Efficacy of Flu Shots in Children

Efficacy of flu shots in children under 2 questioned

Robert Roos   

Feb 25, 2005 (CIDRAP News) – An analysis of 24 studies yielded no clear evidence that influenza vaccines prevent flu in children younger than 2 years old, though they work reasonably well in older children, according to a new report in The Lancet.

Immunization of very young children is not lent support by our findings,” says the report by T. Jefferson of Cochrane Vaccines Field in Alessandria, Italy, and colleagues from there and the University of Oxford in England.

The report comes less than a year after the Centers for Disease Control and Prevention (CDC) recommended that children 6 to 23 months old routinely receive flu shots on grounds that they have an increased risk of flu and its complications.

The CDC says the Lancet analysis left out some important studies showing that flu shots are beneficial for young children. The agency will continue to recommend flu shots for 6- to 23-month-olds, a spokeswoman said.

Jefferson and colleagues combed the worldwide literature up to June 2004 and found 15 randomized controlled trials, eight cohort studies, and one case-control study comparing the effects of flu immunization with placebo or no immunization in children. The researchers looked at the vaccines’ efficacy, defined as prevention of laboratory-confirmed flu; effectiveness in preventing flu-like illness; and effectiveness in reducing hospitalizations, complications, school absences, and secondary transmission.

The authors did separate analyses of studies dealing with live attenuated flu vaccines, which are not used in small children, and those involving inactivated vaccines. The analysis did not include studies assessing children’s immune-system responses to vaccines (serologic studies).

In children under age 2, vaccination yielded 24% efficacy against flu, which was not significantly better than placebo, but this finding was based on one study involving about 800 children, the report says. No data were available on the effectiveness of vaccination for preventing flu-like illness in the under-2 group.

Among children 2 years and older, live attenuated vaccines were 79% efficacious in preventing flu, while inactivated vaccines were 65% efficacious, according to the analysis. The effectiveness of vaccines against flu-like illness was much lower: 38% for live vaccines, 28% for inactivated vaccines.

Differences between efficacy and effectiveness of vaccines are not surprising because influenza vaccines are specifically targeted at influenza viruses and are not designed to prevent other causes of influenza-like illness,” the report states.

The researchers found that immunization reduced long school absences, but they saw little evidence that it reduced hospital admissions and stays, secondary cases, lower-respiratory-tract disease, or acute otitis media.

Although a growing body of evidence shows the effect of influenza on admissions and deaths of children, we recorded no convincing evidence that vaccines can reduce mortality, admissions, serious complications, and community transmission of influenza,” the article concludes.

Kristine Sheedy, a spokeswoman for the CDC’s National Immunization Program in Atlanta, told CIDRAP News that the analysis left out some important evidence on the effects of flu immunization in small children.

The authors “included many important studies, but they did exclude other important studies,” she said. She mentioned a CDC study published in Morbidity and Mortality Weekly Report in August 2004 and a 2001 study by K. M. Neuzil and colleagues, published in the Pediatric Infectious Disease Journal.

A careful review of the Lancet report itself as well as the excluded studies “indicates that influenza vaccination is effective in this population” (6- to 23-month-olds), Sheedy said.

She added that serologic studies of small children have shown a strong immune response to flu vaccine. Also, additional studies soon to be reported by the CDC will provide more support for the effectiveness of flu immunization in preventing hospitalization and outpatient visits in children, she said.

“I hope people will keep in mind the burden of disease in children,” Sheedy said. “When you have a safe and effective vaccine for influenza, why wouldn’t you want to protect the children at greatest risk?”

Jefferson T, Smith S, Demicheli V, et al. Assessment of the efficacy and effectiveness of influenza vaccines in healthy children: systematic review. Lancet 2005;365(Feb 26):773-80 [Abstract]

See also:

Neuzil KM, Dupont WD, Wright PF, et al. Efficacy of inactivated and cold-adapted vaccines against influenza A infection, 1985 to 1990: the pediatric experience. Pediatr Infect Dis J 2001;20(8):733-40 [Abstract]

CDC. Assessment of the effectiveness of the 2003-04 influenza vaccine among children and adults-Colorado, 2003. MMWR 2004 Aug 13;53(31):707-10 [Full text]

Center for Infectious Disease Research & Policy
Academic Health CenterUniversity of Minnesota
Copyright © 2006 Regents of the University of Minnesota

 

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Flu

Shedding and immunogenicity of live attenuated influenza vaccine virus in subjects 5-49 years of age

 

Stan L. Blocka, , , Ram Yogevb, Frederick G. Haydenc, 1, Christopher S. Ambrosed, Wen Zengd and Robert E. Walkerd aKentucky Pediatric and Adult Research, 201 S. 5th Street, Bardstown, KY 40004, United States bChildren’s Memorial Hospital, Chicago, IL, United States cUniversity of Virginia, Charlottesville, VA, United States dMedImmune, Gaithersburg, MD, United States.Received 17 March 2008;  revised 25 June 2008;  accepted 8 July 2008.  Available online 26 July 2008.

 

Abstract-

 

Background

 

 

Live attenuated influenza vaccine (LAIV) is indicated for influenza prevention in persons 2-49 years of age. This study describes the incidence and duration of vaccine virus shedding and serum immune responses after receipt of LAIV.

 

 

Methods

A single open-label dose of trivalent LAIV was administered intranasally to 344 subjects in 3 age cohorts: 5-8, 9-17, and 18-49 years of age. Shedding was determined by culture of nasal swabs (on days 1-7, daily; days 9-25, every other day; and day 28). Immunogenicity was measured as serum strain-specific hemagglutinin inhibition (HAI) titers (days 0, 28).

