Effectiveness of Flu Vaccine Raises More Red Flags

Posted: 3/26/2013 4:15:20 AM | with 21 comments
by Patrice La Vigne

The news may be well known now about the influenza vaccine being only 56 percent effective overall and 9 percent effective for the type A H3N2 strain in adults aged 65 years or older during the 2012-13 flu season. 1 The latest buzz, however, is about how getting a flu shot year after year may make people more susceptible to getting influenza.

Year-to-Year Flu Vaccination Could Limit Effectiveness

In February, Clinical Infectious Diseases published a new prospective study noting the failure of the flu vaccine in people vaccinated against influenza during the previous year.

The researchers followed 328 households with 1,441 members from before the 2010-2011 flu season through the end of it. A total of 866 study participants received the flu shot before the flu season started. Nearly one quarter of the households with 125 members contracted the flu during the 2010-11 season, as confirmed by laboratory tests.

When the researchers separated out those, who were not vaccinated in the previous flu season, they found less of a benefit with the flu vaccine. The influenza vaccine was 62 percent effective among people, who did not receive a flu shot in the prior year. In comparison, vaccine effectiveness among those, who did get a flu shot in the previous year, was substantially lower at -45 percent.

Furthermore, the study found that those who were vaccinated in both years and those who were not vaccinated in either year had similar influenza infection risks. 2

Seasonal Flu Vaccine Could Increase Future H1N1 Infection Risk

This is not the first study questioning vaccine effectiveness based on repeated annual influenza vaccination. In fact, there is a large body of literature examining the impact of previous use of seasonal trivalent flu vaccines on the risk of contracting the 2009 pandemic H1N1 swine flu.  

In 2010, PLoS Medicine published an analysis of Canadian epidemiological studies suggesting that people, who had received seasonal flu shots the year before the 2009 H1N1 swine flu pandemic, had an increased risk of becoming infected with the pandemic swine flu.

During the spring 2009 pandemic H1N1 virus wave, investigators noted a link between prior receipt of the trivalent inactivated influenza vaccine during the 2008-09 season and fever/cough illness. In response, they conducted four follow-up epidemiologic studies (three case-control studies and one household transmission study) during the summer of 2009 to further explore the original finding.

Studies Identify Flu Vaccine Failures

Findings from one of the case-control studies showed that prior vaccination with trivalent inactivated influenza vaccine is protective against seasonal influenza and reduced the flu risk by 56 percent. However, results from all four studies revealed that those vaccinated in the previous 2008-09 season were between 1.4 and 2.5 times more likely to contract H1N1 during the spring and summer of 2009. 3

A second study in 2009 identified a similar association between previous vaccination and pandemic H1N1 illness in a military population. Between April 21 and May 8, a total of 97 patients developed the H1N1 virus. Of these, 63 people, or 66 percent, received the influenza vaccination in the previous 12 months. In comparison, only 40 percent of patients without H1N1 virus had no history of vaccination. 4

In Nov. 13, 2009, the Center for Disease Control and Prevention published a case-cohort study on the effectiveness of 2008-09 trivalent influenza vaccine against 2009 pandemic H1N1. The CDC concluded that there was no decreased or increased risk of pandemic H1N1 following seasonal flu vaccine. 5

Doctors Intrigued and Troubled by Findings

In an accompanying editorial, Drs. John Treanor and Peter Szilagyi wrote a response to the findings for the most recent study showing lower effectiveness with back-to-back flu shots.

“As we are currently struggling through one of the most vigorous influenza seasons in recent memory, the apparent failure of influenza vaccine under optimal conditions seen in this study is indeed troubling,” they wrote. 6

As usual, further study on flu vaccine effectiveness is necessary. There are a lot of conflicting data available. However, the growing number of studies showing low overall effectiveness, waning immunity and a negative effect of prior-year vaccination cast doubt on influenza vaccine policies and strategies, especially when influenza vaccinations now are being required as a condition of employment for health care workers.  

References:

2 Ohmit SE, Petrie JG, Malosh RE, et al. Influenza Effectiveness in the Community and the Household. Clinical Infectious Diseases  Feb. 14, 2013.

6 Treanor JJ and Szilagyi P. Influenza Vaccine: Glass Half Full or Half Empty? Clinical  Infectious Diseases  Feb. 14, 2013.


