that children are now becoming resistant to antibiotics. (1).

WAYS TO PROTECT YOUR CHILD FROM PNEUMONIA

1. Breast feed! (see ‘Breast Milk: A Natural Immunisation’, from VAN UK shop, www.vaccine-info.org, or right here at Novel Book Shop).
2. If giving your baby bottles of juice, DON’T share them round with other babies or let your baby drink from another baby’s bottle.
3. Sterilise any soothers/dummies used.
4. Don’t share plates of food, knifes, forks, spoons etc
5. Avoid antibiotics except in the case of life-threatening emergency.
6. If your child has suffered from ear infections, strengthen his immune system with vitamin supplementation, breast milk, a healthy whole grain diet and homeopathic treatment instead of repeated antibiotic use.
7. Avoid day care facilities. If you work, pick a childminder instead as there will be less children in a more homely environment, which lessens the risk of pneumonia.

THE VACCINE – COMPOSITION:

Ingredients of the vaccine are: Streptococcus pneumoniae, diphtheria CRM protein, casamino acids, yeast extract, ammonium sulphate, aluminium.

SCHEDULE: It is intended to be given in 5 doses, at 2 months, 3 months, 4 months, 12 months and 13 months.

SIDE-EFFECTS:

50% of recipients will get redness and soreness at the injection site, 21% get a fever (over 100.3 F), chills, general malaise, irritability, drowsiness, decreased appetite, arthritis. 1 in 10,000 cases involves a serious reaction including trouble breathing, hives, having a fast heartbeat and becoming dizzy. Seizures also occurred in 1 in 10,000 – almost all seizures occurred within 4 days of vaccination. (2 and 3).

According to the manufacturer, Wyeth, the following reactions may also occur:
Vomiting, diarrhoea, injection site redness, fever over 38 Degrees C, drowsiness, irritability, swelling interfering with movement, seizures, hypotonic hyperesponsive episode, dermatitis, face oedema, angioneurotic oedema, dyspnoea, bronchospasm, anaphylactic shock.
As with other aluminium-containing vaccines, a nodule may occasionally be palpable at the injection site for several weeks
As the rate for pneumonia is 10 in 100,000 and the rate for serious vaccine side-effects is 1 in 10,000, this makes the risk from the vaccine the same, if not more, than the risk from the disease.

SAFETY TRIAL
Of the 17,066 children involved in the Prevnar safety trial, there were 24 hospitalisations, including 2 cases of pneumonia and 1 case of otitis media (the very things they are supposed to be immunising against) and 1 case of congestive heart failure. In addition to this there were also 162 visits to the emergency room department including 20 cases of seizure, 15 cases of otitis media, 6 cases of pneumonia and 1 case of sepsis.
12 cases of SIDS death also occurred in subjects receiving Prevnar and 1 SIDS like death in a child over 1 year old. This included 1 death within 1 week of vaccination, 2 deaths 2 weeks after vaccination, 2 deaths one month after vaccination and 4 deaths in the year following vaccination. (4).
There have also been 217 DEATHS reported to Vaccine Adverse Events Reporting System in the US since 2000.
E.G. VAERS case number 167703 states: ‘Information has been received from an investigator regarding a 3 month old female who received her first dose of Prevnar as part of a post-marketing safety surveillance trial. At 39 days, post vax, the infant died due to Sudden Infant Death Syndrome.’ (5).

CONTRAINDICATIONS (people who should not receive the vaccine)

Hypersensitivity to any part of the vaccine
Illness with fever
Seizure disorder
Latex allergy (since the vaccine is packaged in latex)
Thrombocytopenia or any coagulation disorder
Adults – especially pregnant and lactating women

Prevnar has not been evaluated for any carcinogenic or mutagenic potential, or impairment of fertility (i.e. they don’t know if it causes cancer, mutates into other illnesses or impairs people’s ability to have children). (4).

SOURCES:
1. National Network For Immunization Information, a PRO-vaccine organisation.
2. NTW Information Series – Health Information Leaflet.
3. Walgreen’s Pharmacy.com
4. Wyeth Lederle Vaccine Manufacturer’s Data Sheet for Prevnar vaccine – Lederle Laboratories.
5. Vaccine Adverse Event Reporting System, Database.


