by The HPV Vaccine, Gardasil

Malia Obama celebrated her 11th birthday over the Fourth of July weekend. The  festivities included a Camp David birthday party with about 20 of her friends and as part of America’s first family, hosting 1,200 military families for a Fourth of July barbecue on the White House South Lawn.

As I looked at the happy images of Malia, Sasha and their mom, the formidable Michelle Obama, I still wonder WWMOD, What Will Michelle Obama DO? I first ask the question a few months ago as additional states seemed poised to mandate the HPV vaccine Gardasil for all school girls, some legislation targeting girls as young as the age of ten.  In 2007, Virginia, the District of Columbia’s very close southern neighbor passed House Bill 2035 requiring that 12 year-olds girls be vaccinated for the sexually transmitted disease Human papillomavirus (HPV). So as Malia, and soon Sasha enter the targeted demographic, I again ask the question,  WWMOD —What Will Michelle Obama Do?

No matter where you stand within the American, political color-spectrum, Reds and Blues all agree: Michelle Obama is a fiercely protective Momma. To my mind that is a very good thing. However as the Adverse Reactions to the HPV vaccine Garasil continue to mount, I find myself asking WWMOD? What Will Michelle Obama DO?

Like many moms out there she wants what is best for her girls. At 7 and 11years old, Sasha and Malia are in Merck’s TARGETED demographic. Thanks to some well-spent lobby-bucks several States mandated Gardasil vaccinations. The parents of those public school girls might not have the choices available to Mrs. Obama.

Several months ago, President Obama stated that his youngest liked PB&J sandwiches and she has a right to expect a safe sandwich. Sasha, Malia and every other American girl have a right to expect safe vaccines. MERCK is experimenting with the reproductive systems of an entire generation of young woman… so what, if anything with President Obama do to insure the safety of his as well as all the other girls of this nation?

NVIC Petitions White House and Congress to Investigate Gardasil

On February 9, the NVIC launched a petition and issued a national press release calling on President Barack Obama, his Administration and Congress, to investigate the fast track licensure and universal use recommendation of Gardasil in 2006, and the dismissal of more than 10,000 reports of Gardasil-related reactions, injuries and deaths to the Vaccine Adverse Events Reporting System as a “coincidence” by federal health officials.

NVIC’s latest Gardasil risk report, which compares the number and severity of adverse events reported to VAERS through November 30, 2008, reveals that death and serious health problems such as stroke, blood clots, cardiac arrest, seizures, fainting, lupus and rechallenge cases are reported three to 30 times more frequently after Gardasil vaccination than after meningococcal (Menactra) vaccination.
Barbara Loe Fisher explains the significance of this fact:

“If the deaths and serious injuries reported after Gardasil were only a “coincidence,” there would be little or no difference between the frequency and severity of vaccine-related adverse events between two vaccines, if the vaccines were equally reactive, and the number of doses were roughly the same.

Gardasil and Menactra vaccines were licensed within a year of each other and recommended by the CDC for universal use in 11-12 year olds.

Although Menactra is given to boys and girls and has already been mandated in many states for high school and college entry, Gardasil is only given to girls and is not yet mandated.

Menatra is given as a one-dose series and, by February 25, 2008, the CDC reported that about 15.5 million doses of Menactra had been distributed in the U.S.. Gardasil is given in a three dose series and the CDC reported that, by July 2008, about 16 million doses had been distributed in the U.S.

This means that about 15 million doses of Menactra were given to about 15 million boys and/or girls and about 16 million doses of Gardasil – if every girl got three doses – were given to about five million girls.

It is individuals – not doses of vaccine – who collapse, convulse, become paralyzed, have heart attacks, develop lupus and other chronic health problems after being vaccinated. The fact that death and serious health problems are reported 3 to 30 times more frequently after Gardasil than after Menactra is highly significant and it is irresponsible for federal health officials and Merck to blow it off as unimportant.”

What Does Merck Have to Say About it?