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Dead Pigs Raise Questions About Rotavirus Vaccines

Posted: 3/26/2013 2:35:23 AM | with 4 comments
by Patrice La Vigne

China has reported a mysterious spike in the number of dead pigs, including baby pigs, turning up near Shanghai. This is prompting our revisit of the pig virus contamination issue with rotavirus vaccines that raised some eyebrows in 2010.

Where Are the Pigs From and How Did They Die?

The fact is that more than 13,000 pigs have turned up dead in and along the Huangpu River and nearby area during the past few weeks. Authorities have yet to isolate any one cause of the deaths, how or where the pigs originated

Even though the Agriculture Ministry has stated there is "no major swine epidemic," one suspected cause of death is pointing to porcine circovirus (PCV), as samples of the deceased pigs have tested positive for the common pig infection that has not yet been shown to be harmful to humans. Authorities have also assured Shanghai residents that the drinking water from the Huangpu River−−a major supplier for the city of Shanghai−−is safe. 1 2

Jiaxing, where thousands of hog farms are located and where there have been previous reports of inexplicable pig deaths, is the suspected main source. Some of the pigs had ear tags from from Jiaxing. 3

How Are Pig Deaths Related to Rotavirus Vaccines?

Porcine circovirus types 1 and 2 (PCV1 and PCV2) have been in the news before as a potential threat to public health. Although PCV1 infection is thought to be relatively harmless in pigs, PCV2 is associated with a lethal wasting disease in baby pigs.. 4

In May 2010, the Food and Drug Administration (FDA) temporarily suspended use of GlaxoSmithKline's (GSK) rotavirus vaccine, Rotarix, because DNA from PCV1 was found in the vaccine. Merck's RotaTeq was found to contain PCV1 plus PCV2 DNA fragments, but its use was not suspended.

Shortly thereafter, the FDA said use of Rotarix could resume because the vaccine had "strong safety records" and there is "no evidence that either PCV1 or PCV2 poses a safety risk in humans." 5 6

NVIC Calls For Elimination of Pig Virus DNA From Rotavirus Vaccines  

In 2010, NVIC called on GSK to eliminate PCV1 DNA from Rotarix and called on Merck to voluntarily recall RotaTeq until the vaccine was free from PCV2 DNA fragments because PCV2 is “an aggressive virus that causes immune suppression, wasting disease and death in baby pigs.” 7 No such action occurred.

The FDA asked both GSK and Merck to update labels for Rotarix and RotaTeq to include information about the presence of DNA from porcine circoviruses, which the drug companies have since done. 8 9 But the pig virus DNA is still present in the vaccines and strong evidence that it is safe for infants to swallow pig virus DNA in live rotavirus vaccines is still missing.

EMA Proposes Guidelines On Use of Pig Products In Vaccines

In response to the questions surrounding porcine circoviruses, the European Medicines Agency (EMA) has been working to tighten quality controls. In February, the agency published draft guidelines for use of trypsin, a protein-processing enzyme derived from the pig pancreas that is thought to be the origin of PCV contamination. The guidelines suggest ways to minimize the risk of contamination, such as selecting healthy pigs, testing of starting material for adventitious agents, appropriate cleaning methods during the manufacturing process and quality controls. The EMA also noted that there are alternative reagents available other than porcine trypsin that should be explored.

The EMA concluded that vaccine manufacturers “should have sufficient information on the trypsin to allow a comprehensive risk assessment and provide a sufficient data package to the competent authority for assessment.” 10

China’s Turn For Action

Public health and food safety issues in China have a history of being disastrous (think SARS). So it is only natural to be concerned when pig carcasses are turning up by the thousands. The hope is that a full investigation will reveal exactly how and why the pigs died.


References

3 Hongyi W. Epidemic ruled out as cause of dead pigs. China Daily March 13, 2013.

4 Background on PCV. Food and Drug Administration Vaccine, Blood & Biologics. (Updated May 14, 2010).

5 Update on Recommendations for the Use of Rotavirus Vaccines. Food and Drug Administration. May 14, 2010.

6 McClenahan SD, Krause PR, Uhlenhaut C. Molecular and infectivity studies of porcine circovirus in vaccines. Vaccine 2011; 29:4745-53.

8 Rotarix. Food and Drug Administration Vaccines, Blood & Biologics. Online. (Updated June 4, 2010).

9 RotaTeq. Food and Drug Administration Vaccines, Blood & Biologics. Online. (Updated Dec. 12, 2012).


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NVIC Launches National "Know The Risks" Billboard Vaccine Education Campaign

Posted: 3/12/2013 3:58:33 PM | with 18 comments
During March and April 2013, the National Vaccine Information Center is conducting an educational billboard campaign in Arizona, Illinois, Oregon, Washington and Texas to encourage citizens to become informed vaccine decision-makers. The NVIC billboard features a photo of a mother and child and asks “Vaccination? Know the risks and failures”. Click the image below to read the press release and learn more on our Know the Risks webpage. 