By Joanna Karpasea-Jones.

PREVNAR CAUSES SUPER BUG EAR INFECTIONS IN CHILDREN

Prevnar vaccine is having an unfortunate effect: promoting new superbugs that cause ear infections.

On Monday, doctors reported discovering the first such germ that is resistant to all drugs approved to treat childhood ear infections. Nine toddlers in Rochester, N.Y., have had the germ and researchers say it may be turning up elsewhere, too.

Flourishing strains

Prevnar prevents seven strains responsible for most cases of pneumonia, meningitis and deadly bloodstream infections. But dozens more strep strains exist, and some have flourished and become impervious to antibiotics since the vaccine combats the more common strains.

"It is very worrying," said Dr. Keith Klugman, an infectious diseases specialist at Emory University. "With the eradication of all the other types in the vaccine, this one is emerging."

Losing its punch

Prevnar, however, is losing its punch because strains not covered by the vaccine are filling the biological niche that the vaccine strains used to occupy, and they are causing disease.

Big trouble

One strain in particular, called 19A, is big trouble. A new subtype of it caused ear infections in the nine Rochester children, ages 6 months to 18 months, that were resistant to all pediatric medications, said Dr. Michael Pichichero, a microbiologist at the University of Rochester Medical Center.

The children had been unsuccessfully treated with two or more antibiotics, including high-dose amoxicillin and multiple shots of another drug. Many needed surgery to place ear tubes to drain the infection, and some recovered only after treatment with a newer, powerful antibiotic whose safety in children has not been established.

All 19A strep subtypes tend to be resistant to some drugs and have been growing in prevalence:

* Scientists from a drug company and two labs analyzed more than 21,000 bacterial samples from around the nation and found 19A increasing. Among children 2 and under, the portion of samples that were this strain rose to 15 percent in 2005-2006, from 4 percent in the previous three years.
* A British lab tracking respiratory infections in U.S. kids found that the 19A strain accounted for 40 percent of drug-resistant cases.
* University of Iowa researchers found 19A accounted for 35 percent of penicillin-resistant infections in 2004-05, compared with less than 2 percent the year before the new vaccine came out.

This is just extracts of the article. You can see msnbc's article here:

http://www.msnbc.msn.com/id/20825107/

Vaccines CAUSE Pneumonia!

The Rotavirus vaccine - an American vaccine against childhood diarrhea and dehydration - has been found to cause pneumonia!

It has already been withdrawn once for causing intersuption of the bowel (where the bowel sticks together - the condition can be life threatening if not treated).

Now the FDA have said that according to 11 trials, rotavirus vaccine causes pneumonia, bronchitis, convulsions and death.

63,000 children were given the vaccine and there was a 'statistically significant' increase in the number of pneumonia deaths compared with the placebo, and the rotavirus vaccine group also had more bronchitis and a higher rate of convulsions.

The FDA now want to bring in an oral rotavirus vaccine instead of using the injection.

Source: Reuters, 15 February 2008.

Editor's Comment: I wonder what substance the placebo were given? As this is a vaccine trial, it would not have been water or a sugar pill, but another vaccine or aluminium.

The most common cause of infant diarrhea is bottle feeding. Breast fed babies do not normally get diarrhea. Most life threatening cases of diarrhea and dehydration are in the third world, not in Western countries.

Here it can easily be remedied by doctor's educating on the importance of breast feeding and giving plenty of water.

Pneumonia Vaccinated Children May Aquire More Strains of Bacteria

A pneumonia vaccine reduces the incidence of acute otitis media (AOM, acute ear infection) caused by the bacterium Streptococcus pneumoniae by 34 percent and reduces the overall incidence of AOM by 6 to 8 percent. However, a new study found that children with AOM who were immunized with the heptavalent pneumococcal conjugate vaccine (PCV7) were as likely as nonimmunized children to have nasopharyngeal colonization with S. pneumoniae and were more likely to have other types of bacteria in their nasopharynx. The nasopharynx is located at the back of the throat and has two passages leading to the inner ear, through which bacteria can travel.

