Rotavirus

RotaSheild was produced and marketed by Wyeth-Ayerst Laboratories. It was approved for use by the FDA in August of 1998 and was recommended for universal use by the FDA in March of 1999. The oral Rotavirus vaccine is the first Rhesus-human re-assortment vaccine and was created by co-cultivating rhesus monkey Rotavirus with human rotavirus strains to create a genetic human-monkey hybrid strain of Rotavirus. It was recommended that three doses be given to all infants before six months of age. Six months later it was pulled from the market after some 1.5 million babies had received it. Monitoring studies found that vaccinated babies had a 21-times higher chance of Intussusception, a serious bowel obstruction, which in most cases required surgery to correct.  How did this happen? Was this not tested?

The disturbing issue here is that clinical trials showed that the risk of this condition was 1 in 2010 but the approval committee determined that this rate was not statistically significant. The manufacturer's package insert stated that the incidence was statistically significant.  It is often claimed on pro-vaccine information that the withdrawal of the rotavirus vaccine is an excellent example of the effectiveness of vaccine surveillance. However it appears that there was sufficient evidence to show that this vaccine should never have been licensed. Given this fact, the prompt removal of its license is irrelevant.

New update....It's back! click here:Rotavirus.

Latest news on the Rotavirus vaccine: Its happening again....

FDA Public Health Notification

Information on RotaTeq and Intussusception

February 13, 2007

The Food and Drug Administration (FDA) is notifying health care providers and consumers about 28 post-marketing reports of intussusception following administration of Rotavirus, Live, Oral, Pentavalent vaccine (trade name RotaTeq), manufactured by Merck and Co., Inc. Intussusception is a serious and potentially life-threatening condition that occurs when the intestine gets blocked or twisted. One portion of the intestine telescopes into a nearby portion, causing the intestinal obstruction. The most common site is where the small intestine joins the large intestine.

Intussusception can occur spontaneously in the absence of vaccination. Of the reported 28 cases of intussusception, the number that may have been caused by the vaccine, or occurred by coincidence, is unknown.

FDA is issuing this notification both to encourage the reporting of any additional cases of intussusception that may have occurred or occur in the future after administration of RotaTeq, and to remind people that intussusception is a potential complication of RotaTeq,.

Current Status

Approximately 3.5 million doses of RotaTeq have been distributed in the United States through February 1, 2007. Not all of these doses have been administered. Since its licensure on February 3, 2006 until January 31, 2007, 28 cases of intussusception have been reported in the U.S. in infants who received RotaTeq. These cases have been reported to the Vaccine Adverse Event Reporting System (VAERS). The reported 28 cases occurred after dose 1, dose 2 and dose 3. Approximately half of the cases occurred 1 to 21 days after vaccination, with a range of 0 to 73 days. Sixteen of the 28 infants with intussusception required hospitalization and surgery on their intestine. The remaining 12 infants had reduction of the intussusception by contrast or air enema. No deaths due to intussusception were reported.

The number of intussusception cases reported to date after RotaTeq administration does not exceed the number expected based on background rates of 18-43 per 100,000 per year for an unvaccinated population of children ages 6 to 35 weeks (CDC, unpublished data).

History

RotaTeq is indicated for the prevention of rotavirus gastroenteritis and was studied pre-licensure in a clinical trial population of approximately 70,000 infants (35,000 infants received RotaTeq and 35,000 received placebo), and no significant increased risk of intussusception was found (e.g., six cases were seen in RotaTeq recipients vs. five in placebo recipients). However, a different rotavirus vaccine, which is no longer marketed, may have increased the incidence of intussusception following its use. Therefore, to further evaluate whether, in the general population, RotaTeq could be associated with increased rates of intussusception or other serious adverse events, not only is VAERS data being evaluated continually, but Merck is conducting a post-marketing study of approximately 44,000 infants, and the CDC Vaccine Safety Data Link is conducting a post-marketing study of approximately 90,000 infants.

