By: Dr. F. Edward Yazbak
In the United States, we have Emeril Lagasse and then we have the CDC.
Lagasse grew up in Fall River, Massachusetts and was apparently talented enough to become a career musician. Instead, he became America's most famous TV chef. After graduating from the College of Culinary Arts at Johnson & Wales University in Providence, he trained in Lyon and Paris. When he returned to the U.S., he worked in well-known restaurants in Boston, New York, Philadelphia and New Orleans, where he later opened his first restaurant; he now owns several.
The highlight of his television show is when he stops talking for a few seconds, scans the theater audience with his dark eyes, beams a big devilish smile and says with his inimitable Massachusetts accent, "Let's kick it up a notch!" Then with a dramatic circling motion, he spreads some special spice all over his sauce pan, pitching the last few grains - forcefully - into the center of his creation. Suddenly it is pandemonium in the audience: women scream, men cheer and young people jump up and down as if the first goal in sudden-death overtime has just been scored.
The CDC (Centers for Disease Control and Prevention) has its own version of "kicking it up a notch." But it is always done very quietly and often feels like a morbid game of Gotcha!
In the Mortality and Morbidity Weekly Report (MMWR) of Jan. 6, 2006, it was called the "Harmonized Childhood and Adolescent Immunization Schedule, 2006." (1)
Most parents and, in fact, most American citizens never saw that report and certainly no one is jumping up and down cheering about it. No one should.
The MMWR started with a sweet and "harmonized" statement of its own:
"The Advisory Committee on Immunization Practices (ACIP) periodically reviews the recommended childhood and adolescent immunization schedule to ensure that the schedule is current with changes in vaccine formulations and reflects revised recommendations for the use of licensed vaccines, including those newly licensed."
The next sentence was the usual disclaimer: This was not the National Immunization Program's or the CDC's idea. "The recommendations and format of the childhood and adolescent immunization schedule and catch-up schedule for January-December 2006 were approved by ACIP, the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP)." In other words, the CDC had nothing to do with it.
So what were the "2006 changes" from the January 2005 recommendations?
And how did the CDC "kick it up a notch"?
The newborn dose of Hepatitis B vaccination
"The importance of the hepatitis B vaccine (HepB) birth dose has been emphasized."
Experience will eventually prove that the "importance" of the hepatitis B vaccine birth dose should have been de-emphasized, except when it is actually needed - and that is less and less frequently.
In the United States, hepatitis B virus (HBV) infection is essentially an adult lifestyle disease spread primarily by sexual contact and sharing of needles. In spite of the fact that the hepatitis B vaccination programs of adults in high-risk groups have been dismal failures, the incidence of the disease has been decreasing because of better understanding and more careful behavior.
HBV infection is only transmitted vertically in infants, from the infected mother to her baby. Before 1991, infants born to infected mothers in the U.S. were given hepatitis B immune globulin immediately after birth, followed promptly by the first dose of the vaccine. A second dose of vaccine was given a month later and the third at the age of six months. Vaccinating newborns, whose mothers' immune status was not known, also made sense. So did the vaccination of children whose parents were born in Alaska, Asia, Africa, the Amazon basin, the Pacific Islands, Eastern Europe and the Middle East, and those potentially exposed to abusive, aggressive or infected classmates or living in the same household with infected adults.
Except for the groups listed above, the risk of HBV infection in healthy infants and children has always been negligible and the side effects of the vaccine often far outweighed its benefits.
In any case, the CDC decided to kick it up a notch: "Vaccination of infants born to hepatitis B surface antigen (HBsAg)-negative mothers can be delayed in rare circumstances, but only if a physician's order to withhold the vaccine and a copy of the mother's original HBsAg-negative laboratory report are documented in the infant's medical record."
So the poor anxious mother with five-minute labor pains, who is arriving to deliver a baby and leave in a day or two, must produce a copy of her original hepatitis B laboratory report and chase after the pediatrician, so that he can write an order to the effect that the new baby, when he/she arrives, should not receive a vaccine that he does not need in the first place.
During my many years in practice, I was evidently doing it all wrong. I used to explain the pros and cons of every vaccine, show the parents the vaccine information statement published by the CDC, record its publication date, obtain the parents' consent and then and only then, legibly write the order to administer the vaccine and sign it.