The study, supported in part by the Agency for Healthcare Research and Quality (HS10613), raises concern that colonization of the nasopharynx of children with AOM with multiple types of bacteria could increase the likelihood of multiple AOM pathogens. This, in turn, could possibly lead to more children failing to respond to a single-antibiotic treatment for an ear infection. It could also lead to increased risk for developing recurrent AOM after antibiotic treatment. Researchers advise continued vigilance in observing the effect of PCV7 on acute ear infections.

They specifically investigated the impact of PCV7 on nasopharyngeal colonization with S. pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis during AOM in the pre-PCV7 and post-PCV7 vaccination eras. They enrolled 417 children (6 months to 4 years of age) in AOM studies between September 1995 and December 2004. Of these, 200 were enrolled before the vaccine's use (historical controls), and 217 were enrolled after initiation of PCV7 vaccination (101 were underimmunized, that is missed 1 or 2 doses due to early shortage of vaccines, and 116 were immunized). The colonization rate for S. Pneumoniae was not different between the three groups. However, a significantly higher proportion of PCV7-immunized children with AOM were colonized with M. Catarrhalis (74 percent) compared with historical controls (56 percent) and the underimmunized group (62 percent). Overall, the mean number of pathogenic bacteria types isolated from immunized children (1.7) was significantly higher than in controls (1.4).

See "Effect of pneumococcal conjugate vaccine on nasopharyngeal bacterial colonization during acute otitis media," by Krystal Revai, M.D., M.P.H., David P. McCormick, M.D., Janak Patel, M.D., and others in the May 2006 Pediatrics 117(5), pp. 1823-1829.

To summarize: vaccinated children are as likely as unvaccinated children to get pneumonia and in addition to that they also get other strains of bacteria that unvaccinated children don't get.

Prevnar Vaccine Is Causing The Pneumonia To Mutate Into A Different Type

At the same time we were heralding the benefits of PCV7, we were alert to the unintended consequence of serotype replacement. This phenomenon, demonstrated convincingly in randomized, controlled trials [11], occurs when serotypes not included in a conjugate vaccine colonize the nasopharynx and “replace” the vaccine serotypes whose colonization is prevented by the vaccine. The net effect is that PCV7 does not reduce the overall prevalence of nasopharyngeal colonization. PCV7 serotypes are, on average, better suited to causing invasive disease than non‐PCV7 serotypes.

First, serotype 19A has relatively high propensities for colonizing the nasopharynx (to maximize transmissibility) and for causing invasive disease. Second, serotype 19A was associated with antibiotic resistance even before the introduction of PCV7; therefore, when exposed to antibiotics prescribed for upper respiratory tract infections, it had a selective advantage over other, more susceptible serotypes. Finally, PCV7 has no efficacy against serotype 19A.

Increases in the incidence of serotype 19A associated with otitis [14], mastoiditis [15], and invasive disease [16–18] have been described in multiple US settings since 2000, making it impossible to ignore the temporal association between the introduction of PCV7 and the emergence of serotype 19A. It seemed safe to assume that PCV7 had caused replacement with serotype 19A.

Source: The Journal of Infectious Diseases 2009;199:771–773

Prevnar Makes Drug Company Wyeth $755 Million In The First Quarter Of 2009

Sales of anti-depressant Effexor tumbled 20 percent to $819
million as the drug began facing generic competition in Europe.
It was also hurt by lingering concerns that such medicines
increase the risk of suicidal thoughts.

The magnitude of the Effexor sales decline was far greater
than the 3 percent drop seen in the prior quarter.

But global revenue from Prevnar, a vaccine to protect
children from being infected with pneumococcal bacteria, which
has been one of Wyeth's fastest-growing products, rose 7 percent
to $755 million.

"At the end of the day, Wyeth is executing well," said
Edward Jones analyst Linda Bannister. "Like others in the
industry, they beat on the bottom line but missed a little on
the top line."

