Doctors Slam Parents for Vaccine Choices & FDA Licenses New Combo Vaccine

Posted: 6/26/2012

by Barbara Loe Fisher

On June 13, 2012, a study conducted by government health employees working at the Oregon Health Authority and the U.S. Centers for Disease Control (CDC) was published in Pediatrics, a medical journal owned by the American Academy of Pediatrics (AAP).[1]

Government Tracking Systems Identify Oregon Parents

Using electronic vaccine records tracking systems, public health doctors concluded that about 10 percent of parents living in Portland, Oregon are making independent decisions about how many vaccines their babies should get and when they should get them. Those parents are rejecting the CDC’s aggressive vaccination schedule[2] promoted by the AAP that directs pediatricians to give two to six month old babies between seven to nine vaccines on the same day –no exceptions.

Doctors Demonize Parents Making Informed Vaccine Decisions

Public health doctors are slapping the label of “shot limiters” on parents giving their babies fewer vaccines. It has become fashionable in medical journals and media circles[3] to demonize these parents, who engage in critical thinking about vaccination and follow their conscience instead of saluting smartly and doing what doctors tell them to do – no questions asked.

Can an attack on the legal right for Oregon parents to exercise religious exemption to vaccination be far behind?[4]


FDA Licenses New Combo Vaccine For Babies

Ironically, on June 14, the FDA awarded GlaxoSmithKline (GSK) a license to sell MenHibrix, a new vaccine that combines two meningitis vaccines into one shot.[5][6] The FDA had rejected the license in 2010 and 2011 because, reportedly, the British drug company giant was having trouble proving the vaccine actually worked.[7]

FDA Advisory Committee Cut Out of Licensing Process

This time, FDA staff did not bother to ask for an opinion from the agency’s own vaccine advisory committee before giving GSK the green light to market MenHibrix in the U.S. for babies as young as six weeks old. In a letter, FDA official Marion Gruber, PhD, told the company that “We did not refer your application to an additional VRBPAC [review] because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise particular concerns or controversial issues which would have benefited from an advisory committee discussion.”[8]

Really? Sounds like some FDA officials didn’t want Advisory Committee members to ask the drug company lots of questions about this new vaccine, just like CDC and AAP officials don’t want parents to ask lots of questions about ANY vaccine.

Nine or Ten Vaccines On One Day: Where’s the Science?

MenHibrix has not yet been studied in combination with every one of the other vaccines already given to babies simultaneously.[9] But that is not likely to stop pediatricians from assuming safety and throwing MenHibrix into the mix - for a grand total of nine or ten vaccines given to tiny babies on the same day.[10]

Even premature babies weighing less than four and a half pounds are subjected to the mindless one-size-fits all “no exceptions” vaccine schedule.[11][12] Where is the solid scientific evidence that it is safe or effective to give eight or nine vaccines to an eight or nine pound newborn?

Where is the solid evidence that babies, who get more than two-dozen doses of vaccines by age six months, are healthier as they grow up than those, who get fewer vaccines or fewer vaccines on one day? No large, prospective studies have been done comparing the long-term health outcomes of children, who are vaccinated according to the CDC schedule, with those, who are not.[13]

It is no wonder that smart parents – like the ones in Oregon - are challenging the wisdom of the bloated and expensive vaccine schedule and are telling doctors and legislators: “Show Us the Science, and Give Us the Choice.”[14]

CDC Officials Might Vote in October: What Will They Do?

The CDC’s Advisory Committee on Immunization Practices (ACIP) has not yet voted on what to tell pediatricians to do with MenHibrix. That vote is rumored to be taking place in October.[15]

Will government health officials do the right thing and make this an optional vaccine? Or will they give another big pharmaceutical corporation a guaranteed, liability free market by adding four doses of an expensive new vaccine to the child vaccine schedule so parents can be forced to buy it and give it to their newborns – no questions asked and no choices allowed?

Parents are watching. Stay tuned.



References

[1] Robison SG, Groom H, Young C. Frequency of Alternative Immunization Schedule Use in a Metropolitan Area. Pediatrics. Published online June 18, 2012. http://pediatrics.aappublications.org/content/early/2012/06/13/peds.2011-3154.abstract

[3] Seaman AM. More Oregon Kids on “Alternative” Vaccine Schedules. Reuters/Chicago Tribune. June 18, 2012.

[4] Anderson J. Religious Exemptions Tilt Immunization’s Balance. Portland Tribune. Feb. 16, 2012.

[5] Food and Drug Administration. FDA Approves New Combination Vaccine That Protects Children Against Two Bacterial Diseases. Press Release: June 14, 2012.

[7] Reuters. US Approves Glaxo Meningitis Vaccine for Children. FoxNews.com. June 15, 2012.

[8] Gruber M. June 14 (2012) Approval Letter – MenHibrix. FDA Office of Vaccines, Research and Review, Center for Biologics Evaluation and Research. June 14, 2012.

[9] Ibid.

[10] See Reference #2.

[13] Fisher BL. Need for A Study Comparing Health Outcomes of Children, Who Have and Have Not Been Vaccinated According to the Federally Recommended Schedule. Referenced, written statement based on oral presentation to the Institute of Medicine Committee on Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule. Feb. 9, 2012 Meeting at Pew Charitable Trust, Washington, D.C.

[15] McBride R. GSK Grabs FDA Nod for Combo Meningitis Vaccine. Fierce Biotech. June 15, 2012.
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