It’s incomprehensible that the CDC, FDA, and Merck — the makers of Gardasil – cannot see the facts presented in this VAERS analysis, and choose instead to cling to worn-out propaganda slogans and pre-written advertising messages that fly in the face of reason.

In the hours before a resent CBS News broadcast, Merck addressed the differences between adverse events associated with Gardasil and Menactra as follows:

“It’s important to remember that the proven benefit of GARDASIL is that it helps prevent cervical cancer caused by the two virus types responsible for most cases of cervical cancer.

Nothing is more important to Merck than the safety of our products and we carefully monitor the safety of GARDASIL on a routine basis. Experts at the FDA and CDC also continue to review data and, as recently as four months ago, said “GARDASIL continues to be safe and effective, and its benefits continue to outweigh its risks.”

NVIC is not a medical organization and has a long history of raising concerns about vaccines that are in direct conflict with the opinion of leading medical experts. We encourage consumers to get reliable information about the safety of vaccines from www.cdc.gov.”

Spain Already Removed the Vaccine

Spain has, recently withdrawn 75, 000 doses of the HPV vaccine from their market, after two teenagers who received the shots were hospitalized.

Seems  they weren’t as influenced by the drug company’s rhetoric as U.S. authorities, and are more concerned about the safety of their citizens.

Get Involved and Help Save the Daughters of This Nation

Says Fisher:

“In the past 27 years, the stories of death and brain damage that have been reported to the NVIC have never changed. Whether the vaccine victims are 15 months old or 15 years old, the stories are the same: a trusting parent took a bright, healthy child to a doctor for a routine vaccination and the child was never the same again.

The Gardasil vaccine was inappropriately fast tracked and licensed by the FDA and recommended by the CDC with too little attention paid to the reports of brain and immune system dysfunction that developed after vaccination in pre-licensure clinical trials.

That same cavalier attitude toward Gardasil-related deaths and serious health problems, which have been experienced by many girls and young women after licensure, is inexcusable.”

Most Americans have blindly placed their trust in the vaccine makers and in federal health agencies, whose responsibility is to ensure that drugs and vaccines licensed for public use are safe, effective and necessary.

However, over the years it has become very clear that those responsible for protecting your health are not looking out for your best interest and that of your children.

And if they won’t do it, then it is up to you and me to do it.

I urge you to sign the Investigate Gardasil Vaccine Risks Now! petition available on the http://www.NVIC.org web site that my team helped create for them.

If you believe strongly in NVIC’s effort to inform the  public about these types of issues, you can support their cause by making a donation of $25 or more to NVIC and receive a gift of Barbara’s 2008 book Vaccines, Autism & Chronic Inflammation: The New Epidemic. Click HERE to make a donation.

You may also print out this NVIC flyer detailing how to recognize a vaccine reaction.

Says Fisher:

“In 2009, I have a sense of déjà vu as the story of Gardasil vaccine plays out real time. There are striking parallels between how those operating the mass vaccination system reacted in the 1980′s to persistent reports that the DPT vaccine was harming more children than originally assumed, and the way they are reacting now to persistent reports that Gardasil is more reactive than it was originally assumed.

Assumption of safety is no substitute for proof of safety.

And turning away from human suffering in order to protect the status quo is not the way to run a government that needs the trust and support of the people.

In the 18th century, Queen Marie Antoinette looked down at a starving people pleading for bread to stay alive and said “Let them eat cake.” It is time for everyone in government, industry and medicine to take a different approach to persistent reports of vaccine injuries and deaths or risk metaphorically suffering the same fate that ended the monarchy in France.

In the 21st century, today’s peasants don’t have pitchforks – they have laptops, desktops, smartphones and the internet.”

I strongly urge you to join in petitioning our new U.S. administration and Congress to take a close, hard look at the HPV vaccine, to end the needless suffering of tens of thousands of young, bright, innocent girls.

To read the full article, Please click on: http://articles.mercola.com/sites/articles/archive/2009/02/19/Katie-Couric-Reports-on-Serious-Vaccine-Issues.aspx

©2012 An Inconvenient Woman. All Rights Reserved.

