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My own opinion about vaccinations is not relevant.  Each parent needs to make a decision based on the information about vaccinations available.

 

Numerous anti-vaccination information sites exist. (eg. thinktwice.com, etc.) But the information they provide is not generally respected by medical doctors.  Everything below is from the CDC website, which informs doctors and runs vaccination in this country. You cannot get more pro vaccination.

 

The CDC also runs the VAERS, the vaccine adverse events reporting site.  It might seem contradictory to some that the agency charged with promoting vaccination should also be monitoring the adverse effects, but the CDC handles both roles. 

 

The following information has been taken from numerous locations on the CDC website in an effort to concentrate the information.   All bolds have been added.  Any inserted comments have been noted.  For complete information, please consult www.cdc.gov.

 

Some of the information may seem contradictory, such as the following two quotations from the CDC information service:

 

http://www.cdc.gov/nip/publications/niiw/pastPDF/SampleOpEdChickenpox.pdf

from an OPED piece for the public:

"While Varicella is the greatest vaccine preventable killer of children in the United states, only 26% of children 19 to 36 months old had received varicella vaccine by 1997"

http://www.cdc.gov/nip/publications/surv-manual/chpt14_varicella.pdf

for practitioners:

Vaccine efficacy varies between 70-90%.  Vaccination levels range from 73-84%, with a goal of 95% of the population. 

 

Some of the information involves different  risk assessments:

http://www.cdc.gov/nip/publications/Parents-Guide/PGVaricella.pdf

In the parents guide for Chickenpox:

“4 in 100,000 under one may die, 1 in 100,000 2-14 year olds may die”

 (In 1998 3 fatal cases of Varicella in the entire U.S. were reported, in 1997 3 fatal cases were reported)

 

http://www.cdc.gov/nip/vacsafe/vacsafe-parents.htm

 

Vaccines: The Safe Choice

Vaccine Safety Information for Parents

 

Not vaccinating your child? Be aware of the risks.

Immunizations, like any medication, can cause side effects. However, a decision not to immunize a child also involves risk. It is a decision to put the child and others who come into contact with him or her at risk of contracting a disease that could be dangerous or deadly. Consider measles. One out of 30 children with measles gets pneumonia. For every 1,000 children who get the disease, one or two will die from it. Thanks to vaccines, we have few cases of measles in the U.S. today. However, the disease is extremely contagious and each year dozens of cases are imported from abroad into the U.S., threatening the health of people who have not been vaccinated and those for whom the vaccine was not effective. Unvaccinated children are also at risk from meningitis (swelling of the lining of the brain) caused by Hib (a severe bacterial infection), bloodstream infections caused by pneumococcus, deafness caused by mumps, and liver cancer caused by hepatitis B virus.

 

http://www.cdc.gov/ncidod/dvrd/revb/measles/documents/measles_update_weeks_24_32_2002_no_2.pdf

 

Measles cases by week 32, 2002  in the U.S. 16

 

Measles cases by week 32, 2001 in the U.S. 91

 

About 1 in every 1000 children who get the measles will get encephalitis, and about 1 in every thousand will die from it.  (My added notation:  I would put the risk at 1/1000 multiplied by 1/1000, giving one in a million, rather than the one in 1000 risk listed above.)

 

Haemophilus influenzae Serotype b (Hib) Disease

 

http://www.cdc.gov/ncidod/dbmd/diseaseinfo/haeminfluserob_t.htm

 

In the United States and other industrialized countries, more than one-half of Haemophilus influenzae serotype b (Hib) cases present as meningitis with fever, headache, and stiff neck. The remainder present as cellulitis, arthritis, or sepsis. In developing countries, Hib is the second leading cause of bacterial pneumonia deaths in children as well.

 

3%-6% of cases are fatal; up to 20% of surviving patients have permanent hearing loss.

