Posted: 4/28/2010 12:46:53 AM
U.S. and Australia Report Vaccine Safety Signals
Washington, D.C. April 29, 2010 – In response to an April 23, 2010 report by the H1N1 Vaccine Safety Risk Assessment Working Group (VSRAWG) of the National Vaccine Advisory Committee (NVAC)identifying three potential pandemic H1N1 vaccine safety signals for neuroimmune (Guillain- Barre Syndrome, Bell’s palsy) and blood disorders (thrombocytopenias), the National Vaccine Information Center (NVIC) is urging an expansion of influenza vaccine safety monitoring and assessment. NVIC’s call coincides withAustralia halting use of the 2010 trivalent seasonal influenza vaccine containing a pandemic H1N1 vaccine component in children under age five due to an unusual number of nationwide reports of high fever, vomiting and convulsions leading to hospitalizations and a report of at least one child death.
DHHS created the VSRAWG to provide independent oversight of federal post-marketing monitoring of pandemic H1N1 vaccine adverse events. Among the experts serving on the risk assessment team is Vicky Debold, PhD, RN, who is also the consumer member of the FDA Vaccines & Related Biological Products Advisory Committee. The VSRAWG’s main objective is to conduct rapid reviews of adverse events associated with the 2009 pandemic H1N1 vaccine to assess potential causation, as well as establish priorities for additional investigations.
In four months, millions of healthy and chronically ill American children, pregnant women and adults will be told by their doctors to get a flu shot that contains the 2009 pandemic H1N1 vaccine component.” said NVIC co-founder & president, Barbara Loe Fisher. “The potential safety signals in the U.S. and Australia underscore the need to expand and improve vaccine safety surveillance systems to make sure that all signals are being picked up and responded to quickly. Timely reports help doctors and patients identify symptoms that may be associated with vaccination and facilitate informed medical decision-making and better management of vaccine adverse events.”
Earlier this month, NVIC participated in a federally sponsored meeting to evaluate the effectiveness of the U.S. vaccine safety system and NVIC supported the creation of an independent vaccine safety oversight agency funded by congressional appropriations that reports directly to the President. NVIC has long been critical of the failure of most vaccine providers to obey safety provisions in the 1986 National Childhood Vaccine Injury Act. The Act mandated reporting of serious health problems following vaccination to the federal Vaccine Adverse Events Reporting System (VAERS), which acts as a sentinel post-marketing surveillance system.
“Safety signals can’t be picked up and responded to quickly if vaccine providers do not step up to the plate and make full and rapid reports of all serious health problems following vaccination to the government through VAERS,” said NVIC executive director Theresa Wrangham. “It is a legal, medical and social obligation for anyone giving a vaccine to report vaccine adverse events to VAERS. It is also important for the public to understand that if their doctor won’t report a vaccine adverse event to VAERS, the system is set up to accept reports from patients as well.”
Symptoms of neuroimmune and blood disorders currently being investigated by the pandemic H1N1 vaccine safety oversight Working Group include weakness and paralysis of arms and/or legs (Guillain-Barre' Syndrome); weakness and paralysis of one side of the face (Bell's palsy) and bruising under the skin or unusual bleeding (thrombocytopenia). “Vaccine providers and patients should immediately report these and other serious symptoms following vaccination to VAERS either by filing an online report or by calling 1-800-822-7967,” said Wrangham.
Posted: 4/22/2010 10:31:47 PM
On April 21, 2010, NVIC President Barbara Loe Fisher and NVIC Director of Research & Patient Safety, Vicky Debold, PhD, RN, testified about HPV vaccine risks at a Washington, D.C. City Council health committee budget hearing. For two years, NVIC has testified to urge funding of education programs in D.C. so parents can make fully informed choices about HPV vaccination, including the right to opt-out of a 2007 D.C. law requiring all sixth grade girls to get three HPV shots.