Recommendations

Because vaccine adverse events are not always reported to FDA, there may be additional cases of intussusception following vaccination of which we are unaware of at this time. This information is important in helping FDA and CDC assess whether RotaTeq may be associated with an increased risk of intussusception and, if so, to what degree. Therefore, we are encouraging all health care professionals, and any other individuals, to report any cases of intussusception or other serious events that may be associated with the use of RotaTeq to VAERS, which is maintained by FDA and CDC. For a copy of the vaccine reporting form, call 1-800-822-7967 or report on line to www.vaers.hhs.gov

Parents should contact their child’s doctor immediately if the child has stomach pain, vomiting, diarrhea, blood in their stool or change in their bowel movements, as these may be signs of intussusception. It is important to contact the child’s doctor if there are any questions or if the child has any of these symptoms at any time after vaccination, even if it has been several weeks since the last vaccine dose.

FDA and the CDC will continue close monitoring of intussusception and other adverse events associated with RotaTeq. The RotaTeq label and Patient Product Information have been updated to include post-marketing reports of intussusception. The dosage and administration schedule remains unchanged in the label.

RotaTeq Label (PDF - 161 KB)
Patient Product Information (PDF - 69 KB)

RotaTeq Safety Labeling Updated to Include Cases of Kawasaki Disease
http://www.medscape.com/viewarticle/558530?src=mp
Yael Waknine Medscape Medical News 2007. © 2007 Medscape
 

It looks here as if the vaccine is causing another illness.....Prediction: Kawasaki vaccine coming coming soon to a health provider near you......

June 19, 2007 — Changes have been made to the adverse reactions and postmarketing sections of the safety labeling for a live, oral, pentavalent rotavirus vaccine (RotaTeq, Merck and Company, Inc); it now includes cases of Kawasaki disease, the US Food and Drug Administration (FDA) told healthcare professionals on Friday. The poorly understood disease is uncommon in children, is characterized by high fever and blood vessel inflammation, and affects the lymph nodes, skin, mouth, and heart. During a phase 3 clinical trial, 5 cases of Kawasaki disease were reported among 36,150 infants who received the vaccine, compared with only 1 case among 35,536 who were given placebo, according to an alert sent from MedWatch, the FDA's safety information and adverse event reporting program.

Three other cases have been reported through the Vaccine Adverse Event Reporting System (VAERS) since the vaccine was approved on February 3, 2006. There is no known cause-and-effect relationship between the use of this or any other vaccine and Kawasaki disease, the FDA said, noting that the cases reported to date are not more frequent than what would be expected to occur by coincidence. Rotavirus vaccine is indicated for the prevention of rotavirus gastroenteritis in infants and children, which is caused by the serotypes G1, G2, G3, and G4, when administered orally as a 3-dose series to infants between the ages of 6 and 32 weeks. Healthcare professionals are encouraged to report cases of Kawasaki disease and other adverse events potentially associated with the vaccine to VAERS by going online at www.vaers.hhs.gov or calling 1-800-822-7967 for a report form.

Additional information about the use of the vaccine can be obtained by contacting the FDA’s Center for Biologics Evaluation and Research at 1-800-835-4709 or by e-mail at octma@cber.fda.gov.
 

RSV Virus

I am adding this information on the new RSV treatment since lately I have seen so many babies receiving this protocol.  First I will give you this question and answer that I found on an information website followed by the package insert. When you read the insert, keep in mind that "murine" means mouse. Basically they developed a murine or mouse antibody, overlaid it onto a human frame, and developed what they call a humanized chimeric monoclonal antibody (antibody produced artificially by a genetic engineering technique), which is 95% human and about 4 to 5% murine. This vaccine is given to premature babies once a month for six months and is extremely expensive.  Read this article to see why using mouse molecules or other animal material is dangerous.

Q: What is Respiratory Syncytial Virus (RSV) and how does it affect babies?
Respiratory Syncytial Virus is the most common respiratory virus in infants and young children. It infects virtually all infants by the age of two years. In most infants, the virus causes symptoms resembling those of the common cold. In infants born prematurely and/or with chronic lung disease, RSV can cause a severe or even life-threatening disease. Each year, RSV disease results in over 125,000 hospitalizations, and about 2% of these infants die.

Q: How is RSV transmitted?

RSV is highly contagious. Each year, up to 50% of infants are infected. Transmission occurs by touching an infected person, and then rubbing your own eyes, nose, or mouth. The infection can also be spread through the air, by coughing and sneezing. RSV can survive for 4-7 hours on surfaces such as cribs and countertops. Transmission may be prevented by standard infection control practices, such as hand washing. 

Q: How often do out breaks occur?

