Our Gardasil injury lawyers are investigating serious side effects linked to Gardasil, including blood clots, neurological disorders and even death. Gardasil was approved by the FDA in June 2006. As of June 30, 2008, there have been 9,749 VAERS reports of adverse events following vaccination with Merck’s Gardasil HPV vaccine. Of these, 94% were classified as reports of non-serious adverse reactions events, and 6% as serious adverse reactions.

Guillain-Barre Syndrome (GBS) has also been reported in individuals following vaccination with Gardasil. GBS is a rare neurological disorder that causes muscle weakness. It occurs spontaneously in unvaccinated individuals after a variety of specific infections. Finally, thromboembolic disorders (blood clots) have been reported to VAERS in people who have received Gardasil.

Contact our Vaccine Injury Lawyers

At Law Offices of Sadaka Associates, we can assure you that if you are injured by a vaccine we will fight to get you the compensation you deserve. Our Vaccine Injury Lawyers are standing by to assist you. In most instances, with exception, you only have three years from the date of injury to file a claim in vaccine court or two years from the date of death. Contact our Vaccine Injury Lawyers today, toll-free, at 1-800-810-3457 or fill out our online form for a free case evaluation.

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FDA and CDC Report: Gardasil Continues to be Safe and Effective

Gardasil Vaccine Safety

August 20, 2009

Consumers, parents, health care professionals and others have raised questions regarding the safety of the human papillomavirus (HPV) vaccine, Gardasil. FDA and the U.S. Centers for Disease Control and Prevention (CDC) take all concerns about vaccine safety seriously, and have been closely monitoring the safety of Gardasil.

Below is a summary of Gardasil vaccine safety monitoring activities and findings. Based on ongoing assessments of vaccine safety information, FDA and CDC continue to find that Gardasil is a safe and effective vaccine. FDA and CDC continue to monitor the safety of this vaccine, with the public’s health and safety our top priority.

Gardasil Background

FDA approved Gardasil on June 8, 2006. It is approved for females 9-26 years of age to protect against cervical, vulvar and vaginal cancers caused by Human Papillomavirus (HPV) types 16 and 18 and genital warts caused by HPV types 6 and 11. CDC’s Advisory Committee on Immunization Practices (ACIP) recommended a routine 3-dose vaccination series for girls 11 and 12 years of age. The vaccine is also recommended for girls and women ages 13 through 26 years who have not yet been vaccinated or who have not received all 3 doses.

Studies involving approximately 21,000 girls and women were conducted to evaluate the safety and effectiveness of Gardasil before receiving approval by FDA. Approximately half of the study participants received the vaccine, and the other half received a control. These studies showed that in women who have never been infected by HPV types 6, 11, 16 or 18, the vaccine is highly effective, both in preventing precancerous lesions that often develop into cancer of the cervix, vagina and vulva, and in preventing genital warts caused by these HPV types.

This vaccine is an important cervical cancer prevention tool that will potentially benefit the health of millions of women. Every year, about 12,000 women are diagnosed with cervical cancer and almost 4,000 die from this disease in the United States. Worldwide, cervical cancer is the second most common cancer in women, causing an estimated 470,000 new cases and 233,000 deaths per year.

Monitoring the Safety of Gardasil

Vaccine Safety Overview

FDA and CDC closely monitor the safety of all vaccines through the Vaccine Adverse Event Reporting System (VAERS). VAERS receives unconfirmed reports of possible side effects following the use of Gardasil and all vaccines licensed in the U.S. VAERS reports are regularly reviewed for safety concerns or trends of adverse events (possible side effects).

Vaccines are manufactured in batches called lots. All vaccine lots are routinely tested and must pass all tests before they can be used, and vaccine manufacturers must comply with strict manufacturing standards. FDA also analyzes adverse events (possible side effects) associated with individual lots to look for any unusual patterns. No such patterns have been observed in FDA’s review of HPV vaccine lots since the vaccine was licensed.