Parents, Health Professionals Testify
Emily Tarsell, whose daughter, Chris, died suddenly in 2008 following Gardasil shots, testified along with District of Columbia parents, health care professionals and HPV vaccine choice supporters, including Vanessa Dixon, Dr. Paul Levine, Chris Nidel, Brigette Rouson, Kea Taylor, Peter Tucker, Dr. Tilli Williams and others. They were aggressively questioned by the Chair of the Committee on Health, attorney David A. Cantania, who was sponsor of the Human Papillomavirus Vaccination and Reporting Act of 2007.
NVIC Appeals for HPV Vaccine Education Program
Former Mayor and DC City Council Member Marian Barry was also present and expressed concern and support for HPV educational outreach programs. The 2007 law stipulated that $150,000 would be spent to educate parents about HPV vaccine benefits and risks and inform them they could decline the vaccine for their daughters. However, the promised city-wide education program has not been implemented.
“There have been about 18,000 HPV vaccine adverse event reports made to the government. HPV vaccine surveillance data is seriously compromised by the fact that the majority of all reports are submitted by drug companies making and selling HPV vaccine and nearly 90 percent of these reports are of such poor quality, they cannot be properly reviewed or followed up by federal health officials,” said Fisher in her testimony. “Please use the $150,000 appropriated in the 2007 law to produce accurate information about HPV and HPV vaccines and hold well publicized meetings in every ward to make citizens aware of how to recognize and report HPV vaccine reactions and how to opt-out of the HPV vaccine requirement, if that is their choice.”
First Gardasil Injury Report to VAERS Was D.C. Girl
Dr. Debold described the HPV vaccine reaction of a Washington, D.C. girl, which was the first adverse event to be reported to the federal Vaccine Adverse Event Reporting System (VAERS) after the licensing of Gardasil vaccine on June 8, 2006.
“A 14-year old District of Columbia girl was vaccinated, developed severe pain, fainted for 10-15 seconds, fell off the examining table, developed speech problems and was hospitalized. This case was described in the first of four analyses of Gardasil-related adverse events published by the National Vaccine Information Center between 2007 and 2009,” said Debold in her testimony. “Policy and lawmakers, including the DC City Council, should make sure that all citizens are informed about the individual benefits and risks and are able to work with their doctors to make individual vaccine decisions.”
Daughters Lost to Gardasil Vaccine
In her testimony, Emily Tarsell called for suspension of Gardasil vaccine use pending further investigation and research. She described what happened to her only child, daughter Christina, who was a talented artist and honor student at Bard College when she died suddenly and without explanation following a series of Gardasil shots that produced vaccine reaction symptoms.
“Chris began to develop symptoms of various kinds but, because we were never told of any adverse side effects related to the vaccine, we viewed each symptom in isolation. We never got the big picture before it was too late,” said Tarsell. “Mounting evidence suggests that she died from an autoimmune response to the vaccine, and she is not alone.”
She went on to describe other girls who have died after Gardasil vaccination: “Another young lady, Megan, died suddenly while taking a shower, as did 13-year old Sparkyl. Jessica collapsed and died in her bathroom. Amber collapsed with seizures in the parking lot on her way to work; she died in the hospital seven days later. Both Santana and Jasmine, like Chris, were found dead in their beds. What did these wonderful, healthy girls have in common? They all died shortly after receiving Gardasil and cause of death was undetermined.”
In the News:
HPV Vaccine Trials Halted in India After Deaths
Clinical trials using Gardasil and Cervarix vaccines were halted by the government on April 16, 2010 after the deaths of six tribal girls. Health activists have reportedly criticized ethics of the trials and charged that the pharmaceutical companies and PATH were conducting the pre-importation/marketing clinical trials among poor and socio-economically marginal tribes, who were being treated as "guinea pigs."
The non-profit Program for Appropriate Technology in Health (PATH) was founded in the mid-1970's as an organization dedicated to promoting contraception and population control but has since expanded its operations to include disease control.
Australia Stops Flu Shots for Children under Five
Today (April 23), the Australian Medical Association backed a government call to suspend influenza vaccinations in children under age five. The new seasonal influenza vaccine, which contains H1N1 along with two other influenza strains, has resulted in many severe reactions, including high fevers and convulsions leading to hospitalizations in young children.
