HPV vaccine leads to more than 80% drop in infections: What parents need to know

Source: Good Morning, America
Date: April 2nd, 2021
Author: Katie Kindelan

 

A new study has shown the effectiveness of the HPV vaccine, and found a dramatic decline in human papillomavirus infections in both vaccinated and unvaccinated teen girls and young women in the United States.

“This study shows that the vaccine works very well against a common virus, HPV,” Dr. Hannah Rosenblum, lead author of the study and medical epidemiologist at the Centers for Disease Control and Prevention (CDC), told “Good Morning America.”

“HPV can cause serious health problems later in life, including some cancers in both women and men,” she said. “HPV vaccination is cancer prevention — by vaccinating children at age 11 or 12, we can protect them from developing cancers later in life.”

HPV is the most common sexually transmitted infection in the United States and can cause health problems like genital warts in addition to cancer, which are most commonly cervical cancer in women and throat cancer in men, according to the CDC.

The HPV vaccine was first authorized in the U.S. for females in 2006, and for males in 2011. There has since been a more than 80% decline in HPV infections nationally, according to the CDC study.

The newly-released data from the CDC shows an 88% decrease in HPV infections among 14 to 19-year-old females and an 81% decrease among 20 to 24-year-old females.

There has also been a drop in unvaccinated females, according to Rosenblum, who warned that does not mean people should let their guard down.

“We also see an effect among unvaccinated females in these age groups due to less spread of the virus, however, unvaccinated persons are not immune and are still at risk of getting HPV,” she said. “They should talk to their doctor about getting vaccinated if they are 26-years-old or younger.”

HPV viruses are found in 80 million people in the United States, according to the CDC. There are hundreds of subtypes of HPV, and 1 in 4 people in the U.S. are infected with HPV at some point in their lives.

The CDC recommends two doses of the HPV vaccine, taken six to 12 months apart, for all girls and boys ages 11 to 12, but says the vaccine can be given to children as young as 9.

Teens and older who are not vaccinated are encouraged to do so by the age of 26. People ages 15 and older need three doses of the vaccine, according to the CDC.

The timing of the vaccine has to do with the state of children’s immune systems and also trying to vaccinate pre-teens before they are sexually active, Dr. Laura Riley, chair of obstetrics and gynecology at Weill Cornell Medicine and New York-Presbyterian in New York City, told “GMA.”

“Your immune system [at ages 11 and 12] is such that you have a robust response to this vaccine, and it lasts for a really long time,” she said. “But if you haven’t had it, still continue talking to your doctor about getting it up to age 26.”

Riley said she hopes the CDC’s new data — which stands out for being a 10-year study — combined with the safety of the HPV vaccine eases any remaining concerns parents may have about getting their children vaccinated against HPV.

“When [the HPV vaccine] first rolled out, the message wasn’t quite clear, so instead of people recognizing that you were going to prevent your kid from getting cancer, people were focused on the fact that HPV is a sexually transmitted disease,” she said. “The education has to continue so that parents can understand the real benefit of this vaccine.”

“The real benefit is to prevent your child from getting cervical cancer,” Riley said. “The fact that you can prevent [cervical cancer] with a vaccine that has been used for years and has shown to be safe, why wouldn’t you do it?”

Long-lasting infection with certain types of HPV is the main cause of cervical cancer, which has the best survival rates if detected early according to the CDC. Doctors routinely screen for cervical cancer with the Pap test and HPV DNA testing depending on age and risk factors.

“We need to make sure that the teenagers and pre-teens are getting the benefit of the HPV vaccine, because it really is an anti-cancer vaccine,” said Riley. “[Cervical cancer] is a really devastating disease.”

Globally, a woman loses her life to cervical cancer every two minutes, according to a 2019 article published in the medical journal The Lancet.

In the U.S., doctors on the frontlines like Riley said more must continue to be done to educate parents about the HPV vaccine and make sure that all children across the country have access to the vaccine. As of 2018, nearly 40% of adults ages 18 to 26 reported receiving one or more doses of the HPV vaccine, according to the CDC.

“We need to make sure that we work on access to this vaccine and make sure that all girls of all races and ethnicities have the access,” said Riley. “And we need to be sure that the message is clear so that everyone gets the two doses of the vaccine, because that’s what is associated with the best protection.”

2021-05-11T10:31:22-07:00May, 2021|Oral Cancer News|

HPV vaccine leads to more than 80% drop in infections: What parents need to know

Source: Good Morning, America
Date: April 2nd, 2021
Author: Kathleen Kindalen

 

A new study has shown the effectiveness of the HPV vaccine, and found a dramatic decline in human papillomavirus infections in both vaccinated and unvaccinated teen girls and young women in the United States.