In addition to VAERS, CDC has two other systems in place to monitor the safety of all licensed vaccines. The Vaccine Safety Datalink (VSD) Project is a collaborative effort between CDC and eight managed care organizations that monitors vaccine safety and addresses the gaps in scientific knowledge about rare and serious side effects following immunization. The Clinical Immunization Safety Assessment (CISA) Network is a collaboration with six academic centers in the United States to conduct clinical research on vaccine-associated adverse events.

Adverse Event Reports following Gardasil

Given the large number of doses distributed, it is expected that, by chance alone, serious adverse events and some deaths will be reported in this large population during the time period following vaccinations. Our monitoring and analysis of reports, including in-depth medical review, statistical data mining techniques, and analysis of reporting rates (number of adverse events/number of doses distributed) are designed to detect serious events that occur at rates greater than expected.

VAERS receives reports of many events that occur following immunization. Some of these events may occur coincidentally during the time period following vaccination, while others may actually be caused by vaccination. In our analysis of VAERS data, we look for patterns of adverse events that may be plausibly linked to a vaccine. Such patterns of adverse events may require further study.

On August 19, 2009, the Journal of the American Medical Association (JAMA) published an article coauthored by FDA and CDC that reviews the safety data for Gardasil for select adverse events that have been reported to VAERS, from the time period starting from product licensure in June 2006 through December 31, 2008 (JAMA. 2009;302(7):750-757). The article describes 12,424 reports of adverse events following Gardasil vaccination. Of these, 772 were reports of serious events (6.2% of the reports) and the remaining 11,652 (93.8%) were classified as non-serious. During this time period, the manufacturer, Merck and Co., has distributed over 23 million doses of Gardasil in the United States. The information contained in this update is based on the same information contained in the article published in JAMA. FDA will provide a future update to information on the number of reports of adverse events and doses distributed.

The Gardasil safety review assessed the following adverse events: local injection site reactions, syncope, dizziness, and nausea, headaches, hypersensitivity reactions, such as rashes, hives, itching, anaphylaxis, Guillain-Barré syndrome (GBS), transverse myelitis, motor neuron disease, venous thromboembolic events (VTEs), pancreatitis, autoimmune disorders, pregnancy, and deaths. All of these events are included in Gardasil’s labeling. In VAERS, a higher proportion of Gardasil reports were of syncope and VTEs compared with other vaccines. However, none of the adverse events in the safety review, including syncope and VTEs, were reported at rates (number of adverse events/number of doses distributed) greater than expected in a population of this age and gender and with other known contributing factors to these adverse events.

VAERS reports include syncope (fainting), pain at the injection site, headache, nausea and fever. Fainting is common after injections and vaccinations, especially in adolescents. Falls after syncope may sometimes cause serious injuries, such as head injuries, which can be prevented with simple steps, such as keeping the vaccinated person seated for up to 15 minutes after vaccination. FDA and CDC have taken steps to remind immunization providers about the recommendation that individuals be watched carefully for 15 minutes after vaccination to avoid potential injury from a fall. FDA approved revised labeling on June 9, 2009, to highlight this information in the Warnings and Precautions section, and new information was added noting that individuals who faint sometimes have tonic-clonic (jerking) movements and seizure-like activity. As a part of a Back to School immunization campaign, FDA and CDC are also continuing to remind health care providers to take measures to prevent fainting and the possible traumatic injury resulting from fainting.

Thromboembolic disorders (blood clots) have been reported to VAERS in people who have received Gardasil. Most of these individuals had risk factors for blood clots such as use of oral contraceptives which are known to increase the risk of clotting. The JAMA article describes 56 cases, 31 of which were confirmed blood clot reports. Twenty eight reports (90%) had underlying known risk factors such as hormonal birth control, genetic clotting abnormalities, obesity, smoking, and immobility. In the CDC’s VSD, blood clots have not been found to occur more often than expected after over 450,000 doses of Gardasil.

Concerns have been raised about reports of deaths occurring in individuals after receiving Gardasil. As of December 31, 2008, 32 deaths had been reported to VAERS. There was not a common pattern to the deaths that would suggest they were caused by the vaccine. In the majority of cases with available autopsy, death certificate and medical records, the cause of death was explained by factors other than the vaccine.