RSV outbreaks occur each year on a fairly predictable schedule that varies from one region to another. In the United States, the “RSV season” usually begins in the Fall, and lasts through Spring.

Q: How is RSV infection treated?

Treatment of severe RSV infection is mostly supportive. It is important to help ensure that the infant is able to breathe, drink, eat and sleep comfortably. Your child's doctor may use a blood test to help determine the severity of the infection and the need for hospitalization. If your infant gets a severe case of RSV disease, the antiviral medication virazole (brand name Ribavirin®, a registered trademark of ICN) may be useful. Your child's doctor is the best source of information about the treatment of serious RSV disease.

Q: Is there an RSV vaccine available?

At this date, there is no RSV vaccine available. However, there is an effective prevention product available. During the RSV season (Fall through Spring), simple monthly injections of Synagis® (palivizumab) provide protection against serious lower respiratory tract infections caused by RSV in infants and children at high risk for RSV disease. Your child's doctor can provide complete information about RSV prevention and Synagis®.

Ask your pediatrician for more information about RSV disease and Synagis® (palivizumab).

Now for the package insert:

SYNAGIS® (PALIVIZUMAB)

for Intramuscular Administration

DESCRIPTION: Synagis® (palivizumab) is a humanized monoclonal antibody (IgG1) produced by recombinant DNA technology, directed to an epitope in the A antigenic site of the F protein of respiratory syncytial virus (RSV). Palivizumab is a composite of human (95%) and murine (5%) (mouse) antibody sequences. The human heavy chain sequence was derived from the constant domains of human IgG1 and the variable framework regions of the VH genes Cor (1) and Cess (2). The human light chain sequence was derived from the constant domain of C
and the variable framework regions of the VL gene K104 with J-4 (3). The murine sequences were derived from a murine monoclonal antibody, Mab 1129 (4), in a process which involved the grafting of the murine complementarity determining regions into the human antibody frameworks. Synagis® (palivizumab) is composed of two heavy chains and two light chains and has a molecular weight of approximately 148,000 Daltons. Synagis® (palivizumab) is supplied as a sterile lyophilized product for reconstitution with sterile water for injection. Reconstituted Synagis® (palivizumab) is to be administered by intramuscular injection only. Upon reconstitution, Synagis® (palivizumab) contains the following excipients: 47 mM histidine, 3.0 mM glycine and 5.6% mannitol and the active ingredient, palivizumab, at a concentration of 100 milligrams per mL solution. The reconstituted solution should appear clear or slightly opalescent.

CLINICAL PHARMACOLOGY: Mechanism of Action: Synagis® (palivizumab) exhibits neutralizing and fusion-inhibitory activity against RSV. These activities inhibit RSV replication in laboratory experiments. Although resistant RSV strains may be isolated in laboratory studies, a panel of 57 clinical RSV isolates were all neutralized by Synagis® (palivizumab) (5). Synagis® (palivizumab) serum concentrations of 40 µg/mL have been shown to reduce pulmonary RSV replication in the cotton rat model of RSV infection by 100-fold (5). The in vivo neutralizing activity of the active ingredient in Synagis® (palivizumab) was assessed in a randomized, placebo controlled study of 35 pediatric patients tracheally intubated because of RSV disease. In these patients, palivizumab significantly reduced the quantity of RSV in the lower respiratory tract compared to control patients (6).

Pharmacokinetics: In studies in adult volunteers Synagis® (palivizumab) had a pharmacokinetic profile similar to a human IgG1 antibody in regard to the volume of distribution and the half-life (mean 18 days). In pediatric patients less than 24 months of age, the mean half-life of Synagis® (palivizumab) was 20 days and monthly intramuscular doses of 15 mg/kg achieved mean ±SD 30 day trough serum drug concentrations of 37 ±21 µg/mL after the first injection, 57 ±41 µg/mL after the second injection, 68 ±51 µg/mL after the third injection and 72 ±50 µg/mL after the fourth injection (7). In pediatric patients given Synagis® (palivizumab) for a second season, the mean ±SD serum concentrations following the first and fourth injections were 61 ±17 µg/mL and 86 ±31µg/mL, respectively.