“This study shows that the vaccine works very well against a common virus, HPV,” Dr. Hannah Rosenblum, lead author of the study and medical epidemiologist at the Centers for Disease Control and Prevention (CDC), told “Good Morning America.”

“HPV can cause serious health problems later in life, including some cancers in both women and men,” she said. “HPV vaccination is cancer prevention — by vaccinating children at age 11 or 12, we can protect them from developing cancers later in life.”

HPV is the most common sexually transmitted infection in the United States and can cause health problems like genital warts in addition to cancer, which are most commonly cervical cancer in women and throat cancer in men, according to the CDC.

The HPV vaccine was first authorized in the U.S. for females in 2006, and for males in 2011. There has since been a more than 80% decline in HPV infections nationally, according to the CDC study.

The newly-released data from the CDC shows an 88% decrease in HPV infections among 14 to 19-year-old females and an 81% decrease among 20 to 24-year-old females.

There has also been a drop in unvaccinated females, according to Rosenblum, who warned that does not mean people should let their guard down.

“We also see an effect among unvaccinated females in these age groups due to less spread of the virus, however, unvaccinated persons are not immune and are still at risk of getting HPV,” she said. “They should talk to their doctor about getting vaccinated if they are 26-years-old or younger.”

HPV viruses are found in 80 million people in the United States, according to the CDC. There are hundreds of subtypes of HPV, and 1 in 4 people in the U.S. are infected with HPV at some point in their lives.

The CDC recommends two doses of the HPV vaccine, taken six to 12 months apart, for all girls and boys ages 11 to 12, but says the vaccine can be given to children as young as 9.

Teens and older who are not vaccinated are encouraged to do so by the age of 26. People ages 15 and older need three doses of the vaccine, according to the CDC.

The timing of the vaccine has to do with the state of children’s immune systems and also trying to vaccinate pre-teens before they are sexually active, Dr. Laura Riley, chair of obstetrics and gynecology at Weill Cornell Medicine and New York-Presbyterian in New York City, told “GMA.”

“Your immune system [at ages 11 and 12] is such that you have a robust response to this vaccine, and it lasts for a really long time,” she said. “But if you haven’t had it, still continue talking to your doctor about getting it up to age 26.”

Riley said she hopes the CDC’s new data — which stands out for being a 10-year study — combined with the safety of the HPV vaccine eases any remaining concerns parents may have about getting their children vaccinated against HPV.

“When [the HPV vaccine] first rolled out, the message wasn’t quite clear, so instead of people recognizing that you were going to prevent your kid from getting cancer, people were focused on the fact that HPV is a sexually transmitted disease,” she said. “The education has to continue so that parents can understand the real benefit of this vaccine.”

“The real benefit is to prevent your child from getting cervical cancer,” Riley said. “The fact that you can prevent [cervical cancer] with a vaccine that has been used for years and has shown to be safe, why wouldn’t you do it?”

Long-lasting infection with certain types of HPV is the main cause of cervical cancer, which has the best survival rates if detected early according to the CDC. Doctors routinely screen for cervical cancer with the Pap test and HPV DNA testing depending on age and risk factors.

“We need to make sure that the teenagers and pre-teens are getting the benefit of the HPV vaccine, because it really is an anti-cancer vaccine,” said Riley. “[Cervical cancer] is a really devastating disease.”

Globally, a woman loses her life to cervical cancer every two minutes, according to a 2019 article published in the medical journal The Lancet.

In the U.S., doctors on the frontlines like Riley said more must continue to be done to educate parents about the HPV vaccine and make sure that all children across the country have access to the vaccine. As of 2018, nearly 40% of adults ages 18 to 26 reported receiving one or more doses of the HPV vaccine, according to the CDC.

“We need to make sure that we work on access to this vaccine and make sure that all girls of all races and ethnicities have the access,” said Riley. “And we need to be sure that the message is clear so that everyone gets the two doses of the vaccine, because that’s what is associated with the best protection.”

FDA approves Gardasil 9, the HPV vaccine, to prevent head-and-neck cancer

For the past decade, evidence has suggested that Gardasil, the HPV vaccine, could stem an epidemic of throat cancer. But it has also never received approval from the Food and Drug Administration for that use — and it was unclear if it ever would.

On Friday, the agency granted that approval, clearing the latest version of the vaccine, Gardasil 9, to prevent a cancer that affects 13,500 Americans annually. The decision was announced by Gardasil’s maker, Merck.