 

 

Results

 

 

Among subjects aged 5-8 years, 9-17 years, and 18-49 years, 44%, 27%, and 17% of subjects, respectively, shed vaccine virus after vaccination, and the mean number of positive samples per subject was 2.2, 1.8, and 1.5, respectively. Shedding occurred on days 1-11 postvaccination. Shedding incidence peaked on day 2, and maximum observed titers were highest on days 2-3 (<5, <4, and <3 log10 TCID50/mL, respectively, by age group). Despite positive cultures, all titers were <1 log10 TCID50/mL after days 10, 6, and 6, respectively, by age group. Shedding incidence was inversely correlated to age and baseline serum HAI titer. The seroresponse rate (4-fold rise in HAI) to at least 1 strain was 59% (68%, 64%, and 47%, respectively, by age group), and strain-specific rates were higher in baseline seronegative/serosusceptible subjects. Reactogenicity, most commonly runny nose, headache, and sore throat, was not associated with shedding or seroresponse.

 

 

Conclusions

This is the first study to comprehensively evaluate nasal shedding of LAIV in individuals 5-49 years of age. Shedding was generally of short duration and at low titers. Study findings support the current recommendation of the Advisory Committee on Immunization Practices that LAIV recipients should only avoid contact with severely immunosuppressed persons (e.g., hematopoietic stem cell transplant recipients) for 7 days after vaccination.

The Ties that Bind

The Ties Between Pharma & Academic Med Centers

 Want to know how much a drugmaker paid a doctor at an academic medical center? How about the amount of samples dropped off? Or the access given sales reps? Well, The Institute on Medicine as a Profession, or IMAP, has launched what it calls the first database of its kind to let everyone – you and me – review and compare conflict of interest policies among the nation’s 125 academic medical centers.

The data base will be a “one-stop resource to help users identify what academic institutions are doing or not doing to limit the influence of drug and device makers on medical practice and will offer users a toolkit on how to implement strong policies,” according to a statement. Take a look.

The site will focus on 12 key areas that some AMC’s are supposedly examining to regulate relationships with drug and device makers – gifts; meals; drug representative access; samples; purchasing committees; continuing medical education; consulting and honoraria; scholarships and travel; ghostwriting; speakers’ bureaus; enforcement; and implementation.

An analysis in last week’s Journal of the American Medical Association found that AMCs are increasingly adopting COI policies without any backlash from faculty or industry. At least 25 AMCs have embraced policies to regulate industry relationships, and faculty are overwhelmingly supporting those efforts, according to the paper, which was written by two IMAP officials.

IMAP is not rating or ranking AMCs, but does provide examples of “best practices” that feature model policies. IMAP, based at Columbia University’s College of Physicians and Surgeons, formed the database under the auspices of the Prescription Project, funded by the Pew Charitable Trusts. The site is also supported by a grant from the Attorney General Consumer and Prescriber Grant Program.

Conflict of Interest Policy Database

Local, State and Federal Mercury Legislation Laws

Status of Local, State and Federal Mercury Product Legislation and Laws

2007-2008 Legislative Sessions

June 11 – 21, 2007

 

Arkansas

 

SB 911 is a bill to Prohibit or reduce the amount of mercury in childhood vaccines. Introduced on March 5, 2007 and  referred to the Committee on Public Health, Welfare and Labor. Three amendments have been offered, it has been engrossed and re-referred to the Committee on Public Health, Welfare and Labor.

http://www.arkleg.state.ar.us/2007/scripts/ablr/bills/bills.asp?billno=SB911

 

California- *nothing new relating to vaccines

Article 9. Mercury-containing Vaccines 124172. (a) Except for an influenza vaccine described in

subdivision (b), on and after July 1, 2006, a person who is knowingly pregnant or who is under three years of age shall not be vaccinated with a mercury-containing vaccine or injected with a mercury-containing

product that contains more than 0.5 micrograms of mercury per 0.5 milliliter dose.

(b) On and after July 1, 2006, a person who is knowingly pregnant or who is under three years of age shall not be vaccinated with a mercury-containing influenza vaccine that contains more than 1.0 microgram of mercury per 0.5 milliliter dose.

 

 

Connecticut

 

HB 6895 would require dental plans to provide equivalent or greater coverage for nonmercury or composite dental fillings. Introduced January 22, 2007 and referred to the Joint Committee on Insurance and Real Estate.

http://www.cga.ct.gov/asp/cgabillstatus/cgabillstatus.asp?selBillType=Bill&bill_num=6895&which_year=2007
http://www.cga.ct.gov/asp/menu/Search.asp

 

Delaware

 

HB 194 allows the use of mercury-containing vaccines for children less than 8 years of age or to pregnant women when an emergency occurs as declared by the Director of the Division of Public Health, or when there is no mercury-free vaccine manufactured or available for a specific disease. Introduced on June 12, 2007, it was referred to the Health and Human Development Committee, which reported it out favorably.  Substitute amendment HS 1 was offered on June 20, 2007 and it was re-referred to this committee.

http://www.legis.state.de.us/LIS/lis144.nsf/vwLegislation/HS+1+for+HB+194/$file/legis.html?open
http://www.legis.state.de.us/LEGISLATURE.NSF?open

 

Current-Except for vaccines for influenza, no vaccine containing more than a trace amount of mercury shall be made available to a medical provider in this State for administration to children under eight years of age or to pregnant women.

This section shall not apply to vaccines administered during declared states of emergency or epidemics.”

Section 1. of this Act shall become effective on January 1, 2006.

 This section shall not apply to vaccines administered during declared states of emergency or epidemics.”

shall become effective on January 1, 2007.

No vaccine containing mercury shall be made available to a medical provider in this State for administration to children under eight years of age or to pregnant women. 

No vaccine containing mercury shall be administered by a medical provider in this State to a child who is under eight years of age or to a pregnant woman, notwithstanding the expiration date thereof. 

This section shall not apply to vaccines administered during declared states of emergency or epidemics.” become effective on January 1, 2008.