CLINICAL STUDIES: The safety and efficacy of Synagis® (palivizumab) were assessed in a randomized, double-blind, placebo-controlled trial (IMpact-RSV Trial) of RSV disease prophylaxis among high-risk pediatric patients (7). This trial, conducted at 139 centers in the United States, Canada and the United Kingdom, studied patients 24 months of age with bronchopulmonary dysplasia (BPD) and patients with premature birth ( 35 weeks gestation) who were 6 months of age at study entry. Patients with uncorrected congenital heart disease were excluded from enrollment. In this trial, 500 patients were randomized to receive five monthly placebo injections and 1,002 patients were randomized to receive five monthly injections of 15 mg/kg of Synagis® (palivizumab). Subjects were randomized into the study from November 15 to December 13, 1996, and were followed for safety and efficacy for 150 days. Ninety-nine percent of all subjects completed the study and 93% received all five injections. The primary endpoint was the incidence of RSV hospitalization. RSV hospitalizations occurred among 53 of 500 (10.6%) patients in the placebo group and 48 of 1,002 (4.8%) patients in the Synagis® (palivizumab) group, a 55% reduction (p<0.001). The reduction of RSV hospitalization was observed both in patients enrolled with a diagnosis of BPD (34/266 [12.8%] placebo vs. 39/496 [7.9%] Synagis®[palivizumab]) and patients enrolled with a diagnosis of prematurity without BPD (19/234 [8.1%] placebo vs. 9/506 [1.8%] Synagis® [palivizumab]). The reduction of RSV hospitalization was observed throughout the course of the RSV season. Among secondary endpoints, the incidence of ICU admission during hospitalization for RSV infection was lower among subjects receiving Synagis® (palivizumab) (1.3%) than among those receiving placebo (3.0%), but there was no difference in the mean duration of ICU care between the two groups for patients requiring ICU care. Overall, the data do not suggest that RSV illness was less severe among patients who received Synagis® (palivizumab) and who required hospitalization due to RSV infection than among placebo patients who required hospitalization due to RSV infection. Synagis® (palivizumab) did not alter the incidence and mean duration of hospitalization for non-RSV respiratory illness or the incidence of otitis media.

INDICATIONS AND USAGE: Synagis® (palivizumab) is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients at high risk of RSV disease. Safety and efficacy were established in infants with bronchopulmonary dysplasia (BPD) and infants with a history of prematurity ( 35 weeks gestational age). (See Clinical Studies section)

CONTRAINDICATIONS: Synagis® (palivizumab) should not be used in pediatric patients with a history of a severe prior reaction to Synagis® (palivizumab) or other components of this product.

WARNINGS: Very rare cases of anaphylaxis (<1 case per 100,000 patients) have been reported following re-exposure to Synagis® (palivizumab) [see Adverse Reactions, Post-Marketing Experience]. Rare severe acute hypersensitivity reactions have also been reported on initial exposure or re-exposure to palivizumab. If a severe hypersensitivity reaction occurs, therapy with palivizumab should be permanently discontinued. If milder hypersensitivity reactions occur, caution should be used on readministration of palivizumab. If anaphylaxis or severe allergic reactions occur, administer appropriate medications (e.g., epinephrine) and provide supportive care as required.

PRECAUTIONS: General: Synagis® (palivizumab) is for intramuscular use only. As with any intramuscular injection, Synagis® (palivizumab) should be given with caution to patients with thrombocytopenia or any coagulation disorder. The safety and efficacy of Synagis® (palivizumab) have not been demonstrated for treatment of established RSV disease.

The single-use vial of Synagis® (palivizumab) does not contain a preservative. Injections should be given within 6 hours after reconstitution. Drug Interactions: No formal drug-drug interaction studies were conducted. In the IMpact-RSV trial, the proportions of patients in the placebo and Synagis® (palivizumab) groups who received routine childhood vaccines, influenza vaccine, bronchodilators or corticosteroids were similar and no incremental increase in adverse reactions was observed among patients receiving these agents.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenesis, mutagenesis and reproductive toxicity studies have not been performed. Pregnancy: Pregnancy Category C: Synagis® (palivizumab) is not indicated for adult usage and animal reproduction studies have not been conducted. It is also not known whether Synagis® (palivizumab) can cause fetal harm when administered to a pregnant woman or could affect reproductive capacity.