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US Public Health Officials Back Pediatric Anthrax Vaccine Experiment

Posted: 3/12/2013 9:45:54 AM | with 9 comments
The U.S. Department of Health and Human Services (DHHS) and the nation’s sole manufacturer of anthrax vaccine, Emergent BioSolutions, are making plans to go forward with an experimental clinical trial testing anthrax vaccine on American infants and children. Last month, the Alliance for Human Research Protection (AHRP) issued a strongly worded, evidence-based letter to the Presidential Commission for the Study of Bioethical Issues protesting pediatric trials using BioThrax anthrax vaccine for the purpose of proving the vaccine is safe and effective to give to infants and children.[1]  

BioThrax Vaccine: A Military Mandate
 
Emergent BioSolutions, formerly known as BioPort Corp., is the sole source supplier of anthrax vaccine to the U.S. military. All U.S. military personnel are required to take a series of the company’s BioThrax anthrax shots. Despite continuing reports that the vaccine is causing a high number of reactions, injuries and deaths, the Department of Defense (DOD) maintains that all soldiers and civilian military personnel must get a series of anthrax vaccinations based on a theoretical threat of a future bioterrorism attack using weaponized inhalation (aerosol) anthrax.
 
Anthrax is a non-communicable infection usually occurring in cows, horses, sheep and goats and transmitted to humans through contaminated animal by-products and soil. Anthrax has never been used as a bioterrorism weapon by any nation.[2] There are between 10 and 29 million doses of anthrax vaccine in U.S. stockpiles, but every year the Centers for Disease Control (CDC) and Department of Homeland Security throw out about 2 million doses of anthrax vaccine (worth $48 million) that have passed the expiration date.[3]   

BioThrax Vaccine: “A Dangerous Vaccine”
 
Along with AHRP, the National Vaccine Information Center (NVIC) is also on public record since 2011 as opposing proposed anthrax vaccine experiments on children. The 2013 letter to the Presidential Commission, written by AHRP President Vera Sharav and Board Member Meryl Nass, MD, states that the anthrax vaccine’s “effectiveness after exposure to inhalation anthrax is unknown, and the lack of a reliable animal model makes any calculation of effectiveness and dosing impossible. What is known is that BioThrax is a dangerous vaccine. The FDA-approved 2002 label states: 5% to 35% of adults who were vaccinated suffered adverse events.”
 
The AHRP letter comes after several years of meetings in which federal officials and consultants debated the risks and ethics of enrolling infants and children in experimental trials and injecting them with the controversial vaccine. BioThrax anthrax vaccine was first associated with hundreds of cases of chronic brain and immune system damage and death suffered by soldiers in the Gulf War, who received a series of anthrax shots along with many other vaccines.
 
BioThrax Vaccine: Subject of Lawsuits
 
In 2004, a U.S. District Court Judge issued an injunction ordering the Department of Defense (DOD) to stop giving BioThrax anthrax vaccine to U.S. troops because the FDA had not properly tested and licensed the vaccine as effective against weaponized inhalation anthrax.[4]  However, the DOD eventually invoked an “Emergency Use Authorization” created under post 9-11 Bioshield legislation passed by Congress and circumvented the court injunction in order to continue forcing soldiers to get BioThrax vaccinations without voluntary, informed consent.
 
In March 2005, NVIC joined with AHRP and military veterans groups in an amicus brief filed in a U.S. District Court in John Doe #1, et al v. Donald Rumsfeld opposing forced use of experimental anthrax vaccine by U.S. troops in violation of the informed consent ethic. In December 2005, the FDA issued a “Final Order” declaring that BioThrax vaccine was effective against inhalation anthrax, without conducting additional appropriate tests, and the federal court injunction was lifted.
 