 

Florida

SB 222 is an act relating to immunizations; prohibiting  vaccinating a woman who is knowingly pregnant or a child who is younger than a specified age with a vaccine that contains any mercury or injecting such a woman or child with a product that contains more than a specified amount of mercury; prohibiting vaccinating a woman who is  knowingly pregnant or a child under a specified age with an influenza vaccine that contains more than a specified amount of mercury; providing the effective date of such prohibitions; providing for the State Health Officer to authorize the use of vaccines that contain a greater amount of mercury than is otherwise allowed if the Secretary of Health declares a public health emergency and makes certain findings; providing exceptions to the prohibition following disclosure regarding certain risks and benefits; providing an effective date. Introduced December 14, 2006, referred to the Committee on Health Regulation. Withdrawn on January 23, 2007.

http://www.flsenate.gov/Session/index.cfm?Mode=Bills&SubMenu=1&BI_Mode=ViewBillInfo&BillNum=0222 

 

Hawaii- The Hawaii legislature is now adjourned and did not adopt any of the following legislation.

HB 1816.  From July 1, 2007, prohibits persons known to be pregnant or under age 5 from being vaccinated with (1) a mercury-containing vaccine containing more than 0.5 micrograms of mercury per 0.5 milliliter dose; and (2) influenza vaccine containing more than 1.0 microgram of mercury per 0.5 milliliter dose  Allows certain exemptions. Introduced on January 24, 2007 and referred to the Committee on Health, and the Committee on Judiciary.

http://www.capitol.hawaii.gov/sessioncurrent/Bills/HB1816_.htm
http://www.capitol.hawaii.gov/site1/docs/getstatus2.asp?billno=HB1816

 

Illinois

SB 133 amends the state’s mercury free vaccine act and provides that the Department of Public Health shall implement a policy to distribute, preferentially, influenza vaccines that are thimerosal-free or contain only trace amounts of thimerosal for the immunization of children under the age of 3 who are participating in the Vaccines for Children program, provided that the supply of influenza vaccines to health care providers is not impeded by the exercise of this preference. Provides that the Department shall annually communicate this policy to the General Assembly and health care providers. Provides that upon issuing an exemption from the Act, the Department shall remind health care providers to distribute, preferentially, influenza vaccines that are thimerosal-free or contain only trace amounts of thimerosal for the immunization of children under the age of 3, provided that the supply of influenza vaccines to health care providers is not impeded by the exercise of this preference. Provides that the Department shall annually notify health care providers about the requirements of the Act and encourage health care providers to increase immunization rates among persons who are recommended to receive influenza immunization, using all licensed vaccines, with preference given to influenza vaccines that are thimerosal-free or contain only trace amounts of thimerosal. Provides that the Department shall include this annual notification on its Internet web site. Provides that the Department shall annually report to the General Assembly, on or before December 31, on its efforts to inform health care providers about thimerosal-free vaccines. Provides that the Department of Public Health shall notify health care providers about the availability of influenza vaccines and the most effective time for persons to be vaccinated. Adopted by both houses, as of May 30, 2007.

http://www.ilga.gov/legislation/BillStatus.asp?DocNum=0133&GAID=9&DocTypeID=SB&LegID=27356&SessionID=51&GA=95

 

Current- Mercury Ban not in effect until 2008 however on Mar 04, 2006- the Illinois Department of Public Health has declared 4 vaccines with high levels of mercury exempt from the law.

Illinois passed landmark legislation that limits mercury levels in vaccines to 1.25 micrograms per dose by the first of this year and eliminates mercury all together by January 1st 2008, the Illinois Department of Public Health has issued a declaration of exemption which allows four vaccines to exceed the limit. In addition to the flu vaccine, the diphtheria-tetanus, Japanese encephalitis and meningitis vaccines are also exempted from the law.

The Illinois Department of Public Health claims the mercury-free versions of these vaccines are either too expensive, in short supply or non-existent, hence they have allowed thimerosal, the mercury-laden preservative in these vaccines to persist.

 

Indiana

 

HB 1361 requires that before a person administers a vaccine that contains more than a trace amount of mercury, the person must inform the person who will be vaccinated that there are alternatives to mercury preserved vaccines. Allows the state department of health to suspend this requirement during a public health emergency or an epidemic. Provides that a health care practitioner may be subject to disciplinary sanctions for failing to comply with these requirements. Introduced on January 16, 2007, and referred to Committee on Public Health.

http://www.in.gov/legislative/bills/2007/IN/IN1361.1.html
http://www.in.gov/apps/lsa/session/billwatch/billinfo?year=2007&session=1&request=getBill&docno=1361

 

Iowa

 

The Iowa Legislature is now adjourned and did not adopt either of the two mercury product bills that were introduced.

 

HF 515 would require testing of vaccines to determine the amount of mercury that they contain, and that beginning July 1, 2008, a drug or vaccine administered in this state shall not contain more than trace amounts of mercury, and beginning July 1, 2010, a drug or vaccine administered  in this state shall not contain any amount of mercury.  Introduced on February 23, 2007, and referred to Human Resources Committee.

http://www.legis.state.ia.us/

 

Current-Beginning January 1, 2006, immunizations administered in this state shall not contain  more than trace amounts of mercury. The prohibition under this section shall not apply to  early childhood immunizations for influenza or in times of  emergency or epidemic as determined by the director of public  health. 

 

 

Kansas

 

SB 1 says that no person who is eight years of age or younger or who is knowingly pregnant shall be vaccinated in this state with a vaccine containing more than 0.5 micrograms of mercury per 0.5 milliliter dose.  Introduced January 8, 2007, it is now in the Public Health and Welfare Committee; a hearing was scheduled for March 22, 2007. However, according to the schedule for legislation, this bill is now dead.

http://www.kslegislature.org/bills/2008/1.pdf
http://www.kslegislature.org/legsrv-billtrack/index.do

 

Maine

The Maine Legislature has adjourned and adopted three mercury product bills into law.