 

October 2000 Hib reporting by CDC (most recent report available)

361 cases.  Number reporting Meningitis 26 (7.2%).   Number of deaths: 1 (3.8%)  (My notation:  how does 7% suddenly become half?)

 

From www.cdc.gov/abcs

 

Have any vaccines been permanently withdrawn from the US market due to a safety concern?

 

Yes. In 1999, the Advisory Committee on Immunization Practices (ACIP) decided that RotaShield®, the only U.S.-licensed rotavirus vaccine, should no longer be recommended for infants in the United States (Centers for Disease Control and Prevention 1999). This decision was based on the results of a review of scientific studies that indicated a strong association between RotaShield® and intussusception (a rare, potentially life-threatening form of intestinal obstruction) among some infants during the first 1-2 weeks following vaccination. RotaShield® was voluntarily withdrawn by the manufacturer before the ACIP withdrew its recommendation, but after the CDC recommended suspending use of the vaccine. See http://www.cdc.gov/nip/issues/rota/ for more information about RotaShield®.

 

In early 1976, the CDC detected the circulation of a flu virus, known as swine flu, which was similar to the Spanish flu virus that killed many people in 1918. The government, out of fear of a devastating flu epidemic like the one in 1918, began a mass swine flu vaccination campaign. However, in December of 1976 the campaign was stopped because of reports of Guillain-Barré syndrome or GBS (a rare disorder that causes weakness and oftentimes temporary paralysis, usually in the arms, legs or face) in some people who received the swine flu vaccine (Schonberger et al. 1979). The swine flu vaccination campaign did not continue and the swine flu vaccine is no longer used. A study that looked at the 1992-1993 and 1993-1994 flu vaccines found a possible very slight increase in the risk of GBS (Lasky et al. 1998). However, no flu vaccine has been associated with a similar increased risk of GBS as the swine flu vaccine.

 

VAERS in Vaccine Safety Surveillance

 

Intussusception After Rotavirus Vaccine

 

RRV-TV was licensed in August 1998. The Advisory Committee on Immunization Practices (ACIP) recommendations for its use were published in March 1999 (22). From September 1, 1998, through July 7, 1999, VAERS received 15 reports of intussusception among infants who had received RRV-TV vaccine. CDC reported this finding in July 1999 and recommended that health-care providers postpone use of RRV-TV at least until November 1999, pending results of a national case-control study that was being conducted at that time (23). The manufacturer, in consultation with FDA, voluntarily ceased further distribution of the vaccine in mid-July 1999. On October 22, after a review of scientific data from multiple sources, ACIP concluded that intussusception occurred with substantially increased frequency in the first 1--2 weeks after vaccination with RRV-TV, particularly after the first dose. In 1999, ACIP withdrew its recommendation for vaccination of infants in the United States with RRV-TV (24).

 

From September 1998 through December 1999, VAERS received 121 reports of intussusception among infants who received RRV-TV vaccine (Figure 2). The first intussusception case was reported in December 1998. During the first half of 1999, a total of 14 additional cases of intussusception were reported to VAERS. The majority of cases were reported during July--August 1999, peaking soon after a MMWR publication (July 16, 1999) (23). Other studies have documented similar findings (25--29). All intussusception case-patients reported to VAERS through December 31, 1999, were vaccinated before July 17, 1999 (Figure 3). Before RRV-TV was licensed and marketed in the United States, VAERS had received a total of only three reports of intussusception after other vaccinations (Figure 4).