Creating Civilian Markets for Bioterrorism Vaccines
 
In October 2011, the National Biodefense Science Board (NBSB) voted to endorse pediatric anthrax vaccine trials in the U.S. with the justification that government officials need to know whether the vaccine is safe and effective in children in case there is ever a future bioterrorism attack involving weaponized inhalation anthrax.[5]  At a July 2011 NBSB public meeting, NVIC’s director of research and patient safety, Vicky Debold, RN, PhD, stated NVIC’s opposition to the pediatric trial:
 
“NVIC is deeply concerned about the safety of pre-event testing of BioThrax anthrax vaccine in pediatric populations in light of the continuing adverse event reports in previously healthy adult men and women, who have taken the vaccine. Without a credible, substantiated threat of weaponized anthrax being used against the U.S. civilian population, NVIC finds it hard to justify this kind of experimentation on American children.”[6]   
 
The National Biodefense Science Board, which is housed in the Department of Health and Human Services (DHHS), was created by Congress in 2006, under the “Pandemic & All-Hazards Preparedness Act.” The law fosters a public-private partnership between the federal government and the pharmaceutical industry to develop new “bioterrorism” vaccines.[7]      
 
Highlights of AHRP Letter Focus on Ethical Violations
 
In their Feb. 18 letter, Vera Sharav and Dr. Meryl Nass appealed to Dr. Amy Gutman of the Presidential Commission for the Study of Bioethical Issues to help put a stop to the proposed anthrax vaccine trials on American children. Stating that they are making “the case that the proposed pediatric anthrax vaccine trial… involves greater than minimal risk and is unethical and unapprovable in the absence of a clear and present danger to children,” the letter outlines a number of basic flaws associated with the anthrax vaccine, such as: 
 
  • FACT: No bioterrorism events have happened since 2001, due to anthrax or any other biological agent. Anthrax is only one of dozens of possible agents that could be used as biological weapons by terrorists or foreign militaries—or only one of hundreds more that could be genetically engineered.
  • FACT: of many thousands of people exposed to anthrax spores in 2001, antibiotics prevented illness in 100% of those treated after exposure. Five people died, their cases unrecognized until very late. There was no additional benefit from anthrax vaccine, which was accepted by less than 2% of those who used antibiotics.
  • FACT: Due to lack of an animal bridging model for anthrax vaccines, there are only immunogenicity data in humans, not human efficacy data. Immunogenicity data cannot reliably predict efficacy for this vaccine, either in adults or children.
  • FACT: Possibly 30,000 people were exposed to spores from the anthrax letters in 2001. Most took antibiotics alone; only 198 accepted vaccine. Indeed, according to the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control (CDC): “No cases of anthrax have been detected among persons recommended to take antimicrobial prophylaxis after the terrorist attacks of 2001.”[8]
  • FACT: No other country in the world mandates that its troops be vaccinated with anthrax vaccine. Canada, Australia and the United Kingdom all began anthrax vaccination of their troops during the Gulf War, but all three vaccination programs were soon cancelled.
  • FACT: The proposed anthrax vaccine experiment indisputably poses greater than minimal risks with no direct benefit for the specific children involved. This government-initiated experiment fails to meet the statutory standard in Federal regulations for exposing children to greater than a “minor increase over minimal risk” in research.FACT: The antibody data to be gained from a pediatric trial will thus be clinically and scientifically uninformative. The proposed experiment will be scientifically useless and unnecessary—thereby violating ethical principles of the Nuremberg Code and Federal regulations.
  • FACT: The proposed trial cannot answer meaningful safety questions—which would require using thousands of children. The inescapable conclusion, therefore, is that data to be obtained from the proposed pediatric experiment will have no scientific or clinical value. Undertaking such trials is, therefore, unethical and unapprovable under US statute.
The letter closes with a challenge to the Commission: “Your decision will draw a moral line in the sand—either you uphold children’s statutory protected human rights—or you provide the Administration with a disingenuous rationale for circumventing statutory safeguards enacted to protect children from exploitation as human guinea pigs. Which legacy do you wish to leave?”
 
The Alliance for Human Research Protection (AHRP) is a national network of lay people and health professionals dedicated to advancing responsible and ethical medical research practices.
 
Read the entire AHRP Feb. 18, 2013 letter here.

References

[2] NVIC.org. Anthrax. 2013.
[4] M. Kaufman. U.S. Barred From Forcing Troops to Get Anthrax Shots. Washington Post Oct. 28, 2004.  
[5] R. Stein. Federal advisers endorse testing anthrax vaccine in children. Washington Post Oct. 28, 2011.
[6] Debold V. Public Comment on Behalf of NVIC Opposing Pediatric Anthrax Vaccine Trials. National Biodefense Science Board Public Engagement Workshop Meeting, Anthrax Vaccine Working Group July 7, 2011.
[7] U.S. Department of Health *& Human Services. National Biodefense Science Board (NBSB). March 7, 2013.

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