From Vaccines Exposed

Wednesday, April 29, 2009

Death by Vaccination and Insurance Coverage

I just read online that there is a little “clause” on life insurance policies that states “death by vaccination is not covered”. I am going to have to check this out with our insurance company. I suggest you do the same!

So, if you or your child dies AND you are awarded the $250,000 for death through the National Vaccine Injury Compensation Program – that is all of the money that your family will ever see if this is true.
What More Information about National Vaccine Injury Compensation Program ?

http://www.shoemakerassociates.com/index.php?option=com_content&view=article&id=66:whatarealloweddamages&catid=7:client-questions&Itemid=64

©2012 An Inconvenient Woman. All Rights Reserved.

“The tragic story of Gardasil vaccine is one that is playing out real time in the homes of trusting parents, who thought they were doing the right thing to try to make their daughters “one less,” and in the 21st century cyberspace forum of public opinion as well as on television.”

Barbara Loe Fisher, President and co-founder of the National Vaccine Information Center (NVIC):

The Gardasil Marketing campaign is one of egregious deception. With its catchy tune and wholesome images, mothers and Doctors who don’t take the time to do their own research are drawn into a misleading, intricately drawn lie. Merck has come up with a billion dollar fix to a non-existent problem. Cervical cancer is no longer a clear and present danger to modern teenagers with access to normal preventative health care and PAP tests. We are putting a generation of young women at risk and ‘playing dice’ with the reproductive future of our nation.  The FDA, CDC and a raft of either uncaring, or simply corrupt, political hacks are taking Merck’s money and looking the other way, while an unsafe drug and a flawed medical hypothesis are irreparably harming our girls and bankrupting public health care coffers.

While the FDA and CDC refuse to take action, well-meaning mothers are being deceived into thinking the Gardasil HPV vaccination  will protect their daughters from cervical cancer, and some of them are now wondering HOW and WHY their young child died or became suddenly paralyzed.

Another GARDASIL VICTIM’S Story

A month after 13 year old Jenny Tetlock was vaccinated against the HPV virus, she missed the lowest hurdle in gym class. It was the first sign of a degenerative muscle disease that 15 months later left her nearly completely paralyzed.

Her father, Philip Tetlock, a professor at UC-Berkeley, has embarked on an odyssey to find out whether the vaccine, Gardasil, is to blame.

Tetlock is not the only one concerned. The public watchdog group Judicial Watch has been periodically obtaining adverse event reports on Gardasil from the FDA. 10 deaths have been linked to Gardasil since September 2007, and there have been 140 reports so far this year of serious side effects such as miscarriage and Guillain-Barré syndrome.

Sources:

A Judicial Watch Special Report: Examining the FDA’s HPV Vaccine Records June 30, 2008

©2012 An Inconvenient Woman. All Rights Reserved.

by The HPV Vaccine, Gardasil

No matter where you stand within the American, political color-spectrum, Reds and Blues all agree: Michelle Obama is a fiercely protective Momma. To my mind that is a very good thing. However as the Adverse Reactions to the HPV vaccine Garasil continue to mount, I find myself asking WWMOD? What Will Michelle Obama DO?

Like many moms out there she wants what is best for her girls. At 7 and 11years old, Sasha and Malia are in Merck’s TARGETED demographic. Thanks to some well-spent lobby-bucks several States mandated Gardasil vaccinations. The parents of those public school girls might not have the choices available to Mrs. Obama.

Several months ago, President Obama stated that his youngest liked PB&J sandwiches and she has a right to expect a safe sandwich. Sasha, Malia and every other American girl have a right to expect safe vaccines. MERCK is experimenting with the reproductive systems of an entire generation of young woman… so what, if anything with President Obama do to insure the safety of his as well as all the other girls of this nation?

NVIC Petitions White House and Congress to Investigate Gardasil

On February 9, the NVIC launched a petition and issued a national press release calling on President Barack Obama, his Administration and Congress, to investigate the fast track licensure and universal use recommendation of Gardasil in 2006, and the dismissal of more than 10,000 reports of Gardasil-related reactions, injuries and deaths to the Vaccine Adverse Events Reporting System as a “coincidence” by federal health officials.

