Vaccine Tales By F. Yazbak, MD, FAAP

[Guest guest]

http://www.redflagsdaily.com/yazbak/2006_mar01.php

Dr. Yazbak, a pediatrician, now devotes his time to the research of

autoimmune regressive autism and vaccine injury.

Vaccine Tales

By Red Flags Columnist, F. Yazbak, MD, FAAP

(tlautstudy@...)

“The 2004-2005 mumps epidemic in the U.K. did not result from the decrease

in MMR vaccination coverage in recent years, but rather from gaps in

eligibility of certain cohorts.”

— MMWR. Feb. 24, 2006

“Small fold increases were observed for measles, mumps and rubella antibody

titers. In contrast, substantial boosts in varicella antibody titers were

observed among recipients of a second dose of varicella vaccine,

administered as ProQuad or Varivax.”

— PEDIATRICS. February 2006

“Although some persons who develop normal antibody titers in response to a

single dose of MMR vaccine will develop higher antibody titers to the three

component vaccines when administered a second dose of vaccine, these

increased antibody levels typically do not persist.”

— MMWR. May 22, 1998

“Children and adolescents who have received the varicella (chicken pox)

vaccine and contract varicella are about half as contagious as those who

have not been vaccinated.”

— JAMA. August 2004

In an August 2005 Red Flags’ column, I commented on a mumps outbreak in the

United Kingdom and how the Department of Health and the press suggested, as

usual, that somehow it was caused by researcher Wakefield’s 1998

Lancet publication, in which he suggested that more investigation was

indicated into the role of the MMR vaccine, if any, in regressive autism.

The majority of cases in the outbreak were in adolescents and young adults

who were born before the introduction in 1988 of the MMR II vaccine in the

U.K. Although the single measles and rubella vaccine had been available and

widely used in the U.K. before the advent of MMR II, the monovalent mumps

vaccine had not. That’s because both the British Medical Association and

the Pharmaceutical Society of Great Britain had decreed that there was

little indication for its use until 1988 and the National MMR Campaign,

when it suddenly became essential. (1)

The Center for Disease Control and Prevention’s Morbidity and Mortality

Weekly Report (MMWR) of Feb. 24, 2006 was exclusively devoted to the recent

U.K. mumps epidemic. “During 2004-2005, the United Kingdom experienced a

nationwide epidemic of mumps, which peaked during 2005, when 56,390

notified cases were reported in England and Wales. The majority of

confirmed cases during 2004-2005 were in persons aged 15-24 years, most of

whom had not been eligible for routine mumps vaccination. Mumps usually is

a self-limited viral disease that appears as parotitis.”

This report also mentioned that “among all mumps patients during 2004,

approximately 3.3 percent were reported as having received two doses of

measles, mumps and rubella (MMR) vaccine, and another 30.1 percent had

received one dose of MMR.” (2)

The report was authored, interestingly, by a British epidemiologist from

the immunization department of the Health Protection Agency Centre for

Infections in London, England.

The unsigned editorial comment, in all likelihood by an American

epidemiologist, stated, “The 2004-2005 mumps epidemic in the U.K. did not

result from the decrease in MMR vaccination coverage in recent years, but

rather from gaps in eligibility of certain cohorts, which has been evident

during the epidemic by the age breakdown among patients with confirmed

cases; mumps occurred predominantly in older teens and young adults, with

the highest attack rate occurring in those born during 1983-1986. Persons

born before September 1987 generally were not eligible for any routine

mumps vaccination, although some might have received one dose of MMR upon

school entry as part of a catch-up campaign after October 1988 that

targeted children who missed their measles vaccination. Persons born before

1982 are more likely to have been exposed to mumps infection when it was

still a common childhood disease. Only 2.4 percent of confirmed cases in

2004 occurred in persons who would have been eligible for two doses of MMR

routinely.”

So apparently, Wakefield did not do it.