 

Influenza Vaccine and Guillain-Barré Syndrome

 

Vaccination with swine influenza vaccine is known to increase the risk for Guillain-Barré syndrome (30--34). Reports of Guillain-Barré syndrome after any vaccination are considered serious and followed up by VAERS to obtain additional information. An increase in reports of Guillain-Barré syndrome after the receipt of influenza vaccine was noted in VAERS data by week 29 of the 1993--94 influenza season (35). The number of reports increased from 23 during 1991--92 to 40 during 1992--93 and to 80 during 1993--94 (Figure 5). These findings raised concerns regarding a possible increase in vaccine-associated risk for Guillain-Barré syndrome. A study was initiated to investigate the VAERS signal (35). The study documented that the relative risk of Guillain-Barré syndrome after influenza vaccination, adjusted for age, sex, and vaccine season was 1.7 (95% confidence interval = 1.0--2.8). However, no increase occurred in the risk of vaccine-associated Guillain-Barré syndrome from 1992--93 to 1993--94. For the two seasons combined, the adjusted relative risk of 1.7 indicated that slightly >1 additional case of Guillain-Barré syndrome occurred per 1 million persons vaccinated against influenza. This risk is less than the risk from severe influenza, which can be prevented by the vaccine. In addition, no correlation existed between the number of Guillain-Barré syndrome reports received in VAERS and influenza vaccine doses administered (Figure 5). The annual number of Guillain-Barré syndrome reports has been low and stable during the previous four influenza seasons when the net doses of influenza vaccine distributed increased substantially. This finding reflects data compared with the 1993--94 influenza season in which VAERS received the highest numbers of Guillain-Barré syndrome reports in a single influenza season. This example indicates that VAERS is useful in preliminary evaluation of rare adverse events when the relation to vaccination is uncertain.

 

My notation:  Rotavirus remains off the market, while influenza or flu vaccine remains one of the most widely distributed vaccines.

 

http://www.cdc.gov/mmwr/preview/mmwrhtml/ss5201a1.htm

 

Both the CDC and the FDA review data reported to VAERS. The FDA reviews reports to assess whether a reported event is adequately reflected in product labeling, and closely monitors reporting trends for individual vaccine lots. Copies of published reviews are available from VAERS. Many different types of events occur after vaccination. Approximately 85% of the reports describe mild events such as fever, local reactions, episodes of crying or mild irritability, and other less serious experiences. The remaining 15% of the reports reflect serious adverse events involving life-threatening conditions, hospitalization, permanent disability, or death, which may or may not have been truly caused by an immunization.

 

Surveillance for Safety After Immunization: Vaccine Adverse Event Reporting System (VAERS) --- United States, 1991--2001

 

Abstract

 

Problem/Condition: Vaccines are usually administered to healthy persons who have substantial expectations for the safety of the vaccines. Adverse events after vaccinations occur but are generally rare. Some adverse events are unlikely to be detected in prelicensure clinical trials because of their low frequency, the limited numbers of enrolled subjects, and other study limitations. Therefore, postmarketing monitoring of adverse events after vaccinations is essential. The cornerstone of monitoring safety is review and analysis of spontaneously reported adverse events.

 

Reporting Period Covered: This report summarizes the adverse events reported to the Vaccine Adverse Event Reporting System (VAERS) from January 1, 1991, through December 31, 2001.

 

Description of Systems: VAERS was established in 1990 under the joint administration of CDC and the Food and Drug Administration (FDA) to accept reports of suspected adverse events after administration of any vaccine licensed in the United States. VAERS is a passive surveillance system: reports of events are voluntarily submitted by those who experience them, their caregivers, or others. Passive surveillance systems (e.g., VAERS) are subject to multiple limitations, including underreporting, reporting of temporal associations or unconfirmed diagnoses, and lack of denominator data and unbiased comparison groups. Because of these limitations, determining causal associations between vaccines and adverse events from VAERS reports is usually not possible. Vaccine safety concerns identified through adverse event monitoring nearly always require confirmation using an epidemiologic or other (e.g., laboratory) study. Reports may be submitted by anyone suspecting that an adverse event might have been caused by vaccination and are usually submitted by mail or fax. A web-based electronic reporting system has recently become available. Information from the reports is entered into the VAERS database, and new reports are analyzed weekly. VAERS data stripped of personal identifiers can be reviewed by the public by accessing http://www.vaers.org. The objectives of VAERS are to 1) detect new, unusual, or rare vaccine adverse events; 2) monitor increases in known adverse events; 3) determine patient risk factors for particular types of adverse events; 4) identify vaccine lots with increased numbers or types of reported adverse events; and 5) assess the safety of newly licensed vaccines.