LD 637 requires the elimination of mercury in dental offices over a 3-year period, and requires dental schools to include in their curricula by January 2008 the risks of exposure to mercury. Dental offices are to post in the office the disclosure statement published by the Department of Health and Human Services, Bureau of Health on the risks of having mercury fillings. Introduced on February 28, 2007, it is listed as being dead.

http://janus.state.me.us/legis/LawMakerWeb/summary.asp?LD=637

 

LD 1446. Beginning January 1, 2008, this bill prohibits the use of more than trace amounts of mercury or thimerosal in any immunizing agent for administration to children under 8 years of age and to pregnant women. It imposes requirements for labeling and written information packaged with the immunizing agent. It provides for an exemption if the Commissioner of Health and Human Services determines that an immunizing agent containing more than a trace amount is necessary due to an actual or potential bioterrorist incident or public health emergency. The bill also directs the department to develop a plan to ensure that all immunizing agents are mercury-free and thimerosal-free, including considering the requirement of the use of single-dose immunizing agents.  Introduced on March 15, 2007 and referred to the Committee on Health and Human Services by both houses. It is listed as being dead.

http://janus.state.me.us/legis/LawMakerWeb/summary.asp?LD=1446

LD 1523. Beginning January 1, 2008, this bill prohibits the use of more than trace amounts of a heavy metal, including mercury or thimerosal, in any immunizing agent for administration to a person in this State. It imposes requirements for labeling and written information packaged with the immunizing agent. It provides for an exemption if the Commissioner of Health and Human Services determines that an immunizing agent containing more than a trace amount is necessary due to an actual or potential bioterrorist incident or public health emergency. The bill also directs the Department of Health and Human Services to develop a plan to ensure that all immunizing agents are free of heavy metals, including mercury and thimerosal, including considering the requirement of the use of single-dose immunizing agents. Introduced on March 20, 2007 and referred to the Committee on Health and Human Services by both houses. Listed as dead.

http://janus.state.me.us/legis/LawMakerWeb/summary.asp?LD=1523

 

Maryland

SB 902 requires an individual to be vaccinated with a vaccine containing less than a specified amount of mercury per dose on or after January 1, 2009, unless vaccines that meet the requirement are not readily available or appropriate.. Introduced February 22, 2007 and referred to the Rules Committee.

http://mlis.state.md.us/2007rs/billfile/sb0902.htm

 

 

 

Massachusetts

Petition 2115  relates to prohibiting the use of certain vaccines and serums containing mercury and is scheduled to have a hearing on June 13, 2007.

http://www.mass.gov/legis/185history/h02115.htm

 

 

Michigan

SB 412 says that state agencies shall, to the extent possible, avoid the purchase of products with mercury in them if non-mercury alternatives exist.  Introduced on April 18, 2007; adopted unanimously by the Senate on May 15, 2007 and sent to the House, where it was referred to the Committee on Great Lakes and the Environment.

http://www.legislature.mi.gov/(S(dvqpoimxxowgof45mq3pnz45))/mileg.aspx?page=getObject&objectName=2007-SB-0412

 

 

Minnesota

HF 0470 is a companion to SF 0746 and would require patient notification when a vaccine contains more than a
trace amount of mercury. Introduced on February 1, 2007 and referred to the Health and Human Services Committee.

http://www.revisor.leg.state.mn.us/revisor/pages/search_status/status_detail.php?b=House&f=HF0470&ssn=0&y=2007

 

 

HF 1917 is a companion to SF 1780, providing a preference for a mercury-free vaccines preference established. Introduced on March 12, 2007 and referred to the Committee on Health and Human Services.

http://www.revisor.leg.state.mn.us/revisor/pages/search_status/status_detail.php?b=House&f=HF1917&ssn=0&y=2007

 

HF 2350 would prohibit the use of mercury in certain vaccines. Introduced on March 24, 2007 and referred to the Committee on Health and Human Services.

http://www.revisor.leg.state.mn.us/revisor/pages/search_status/status_detail.php?b=House&f=HF2350&ssn=0&y=2007

 

 

SF 0746 is an act requiring medical providers administering vaccines to school children to notify
parents and guardians of certain mercury (thimerosal) content in vaccines was introduced on February 12, 2007 and referred to the Committee on Health, Housing and Family Security. Companion is HF 0470.

http://www.revisor.leg.state.mn.us/revisor/pages/search_status/status_detail.php?b=Senate&f=SF0746&ssn=0&y=2007

 

SF 1780 is a companion to HF 1917 and is a bill for establishing a preference for mercury free vaccines in the state; authorizing the use of vaccines containing a trace amount of mercury under certain conditions; specifying certain patient informed consent requirements prior to administering the vaccine; specifying certain disclosure requirements for immunization providers; requiring the commissioner of health to provide and maintain vaccine information on the department Web site.  Introduced on March 12, 2007 and referred to the Committee on Health, Housing and Family Security.

http://www.revisor.leg.state.mn.us/revisor/pages/search_status/status_detail.php?b=Senate&f=SF1780&ssn=0&y=2007

 

Mississippi

 

*nothing relating to vaccines

 

Missouri-*nothing new in relation to vaccines

Current-Prohibits immunizations administered to children less than eight years old from containing mercury after January 1, 2007.PASSED IN MAY 2005. Under the act, after April 1, 2007, any immunizations administered to knowingly pregnant women or children under three years of age shall not contain more than 1 microgram of mercury per 0.5-milliliter dose.

 

Montana

The Montana Legislature adjourned on Friday, April 27, 2007 and none of the following mercury product bills was adopted into law.

SB 0236 is an act requiring mercury-free childhood vaccines; and establishing an interim preference for dispensing mercury-free influenza vaccines. Introduced on January 10, 2007, it was referred to the Committee on Public Health, Safety and Welfare. It was recommended for adopted and passed the Senate on February 5, 2007. It has been sent to the House, where it is in the Committee on Human Services, which had a hearing on March 16, 2007. It died in committee on April 27, 2007.

http://data.opi.mt.gov/bills/2007/billhtml/SB0236.htm

 

Nebraska

 

The Nebraska Legislature has adjourned, without adopting the following bill.