I have to say that I was somewhat surprised at the CDC devoting an entire

issue of MMWR to mumps in England, when the U.S. and the whole world are

faced with possible annihilation by the may-be-may-be-not bird flu pandemic.

Investigating further, I found out that, in fact, the British mumps

outbreak had touched the U.S., ever so slightly. On Feb. 23, 2006, the

Children’s National Medical Center reprinted a Reuters report about a mini

outbreak of mumps in New York State titled “Mumps outbreak at camp among

immunized children.” (3)

“In 2005, an outbreak of mumps occurred in a New York summer camp despite

the fact that all of the children involved had adequate vaccination

coverage…. The camp, which had 541 staff members and campers, was in

session between June 28 and August 18. Thirty-one cases of mumps were

identified, for a 5.7 percent attack rate … the first case was in a

20-year-old unvaccinated man who arrived from the U.K., where a mumps

epidemic was ongoing, to work as a counselor at the camp.”

This counselor’s symptoms started on June 30.

“Between July 15 and July 23, 25 more cases of swollen salivary glands were

identified, but no diagnoses of mumps were made until July 24.

Twelve cases were among campers between 10 and 15 years old, all of whom

had been vaccinated with two doses of measles-mumps-rubella (MMR) vaccine

after their first birthday. The 19 cases among staff members included nine

individuals from the U.K., five from the U.S., three from Australia, and

two from Germany. Vaccination was documented for only eight of those

affected.”

As expected, the Sullivan County Health Department recommended that “camp

counselors be vaccinated against vaccine-preventable diseases such as

mumps” apparently to avoid infecting any American children who have

received two doses of MMR.

* * * *

The February 2006 issue of PEDIATRICS contained an interesting article by

K.S. Reisenger and others describing the findings of a research group in

Pittsburgh investigating the use of ProQuad in 4- to 6-year-old healthy

children vaccinated previously with MMR II and Varivax. (4)

For the sake of brevity, only Med Line results and conclusions are quoted:

“Results: ProQuad was generally well tolerated. Similarity (noninferiority)

was demonstrated in postvaccination antibody responses to measles, mumps

and rubella between recipients of ProQuad and all recipients of MMR II and

in responses to varicella between recipients of ProQuad and recipients of

Varivax. Postvaccination seropositivity rates for antibodies against all

four viruses were nearly 100 percent in all three groups. Small fold

increases were observed for measles, mumps and rubella antibody titers. In

contrast, substantial boosts in varicella antibody titers were observed

among recipients of a second dose of varicella vaccine, administered as

ProQuad or Varivax. Conclusions: ProQuad may be used in place of a second

dose of MMR II or second doses of MMR II and Varivax for 4- to 6-year-old

children.”

The important statement is obviously, “Small fold increases were observed

for measles, mumps and rubella antibody titers. In contrast, substantial

boosts in varicella antibody titers were observed among recipients of a

second dose of varicella vaccine.”

I interpret this to mean:

1. The administered combination vaccine did not much improve the already

existing vaccine immunity against measles, mumps and rubella because they

were already very close to 100 percent.

2. The vaccine-acquired immunity that followed the first varicella

vaccination administered at age 12 months had substantially decreased by

the age of four.

In 1995, when the chicken pox vaccine was released, Philip Krause, MD,

senior research investigator in the Food and Drug Administration's Center

for Biologics Evaluation and Research was quoted as saying, " Over the

period of time it's been looked at carefully, which is about five years,

we're not able to find evidence for substantial waning in immunity. " (5)

That was obviously the statement that was repeated to doctors by their

professional associations and to parents by the lay press and the 24-hour

television news channels. The next sentence in Krause’s statement was

rarely stressed: " It's complicated to determine how long immunity lasts

because right now, people who are vaccinated are exposed to children who

have [naturally acquired] chicken pox and they presumably are getting a

booster effect from those repeated exposures…. Longer is more difficult to

tell. The only way to sort that out is going to be to see what happens

after the vaccine is introduced. "

We obviously now know that in no time, the U.S. immunity to chicken pox was

compromised by the very “success” of the vaccination campaign. When wild

chicken pox disappeared, so did its boosting effect on immunity. It is,

therefore, strange that currently the CDC can really believe that the

Varivax vaccine, whether alone or in combination with MMR, will provide

longer lasting immunity at the age of five than it did at age one.