NVIC’s latest Gardasil risk report, which compares the number and severity of adverse events reported to VAERS through November 30, 2008, reveals that death and serious health problems such as stroke, blood clots, cardiac arrest, seizures, fainting, lupus and rechallenge cases are reported three to 30 times more frequently after Gardasil vaccination than after meningococcal (Menactra) vaccination.
Barbara Loe Fisher explains the significance of this fact:

“If the deaths and serious injuries reported after Gardasil were only a “coincidence,” there would be little or no difference between the frequency and severity of vaccine-related adverse events between two vaccines, if the vaccines were equally reactive, and the number of doses were roughly the same.

Gardasil and Menactra vaccines were licensed within a year of each other and recommended by the CDC for universal use in 11-12 year olds.

Although Menactra is given to boys and girls and has already been mandated in many states for high school and college entry, Gardasil is only given to girls and is not yet mandated.

Menatra is given as a one-dose series and, by February 25, 2008, the CDC reported that about 15.5 million doses of Menactra had been distributed in the U.S.. Gardasil is given in a three dose series and the CDC reported that, by July 2008, about 16 million doses had been distributed in the U.S.

This means that about 15 million doses of Menactra were given to about 15 million boys and/or girls and about 16 million doses of Gardasil – if every girl got three doses – were given to about five million girls.

It is individuals – not doses of vaccine – who collapse, convulse, become paralyzed, have heart attacks, develop lupus and other chronic health problems after being vaccinated. The fact that death and serious health problems are reported 3 to 30 times more frequently after Gardasil than after Menactra is highly significant and it is irresponsible for federal health officials and Merck to blow it off as unimportant.”

What Does Merck Have to Say About it?

It’s incomprehensible that the CDC, FDA, and Merck — the makers of Gardasil – cannot see the facts presented in this VAERS analysis, and choose instead to cling to worn-out propaganda slogans and pre-written advertising messages that fly in the face of reason.

In the hours before a resent CBS News broadcast, Merck addressed the differences between adverse events associated with Gardasil and Menactra as follows:

“It’s important to remember that the proven benefit of GARDASIL is that it helps prevent cervical cancer caused by the two virus types responsible for most cases of cervical cancer.

Nothing is more important to Merck than the safety of our products and we carefully monitor the safety of GARDASIL on a routine basis. Experts at the FDA and CDC also continue to review data and, as recently as four months ago, said “GARDASIL continues to be safe and effective, and its benefits continue to outweigh its risks.”

NVIC is not a medical organization and has a long history of raising concerns about vaccines that are in direct conflict with the opinion of leading medical experts. We encourage consumers to get reliable information about the safety of vaccines from www.cdc.gov.”

Spain Already Removed the Vaccine

Spain has, recently withdrawn 75, 000 doses of the HPV vaccine from their market, after two teenagers who received the shots were hospitalized.

Seems  they weren’t as influenced by the drug company’s rhetoric as U.S. authorities, and are more concerned about the safety of their citizens.

Get Involved and Help Save the Daughters of This Nation

Says Fisher:

“In the past 27 years, the stories of death and brain damage that have been reported to the NVIC have never changed. Whether the vaccine victims are 15 months old or 15 years old, the stories are the same: a trusting parent took a bright, healthy child to a doctor for a routine vaccination and the child was never the same again.

The Gardasil vaccine was inappropriately fast tracked and licensed by the FDA and recommended by the CDC with too little attention paid to the reports of brain and immune system dysfunction that developed after vaccination in pre-licensure clinical trials.

That same cavalier attitude toward Gardasil-related deaths and serious health problems, which have been experienced by many girls and young women after licensure, is inexcusable.”

Most Americans have blindly placed their trust in the vaccine makers and in federal health agencies, whose responsibility is to ensure that drugs and vaccines licensed for public use are safe, effective and necessary.