Guillain-Barre Syndrome (GBS) has also been reported in individuals following vaccination with Gardasil. GBS is a rare neurological disorder that causes muscle weakness. It occurs spontaneously in unvaccinated individuals after a variety of specific infections. FDA and CDC have reviewed the reports of GBS that have been submitted to VAERS. To date, there is no evidence that Gardasil has increased the rate of GBS above that expected in the population. While we continue to carefully analyze all reports of GBS submitted to VAERS, the data do not currently suggest an association between Gardasil and GBS.

Because VAERS data are subject to many limitations of passive reporting systems, FDA and CDC also utilize additional surveillance tools. This includes the CDC’s VSD which incorporates eight large Managed Care Organizations, and now has health records linked to over 450,000 doses of Gardasil, and focuses on several potential risks: thrombotic events (blood clots), seizures, syncope, appendicitis, anaphylaxis, and GBS. Thus far, the VSD studies have not found safety signals or concerns for any of these events. The manufacturer has also committed to conduct a large postmarketing study to further assess the vaccine’s safety.

Summary

Based on the review of available information by FDA and CDC, Gardasil continues to be safe and effective, and 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 prescribing information for how the vaccine is used. In addition, FDA routinely reviews manufacturing information, and has not identified any issues affecting the safety, purity and potency of Gardasil.

Public health and safety are priorities for FDA and CDC. As with all licensed vaccines, we will continue to closely monitor the safety of Gardasil. FDA and CDC continue to find that Gardasil is a safe and effective vaccine that will potentially benefit the health of millions of women by providing protection against the types of HPV in the vaccine that cause cervical, vulvar and vaginal cancer, genital warts, and other HPV-related genital diseases in females.

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Report from the CDC about Gardasil Safety

Reports of Health Concerns Following HPV Vaccination

HPV Vaccine Safety

The safety of the HPV vaccine was studied in 5 clinical trials before it was licensed. There were over 21,000 girls and women ages 9 through 26 in these clinical trials.

Since it was licensed, CDC and FDA have been closely monitoring the safety of the HPV vaccine. There are 3 systems used to monitor the safety of vaccines after they are licensed and being used in the U.S. These systems can monitor side effects already known to be caused by vaccines as well as detect rare side effects that were not identified during a vaccine’s clinical trials. The 3 systems are:

The Vaccine Adverse Event Reporting System (VAERS)–a useful early warning public health system that helps CDC and FDA detect possible side effects or adverse events following vaccination.

The Vaccine Safety Datalink (VSD) Project–a project between CDC and 8 health care organizations to study patterns in reports detected by VAERS and determine if a vaccine is causing a side effect.

The Clinical Immunization Safety Assessment (CISA) Network–a project between 6 academic centers in the U.S. which conduct research on adverse events that might be caused by vaccines.

Reports to VAERS Following HPV Vaccination

As of June 1, 2009, more than 25 million doses of Gardasil were distributed in the United States.

As of June 1, 2009, there were 14,072 VAERS reports of adverse events following Gardasil vaccination in the United States. Of these reports, 93% were reports of events considered to be non-serious, and 7% were reports of events considered to be serious.

Based on all of the information we have today, CDC continues to recommend Gardasil vaccination for the prevention of 4 types of HPV. As with all approved vaccines, CDC and FDA will continue to closely monitor the safety of Gardasil. Any problems detected with this vaccine will be reported to health officials, healthcare providers, and the public, and needed action will be taken to ensure the public’s health and safety.

Non-serious adverse event reports

VAERS defines non-serious adverse events as those other than hospitalization, death, permanent disability, and life-threatening illness.

The vast majority (93%) of the adverse events reports following Gardasil have been non-serious. Reports of non-serious adverse events after Gardasil vaccination have included fainting, pain and swelling at the injection site (the arm), headache, nausea and fever. Fainting is common after injections and vaccinations, especially in adolescents. Falls after fainting may sometimes cause serious injuries, such as head injuries, which can be prevented by closely observing the vaccinated person for 15 minutes after vaccination.

Serious adverse event reports

VAERS defines serious adverse events as adverse events that involve hospitalization, permanent disability, life-threatening illness, and death. As with all VAERS reports, serious events may or may not have been caused by the vaccine.

