Tuesday, September 22, 2009

Oct2008 NJDHSS phone conversation passes the buck

October 17, 2008
Topics include why the Health Department has not ensured an adequate thimerosal-free vaccine supply, anaphylactic shock as an adverse reaction, and safely handling biologicals in the chip aisle of the grocery store.
Co-founder of the NJCVC, Maureen Drummond called Heather Howard, explaining that she represented thousands of Coalition members across NJ with concerns over the new flu shot mandate. Angela Sorrells-Washington, Program Manager, NJ’s Vaccine Preventable Disease Program returned the call a few days later and the following was discussed:

When asked why the Health Department has not ensured an ample supply of thimerosal- free flu shots across NJ? Ms. Sorrells responded that they “cannot tell doctors to use one product over another.”
Options were actually few if a pediatrician was in fact trying to avoid administering regular flu shots to his patients, which are loaded with 25 mcg of thimerosal (an amount the EPA says exceeds the safe, allowable mercury limit for a 550 pound person). They could either buy the live virus Flumist vaccine (which many oppose) or the Sanofi FluZone single dose vials or pre-filled syringes. While Sanofi is the only manufacturer licensed to sell flu shots in America for the 6 month- 2 year old population, it is interesting to note that the clinical trials performed to bring their product to market were conducted during the 2003-2004 flu season. In the 6-24 months old group, clinical trials were conducted on only NINETEEN (19) children, although the vaccine will be given to millions! As the flu shot formulations change every year, NJCVC questions whether testing Fluzone on just TWELVE (12) children in the 2-3 years old age group, and then following the trial participants for just THREE (3) days after their flu shot, consists of a thorough and efficient safety review process by the FDA. In fact, during the post-approval use of Fluzone, reports of events from patients who received the shot include: anaphylaxis, blood & lymphatic disorders, immune system disorders, convulsions, facial palsy/ tics, and vascular, respiratory and skin disorders among others. Every package insert for every vaccine states that vaccinating mass populations will reveal adverse reactions not observed in the clinical trials.

Regarding sketchy availability of the thimerosal-reduced flu shots, Ms. Sorrells suggested that if one's regular pediatrician doesn’t have them, to look outside of the practice.
Few parents are eager to start shopping a la carte medical care for their children. Their pediatrician knows their child, and will be best able to track reactions. Ms. Sorrells said that if any parents were having trouble locating a thimerosol-free flu shot that they should contact the office and that the NJDHSS would help them find it.

Every package insert for the influenza vaccines lists as a contraindication, an allergy to eggs. How would a parent know if their child is allergic to eggs when most 6 month olds are not eating solid food yet? The risk of reaction is anaphylaxis. Ms. Drummond told Ms. Sorrells that NJCVC thought this posed a greater and disproportionate risk for those infants whose potential allergies may not yet be determined.
Ms. Sorrels suggested that children’s health and safety is ultimately up to the parents, and that it is possible to test for allergies, however, that is not routinely done unless evidence of allergies emerge. Allergy testing would also be an out of pocket expense borne by concerned parents.

Regarding flu shot clinics being held across NJ in drug and grocery stores, Ms. Drummond asked Ms. Sorrells what sort of regulation or oversight is carried out by the Health Department. The possibility of a multi-dose vial of mercury-containing vaccine breaking in the chip isle of the grocery store was specifically raised.
Ms. Sorrells offered that the protocol for biological agent cleanup is that the area would have to be cleared and that a masked and gloved person would have to clean up the broken glass and spilled components and then disinfect the area with whatever was appropriate to that substance. When asked how it would be determined safe for people to enter the area again considering airborne material that cannot be accounted for, Ms. Sorrells deferred that protocol to the Occupational Safety and Health Administration, OSHA, because the store is a place of business.

In a separate conversation with an industrial hygienist at OSHA, Maureen explained her earlier conversation with Angela Sorrells and related the fact that they claimed no regulation nor oversight where influenza vaccine is distributed in retail stores. He expressed surprise and wondered why the Health Department would defer to OSHA, as they are only responsible for the safety of employees in the workplace in the private sector. He hoped they were using sharps containers as required for all hazardous medical waste, however, without public health oversight, how would we know? When asked if OSHA could step in to check it out, he said their role is enforcement. An employee would first have to file a complaint expressing concern over safety hazards in the workplace. With regard to a vial of vaccine breaking on the floor of the grocery store; OSHA would be required to follow Centers for Disease Control and Prevention protocols for cleaning up blood borne pathogens, involving sealing off the area, and utilizing gloves and respirators.

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