 

Results: During 1991--2001, VAERS received 128,717 reports, whereas >1.9 billion net doses of human vaccines were distributed. The overall dose-based reporting rate for the 27 frequently reported vaccine types was 11.4 reports per 100,000 net doses distributed. The proportions of reports in the age groups <1 year, 1--6 years, 7--17 years, 18--64 years, and >65 years were 18.1%, 26.7%, 8.0%, 32.6%, and 4.9%, respectively. In all of the adult age groups, a predominance among the number of women reporting was observed, but the difference in sex was minimal among children. Overall, the most commonly reported adverse event was fever, which appeared in 25.8% of all reports, followed by injection-site hypersensitivity (15.8%), rash (unspecified) (11.0%), injection-site edema (10.8%), and vasodilatation (10.8%). A total of 14.2% of all reports described serious adverse events, which by regulatory definition include death, life-threatening illness, hospitalization or prolongation of hospitalization, or permanent disability.

 

Serious Adverse Events

 

Overall, 14.2% of all reports received in VAERS during 1991--2001 described serious adverse events (10) (Table 9). During 1991--2001, reports of deaths ranged from 1.4%--2.3%, and reports of life-threatening illness ranged from 1.4%--2.8% of all adverse event reports. During the previous 3 years when distribution of vaccines reached the highest level, the annual percentage of reports of death was stable, approximately 1.5% of all adverse event reports. The reports of life-threatening illness were also stable throughout the years except for a peak of 2.8% in 1999, which reflected RRV-TV and intussusception incident that occurred in that year.

 

A clinical research team follows up on all deaths reported to VAERS. The majority of these deaths were ultimately classified as sudden infant death syndrome (SIDS). Analysis of the age distribution and seasonality of infant deaths reported to VAERS indicated that they matched the age distribution and seasonality of SIDS; both peaked at aged 2--4 months and during the winter (15). The decrease in deaths reported to VAERS since 1992--1993 parallels the overall decrease in SIDS in the U.S. population since the implementation of the Back to Sleep campaign (15). Carefully controlled epidemiologic studies consistently have not found any association between SIDS and vaccines (16--19). FDA and the Institute of Medicine (IOM) reviewed 206 deaths reported to VAERS during 1990--1991. Only one death was believed to have resulted from a vaccine. The patient was a woman aged 28 years who died from Guillain-Barré syndrome after tetanus vaccination (20). IOM concluded that the majority of deaths reported to VAERS are temporally but not causally related to vaccination (20). A similar conclusion was reached regarding neonatal deaths temporally reported to VAERS in association with hepatitis B vaccination (21).

 

 

 

Safety Assessment After Whole Cell Versus Acellular Pertussis-Containing Vaccines

 

Concerns regarding the safety of DTP vaccines led to a gradual introduction of acellular pertussis-containing vaccines in the United States. In December 1991, FDA licensed the first DTaP vaccine for use in the United States (36). Shortly thereafter, a second DTaP formulation was also licensed (37). Both DTaP vaccines were licensed for use only as the fourth and fifth doses of the DTP series recommended for children aged 15 months--7 years. In July 1996, FDA approved the first DTaP vaccine for infants (38).