Please note: A major limitation of VAERS data is that there is no proven causal association between the vaccine and the adverse event. The only association is in time, meaning that the adverse event occurred sometime after vaccination. Therefore we cannot conclude that the events reported to VAERS were caused by the vaccine.

All serious reports (7%) for Gardasil have been carefully analyzed by medical experts. Experts have not found a common medical pattern to the reports of serious adverse events reported for Gardasil that would suggest that they were caused by the vaccine. The following is a summary of selected serious adverse event reports that were submitted to VAERS between June 8, 2006 and June 1, 2009.

Guillain-Barré Syndrome (GBS)

Guillain-Barré Syndrome (GBS) has been reported after vaccination with Gardasil. GBS is a rare disorder that causes muscle weakness. It occurs in 1-2 out of every 100,000 people in their teens. A number of infections can cause GBS. There has been no indication that Gardasil increases the rate of GBS in girls and women above the rate expected in the general population, whether or not they were vaccinated.

Blood Clots

Rarely, people have reported blood clots after getting Gardasil. These clots have occurred in the heart, lungs, and legs. Most of these people had a risk of getting blood clots, such as taking oral contraceptives (the birth control pill).

Deaths

As of June 1, 2009, there have been 43 U.S. reports of death among females who have received the vaccine. Twenty six of these reports have been confirmed, 9 are still under investigation, and 8 remain unconfirmed due to no identifiable patient information in the report such as a name and contact information to confirm the report. Confirmed reports are those that scientists have followed up on and have verified the claim. In the 26 reports confirmed, there was no unusual pattern or clustering to the deaths that would suggest that they were caused by the vaccine.

More information is available at:

http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-oct08/12-3-hpv.pdf

Reports of adverse events after getting a vaccine can be submitted to VAERS by fax at 1-877-721-0366, online at https://secure.vaers.org/VaersDataEntryintro.htm, or by mail to Vaccine Adverse Event Reporting System, P.O. Box 1100, Rockville, MD 20849-1100.

Page last modified: June 18, 2009
Content source: Immunization Safety Office

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The following was posted by the FDA regarding the labeling revising for Gardasil:

Reminder to HealthCare Providers: 15-minute Observation Period Needed After Vaccination

On June 9, 2009, the Food and Drug Administration (FDA) approved a revised label for Gardasil, a vaccine to protect against cervical, vulvar and vaginal cancers caused by Human Papillomavirus (HPV) types 16 and 18 and genital warts caused by HPV types 6 and 11. In the new label, information pertaining to syncope (fainting) is now also included in the Warnings and Precautions section, and this section has new information noting that individuals who faint sometimes have tonic-clonic (jerking) movements and seizure-like activity. The addition of syncope to the Warnings and Precautions section emphasizes that healthcare providers and consumers should be alert that fainting may occur following vaccination with Gardasil, sometimes resulting in falling and injuries. To prevent falls and injuries all vaccine recipients should remain seated or lying down and be closely observed for 15 minutes following vaccination.

As with all vaccines, FDA closely monitors the safety of Gardasil. Syncope (fainting) has been in Gardasil’s labeling for both the healthcare provider and the patient since October 2007; however, FDA and the Centers for Disease Control and Prevention (CDC) continue to receive reports of traumatic injuries of individuals fainting and falling after receiving Gardasil. Some who fainted have had serious injuries from falling, which have often occurred while still in the healthcare provider’s office, and other fainting episodes resulted in motor vehicle accidents. Therefore, FDA requested the manufacturer, Merck and Co., Inc., to add this information to the Warnings and Precautions section of the label, so that it is more prominent, and reminds healthcare providers that recipients of Gardasil should be closely observed for 15 minutes after vaccination. Gardasil recipients should be encouraged to remain seated or lying down for this length of time and be alert to the following warning signs and symptoms that may happen before a person faints: paleness, sweating, dizziness, ringing in ears or vision changes.

