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HEALTH - Again, the news circulated stating that vaccination is not a secure health decisions. This time it was under the spotlight is the HPV vaccine and its relation with the risk of ovarian failure.
Vaccines, before distributed to the public, has experienced a variety of clinical trials are long, either by government health authorities where the vaccine was derived as well as by local health authorities where the vaccine is distributed.
Health authorities in the United States such as the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) is the one that becomes a reference of various countries in the world, in addition to the World Health Organization or WHO.
This is a review of the CDC regarding the safety of the HPV vaccine, generally linked with information that says the HPV vaccine causes ovarian failure.
How does CDC ensure the HPV vaccine safe?
All vaccines will be circulated asked to conduct extensive safety tests before they are allowed to circulate by the Food and Drug Administration (FDA).
After a licensed vaccine, CDC and FDA continue to monitor each of the vaccine to ensure safety and effectiveness. All vaccines continue to be developed, tested and monitored.
HPV vaccine studied in clinical trials rigorous to ensure safety:
- Gardasil 9 studied in more than 15,000 women and men.
- Gardasil studied in 29,000 women and men.
- Cervarix studied in more than 30,000 women.
Clinical trials show the vaccine is safe and effective. Each of vaccines continues to be monitored to ensure the safety of the wearer. The monitoring is mainly looking for rare or new problems that might occur after vaccination.
CDC uses three systems to monitor the safety of vaccines after they are licensed:
1. Vaccine Adverse Event Reporting System (VAERS).
2. Vaccine Safety Datalink (VSD).
3. The Clinical Immunization Safety Assessment (CISA) Network.
What are the benefits of the HPV vaccine compared with the risk?
CDC has been very careful studying the risks and benefits of HPV vaccination. HPV vaccination is recommended for its benefits, such as preventing cancer, far outweigh the risk of side effects.
Health decision is a personal thing, and everyone has to make the right choices for themselves and their families.
It is important to remember that choosing not to vaccinate, will not relieve you of the risks. The HPV vaccine prevents cancer and other serious diseases in men and women.
Are there any serious health problems were reported after people receive the vaccine?
Nearly 90 million doses of HPV vaccine distributed only in the United States from June 2006 to March 2016. Most of the monitoring and research focused on Gardasil, the vaccine has accounted for 87 percent of HPV vaccine doses distributed in the United States.
From June 2006 until March 2016, approximately 79 million doses of Gardasil distributed in the United States. During the same period, VAERS received the 33 945 reports of side effects that occurred after vaccination Gardasil.
There were 232 reports of side effects after vaccination Cervarix (Cervarix amount distributed is as many as 720,000) since they receive a license until March 31, 2016.
VAERS had received 1,447 reports of side effects of Gardasil 9 since they receive a license to March 31, 2016. Approximately 10 million doses of Gardasil 9 has been distributed in the United States.
Drug or vaccine can cause side effects and (such as vaccines or other drugs) is difficult to determine whether the HPV vaccine causes certain side effects or not.
Can HPV vaccine damage the ovaries?
CDC aware of public concern about the safety of human papillomavirus vaccine (HPV). Since 2006, monitoring and research of HPV vaccine are being conducted by the CDC, the FDA and other health organizations, has confirmed that this vaccine has an excellent safety record with no evidence that it causes reproductive problems in women.
What about premature ovarian failure?
Post ovarian failure, or POF or primary ovarian insufficiency, or so-called premature ovarian failure is a condition in which a woman's ovaries stop functioning before the age of 40. The cause of premature ovarian failure include:
- Genetics
- Chemicals in the environment
- Treatment of Cancer
- Cigarette
- Autoimmune Disorders
- Some types of viral infections
However, in most cases it is impossible to determine the cause. CDC and FDA have not found evidence that Gardasil causes of premature ovarian failure.
How does the FDA and CDC are looking for health problems that occur after vaccination?
Before Gardasil is licensed, safety has been studied extensively in clinical trials. The study found no difference amenorrhea (when a woman of reproductive age are not getting your period) among women who received Gardasil compared with women who received a placebo (an injection without medication in it).
We found POF does not occur in women who have been recipients of Gardasil clinical trials.
Between June 2006 until September 2015, more than 80 million doses of Gardasil were distributed for use in the United States. VAERS received 16 reports of premature ovarian failure and 10 reports of conditions associated with ovarian disorders.
The reports have been diagnosed for some time when a woman has received Gardasil vaccination. Regarding the reported side effects, it does not mean that such interference must be caused by vaccination.
To understand reports with a better, FDA and CDC to see if there are patterns that may indicate that the vaccine is causing the problem.
No such pattern was found among these VAERS reports, so it seems unlikely that the vaccine caused the problem ovaries.
CDC continues to monitor and evaluate the safety of the HPV vaccine. Although VAERS does not see a pattern among reports on POF, VSD is conducting a study to examine this issue further.
Is the HPV vaccine can prevent any condition that causes women to lose its fertility?
HPV vaccination to prevent infection of HPV virus that causes cervical cancer. In some cases, women with cervical cancer before they have children.
Treatment of cervical cancer (cervix and uterus removal, chemotherapy and / or radiation) can make a woman can not get pregnant. Preventing cervical cancer through HPV vaccination may reduce this risk.
CDC in collaboration with the American Academy of Pediatrics (AAP), the American Academy of Family Physicians (AAFP) and American College of Obstetrics and Gynecologists to continue to monitor the safety of HPV vaccination.
Has anyone died after receiving the vaccine?
Several deaths among those who received the HPV vaccine has been reported to VAERS. Just because the death occurred after vaccination, does not mean that the vaccine was the cause of death.
CDC and FDA to review all the available information on the incoming reports of deaths, not only against the HPV vaccine but also against all types of vaccines.
From June 2006 until September 2015, when about 80 million doses of the HPV vaccine have been given in the United States, VAERS receives 117 reports of deaths after receiving the Gardasil vaccine.
Among the 117 reports of deaths, many of which can not be studied further, because there is not enough information to verify the problem.
In 51 reports, CDC reviewed medical records, autopsy reports or death certificates and verify that the person is indeed dead. After observing closely, CDC concluded:
1. No diagnosis confirming that Gardasil causes death.
2. There is no pattern of deaths that occur over time after vaccination.
3. No number of doses of vaccine or a combination vaccine consistently included in the report.
Based on the monitoring of vaccine safety, whether the FDA and the CDC changed the recommendation on the HPV vaccine?
Yes. When we found the incidence of patients with shortness of breath after vaccination, the FDA immediately change instructions Gardasil vaccine.
FDA include information on how to prevent falls and injuries due to suffocation after HPV vaccination. Then the CDC and the Advisory Committee on Immunization Practices (Advisory Committee on Immunization Practices) include instructions into HPV vaccination recommendations.
CDC continues to remind doctors and nurses to continue studying these instructions and to share this information with all of their patients.