Professor of Infectious Diseases, Peter Collignon, is quoted in a news report as saying "If you were infected with swine flu itself last year or had been given the swine flu vaccine, if you then get exposed again to part of the virus, you've already got antibodies and white cells that are turned on to try to fight the virus. If you get exposed to it again, you may have a brisk reaction, where you produce more antibodies and more white cells, which gives you a fever and an inflammatory reaction."
PBS Frontline Documentary: "The Vaccine War" April 27, 2010 at 9 p.m. EST
PBS Description of the One Hour Documentary: This is the vaccine war: On one side sits scientific medicine and the public health establishment; on the other a populist coalition of parents, celebrities (like Jenny McCarthy), politicians and activists. It's a war that increasingly takes place on the internet with both side using the latest social media tools, including Facebook and Twitter, to win the hearts and minds of the public."
Excerpt From a PBS Press Release: "Surveys reveal that America's conversation about vaccines is complex, involving not only medical risks and benefits but also ideological beliefs about parental choice and the limits of government."This is true even of individuals who see the benefits of vaccines as substantial," political scientist Hank Jenkins-Smith tells FRONTLINE. Government control over individual choice is another factor fueling the anti-vaccine backlash, despite the peer-reviewed science that vaccines are safe. "People now have a way to get the information they couldn't before, to communicate it to people, and to have a robust public debate that is not controlled by money or political power or by government policy," says Barbara Loe Fisher, president of the National Vaccine Information Center. "Physicians are going to have to get over the idea that they tell people what to do, and people are going to do it without questioning."
Posted: 4/16/2010 1:08:50 AM
Washington, D.C. April, 16th 2010 – The National Vaccine Information Center (NVIC) participated in a meeting sponsored by the federal National Vaccine Advisory Committee (NVAC) and facilitated by The Keystone Center April 11-13 in Salt Lake City to discuss strengthening the U.S. vaccine safety system. Invited attendees represented a diverse group of government and private stakeholders, who agreed an effective vaccine safety system would benefit from both internal and independent, external assessment and a focus on detection, prevention and reduction of vaccine adverse events.
Representatives at the meeting included NVIC Co-founder and President Barbara Loe Fisher; NVIC Director of Research and Patient Safety, Vicky Debold, PhD, RN, who is also the consumer representative on the FDA Vaccines & Related Biological Products Advisory Committee (VRBPAC); and NVIC Director of Government Relations, Tawny Buck, who is the consumer representative on the National Vaccine Advisory Committee and co-chair of the NVAC Vaccine Safety Working Group.
NVIC has long supported the creation of an independently operated and funded vaccine safety agency that reports directly to the President. NVIC President, Barbara Loe Fisher said, “It was encouraging that a diversity of perspectives were brought to the table. Acknowledgement of the importance of independent external assessment and reducing vaccine risks for individuals is an excellent starting point for improving confidence in the integrity of the vaccine safety system.” On June 1, a public meeting sponsored by NVAC will be held in Washington, D.C. to obtain further public input on strengthening the vaccine safety system.
The federal public engagement initiative occurred against the backdrop of an emerging vaccine safety issue related to vaccine contamination. The Food and Drug Administration’s (FDA) vaccine licensing advisory committee (VRBPAC) will meet May 7th to discuss vaccine contamination following the FDA’s March recommendation to suspend use of Rotarix vaccine after pig virus DNA was discovered in the vaccine’s seed stock. As the VRPBAC consumer representative, Dr. Debold cast the only dissenting vote during the 2008 FDA pre-licensure hearings on Rotarix safety. Additionally, during VRBPAC’s November 2009 meeting , NVIC’s Fisher questioned the potential for insect virus contamination of an experimental H1N1 vaccine grown in caterpillar cells.
In 2009, NVAC reviewed the federal vaccine research agenda and NVIC, as a participant of that public engagement initiative, supported creating a robust national vaccine safety research agenda including a study comparing health outcomes in highly vaccinated and unvaccinated individuals. In June 2009, NVAC unanimously recommended expansion of the federal vaccine safety research agenda and the feasibility of conducting a study to evaluate health outcomes among vaccinated and unvaccinated individuals.