 

LB 49 states that on and after July 1, 2007, no vaccine or other drug administered in the State of Nebraska shall contain more than a trace amount of mercury; and on and after July 1, 2009, no vaccine or other drug administered in the State of Nebraska shall contain any amount of mercury. Introduced on January 4, 2007 and referred to Health and Human Services. Indefinitely postponed on February 26, 2007.

http://uniweb.legislature.ne.gov/Apps/BillFinder/finder.php

 

New Hampshire

 

*nothing relating to vaccines

 

New Jersey-

The New Jersey Legislature is unusual in that it starts in the even year and carries its bills over into the odd-numbered year.

 

A1324 is the same as A4433 from the 2004-2005 session and would phase out the use of mercury in vaccinations over a period of three years. Introduced January 10, 2006, referred to Assembly Health and Senior Services Committee. It was reported out of committee on May 11, 2006, with amendments.

http://www.njleg.state.nj.us/2006/Bills/A1500/1324_I1.HTM

http://www.njleg.state.nj.us/Default.asp

S618 is the same as A1324 and would phase  out the use of mercury in vaccinations over a period of three years. Introduced on January 10, 2006 and referred to Senate Health, Human Services and Senior Citizens Committee.

http://www.njleg.state.nj.us/2006/Bills/S1000/618_I1.HTM
http://www.njleg.state.nj.us/Default.asp

 

New Mexico-

New Mexico adopted a resolution and is now adjourned.

 

SJM 25 is a joint memorial resolution that encourages the use of vaccines with no more than a trace of mercury in them. Adopted and signed.

http://legis.state.nm.us/Sessions/07%20Regular/memorials/senate/SJM025.html

http://legis.state.nm.us:8080/lcsbillsearch/session.jsp?year=2007R&type=JM&chamber=S&number=25

 

New York

*nothing new relating to vaccines

Current: Mercury Ban does not take effect until 2008. Prohibits the administration to any person under the age of three years and to women who know they are pregnant of any vaccine containing more than 0.5micrograms of mercury per 0.5 milliliter dose, except that, for children under3 years, an influenza vaccine may contain not more than 0.625 micrograms ofmercury per 0.25 milliliter dose, and for pregnant women, an influenza vaccinemay contain not more than 1.25 micrograms of mercury per 0.50 milliliter dose;authorizes the commissioner of health to grant exemptions in cases of diseaseoutbreaks and vaccine shortages, and exempts influenza vaccines for pregnantwomen if there is in any year an insufficient supply of such vaccine which complies with the provisions of this act.

 

 

North Carolina

 

HB 431 would require that vaccines, containing the preservative thimerosal, administered to children under the age of eight years shall not contain more than 0.5 micrograms of mercury per 0.5 milliliter dose. Influenza vaccines administered to children 6‑35 months of age and pregnant women shall not contain the preservative thimerosal, except:  (1) vaccines with a trace amount (<0.5ug/0/5ml dose) of mercury are permissible only if there are no alternative vaccines available; and(2) in times of emergency or epidemic as determined by the State Health Director. If an emergency or epidemic is determined to exist, the State Health Director shall notify the Commission for Health Services, the Governor, and the Joint Legislative Commission on Governmental Operations, and the general public. The Department of Health and Human Services, Division of Public Health, shall develop and produce a brochure that explains the use of thimerosal and other preservatives in vaccines. The brochure shall describe what alternatives are available and what potential advantages and disadvantages are posed by the use of thimerosal and the alternatives. Introduced February 28, 2007, referred to the Committee on Health. A substitute was favorably reported on April 26, 2007 and it was referred to the Committee on Appropriations.

http://www.ncleg.net/gascripts/BillLookUp/BillLookUp.pl?Session=2007&BillID=H431

 

 

Oregon

*nothing new relating to vaccines

Current-Restricts use of vaccines containing mercury by pregnant women and children under three years of age.  Takes effect January 1, 2007. A woman who is known to be pregnant or a child under three years of age may not be vaccinated with a vaccine containing mercury or injected with a product that contains more than 0.5 micrograms of mercury per 0.5 milliliter dose.

(b) Notwithstanding paragraph (a) of this subsection, a woman who is known to be pregnant or a child under three years of age may be vaccinated with an influenza vaccine that contains 1.0 microgram of mercury or less per 0.5 milliliter dose.

 

 

Pennsylvania

HB 790 prohibits certain persons from being vaccinated with vaccines containing mercury or injected with any mercury-containing product. Referred to Health and Human Services, March 19, 2007.

http://www.legis.state.pa.us/cfdocs/billinfo/billinfo.cfm?&syear=2007&sind=0&body=H&type=B&bn=0790

 

HB 1001 amends existing law, known as the Childhood Immunization Insurance Act, further providing for definitions; and providing for mercury-free vaccines. Referred to Health and Human Services, April 2, 2007.

http://www.legis.state.pa.us/cfdocs/billinfo/billinfo.cfm?&syear=2007&sind=0&body=H&type=B&bn=1001

 

Rhode Island

 

H 5282  would require, prior to any vaccination of a minor child, a physician shall provide notice to a parent or guardian if the vaccination contains mercury. A standardized consent form stating that mercury is a dangerous toxin, and that  exposure to even low levels may permanently damage the brain and nervous system and cause  behavior changes, shall be developed and provided by the department of health. This form shall  be signed and dated by a minor child’s parent or guardian prior to vaccination and kept with the  minor child’s permanent record. Introduced on  February 01, 2007, and referred to the House Health, Education & Welfare Committee.

http://www.rilin.state.ri.us/billtext07/housetext07/h5282.htm

 