 

VAERS reports from 1991 (when whole cell pertussis vaccines were used exclusively) through 2001 (when acellular pertussis vaccines were used predominantly) documented that the overall vaccine-specific reporting rates of both serious and nonserious reports for DTaP had decreased to less than one half of that for DTP among children aged <7 years (Table 10). In comparison with all whole cell pertussis-containing vaccines (DTP and DTPH), the overall nonserious adverse events reporting rate for DTaP vaccines was approximately 40% lower (10.5 versus 16.8 reports per 100,000 net doses distributed). Although reduction in adverse reporting rates is suggestive of a safer vaccine, such comparisons must be interpreted cautiously because reporting rates cannot be viewed as incidence rates. Two studies have documented an improved safety profile of DTaP vaccines based on review of VAERS data from 1991--1993 among children and 1995--1998 among infants (39,40). The decreasing trends for selected systemic adverse events (e.g., fever) and neurologic reactions (e.g., seizures) continued to be observed during 1999--2001 (Figures 6 and 7). However, an increase in the number of reports concerning injection-site reactions was detected by the end of this surveillance period (Figure 8). The increase is more prominent among the recipients of booster doses of DTaP (fourth and fifth dose). This finding is consistent with the results of a recent study that documented an increase in the risk of extensive local reactions in recipients of fourth and fifth doses of the DTaP vaccines (41).

DTaP

 

http://www.cdc.gov/nip/publications/Parents-Guide/PGDTaP.pdf

 

After DTaP a fever over 3hrs of 104F may result in anywhere from one child in 900 to one child in 8,000, depending on studies.  No deaths have been attributed to DTaP, but precautions include not getting another shot if your child has a life threatening allergic reaction or develops encephalitis within a week. 

 

Safety Assessment After IPV Versus OPV

 

Since it was licensed in 1963, OPV has been the vaccine used for the prevention of poliovirus infection in the United States. The use of OPV led to the elimination of wild-type poliovirus in the United States in <20 years. However, the risk of vaccine-associated paralytic poliomyelitis (VAPP) was estimated to be approximately 1 case per 2.4 million doses distributed, with the majority of VAPP cases occurring after the administration of the first dose (1 case per 750,000 first doses) (42,43). The reporting sensitivity of VAPP in VAERS was an estimated 68%--72% (44). In September 1996, to reduce the occurrence of VAPP, ACIP recommended an increase in the use of IPV through a sequential schedule of IPV followed by OPV (42). VAERS has not received any report of VAPP after OPV/IPV vaccination since 1997, suggesting a positive effect of the sequential schedule of IPV followed by OPV (Figure 9). This result is consistent with previously reported data (45). In July 1999, ACIP recommended that IPV be used exclusively in the United States to maintain disease elimination and to prevent any further cases of VAPP (46).

 

Safety Assessment After Varicella Vaccine

 

In March 1995, varicella vaccine was licensed in the United States. In July 1996, varicella vaccine was recommended by ACIP for all children without contraindications at aged 12--18 months, for all susceptible children by their thirteenth birthday, and for susceptible adolescents and adults who are at high risk for exposure to varicella (47). In February 1999, ACIP expanded its recommendations for varicella vaccine to promote an expanded use of the vaccine for susceptible children and adults (48).

 

VAERS received 15,180 adverse event reports after varicella vaccination from March 1995 through December 2001, the majority (14,421, or 95%) of which described nonserious events. The highest numbers of reports were received soon after licensure (Figure 10). As the net distribution of varicella vaccine increased, the number of adverse event reports decreased continuously over the years. Of the 15,180 adverse event reports received, the number of serious adverse events reported for varicella vaccine was 759 (5%). The proportion of reports of serious adverse events was stable over the years (range: 3.7%--6.3%).

 

A detailed review of VAERS reports received during the first 3 years after the licensure of varicella vaccine documented that the majority of reported adverse events for varicella vaccine were minor, and serious events were rare (49). A vaccine etiology for the majority of reported serious events could not be confirmed; further research is needed to clarify whether varicella vaccine played a role. 

 

 

 

 (207) 623-1681 Maloney Medical, 4 Drew St., Augusta ME 04330 docleroymaloney@hotmail.com 
"If you get hit by a bus, go see your MD.  If you just feel like you were, it's time to see me."  

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