ADVERSE REACTIONS: In the combined pediatric prophylaxis studies of pediatric patients with BPD or prematurity involving 520 subjects receiving placebo and 1,168 subjects receiving 5 monthly doses of Synagis® (palivizumab), the proportions of subjects in the placebo and Synagis® (palivizumab) groups who experienced any adverse event or any serious adverse event were similar. Most of the safety information was derived from the IMpact-RSV trial. In this study, Synagis® (palivizumab) was discontinued in five patients: two because of vomiting and diarrhea, one because of erythema and moderate induration at the site of the fourth injection, and two because of pre-existing medical conditions which required management (one with congenital anemia and one with pulmonary venous stenosis requiring cardiac surgery). Seizures were reported in 0.6% of the placebo group and 0.4% of the Synagis® (palivizumab) group. Deaths in study patients occurred in five of 500 placebo recipients and four of 1,002 Synagis® (palivizumab) recipients. Sudden infant death syndrome was responsible for two of these deaths in the placebo group and one death in the Synagis® (palivizumab) group. Adverse events which occurred in more than 1% of patients receiving Synagis® (palivizumab) in the IMpact-RSV study for which the incidence in the Synagis® (palivizumab) group was 1% greater than in the placebo group are shown in Table 1.

n = 500 n = 1,002

upper respiratory infection 49.0% 52.6%

otitis media 40.0% 41.9%

rhinitis 23.4% 28.7%

rash 22.4% 25.6%

pain 6.8% 8.5%

hernia 5.0% 6.3%

SGOT increased 3.8% 4.9%

pharyngitis 1.4% 2.6%

Other adverse events reported in more than 1% of the Synagis® (palivizumab) group included: fever, cough, wheeze, bronchiolitis, pneumonia, bronchitis, asthma, croup, dyspnea, sinusitis, apnea, failure to thrive, nervousness, diarrhea, vomiting, and gastroenteritis, SGPT increase, liver function abnormality, study drug injections site reaction, conjunctivitis, viral infection, oral monilia, fungal dermatitis, eczema, seborrhea, anemia and flu syndrome. The incidence of these adverse events was similar between the Synagis® (palivizumab) and placebo groups.

IMMUNOGENICITY: In the IMpact-RSV trial, the incidence of anti-palivizumab antibody following the fourth injection was 1.1% in the placebo group and 0.7% in the Synagis® (palivizumab) group. In pediatric patients receiving Synagis® (palivizumab) for a second season, one of the fifty-six patients had transient, low titer reactivity. This reactivity was not associated with adverse events or alteration in Synagis® (palivizumab) serum concentrations. These data reflect the percentage of patients whose test results were considered positive for antibodies to Synagis® (palivizumab) in an ELISA assay, and are highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors including sample handling, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Synagis® (palivizumab) with the incidence of antibodies to other products may be misleading.

POST-MARKETING EXPERIENCE: The following adverse reactions have been identified and reported during post-approval use of Synagis® (palivizumab). Because the reports of these reactions are voluntary and the population is of uncertain size, it is not always possible to reliably estimate the frequency of the reaction or establish a causal relationship to drug exposure. Based on experience in over 400,000 patients who have received Synagis® (palivizumab) (>2 million doses), rare severe acute hypersensitivity reactions have been reported on initial or subsequent exposure. Very rare cases of anaphylaxis (<1 case per 100,000 patients) have also been reported following re-exposure. None of the reported hypersensitivity reactions were fatal. Hypersensitivity reactions may include dyspnea, cyanosis, respiratory failure, urticaria, pruritis, angioedema, hypotonia and unresponsiveness. The relationship between these reactions and the development of antibodies to Synagis® (palivizumab) is unknown. Limited information from post- marketing reports suggests that, within a single RSV season, adverse events after a sixth or greater dose of Synagis® (palivizumab) are similar in character and frequency to those after the initial five doses.

OVERDOSAGE: No data from clinical studies are available on overdosage. No toxicity was observed in rabbits administered a single intramuscular or subcutaneous injection of Synagis® (palivizumab) at a dose of 50 mg/kg.