H 5863  would require, except for an influenza vaccine, on and after July 1, 2008, a person who is knowingly pregnant or who is under 3 years of age shall not be vaccinated with a mercury containing vaccine or  injected with a mercury containing product that contains more than 0.5 micrograms of mercury per five tenths 0.5 milliliter dose. On and after July 1, 2008, a person who is knowingly pregnant or who is under three  years of age shall not be vaccinated with a mercury containing influenza vaccine that contains more than one  microgram of mercury per 0.5 milliliter dose. The director of the department of health may exempt the use of a vaccine from this  section if the director finds, and the governor concurs, that an actual or potential bioterrorist incident or other actual or potential public health emergency, including a pandemic, an epidemic or shortage of supply of a vaccine that would prevent persons from receiving the needed vaccine, makes necessary the administration of a vaccine containing more mercury than the maximum level set forth herein. Date Introduced March 01, 2007 and referred to the House Health, Education & Welfare Committee.

http://www.rilin.state.ri.us/billtext07/housetext07/h5863.htm

 

South Carolina

 

*None relating to vaccines

 

Tennessee-*nothing new

Current-All immunizations administered to any person, including pregnant women, in the State of TN shall not contain mercury, trace amounts of mercury or preservatives containing mercury.

 

Vermont

 

H.0114 proposes to prohibit the use of mercury‑containing vaccines for children and pregnant women. Introduced January 23, 2007 and referred to the Human Services Committee.

http://www.leg.state.vt.us/docs/legdoc.cfm?URL=/docs/2008/bills/intro/H-114.HTM

http://www.leg.state.vt.us/database/status/summary.cfm?Bill=H%2E0114&Session=2008

 

H.0121 proposes to limit the presence of mercury in the air and waters of the state by prohibiting the installation of  mercury-containing dental amalgam, except in back molars, effective January 1, 2011.  It establishes reporting requirements regarding amounts of mercury supplied to the dentists of the state.  It also proposes to establish a comprehensive program by which manufacturers of mercury-added thermostats will collect mercury-added thermostats facing disposal. Introduced January 23, 2007 and referred to the Human Services Committee. Reported out favorably with amendment and referred to the Human Services Committee on March 14, 2007.

http://www.leg.state.vt.us/docs/legdoc.cfm?URL=/docs/2008/bills/intro/H-121.HTM

http://www.leg.state.vt.us/database/status/summary.cfm?Bill=H%2E0121&Session=2008

S.0081 would require that dental patients are notified of alternatives to mercury amalgam dental fillings, using brochures and posters the department of health must produce; phase out the use of mercury amalgam fillings, beginning with a ban on the use of mercury amalgam fillings for pregnant women and children commencing in 2008 and then applying it to the rest of the general public by 2011; and prohibit the use of mercury in flu vaccines except in the case of a shortage or public health emergency. Introduced February 9, 2007 and referred to the Health and Welfare Committee.

http://www.leg.state.vt.us/database/status/summary.cfm?Bill=S%2E0081&Session=2008

http://www.leg.state.vt.us/docs/legdoc.cfm?URL=/docs/2008/bills/intro/S-081.HTM

 

Washington

 

The Legislature of the State of Washington has adjourned and adopted the following bill.

 

HB 1098 modifies the state statutes limiting the amount of mercury in vaccinations to provide an exemption for the use of mercury-containing vaccinations in times of an outbreak of a vaccine-preventable disease. Introduced January 10, 2007, a substitute was adopted with amendment and sent to the Governor on  April 22, 2007, who signed it into law on May 2, 2007. http://search.leg.wa.gov/pub/textsearch/default.asp##

 

West Virginia

 

The Legislature adjourned in March 2007, and the following two bills were not adopted.

HCR 57 Requests that  the Joint Committee on Government and Finance conduct a study on the need to eliminate mercury and mercury preservatives (thimerosal) in vaccines. Introduced February 26, 2007, adopted by the House on March 7 and sent to the Senate, where it has been referred to the Committee on Health and Human Resources.

http://www.legis.state.wv.us/Bill_Text_HTML/2007_SESSIONS/RS/Bills/hcr57%20intr.htm

http://www.legis.state.wv.us/bill_status/Resolution_History.cfm?year=2007&sessiontype=rs&btype=res

 

HB 2152 provides that, effective the first day of July, two thousand seven, vaccines administered in this state shall not contain any mercury or mercury compounds, including but not limited to thimerosal, unless a vaccine containing no mercury is not manufactured; or the provider finds that the mercury-free vaccine is not obtainable by utilizing best efforts, because the vaccine is not on the market for sale. If a mercury-free vaccine is not available according to subsection (a), then a vaccine containing a trace amount of mercury as defined by the United States Food and Drug Administration may be administered. If neither a mercury-free vaccine nor a vaccine containing a trace amount of mercury is available, then the vaccine containing the least amount of mercury may be administered. Introduced January 16, 2007; referred to the Committee on Health and Human Resources, then the Judiciary.

http://www.legis.state.wv.us/Bill_Text_HTML/2007_SESSIONS/RS/Bills/hb2152%20intr.htm

http://www.legis.state.wv.us/bill_status/Bill_Status.cfm

 

Federal

 

HR 881 amends the Federal Food, Drug, and Cosmetic Act to deem a banned mercury-containing vaccine to be adulterated. Amends the Public Health Service Act to provide that a vaccine is a banned mercury-containing vaccine if one dose of the vaccine contains one or more micrograms of mercury in any form. It authorizes the Secretary of Health and Human Services to declare that an actual or potential bioterrorist incident or other public health emergency makes the administration of such vaccines advisable for a specified period. The bill requires the Secretary to prohibit the distribution of banned mercury-containing influenza vaccines that are approved as biological products to: (1) any child under the age of three years old (effective July 1, 2007); (2) pregnant women if the vaccine contains thimerosal (effective July 1, 2007); and (3) any child under the age of six (effective July 1, 2008). It also requires the Secretary to revise the vaccine information included with mercury-containing vaccines to include: (1) a statement that indicates the presence of mercury in the vaccine; (2) information on the availability of any mercury-free or mercury-reduced alternative vaccine and instructions on how to obtain such an alternative vaccine; and (3) a recommendation against administration of any mercury-containing vaccine to a pregnant woman. In addition, the bill expresses the sense of Congress that the Centers for Disease Control and Prevention (CDC) should disseminate, with any vaccine-related information, a recommendation against administration of any thimerosal-containing vaccine to a pregnant woman. Introduced on February 7, 2007, it has 17 sponsors and co-sponsors, and has been referred to the Committee on Energy and Commerce.