As far as the copy of the laboratory report is concerned, any woman who has ever had a baby knows that the reports of all the tests performed at the time of the first prenatal visit are on file at her obstetrician's office - across the street or 50 miles away from the hospital - where they will safely remain until they are shredded. Only a few cursory entries such as "neg." or ""“" will be in those little boxes at the top on the pre-natal summary, which will make it to the hospital "¦ perhaps.
Having copies of the original laboratory reports in the nursery or the delivery room in the U.S. will certainly not be easy "¦ and that is probably what the CDC is hoping will help "better compliance."
Obviously, some of us are still under the impression that "informed consent" is required before vaccinations?
"Administering four doses of HepB is permissible (e.g., when combination vaccines are administered after the birth dose); however, if monovalent HepB is used, a dose at age four months is not needed. For infants born to HBsAg-positive mothers, testing for HBsAg and antibody to HBsAg after completion of the vaccine series should be conducted at age 9-18 months (generally at the next well-child visit after completion of the vaccine series)."
I probably have to take the blame for this statement.
I was one of the rare people who brought up the point that infants who really do not need the hepatitis B vaccine to start with are getting not only the required three doses (0-1-6 months), but are actually getting four doses - a single dose at birth, and then three more in vaccine combinations such as Comvax and Pediarix at 2, 4, and 6 months of age. The new pronouncement may be in reaction to such comments.
It is indeed a strange situation when infants who should and must receive the hepatitis B vaccine because their mothers are HBsAg-positive may actually only get three doses of vaccine, while other infants who do not need to be vaccinated may end up with four.
At the height of the thimerosal crisis in 1999, the newborn dose of hepatitis B vaccine was discontinued for a few weeks and combination vaccines were encouraged and became popular for the 2-, 4-, and 6-months series. When the thimerosal-free product became available in record time, and was recommended for the nursery dose, suddenly we had four doses of hepatitis B vaccine instead of three.
Someone apparently decided to kick it up a notch.
From 1990 to Dec. 31, 2004, there were 283 reports to the Vaccine Adverse Events Reporting System (VAERS) following administration of hepatitis B vaccination to newborns and infants younger that one month of age. Some 37 infants died.
Tdap Adolescent vaccine
"A new tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine recommended by ACIP for adolescents (Tdap adolescent preparation) was approved by the Food and Drug Administration (FDA) on May 5, 2005 for use in the United States. Tdap is recommended for adolescents aged 11-12 years who have completed the recommended childhood diphtheria and tetanus toxoids, and pertussis/diphtheria and tetanus toxoids and acellular pertussis (DTP/DTaP) vaccination series, and have not received a tetanus and diphtheria toxoids (Td) booster dose. Adolescents aged 13-18 years, who missed the age 11- to 12-year Td/Tdap booster dose, should also receive a single dose of Tdap if they have completed the recommended childhood DTP/DTaP vaccination series. Subsequent Td boosters are recommended every 10 years."
The administration of DTP (diphtheria, tetanus and whole cell pertussis) vaccine to children seven years of age and older has been contra-indicated for decades. The DTaP vaccine became available for booster doses in 1991 and for all doses in 1996; it contained an acellular form of the pertussis vaccine and was supposed to be as effective and much less reactogenic than the DTP. Two years ago, in "A Not-So-Perfect Vaccine," I documented that it had problems of its own, when administered to infants and young children. (2)
The CDC kicked it up a notch and allowed Tdap, a special formulation for adolescents, to be used in older children and teens (11 to 18 years of age). The previous adult recommendation for a Td booster (without pertussis vaccine) every 10 years was retained.
Exactly 12 lines later in the same MMWR, the CDC again kicked it up a notch:
"The catch-up schedule for persons aged 7-18 years has been changed for Td; Tdap may be substituted for any dose in a primary catch-up series or as a booster if age appropriate for Tdap. A five-year interval from the last Td dose is encouraged when Tdap is used as a booster dose."
So Tdap can now be used starting the age of seven and only a five-year interval after the last Td is allowed. Previously, 10-year intervals between Td boosters were recommended.