About Us: NVIC is a non-profit charitable organization that has advocated reform of the vaccine safety system since 1982. Dedicated to preventing vaccine injuries and deaths through public education and defending the informed consent ethic in medicine, NVIC does not advise against, or promote use of, vaccines. Over the past three decades, NVIC has been recognized by government agencies for its expertise and responsible vaccine safety advocacy through federal committee appointments and invited participation in public engagement initiatives to give voice to the vaccine safety concerns of health care consumers. For more information, visit www.NVIC.org.
Posted: 4/7/2010 2:17:52 AM
On March 22, 2010, Food and Drug Administration (FDA) officials adhering to the precautionary principle advised American doctors to suspend use of Rotarix 1 vaccine until the agency finds out why DNA from a swine virus (porcine circovirus 1 or PCV1) was found in the live rotavirus vaccine. The FDA said there is “no evidence at this time” that the vaccine manufactured by GlaxoSmithKline and given to babies at 2,4 and 6 months of age to prevent diarrhea poses any safety risk. 2
Independent Lab Using New Technology Found Contamination
The discovery that viral DNA is contaminating Rotarix vaccine was made by a team of scientists at an independent research lab in San Fransisco, California, where they used new technology to detect fragments of viral genetic material in vaccines using genetic sequencing. 3
More testing confirmed that many copies of DNA from the pig virus were present in all Rotarix vaccine lots released since the vaccine was licensed in 2008 because the pig virus DNA also contaminated the working cell bank and the original viral “seed” stock, from which Rotarix vaccine was first produced. 4
Two Other Live Virus Vaccines Contaminated
The surprising discovery reportedly was made after the independent lab used new technology to evaluate the purity of eight live virus vaccines for polio, rubella, measles, yellow fever, human herpes 3 (varicella or chicken pox), rotavirus (Rotarix and RotaTeq) and MMR. In addition to pig viral DNA found in Rotarix vaccine, low levels of DNA fragments from avian (bird) leukosis virus (a retrovirus) was found in measles vaccine and DNA fragments of a virus similar to simian (monkey) retrovirus was found in RotaTeq vaccine. 5
FDA Looking For Answers
After the team double checked their findings, researchers notified GlaxoSmithKline (GSK) on February 9, 2010 and GSK notified the FDA on March 15, 2010, which prompted the FDA’s action on March 22, 2010 to suspend use of Rotarix. The FDA says it “does not know how DNA from PCV1 came to be present in Rotarix” or whether “this means that intact virus is present. Additional studies are being conducted.” 6
Rotavirus Vaccines Use Monkey, Cow, Pig Materials for Production
Rotarix is a genetically engineered vaccine that GSK created by isolating human rotavirus strain infecting a child in Cincinnati and using African Green monkey kidney cells to produce the original viral seed stock from which all Rotarix vaccine has been made. 7 In the FDA licensing process, Rotarix had to meet certain FDA standards, that included demonstrating the vaccine was not contaminated with, for example TSE (Transmissable Spongiform Encephalopathy or “mad cow” disease, a brain wasting disease) 8 or with cow viruses because bovine (cow) serum was used to prepare the original viral seed stock. Porcine trypsin, an enzyme in the pancreatic juice of a pig, was also used to make the viral seed stock. 9
RotaTeq is a genetically engineered vaccine containing five human-cow reassortment strains of rotavirus that were created at the Children’s Hospital of Pennsylvania (CHOP), where strains of rotavirus that give cows diarrhea were combined with strains of rotavirus that cause diarrhea in humans. The reassortment viruses were transported to Merck, where master seeds were produced using African Green Monkey kidney cell cultures. Fetal bovine (cow) serum and porcine trypsin was used to make the “seed” stock. 10 There are small amounts of bovine serum and cell culture media (monkey viral DNA) that remain in RotaTeq vaccine. 11 12
FDA Suggests Drug Companies Test for Vaccine “Purity”
In a February 2010 FDA document, Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications, the FDA lists “non-binding recommendations” for drug companies making vaccines using animal and human cell substrates. 13 Under the heading “Testing for Adventitious Agents,” the FDA states “assurance that products are free of adventitious agents is a critical component of meeting the [FDA regulations] requirement for purity.” Under the heading “Testing for Residual Cellular DNA,” the FDA states, “Residual DNA might be a risk to your final product because of oncogenic (cancer causing) and/or infectivity potential.”