It should be noted that although pediatricians, school authorities and

parents have always referred to the second dose of MMR (recommended before

school) as the “booster,” the CDC has never claimed that it was, indeed, a

“booster.”

Because approximately five percent of children who receive only one dose of

MMR vaccine fail to develop immunity to measles, the Advisory Committee on

Immunization Practices (ACIP) recommended that all states implement a

requirement that every child entering school receive two doses of MMR vaccine.

“The second dose of MMR vaccine is recommended when children are aged 4-6

years…. Evidence now indicates that a) the major benefit of administering

the second dose is a reduction in the proportion of persons who remain

susceptible because of primary vaccine failure, waning immunity is not a

major cause of vaccine failure and has little influence on measles

transmission, and c) revaccination of children who have low levels of

measles antibody produces only a transient rise in antibody levels.” (6)

Just for clarification, the CDC stated in 1998 it had evidence that:

1. The second dose of MMR only reduces the number of children,

approximately five percent, who remained susceptible because their primary

vaccination failed.

2. Waning immunity has little influence on measles transmission.

3. Revaccination only produces a transient rise in antibody levels.

The CDC added, “Almost all persons who do not respond to the measles

component of the first dose of MMR vaccine will respond to the second

dose…. Few data regarding the immune response to the rubella and mumps

components of a second dose of MMR vaccine are available, but most persons

who do not respond to the rubella or mumps components of the first dose

would be expected to respond to the second. The second dose is not

generally considered a booster dose because a primary immune response to

the first dose provides long-term protection. Although some persons who

develop normal antibody titers in response to a single dose of MMR vaccine

will develop higher antibody titers to the three component vaccines when

administered a second dose of vaccine, these increased antibody levels

typically do not persist.” (6)

* * * *

It is now clear that the national chicken pox vaccination program has

increased the incidence of shingles in adults and that a vaccine for

shingles is being tested and is due to be released soon.

There was much celebration when the chicken pox vaccination was added to

the recommended pediatric schedule in 1995. Innocent children were going to

stop “dying” from that dangerous childhood disease and even the U.S.

economy was going to recover, as mothers went to work instead of staying

home for a few days to comfort their itching children and give them oatmeal

baths.

In 2004, a CDC study published in the Journal of the American Medical

Association (JAMA) offered some insight into how “effective” the conquest

of chicken pox had been. The objectives of the study were to describe

secondary attack rates of chicken pox “within households according to

disease history and vaccination status of the primary case and household

contacts and to estimate varicella vaccine effectiveness.”

The population-based, active varicella surveillance project was carried out

in a community of approximately 320,000 in Los Angeles County, California,

during 1997 and 2001. There were 6,316 reported chicken pox cases in all.

Among children and adolescents aged 1 to 14 years, secondary attack rates

varied according to age and by disease and vaccination status of the

primary case and exposed household contacts.

Among contacts aged 1 to 14 years exposed to unvaccinated cases, the

secondary attack rate was 71.5 percent if they were unvaccinated and 15.1

percent if they were vaccinated.

Overall, vaccinated cases were half as contagious as unvaccinated cases.

However, vaccinated cases with 50 lesions or more were similarly contagious

as unvaccinated cases, whereas those with fewer than 50 lesions were only

one third as contagious.

The authors concluded, “Under conditions of intense exposure, varicella

vaccine was highly effective in preventing moderate and severe disease and

about 80 percent effective in preventing all disease. Breakthrough

varicella cases in household settings were half as contagious as

unvaccinated persons with varicella, although contagiousness varied with

numbers of lesions.” (7)

Also in August 2004, another study published in the Journal of Infectious

Diseases, described chicken pox vaccine failure in an elementary school in

Minnesota.