The decision doesn’t change recommendations about who should get the vaccine, which is already recommended for females and males ages 9 through 45 to prevent cervical, vulvar, vaginal, and anal cancer as well as genital warts. But cancers of the head and neck — mainly those of the tonsils and throat — have been left off the list.

It’s a striking omission, because head and neck cancer, mostly cancer of the throat, is the most common malignancy caused by HPV, the human papilloma virus, in the U.S. According to the Centers for Disease Control and Prevention, there are 35,000 cases of HPV-related cancer in the U.S. annually. On top of the 13,500 cases in the throat, 10,900 are cases of cervical cancer.

“That’s excellent news,” said Stewart Lyman, a pharmaceutical consultant whose doctors discovered a tumor in his throat in 2016. It was removed surgically, and was caused by HPV. “To have this extended to head and neck cancer is really very helpful for helping to inform the public that this serious disease, which has significant morbidity and mortality associated with it, can be prevented with the vaccine,” Lyman said.

Marshall Posner, the director of head and neck medical oncology at the Tisch Cancer Institute, said the approval is “a good thing for the FDA to do” and that he would be “thrilled” if head and neck cancer cases could be reduced through vaccination in coming decades. He said he has “every expectation” that an HPV vaccine would reduce cancer rates.

The original version of the Gardasil vaccine was approved in 2006 for girls and women between the ages of 9 and 26 based on data from clinical trials showing that the vaccine, by preventing HPV infection, could also prevent precancerous cervical lesions. But such lesions don’t exist in head and neck cancer, and it was not clear how to prove the vaccine’s efficacy.

Maura Gillison, now a professor at M.D. Anderson Cancer Center, first connected a subset of head-and-neck cancers to HPV in 1999. But then she and other epidemiologists noticed something: The number of head and neck cancers was rising rapidly, and HPV seemed to be a culprit. What’s more, these sexually transmitted cases seemed different — and somewhat easier to treat. The most common victims were middle-aged men who had contracted the virus decades before.

The FDA is granting what’s known as an accelerated approval, meaning that the decision is contingent on the production of more data and is based on what’s known as a “surrogate endpoint” — an indication that a medicine works that is not foolproof. In this case, the FDA is approving the drug based on data on preventing anogenital infection. In February, Merck began a study of  6,000 men that will test whether patients who receive the vaccine are less likely to get persistent HPV infections in their throats.

Adding another disease to the approval does impact what Merck can say to doctors and patients about HPV and head and neck cancer. “It’s something that was missing in the label,” said Alain Luxembourg, director, clinical research, Merck Research Laboratories. “It is something missing in the conversation between patients and doctors.”

Otis Brawley, an oncology and epidemiology professor at Johns Hopkins University, said that while he is usually opposed to surrogate endpoints, in this case he is comfortable with the decision. “There’s already enough reasons to vaccinate for HPV in men,” he said, adding that doing so broadly might make it possible to eradicate the virus, and the cancers it causes.

For Gillison, who spotted the emergence of HPV throat cancer, it came too late. She pushed Merck to do a study, and said that the one that started in February is coming “10 years plus after when it would have really mattered.” She also thinks that the real reason for the decision is the weight of epidemiologic evidence that she and others produced.

“The fact of the matter is that this approval probably has little whatsoever to do with the anal data per se,” Gillison wrote via text message. “It is because the FDA is made more comfortable with inference because of all the data that has been generated regarding the relationship between oral HPV infection and HPV vaccination outside of vaccine trials in the last 10 years.”

National Vaccination Program Leads To Marked Reduction In HPV Infections

Source: Forbes
Date: January 28th, 2020
Author: Nina Shapiro

While widespread vaccination continues to be a source of contention in this country and others, one of the newer vaccines has begun to demonstrate remarkable positive impact, which will hopefully become harder and harder to dispute. The HPV vaccine, with trade name GardasilR, is recommended for both boys and girls, ideally sometime between ages 11 and 12 years, given in two doses at a six month interval. It can be given as early as age 9, and as late as age 26. Older adults, even up to age 45, can receive the vaccine, although it is more likely that these adults have already been exposed to the virus, and are less likely to be protected by the vaccine.

The vaccine prevents infection with the human papillomavirus (HPV), which can cause health problems ranging from nuisance-causing warts to cancer-causing lesions of the cervix, throat, and anorectal area. When HPV-related cancers hit Hollywood, with Michael Douglas publicly attributing his throat cancer to HPV, it became clear that this disease can no doubt affect both men and women. When Marcia Cross announced that her anal cancer was due to HPV infection, it raised yet another red flag that HPV can affect the lower gastrointestinal tract, not just the female reproductive tract. Indeed, HPV can affect any of us, at any age, from stem to stern. As I wrote in an earlier Forbes piece, the vaccine to prevent HPV can prevent not only sexually transmitted infections (STI’s) causing genital warts, but it can also prevent cancer.