In recent years in the United States, there have been 0-5 cases of respiratory diphtheria per year. Death from diphtheria occurs in 5 to 10 percent of respiratory cases.
Since 1980, the incidence of diphtheria in the U.S. has been 0.001 per 100,000 (3)
On its web site, the CDC reports that in 2000, there were 41 cases of tetanus reported in the U.S. and that approximately 20 percent of reported cases end in death. (4)
The mortality rate may have been kicked up a notch for the general public on the web site because in the CDC's Pink Book, used by health professionals, relates that "in recent years, tetanus has been fatal in approximately 11 percent of reported cases." (5)
MCV4, Meningococcal conjugate vaccine
"Meningococcal conjugate vaccine (MCV4), approved by FDA on Jan. 14, 2005, should be administered to all children at age 11-12 years, as well as to unvaccinated adolescents at high school entry (age 15 years). Other adolescents who wish to decrease their risk for meningococcal disease may also be vaccinated. All college freshmen living in dormitories should also be vaccinated with MCV4 or meningococcal polysaccharide vaccine (MPSV4). For prevention of invasive meningococcal disease, vaccination with MPSV4 for children aged 2-10 years and with MCV4 for older children in certain high-risk groups is recommended."
The earlier recommendation was for MCV4 (Menactra) to be administered at age 11-12 or at age 15. ACIP or CDC kicked it up a notch to other adolescents regardless of age.
The Harmonized Childhood and Adolescent Immunization Schedule, 2006 does not make it clear:
- Why junior-high and high school students, not living in dormitories,need to be vaccinated just like college freshmen living in dormitories?
- Why unvaccinated college sophomores or even post-grad students living in dormitories are less likely than freshmen to develop meningococcal meningitis?
- And whether a student who received a dose of Menactra vaccine during his senior year in high school still needs another dose the following year, if he is lucky enough to get into a dorm?
To my knowledge, no further information concerning the cases of Guillain-Barre syndrome after vaccination with Menactra has been made public. (6)
Pediatric Influenza vaccine
"Influenza vaccine is now recommended for children aged >6 months with certain risk factors, which now specifically include conditions that can compromise respiratory function or handling of respiratory secretions or that can increase the risk for aspiration."
Surprisingly, this appears to be a more restrictive recommendation.
Influenza vaccination of all infants starting at the age of six months had been recommended. The above recommendation intimates that only those with respiratory disease should be vaccinated.
It is almost certain that a correction will soon be announced.
Interestingly, even in this strange statement, the CDC kicked it up a notch by not specifying that the influenza vaccine administered to infants should be thimerosal-free like other pediatric vaccines.
Hepatitis A vaccination
"Hepatitis A vaccine is now universally recommended for all children at age one year (12-23 months). The two doses in the series should be administered at least six months apart."
In 1999, the ACIP recommended vaccination of children aged >24 months residing in Alaska, Arizona, California, Idaho, Nevada, New Mexico, Oklahoma, Oregon, South Dakota, Utah and Washington, in addition to those from certain ethnic groups and specifically Hispanics and Native Americans.
Because hepatitis A is a mild and often asymptomatic disease and because the national incidence is only 1:10,000 with 70 percent of affected individuals being 15 years or older, the vaccination of infants and toddlers should have been deemed unnecessary. Nevertheless, the ACIP and the CDC not only included those young children 12 to 24 months old but kicked it up a notch by extending the recommendation to all children in all 50 states and U.S. territories. Two doses of vaccine, six months apart, are required.
Huge vaccination programs already exist in the United States.
It is prudent that they be critically reviewed and scaled down
"Kicking them up a notch" at every opportunity seems excessive and ill-advised.
Reason must prevail.
* * * *
The recommended 2006 U.S. childhood and adolescent vaccination schedule by vaccine and age can be found at the end of the report. (1)
- MMWR Jan. 6, 2006 / 54(52);Q1-Q4 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5451-Immunizationa1.htm
- A Not-So-Perfect Vaccine. The Diphtheria, Tetanus and Acellular Pertussis Vaccine: An Investigation http://www.redflagsweekly.com/conferences/vaccines/2003_dec04.php
- Vaccines - Like Apple Pies On A Conveyor Belt http://www.redflagsdaily.com/yazbak/2005_dec21.php