However, over the years it has become very clear that those responsible for protecting your health are not looking out for your best interest and that of your children.

And if they won’t do it, then it is up to you and me to do it.

I urge you to sign the Investigate Gardasil Vaccine Risks Now! petition available on the http://www.NVIC.org web site that my team helped create for them.

If you believe strongly in NVIC’s effort to inform the  public about these types of issues, you can support their cause by making a donation of $25 or more to NVIC and receive a gift of Barbara’s 2008 book Vaccines, Autism & Chronic Inflammation: The New Epidemic. Click HERE to make a donation.

You may also print out this NVIC flyer detailing how to recognize a vaccine reaction.

Says Fisher:

“In 2009, I have a sense of déjà vu as the story of Gardasil vaccine plays out real time. There are striking parallels between how those operating the mass vaccination system reacted in the 1980′s to persistent reports that the DPT vaccine was harming more children than originally assumed, and the way they are reacting now to persistent reports that Gardasil is more reactive than it was originally assumed.

Assumption of safety is no substitute for proof of safety.

And turning away from human suffering in order to protect the status quo is not the way to run a government that needs the trust and support of the people.

In the 18th century, Queen Marie Antoinette looked down at a starving people pleading for bread to stay alive and said “Let them eat cake.” It is time for everyone in government, industry and medicine to take a different approach to persistent reports of vaccine injuries and deaths or risk metaphorically suffering the same fate that ended the monarchy in France.

In the 21st century, today’s peasants don’t have pitchforks – they have laptops, desktops, smartphones and the internet.”

I strongly urge you to join in petitioning our new U.S. administration and Congress to take a close, hard look at the HPV vaccine, to end the needless suffering of tens of thousands of young, bright, innocent girls.

To read the full article, Please click on: http://articles.mercola.com/sites/articles/archive/2009/02/19/Katie-Couric-Reports-on-Serious-Vaccine-Issues.aspx

©2012 An Inconvenient Woman. All Rights Reserved.

…Probably big words like PROFIT, LOBBYING, POLITICAL EXPEDIENCY, CALLOUS DISREGARD…

Women in Government Cervical Cancer Report 0307

©2012 An Inconvenient Woman. All Rights Reserved.

WASHINGTON–(BUSINESS WIRE)–The National Vaccine Information Center (NVIC) is calling on the Centers for Disease Control (CDC) and Food and Drug Administration (FDA) to publicly release the study design, data and names of principal investigators involved in a statement this week maintaining that Gardasil vaccine is safe with no serious side effects. NVIC will also be calling on the newly elected President and members of Congress to remove the nation’s vaccine safety monitoring system from the Department of Health and Human Services (DHHS) and place it in a separate entity reporting directly to Congress to restore trust in the nation’s public health laws based on federal mass vaccination policies.

The CDC and FDA are alleging that the vast majority – if not all – of the approximately 9,000 HPV vaccine adverse events, including 27 deaths, reported to the federal Vaccine Adverse Event Reporting System (VAERS) are not causally related to the Gardasil vaccine based on internal analysis, including review of medical records of girls and women vaccinated in HMO’s participating in the federal Vaccine Safety Datalink (VSD) Project and other closed government operated databases.

“Transparency in government is essential to trust in government and replication is the hallmark of good science,” said NVIC co-founder and president Barbara Loe Fisher. “Parents of young girls and women cut down in their prime – some of them paralyzed or dead within hours or days of getting Gardasil vaccine – deserve better answers than a whitewashing of this vaccine’s very serious side effects. Until there is an independent confirmation of these unverified findings by individuals and companies without financial ties to the government or industry, it is not credible.”

* In June 2006 NVIC questioned the quality and quantity of Merck’s pre-licensure Gardasil vaccine safety data in girls under age 16 and, in 2007, issued three reports analyzing serious Gardasil adverse events reported to VAERS;

* In 2007, Merck lobbied in many states for Gardasil vaccine mandates but failed in most;

* During 2008, about 20 percent of all vaccine adverse event reports to VAERS were related to Gardasil even though it is not a mandated vaccine like most others;

* Last week, reports that Merck’s Gardasil sales are falling dramatically and are not offsetting similar declining sales of other drugs associated with safety concerns prompted Merck to lower profit projections and layoff employees.