Déjà Vu: Monkey Viruses Contaminated Polio Vaccines
Contamination of vaccines with animal viruses is not new. In the 20th century, polio vaccines given to tens of millions of people worldwide were contaminated with simian virus 40 (SV40), which was found to cause cancer in animals and is associated with human brain, bone and lung cancers but the government denies SV40 is causing those cancers in humans. 14 15 16 17
There has been controversy about the link between experimental polio vaccines tested in Africa in the 1950’s and 1960’s that were contaminated with a monkey virus, simian immunodeficiency virus (SIV). Soon after the polio vaccine trials in Africa, the human immunodeficiency virus (HIV) emerged. 18 Many questions about the failure of researchers and technology to screen for monkey viruses in those vaccines remain to this day.
Using Cancer Cells to Produce Vaccines?
Vaccine manufacturers have long used cell material that comes from the bodies of mammals, including humans, monkeys, cows, pigs, dogs and rodents, as well as birds or insects to make vaccines now in use or to make experimental vaccines. There is an inherent risk of contamination with viruses and other microbes (or DNA from those microbes) that can escape detection during the vaccine development, testing, licensing, manufacturing and oversight process. 19 There has even been discussion among vaccine manufacturers and the FDA in the last decade about using neoplastic (cancer) cell substrates to make vaccines but the risk of contamination with cancer cell DNA is a big risk. 20
New Influenza Vaccines: Is Contamination Possible?
In searching for ways to make seasonal influenza vaccines in a faster, easier and less expensive way than relying on chicken eggs for production, drug companies have experimented with using dog kidney cells and human fetal retinal cells. However, these cell lines have been documented to cause tumors in animals, especially dog kidney cells (MDCK). 21
At a November 19, 2009 meeting of the FDA Vaccines & Related Biological Products Advisory Committee, a vaccine manufacturer asked for permission to use insect (caterpillar) cells to make pandemic influenza shots. But insect cells can be contaminated with insect viruses that are hard to detect. The FDA Committee, on that day, voted “no.” 22
Unanswered Questions about Rotarix Contamination
There are lots of questions about how the manufacturer of Rotarix vaccine and the FDA both missed the pig virus DNA contaminating the original seed stock and all doses of Rotarix vaccine given to more than one million American children in the past few years. 23
Is there state-of-the-art technology that is being used by private laboratories but not by drug companies and the FDA?
Why did the independent team of scientists, who found the contamination, notify the vaccine manufacturer first rather than also immediately reporting their finding directly to the FDA?
What about the significance of finding bird viral DNA in measles vaccine and the monkey viral DNA in RotaTeq vaccine?
Wake Up Call for Industry & Government
The contamination of Rotarix vaccine is only the latest in a long history of vaccine contamination issues that require a re-examination of the way vaccines are made and tested. It is a wake-up call for industry and government
The big question people are asking is: why do drug companies making vaccines continue to use cells from animals, birds and insects that can be contaminated with viruses and other adventitious agents that are hard to detect?
The FDA was right to suspend use of Rotarix vaccine until they know more. Hopefully, this serious vaccine production and testing issue will be addressed immediately by vaccine manufacturers. If not, the next pandemic or serious health problem affecting large populations may be one that comes out of a vaccine lab.
5 See Reference #3 above.
6 FDA. See Reference #4 above.
12 European Medicines Control Agency. See Reference #10 above. Page 6.
14 Bookchin D, Schumacher J. The Virus and the Vaccine: The True Story of a Cancer-Causing Monkey Virus, Contaminated Polio Vaccine, and the Millions of Americans Exposed. St. Martin’s Press: New York. 2004. http://www.nvic.org/resource-center/books.aspx
19 See Reference # 13 above.