Bannister said Prevnar showed decent growth despite the
strong dollar and economic downturn, and could grow
significantly in coming years if an improved form of the vaccine
is approved for children and becomes available for adults.

The company posted quarterly earnings of $1.2 billion, or 89
cents per share, unchanged from year-earlier results.

Source: Reuters, 29th April 2009, by Ransdell Pierson.

Prevnar Recall!

Recall: Prevnar Pneumococcal 7-valent Conjugate Vaccine, Wyeth
DATE RECALL INITIATED:

July 10, 2009

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Prevnar pneumococcal 7-valent Conjugate Vaccine
(Diptheria CRM197Protein)

0.5 mL single dose pre-filled syring (10 per package)
NDC: 0005-1970-50 (10’s)/0005-1970-49 (Singles)

Lot Number: D50002

Expiration Date: February 28, 2011

MANUFACTURER:

Wyeth

Philadelphia, PA

REASON:

Wyeth is voluntarily recalling the above lot of Prevnar®, Pneumococcal 7-valent Conjugate Vaccine, single dose pre-filled syringes. During a routine physical reconciliation of Prevnar® pre-filled syringes, Wyeth determined that a portion of a bulk lot of pre-filled syringes, which was not intended for commercial use, was inadvertently packaged and distributed with commercial product under Lot D50002. The product distributed as Lot D50002 met Wyeth’s quality acceptance criteria. Although some of the units of Lot D50002 were not intended for the commercial market, Wyeth performed a medical assessment and has concluded that the affected syringes present no health or safety risk to patients and that there is no need to revaccinate.

Source: FDA website.

Three Dutch Babies Dead After Prevnar

The Dutch health institute RIVM has stopped the distribution of a batch of Pfizer's Prevnar childhood vaccine following the death of three babies shortly after being vaccinated.

The vaccine has been labeled 'do not use' and and new supplies have been made available to doctors.

The exact cause of the death of the infants is not yet known, the RIVM said. The babies died between one and 11 days after the vaccination.

Source: Dutch News.nl, 6 November 2009.

Prevnar Increases Severe Lung Infections by 70%

OBJECTIVE: To determine if the incidence of empyema among children in the United States has changed since the introduction of the pneumococcal conjugate vaccine in 2000.

METHODS: We used the nationally representative Kids' Inpatient Database to estimate the annual total number of hospitalizations of children ≤18 years of age that were associated with empyema in 1997, 2000, 2003, and 2006. Using US Census data, estimated counts were converted into annual incidence rates per 100000 children. Incidence rates were compared between 1997 and later years to determine the impact of pneumococcal conjugate vaccine on hospitalization rates.

RESULTS: During 2006, an estimated total of 2898 (95% confidence interval [CI]: 2532–3264) hospitalizations of children ≤18 years of age in the United States were associated with empyema. The empyema-associated hospitalization rate was estimated at 3.7 (95% CI: 3.3–4.2) per 100000 children, an increase of almost 70% from the 1997 empyema hospitalization rate of 2.2 (95% CI: 1.9–2.5) per 100000. The rate of complicated pneumonia (empyema, pleural effusion, or bacterial pneumonia requiring a chest tube or decortication) similarly increased 44%, to 5.5 (95% CI: 4.8–6.1) per 100000. The rate of bacterial pneumonia decreased 13%, to 244.3 (95% CI: 231.1–257.5) per 100000. The rate of invasive pneumococcal disease (pneumonia, sepsis, or meningitis caused by Streptococcus pneumoniae) decreased 50%, to 6.3 (95% CI: 5.7–6.9) per 100000.

CONCLUSIONS: Among children ≤18 years of age, the annual empyema-associated hospitalization rates increased almost 70% between 1997 and 2006, despite decreases in the bacterial pneumonia and invasive pneumococcal disease rates. Pneumococcal conjugate vaccine is not decreasing the incidence of empyema.

Source:
PEDIATRICS Vol. 125 No. 1 January 2010, pp. 26-33

http://pediatrics.aappublications.org/cgi/content/abstract/125/1/26