Syncope has been reported after administration of other adolescent and adult vaccines, so it is not unique to Gardasil or even vaccines. Syncope can also occur with certain medications, after blood donation, or in response to pain. Jerking movements, loss of bladder control, and other signs that resemble epileptic seizures may occur with fainting, but do not mean that the person is having epilepsy. New information in the Warnings and Precautions section alerts healthcare providers that tonic-clonic (jerking) movements and seizure-like activity can occur with fainting. Syncope and its associated signs and symptoms generally last only a short time (seconds to minutes) and resolve when the patient is placed in a position, such as lying down, to restore adequate blood flow to the brain.

A Morbidity and Mortality Weekly Report published in May 2008 recommends that all providers administering vaccinations should be aware of the potential for syncope after vaccination and should take appropriate measures to prevent potential injuries. As part of our ongoing surveillance of vaccine safety, FDA is evaluating whether changes to the labeling concerning this particular side effect are needed for other adolescent and adult vaccines. FDA and CDC are also in the process of reviewing the Vaccine Information Statements (VISs) to include syncope. These information sheets explain to vaccine recipients, their parents, or their legal representatives both the benefits and risks of a vaccine. Federal Law requires that VISs be handed out whenever (before each dose) certain vaccinations are given.

Key Facts:

Healthcare providers and consumers should be aware that syncope (fainting) may occur following vaccination with Gardasil, sometimes resulting in falling and traumatic injuries. These falls and injuries are preventable by having Gardasil recipients remain seated or lying down for 15 minutes following vaccination, closely observing them, and watching for the following warning signs and symptoms: paleness, sweating, dizziness, ringing in ears or vision changes, which generally occur before fainting. If an individual faints, and especially if seizure-like activity occurs, the individual should be placed in a position, such as lying down to help restore blood flow to the brain.
FDA has received reports to the Vaccine Adverse Event Reporting System (VAERS) of syncope, as well as, syncope with tonic-clonic (jerking) movements and seizure-like activity that occurred after Gardasil and other vaccinations. Of all of the reports in VAERS pertaining to Gardasil, approximately 13% describe syncope. The percentage is similar to reports of syncope for other adolescent vaccines.

The VAERS is a national vaccine safety surveillance program co-sponsored by the FDA and the CDC. The purpose of VAERS is to detect possible signals of adverse events associated with vaccines. VAERS collects and analyzes information from reports of adverse events (possible side effects) that occur after the administration of US licensed vaccines.

In 2007, FDA and CDC did a comprehensive review of VAERS reports of syncope and related medical charts after adolescent vaccination. The review found that 30-40% of adolescent syncope reports described signs of jerking or other seizure-like activity, approximately 20% described traumatic injury, and 95% occurred within 15 minutes of vaccination.

Since syncope was added to the label in 2007, we continue to receive a consistent number of reports of syncope and traumatic injuries resulting from it. Because the number of reports has not declined, this reminder to healthcare providers emphasizes that preventive measures are warranted.
Syncope has been reported after administration of other adolescent and adult vaccines, so it is not unique to Gardasil or even vaccines. Syncope can also occur with certain medications, after blood donation or in response to pain and the following may occur: jerking movements, loss of bladder control, and other signs that resemble epileptic seizures, but is not epilepsy.

Gardasil is an important tool for the prevention of cervical, vulvar and vaginal cancers and genital warts that will benefit the health of millions of women. HPV types 16 and 18 cause approximately 70 percent of cervical cancers, and HPV types 6 and 11 cause approximately 90 percent of genital warts. According to the National Cancer Institute, in 2009 there will be approximately 11,000 new cases of cervical cancer and 4,000 deaths in the United States. Gardasil will not treat existing diseases caused by HPV types contained in the vaccine and it is important that vaccination with Gardasil occurs before exposure to HPV infection. Females who receive Gardasil should continue to undergo regular pap tests for cervical cancer screening.

Since it was licensed, FDA and CDC have been closely monitoring the safety of Gardasil.

Based on ongoing assessments of vaccine safety information gathered from various surveillance tools, FDA and CDC continue to find that Gardasil is a safe and effective vaccine, and that its benefits continue to outweigh its risks. As part of our ongoing surveillance of vaccine safety, FDA is evaluating whether changes to the labeling concerning syncope are needed for other adolescent and adult vaccines.