NVIC (www.nvic.org) was founded in 1982 and worked with Congress on the 1986 National Childhood Vaccine Injury Act. The non-profit watchdog group advocates for safer vaccine policies and the legal right for Americans to make informed, voluntary decisions about vaccination.

©2012 An Inconvenient Woman. All Rights Reserved.

Gardasil® Deaths, Gardasil® Side Effects, Gardasil® Paralysis -

Is the HPV Vaccine Given to Prevent Cervical Cancer Causing More Medical Problems?

A vaccine designed to prevent cervical cancer is coming under fresh scrutiny amid thousands of complaints linking it to a range of health problems.

Gardasil® has been the subject of 7,802 “adverse event” reports from the time the Food and Drug Administration approved its use two years ago, according to the Centers for Disease Control and Prevention.

Girls and women have blamed the vaccine for causing ailments from nausea to paralysis — even death. Fifteen deaths were reported to the FDA, and 10 were confirmed, but the CDC says none of the 10 were linked to the vaccine. The CDC says it continues to study the reports of illness.

Gardasil prevents the spread of human papillomavirus, known as HPV — a sexually transmitted virus that can cause cervical cancer in a relatively small number of girls and women.

The vaccine’s manufacturer, Merck & Co. Inc., says it has distributed more than 26 million Gardasil® vaccines worldwide, including nearly 16 million in the United States. It estimates that 8 million girls and women have received the vaccine in the United States since June 2006. V

Two girls allege in court that the vaccine made them sick.

One — Jesalee Parsons of Broken Bow, Oklahoma — got the shot at age 13.

Jesalee’s lawyer, Michael McLaren, said she got the shot on February 27, 2007 and soon developed a fever and felt pain. The next day, he said, Jesalee felt pain in her chest and abdomen.

Her mother, Laura Parsons, said Jesalee spent weeks in the hospital and underwent two surgeries after developing pancreatitis. She says the federal government should have studied the drug more before approving its use.

“I just feel let down by the government,” Parsons said.

Merck says it could be a coincidence that the girls got sick after receiving the vaccine.

The company said in a statement that an adverse event report “does not mean that a causal relationship between an event and vaccination has been established — just that the event occurred after vaccination.”

Merck said it would continue to evaluate reports of adverse reactions. It said it “updates product labels with new safety information as appropriate.”

Watch more on complications linked to Gardasil »

For Full Article and more video go to:

http://www.cnn.com/2008/HEALTH/conditions/07/07/cervical.cancer.vaccine/

A sincere thank you to major media outlets, CNN, the Washington Post and the New York Times, for following and reporting the Gardasil® adverse events and asking probing questions about the safety and effectiveness of this aggressively-marketed Merck product.

©2012 An Inconvenient Woman. All Rights Reserved.

Addressing Questions About Gardasil

On this page:

• What is Gardasil?
• Why is Gardasil needed?
• Is Gardasil safe?
• Why have questions been raised about the vaccine’s safety?
• Should these reports worry me?
• What non-serious problems have been reported?
• What are FDA and CDC doing about the concerns?
• How is Gardasil’s safety being monitored?

Recently, questions have been raised about the safety of Gardasil, a vaccine that prevents infection with types of human papillomavirus (HPV) that cause most cases of cervical cancer and genital warts, and some vulvar and vaginal cancers.

What is Gardasil?

Gardasil is a vaccine for use in girls and women 9 through 26 years of age. It is approved for preventing cancer of the cervix, vulva and vagina, and for preventing genital warts caused by the types of HPV contained in the vaccine.

These four HPV types (6, 11, 16, and 18) cause about 70% of cervical cancers and about 90% of genital warts. They are also known to cause some vulvar and vaginal cancers. (Percentages related to these conditions are not well defined.)

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Why is Gardasil needed?