DOSAGE AND ADMINISTRATION: The recommended dose of Synagis® (palivizumab) is 15 mg/kg of body weight. Patients, including those who develop an RSV infection, should receive monthly doses throughout the RSV season. The first dose should be administered prior to commencement of the RSV season. In the northern hemisphere, the RSV season typically commences in November and lasts through April, but it may begin earlier or persist later in certain communities. Synagis® (palivizumab) should be administered in a dose of 15 mg/kg intramuscularly using aseptic technique, preferably in the anterolateral aspect of the thigh. The gluteal muscle should not be used routinely as an injection site because of the risk of damage to the sciatic nerve. The dose per month = [patient weight (kg) x 15 mg/kg ÷100 mg/mL of Synagis®(palivizumab)]. Injection volumes over 1 mL should be given as a divided dose.

•· To reconstitute, remove the tab portion of the vial cap and clean the rubber stopper with 70% ethanol or equivalent.

•· Both the 50 mg and 100 mg vials contain an overfill to allow the withdrawal of 50 milligrams or 100 milligrams respectively when reconstituted following the directions described below.

• Slowly add 0.6 mL of sterile water for injection to the 50 mg vial or add 1.0 mL of sterile water for injection to the 100 mg vial. The vial should be gently swirled for 30 seconds to avoid foaming. DO NOT SHAKE VIAL.

• Reconstituted Synagis® (palivizumab) should stand at room temperature for a minimum of 20 minutes until the solution clarifies.

•· Reconstituted Synagis® (palivizumab) does not contain a preservative and should be administered within 6 hours of reconstitution.

To prevent the transmission of hepatitis viruses or other infectious agents from one person to another, sterile disposable syringes and needles should be used. Do not reuse syringes and needles.

HOW SUPPLIED: Synagis® (palivizumab) is supplied in single use vials as lyophilized powder to deliver either 50 milligrams or 100 milligrams when reconstituted with sterile water for injection. 50 mg vial NDC 60574 -4112-1 Upon reconstitution the 50 mg vial contains 50 milligrams Synagis® (palivizumab) in 0.5 mL. 100 mg vial NDC 60574 -4111-1 Upon reconstitution the 100 mg vial contains 100 milligrams Synagis® (palivizumab) in 1.0 mL. Upon receipt and until reconstitution for use, Synagis® (palivizumab) should be stored between 2 and 8ºC (35.6º and 46.4ºF) in its original container. Do not freeze. Do not use beyond the expiration date.

n = 500 n = 1,002
upper respiratory infection 49.0% 52.6% otitis media 40.0% 41.9% rhinitis 23.4% 28.7% rash 22.4% 25.6% pain 6.8% 8.5% hernia 5.0% 6.3% SGOT increased 3.8% 4.9% pharyngitis 1.4% 2.6%

I found this article written before the vaccine was released to the general public.  Some very interesting things are discovered I have highlighted them in bold.

Dr. Jim Crowe assistant professor of Pediatrics and Microbiology at Vanderbilt conducted the trails of the RSV vaccine. This is excerpts from the article on him.  It’s known that the immune systems of very young children don’t respond vigorously to vaccination. The B- and T-lymphocytes in the bloodstream that typically fight any type of foreign invading organism - which vaccines mimic - aren’t very effective in the first few months of a baby’s life. It’s not entirely clear, Crowe said, why infants differ from older children and adults in this regard. His lab is looking at the molecular level in individual infants to determine what genes are being used at the time of immunization to make an immune response.

“Over the last two years,” Crowe said, “we’ve been able to get the first glimpses of why children are different from adults.” As a study model, Crowe is evaluating the immune response of infants in vaccine trials against respiratory syncycial virus, or RSV, at the Vanderbilt Vaccine Clinic. This particularly infectious virus affects most of us in our lifetimes, and can require hospitalization for some children. Being involved in the RSV vaccine trials has allowed Crowe and his co-workers to probe these questions about newborn immunity. In the trials, babies are intentionally infected with weakened virus at 4 weeks of age. (What! why would parents allow this?) The researchers monitor the genetic changes underlying whether a baby responds well to the vaccine or not.

The vaccine trials will accept any age enrollee - from a very young child to an adult - to help define the immune system transition, but ultimately researchers need to understand the 2-4 week old babies, since they are most vulnerable to infection.

Without the vaccine trials, Crowe said, they couldn’t do the research.

“A unique opportunity presents itself by being able to intentionally infect a child on a known day with a known amount of virus,” he said. “We can measure titer (infection levels) of the virus, and also shedding of the virus. We know the full RNA sequence of the virus, which helps us in our genetic studies. It’s an extremely controlled situation.”