The authors candidly stated in their introduction, “Since licensure in the

United States, studies have shown that varicella vaccine's overall

effectiveness ranges from 44 percent to 100 percent, with substantial

protection against moderate and severe varicella; however, breakthrough

illness has been documented in up to 56 percent of vaccinated individuals.”

There were 319 students in that particular Minnesota school and 54 of them

developed chicken pox. Of these, 29 students, or 53 percent, had been

vaccinated. The authors estimated that the vaccine was 56 percent effective

at preventing any chicken pox. (8)

One can hardly get overly excited about the success of the chicken pox

vaccination initiative or about the planned use of ProQuad for the second

dose recommended at school entry.

What the “ultimate cost” will be, no one really knows. For now, the CDC

seems very happy to purchase the vaccines at “bargain” prices and

distribute them.

Until March 31, 2006, the CDC’s discounted price for ProQuad is $74.85 per

dose. One dose of MMR II costs $16.67 and one dose of Varivax $52.25 — all

available only in boxes of 10. The CDC will, therefore, save $5.93 per

child by buying Proquad. (9)

Pediatricians buying directly from Merck will pay substantially more.

ProQuad will cost them $117.60 per dose; MMR II, $40.37; and Varivax, $66.81.

It would be safe to bet that the price of ProQuad will go up in April as

the CDC anoints it “The Vaccine of Choice” for preschoolers.

For parents whose children sank into deeper regression after the second

dose of MMR vaccine, the cost was enormous. Realizing that the odds of

their children having been immune to measles, mumps and rubella was already

95 percent prior to that second dose has to be unbearable.

* * * *

References

1. F.E. Yazbak. “Mumps: Suddenly a serious problem.” Available at

http://www.redflagsdaily.com/yazbak/2005_aug19.php

2. “Mumps Epidemic — United Kingdom, 2004-2005.” MMWR. Feb. 24, 2006;

55(07); 173-175.

Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5507a1.htm

3. “Mumps outbreak at camp among immunized children.” Children’s

National Medical Center, Feb. 23, 2006.

Available at

http://www.dcchildrens.com/dcchildrens/NewsDisplay.aspx?ArticleId=2354

4. K.S. Reisinger, M.L. Brown, J. Xu, B.J. Sullivan, G.S. Marshall, B.

Nauert, D.O. Matson, P.E. Silas, F. Schodel, J.O. Gress, B.J. Kuter.

Protocol 014 Study Group for ProQuad. “A combination measles, mumps,

rubella and varicella vaccine (ProQuad) given to 4- to 6-year-old healthy

children vaccinated previously with MMR II and Varivax.” Pediatrics.

February 2006; 117(2): 265-72.

5. “First Vaccine for Chicken Pox.” FDA Consumer. September 1995.

Available at http://www.fda.gov/fdac/features/795_chickpox.html

6. “Measles, Mumps, and Rubella — Vaccine Use and Strategies for

Elimination of Measles, Rubella, and Congenital Rubella Syndrome and

Control of Mumps: Recommendations of the Advisory Committee on Immunization

Practices (ACIP).” MMWR 47(RR-8); 1-57. May 22, 1998.

Available at http://wonder.cdc.gov/wonder/prevguid/m0053391/m0053391.asp

7. J.F. Seward, J.X. Zhang, T.J. Maupin, L. Mascola, A.O. Jumaan.

“Contagiousness of varicella in vaccinated cases: a household contact

study.” JAMA. Aug. 11, 2004; 292(6): 704-8.

8. B. R. Lee, S.L. Feaver, C.A. , C.W. Hedberg, K.R. Ehresmann.

“An elementary school outbreak of varicella attributed to vaccine failure:

policy implications.” J Infect Dis. Aug. 1, 2004; 190(3): 477-83.

9. CDC Vaccine Price List, Dec. 22, 2005.

Available at http://www.cdc.gov/nip/vfc/cdc_vac_price_list.htm#pediatric