Gardasil may benefit the health of millions of people. Each year, more than 12,000 American women are diagnosed with cervical cancer, and almost 4,000 women die from this disease. In addition, about 6.2 million Americans become infected with genital HPV each year. Worldwide, cervical cancer is the second most common cancer in women, with 233,000 deaths per year.

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Is Gardasil safe?

Based on ongoing assessments of vaccine safety information, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) continue to find that Gardasil is a safe and effective vaccine.

Studies involving approximately 21,000 girls and women in the United States and worldwide were conducted to evaluate the safety and effectiveness of Gardasil before the vaccine was approved by FDA. Approximately half of the study participants received Gardasil, and the other half received a control.

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Why have questions been raised about the vaccine’s safety?

There have been reports of serious adverse events in girls and women that have received the vaccine. These include death and Guillain-Barre Syndrome (GBS), a rare neurological disorder that causes muscle weakness.

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Should these reports worry me?

Based on the review and assessment of vaccine safety information available, FDA and CDC continue to find that the benefits of Gardasil outweigh the risks.

Twenty deaths had been reported to the FDA- and CDC-administered Vaccine Adverse Event Reporting System (VAERS) as of June 30, 2008, in women that received Gardasil.

However, no common pattern to these deaths has been detected that would suggest they were caused by the vaccine. In cases where autopsy, death certificate, and medical records were available, the cause of death was explained by factors other than the vaccine.

Given the large number of vaccine doses distributed, it is expected that, by chance alone, serious adverse events and some deaths will be reported in a large population during the time period following vaccinations.

The manufacturer, Merck and Co., has distributed more than 16 million doses of Gardasil nationwide. As of June 30, there were 9,749 VAERS reports of adverse events following Gardasil vaccination. Of these, 94% were classified as reports of non-serious events.

Also, FDA routinely reviews manufacturing information, and has not identified any issues affecting the safety, purity, and potency of Gardasil.

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What non-serious problems have been reported?

• Syncope (Fainting)
• Pain at the injection site
• Headache
• Nausea
• Fever

Fainting, which may sometimes cause serious injuries from falling, is common after injections and vaccinations, especially in adolescents. FDA and CDC have reminded health care professionals that women receiving Gardasil should be watched carefully for 15 minutes after vaccination to avoid potential injury from a fall. The vaccine’s prescribing information includes this as well.

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What are FDA and CDC doing about the concerns?

FDA and CDC take all concerns about vaccine safety seriously, and, as they do with all licensed vaccines, will continue to closely monitor Gardasil’s safety.

Because available information indicates that Gardasil continues to be safe and effective, and that its benefits continue to outweigh its risks:

• CDC has not changed its recommendations for use of Gardasil.
• FDA has not made any changes to the Warnings or Precautions sections in the vaccine’s prescribing information related to safety.

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How is Gardasil’s safety being monitored?

• FDA and CDC closely monitor the safety of all vaccines through VAERS, which receives unconfirmed reports of possible side effects following the use of vaccines licensed in the United States.
• Each batch (known as a “lot”) of Gardasil is manufactured and tested for quality control according to the requirements of its FDA license. FDA verifies this, as it does with other vaccines, by performing a lot-by-lot batch review process.
• FDA’s review assures the appropriateness of manufacturing processes and confirmation of testing results. It also includes regular unannounced on-site inspections.
• No batch may be released for distribution until it has successfully completed all testing and review requirements.
• FDA analyzes possible side effects associated with individual lots to look for any unusual patterns.

CDC also has other systems in place to monitor the safety of all licensed vaccines.

This article appears on FDA’s Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.

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For More Information

CDC and FDA Information on Gardasil’s Safety

www.fda.gov/cber/safety/gardasil071408.htm

Vaccine Adverse Event Reporting System (VAERS) Web site

www.vaers.hhs.gov

FDA Press Release (Sept. 12, 2008):

Approval of Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers

www.fda.gov/bbs/topics/NEWS/2008/NEW01885.html

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Date Posted: September 29, 2008

©2012 An Inconvenient Woman. All Rights Reserved.