http://thomas.loc.gov/cgi-bin/bdquery/z?d110:h.r.00881:

 

HR 2101 would prohibit after 2008 the introduction into interstate commerce of mercury intended for use in a dental filling, and for other purposes. Introduced on May 1, 2007, it has two sponsors and co-sponsors and has been referred to the Committee on Energy and Commerce.

http://thomas.loc.gov/cgi-bin/bdquery/z?d110:h.r.02101:

 

 

PDF version

Canada

Canadian vaccines

 Why do Canadian parents repeatedly say their vaccines are mercury free and they say it with absolute. 
So where do they get this from?  

According to Health Canada
 
Currently, the only thimerosal-containing vaccine in routine use in the infant immunization schedules of some Canadian jurisdictions is the hepatitis B vaccine.

 This does not mean that all thimerosal-containing vaccines have been eliminated in Canada. A number of other thimerosal-containing vaccines are licensed that are used in special circumstances, that could continue to expose infants < 6 months of age to ethylmercury.  
 
These include some single antigen acellular pertussis and conjugate H. influenzae vaccines, diphtheria-tetanus, and diphtheria- tetanus-acellular pertussis combination vaccines, all of which contain thimerosal in a concentration of 0.01%, and represent an exposure of 25 µg ethylmercury per 0.5 mL dose(11).  
 
Thimerosal- containing hepatitis B vaccine continues to be used in some Canadian jurisdictions to protect high risk infants born to chronic hepatitis B infected mothers. Influenza vaccines that are licensed in Canada also contain 0.01% thimerosal but are not recommended or used in infants < 6 months of age because of lack of effectiveness early in life.

 Here are the thimerosal concentrations in the Hep B vaxes licensed for use in Canada: 
 
Engerix BTM [Glaxo Smithkline] and Recombivax BTM [Merck Frosst Canada]) have been available in Canada since these programs were initiated, containing thimerosal at a concentration of 0.005% or 50 µg/mL.  
 
A regular infant dose of 0.5 mL Engerix BTM contains 12.5 µg of ethylmercury, while a regular infant dose of 0.25 mL of Recombivax BTM contains 6.25 µg.
 
 
 
Health Canada also states: 
 
There is no legitimate safety reason to avoid the use of thimerosal-containing products for children or older individuals, including pregnant women.

 Vax schedule in Canada (Alberta)

Link 
 
2 months  
• DTaP-IPV-Hib1 
• Pneumococcal conjugate 
• Meningococcal conjugate 
 
4 months  
• DTaP-IPV-Hib 
• Pneumococcal conjugate 
• Meningococcal conjugate 
 
6 months  
• DTaP-IPV-Hib 
• Pneumococcal conjugate 
• Meningococcal conjugate 
 
6-23 months  
• Influenza 
 
12 months  
• MMR2 
• Varicella (Chickenpox) 
 
18 months  
• DTaP-IPV-Hib 
• Pneumococcal conjugate 
 
4 – 6 years  
• DTaP-IPV3 
• MMR 
 
Grade 5  
• Hepatitis B (3 doses) 
• Varicella4 (Chickenpox) 
 
14 – 16 years  
• dTap5 
 
Note: each bullet represents one vaccine/injection 
 
* 1 Diphtheria, tetanus, acellular pertussis, polio, haemophilus influenza type b 
* 2 Measles, mumps, rubella 
* 3 Diphtheria, tetanus, acellular pertussis, polio 
* 4 If no history of disease or not previously immunized 
* 5 Diphtheria, tetanus, acellular pertussis

State Mercury Laws

What do some of the Mercury (Thimerosal) Bans REALLY mean?

 

Mercury free does NOT mean a total ban for most states so read the state law to be sure of what it says. For all states, they can be viewed here:

 

 

`Mercury-Free Vaccines Act of 2005’

 

 

Some Examples:

 

California-The state data do not include children under the age of 3. About 90 percent of all autistic children are entered into the system before the age of 6. According to the state data, 2002 was a record year for new autism diagnoses, with 3,259 cases. In 2003, the number of new cases slipped to 3,125. In 2004, the number was 3,074. For the first half of 2005, there were 1,470 new cases, compared to 1,518 in the same period in 2004. (Source:AP-California)

California- Article 9. Mercury-containing Vaccines

124172. (a) Except for an influenza vaccine described in subdivision (b), on and after July 1, 2006, a person who is knowingly

pregnant or who is under three years of age shall not be vaccinated with a mercury-containing vaccine or injected with a mercury-containing product that contains more than 0.5 micrograms of mercury per 0.5 milliliter dose.

(b) On and after July 1, 2006, a person who is knowingly pregnant or who is under three years of age shall not be vaccinated with a mercury-containing influenza vaccine that contains more than 1.0 microgram of mercury per 0.5 milliliter dose.

 

 

Iowa- Beginning January 1, 2006, immunizations administered in this state shall not contain more than trace amounts of mercury. The prohibition under this section shall not apply to   early childhood immunizations for influenza or in times of  emergency or epidemic as determined by the director of public  health.