Future plans include studying how premature infants differ from full-term babies in their immune response. The more pieces to the puzzle of immune system development that researchers discover, the better able they will be to come up with effective and safe vaccines not only to RSV, but to a host of other pathogens as well.

Also take a look at this excerpt from N.Z. Millers' article entitled: The polio vaccine a critical assessment of its arcane history, efficacy and long term health related consequences found here http://www.thinktwice.com/Polio.pdf.

Thousands of viruses and other potentially infectious micro-organisms thrive in monkeys and cows, the preferred animals for making polio vaccines [83:159]. SV-40, SIV, and BSE associated transmissible agents are just three of the disease-causing agents researchers have isolated. For example, scientists have known since 1955 that monkeys host the “B” virus, foamy agent virus, haemadsorption viruses, the LCM virus, arboviruses, and more [157]. Bovine immunodeficiency virus (BIV), similar in genetic structure to HIV, was recently found in some cows [103:100]. In 1956, respiratory syncytial virus (RSV) was discovered in chimpanzees [158]. According to Dr. Viera Scheibner, who studied more than 30,000 pages of medical papers dealing with vacci-nation, RSV viruses “formed prominent contaminants in polio vaccines, and were soon detected in children [159].” They caused serious cold-like symptoms in small infants and babies who received the polio vaccine [159].

In 1961, the Journal of the American Medical Association published two studies confirming a causal relationship between RSV and “relatively severe lower respiratory tract illness [160].” The virus was found in 57 percent of infants with bronchiolitis or pneumonia, and in 12 percent of babies with a milder febrile respiratory disease [161]. Infected babies remained ill for three to five months [161]. RSV was also found to be contagious, and soon spread to adults where it has been linked to the common cold [162]. Today, RSV infects virtually all infants by the age of two years, and is the most common cause of bronchiolitis and pneumonia among infants and children under one year of age [163]. It also causes severe respiratory disease in the elderly [164]. RSV re-mains highly contagious and results in thousands of hospitalizations every year; many people die from it [165]. Ironically, scientists are developing a vaccine to combat RSV [166]Cthe infectious agent that very likely entered the human population by way of a vaccine [159].

 Dr. John Martin, a professor of pathology at the University of Southern California, has been warning authorities since 1978 that other dangerous monkey viruses could be contaminating polio vaccines. In particular, Martin sought to investigate simian cytomegalovirus (SCMV), a “stealth virus” capable of causing neuro-logical disorders in the human brain. The virus was found in monkeys used for making polio vaccines. The government rebuffed his efforts to study the risks [83:159–61]. However, in 1995, Martin published his findings implicating the African green monkey as the probable source of SCMV isolated from a patient with chronic fatigue syndrome [167]. In 1996, Dr. Howard B. Urnovitz, a microbiologist, founder and chief science officer of Calypte Biomedical in Berkeley, Cali-fornia spoke at a national AIDS conference where he revealed that up to 26 monkey viruses may have been in the original Salk vaccines. These included the simian equivalents of human echo virus, coxsackie, herpes (HHV-6, HHV-7, and HHV-8), adenoviruses, Epstein-Barr, and cytomegalovirus [168-170]. Urnovitz believes that contaminated Salk vaccines given to U.S. children between 1955 and 1961 may have set this generation up for immune system damage and neurological disorders. He sees correlations between early polio vaccine campaigns and the sudden emergence of human T-cell leukemia, epidemic Kaposi’s sarcoma, Burkitt’s lym-phoma, herpes, Epstein-Barr and chronic fatigue syndrome[168:1].

 Urnovitz also discussed “jumping genes”—normal genes that may recombine with viral fragments to form new hybrid viruses called chimeras. He believes that this is exactly what happened when monkey viruses and human genes were brought together during early polio vaccine campaigns. And because the chimera “has the envelope of a normal human gene,” typical cures won’t work. How do you develop a vaccine or other antidote against the body’s own DNA [168:1-4;171]?16. Mutated polio strains Several years ago, the World Health Organization launched the Global Polio Eradication Initiative, with 2000 as its target date for eliminating the disease. However, by 2000 it became clear that not only was polio still around, but new strains of the disease—derived from the vaccine itself—were emerging [172]. Researchers first noticed something unusual in 1983. Outbreaks of polio in doi: 10.1588/medver.2004.01.00027
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