 

 

New York-ban does not take effect until 2008. Prohibits the administration to any person under the age of three years and to women who know they are pregnant of any vaccine containing more than 0.5micrograms of mercury per 0.5 milliliter dose, except that, for children under 3 years, an influenza vaccine may contain not more than 0.625 micrograms of mercury per 0.25 milliliter dose, and for pregnant women, an influenza vaccine may contain not more than 1.25 micrograms of mercury per 0.50 milliliter dose; authorizes the commissioner of health to grant exemptions in cases of disease outbreaks and vaccine shortages, and exempts influenza vaccines for pregnant women if there is in any year an insufficient supply of such vaccine which complies with the provisions of this act.

 

 

Missouri– Prohibits immunizations administered to children less than eight years old from containing mercury after January 1, 2007. PASSED IN MAY 2005. Under the act, after April 1, 2007, any immunizations administered to knowingly pregnant women or children under three years of age shall not contain more than 1 microgram of mercury per 0.5-milliliter dose.

 

 

Illinois-ban not in effect until 2008 however on Mar 04, 2006- the Illinois Department of Public Health has declared 4 vaccines with high levels of mercury exempt from the law. Illinois passed landmark legislation that limits mercury levels in vaccines to 1.25 micrograms per dose by the first of this year and eliminates mercury all together by January 1st 2008, the Illinois Department of Public Health has issued a declaration of exemption which allows four vaccines to exceed the limit. In addition to the flu vaccine, the diphtheria-tetanus, Japanese encephalitis and meningitis vaccines are also exempted from the law. The Illinois Department of Public Health claims the mercury-free versions of these vaccines are either too expensive, in short supply or non-existent, hence they have allowed thimerosal, the mercury-laden preservative in these vaccines to persist.

 

 

Oregon-Restricts use of vaccines containing mercury by pregnant women and children under three years of age.  Takes effect January 1, 2007. A woman who is known to be pregnant or a child under three years of age may not be vaccinated with a vaccine containing mercury or injected with a product that contains more than 0.5 micrograms of mercury per 0.5 milliliter dose.

(b) Notwithstanding paragraph (a) of this subsection, a woman who is known to be

pregnant or a child under three years of age may be vaccinated with an influenza vaccine

that contains 1.0 microgram of mercury or less per 0.5 milliliter dose.

 

Tennessee- All immunizations administered to any person, including pregnant women, in the State of TN shall not contain mercury, trace amounts of mercury or preservatives containing mercury. :)

 

 

Delaware- Except for vaccines for influenza, no vaccine containing more than a trace amount of mercury shall be made available to a medical provider in this State for administration to children under eight years of age or to pregnant women.  This section shall not apply to vaccines administered during declared states of emergency or epidemics.” Section 1. of this Act shall become effective on January 1, 2006. No vaccine containing more than a trace amount of mercury shall be made available to a medical provider in this State for administration to children under eight years of age or to pregnant women.  This section shall not apply to vaccines administered during declared states of emergency or epidemics.” shall become effective on January 1, 2007. No vaccine containing mercury shall be made available to a medical provider in this State for administration to children under eight years of age or to pregnant women.  No vaccine containing mercury shall be administered by a medical provider in this State to a child who is under eight years of age or to a pregnant woman, notwithstanding the expiration date thereof.  This section shall not apply to vaccines administered during declared states of emergency or epidemics.” become effective on January 1, 2008.

Vaccine Makers Shielded From Autism Liability Lawsuit

Vaccine Makers Shielded From Autism Liability Lawsuit

 

An 11-year-old boy with autism and his family cannot proceed with their case against pharmaceutical companies after a judge ruled that federal law pre-empts state claims against companies if their vaccines are FDA-approved.   

Jared Wright, 11, of Texas, was given six vaccines during the first year-and-a-half of his life.

Five of the vaccines contained the mercury-based preservative, thimerosal.  Jared’s parents, Howard and Jacqueline Wright claim the mercury in the vaccines caused Jared’s autism.

The vaccine makers named in the product liability lawsuit were Aventis Pasteur Inc., Merck & Co. Inc., and Wyeth.

But Philadelphia Common Pleas Judge Arnold L. New granted the companies summary judgment and wrote that the drug makers are shielded from liability by the federal National Childhood Vaccine Injury Act.

22(b) of the Vaccine Act expressly pre-empts claims of design defects or a failure to warn the public about a vaccine’s dangers.  

Congress clearly intended when it enacted the Vaccine Act to exercise its constitutionally delegated authority to preempt all state design defect claims without case-by-case determination that the side effects are unavoidable,” New wrote.

The 1986 National Childhood Vaccine Injury Act was created as a no-fault system by the federal government to provide recovery of damages to people hurt by vaccines and to reduce the potential financial liability of vaccine makers due to injury claims.

The Wright’s attorney Marc P. Weingarten of Locks Law Firm, had argued that the drug companies were negligent because the public and doctors were kept in the dark about the use of mercury in vaccines.

But Judge New ruled that violating the protection provided by the Vaccine Act might destabilize the supply of child vaccines.

Weingarten said the case is “an extremely important issue to be heard by the courts of Pennsylvania” because of the federal pre-emption issues arising in pharmaceutical and medical device litigation in both state and federal jurisdictions.

Proponents of vaccines argue that major studies have not found a link between the use of thimerosal and neurological injury. 

But scientists pointing to the case of Hannah Poling earlier this year, put the industry on notice that pre-existing conditions in children, such as mitochondrial disorder in Hannah, might result in autism after vaccinations.

In March, Julie Gerberding, head of the CDC, appeared with Dr. Sanjay Gupta on CNN and confirmed that vaccines can trigger autism in a subset of vulnerable children. That video is available via YouTube on the web site of Adventures in Autism.

To overcome this federal safety blanket for drug makers, the plaintiff would have to show the pharmaceutical companies engaged in fraud or wrongfully withheld information from the FDA; or failed to exercise due care even though the manufacturer complied with federal laws and regulations.

Ultimately, measures aimed at reducing the right to file liability lawsuits against drug and device makers is one tool of the tort reform movement.