A lesser known impact of active HPV infection is that the virus can be transmitted from pregnant mother to her fetus via amniotic fluid. The child can later (usually as a toddler) develop warts on the vocal cords, known as recurrent respiratory papillomatosis, or RRP. These warts lead to progressively worsening airway blockage, and even death. And while there are treatments for RRP, there is no cure; only prevention. In another Forbes article, I explain how reduction of HPV infections, thanks to vaccine programs, can reduce the incidence of RRP in the next generation.

A report released this week by Public Health England, published in Health Protection Report, reviewed surveillance data from outcomes of a national HPV vaccination program, which began in 2008. The vaccine is offered to 12-13 year-old males and females, and the report then looked at incidence of HPV infection of the reproductive tract in sexually active 16-24 year-old females. As is the case with many viruses, HPV has many subtypes, some of which are more likely to be associated with aggressive cancers (subtypes 16 and 18 as well as 31, 33, and 45) and others are more likely to be associated with RRP infections and genital warts (subtypes 6 and 11). Until 2012, the bivalent (HPV 16/18) vaccine (CervarixR) was administered as a three-dose regimen. In years since then, the quadrivalent (HPV 16/18/6/11) (GardasilR) has been the standard vaccine administered in the U.K. as well as the U.S. as a two-dose regimen. Cervical cancer is due to HPV 16 or HPV 18 in up to 80% of cancers.

The recent report out of the U.K. analyzed results of over 18,000 vulvovaginal culture specimens obtained from sexually active 16-24-year-old females, collected between 2010 and 2018. There was significant decline in HPV infection rates in all subtypes in all age groups. Those who had been vaccinated more recently showed more reduction in HPV 6/11 than those who did not receive coverage for these strains in the earlier years of vaccination. Most notable was that the prevalence of HPV 16/18 in the 16-18-year-old cohort declined from 8.2% in 2010 to 0.0% in 2018. In the older groups, there was less decline (from 14% to 0.7% in 19-21-year-olds and 16.4% to 2.6% in 22-24-year-olds), but all reductions were statistically significant.

There was no evidence of increase in the HPV subtypes which were not included in the vaccine. Some have raised concern that vaccinating against specific HPV subtypes would increase growth of subtypes not included in the vaccine, but this was not found to be the case. While there are several limitations to this report, including the fact that each individual sample was not identified as being from a vaccinated or non-vaccinated individual, this marked reduction of all HPV subtype growth in a population which demonstrated a vaccination rate of 86% for both males and females ages 12-13 years is promising. While not all cervical cancers, throat cancers, or anal cancers are directly caused by HPV infection, the high rates of HPV-related cancers due to known HPV subtypes underscores the potential widespread benefits of this vaccine in the decades ahead.

2020-01-30T12:16:44-07:00January, 2020|Oral Cancer News|

HPV vaccine benefits ‘exceed expectations,’ may lead to elimination of cervical cancer

Source: NBC News
Date: June 27, 2019
Author: Katie Sullivan

A new study suggests that the benefits of the vaccine extend to people who aren’t vaccinated — meaning the more people who are vaccinated, the better.

The HPV vaccine is far more effective than expected, with benefits extending beyond those who receive the vaccine, a study published Wednesday finds.

The new study, published in The Lancet, suggests that the more people who receive the vaccine, the better. That’s because vaccination not only reduces rates of HPV infection and the presence of precancerous cells in the cervix in people who receive the vaccine, it also reduces rates of HPV-related diseases in people who were not vaccinated.

The findings come as a U.S. federal advisory panel recommended Wednesday that the HPV vaccine be given to both men and women up to age 26.

HPV, or human papillomavirus, is the leading cause of cervical cancer. The virus can also cause other cancers, including cancers of the penis, head and neck, as well as conditions like genital warts.

The HPV vaccine was first introduced in 2006. Since then, more than 115 countries and territories have implemented it in their vaccination programs. The World Health Organization recommends that girls ages 9 to 13 receive two doses of the vaccine.

“The impact of the HPV vaccination has actually exceeded expectations,” said Lauri Markowitz, associate director of science for HPV at the Centers for Disease Control and Prevention, who worked on the study. “The trials showed that HPV vaccines are very effective, and data from the real world has confirmed that.”

Indeed, the reductions in HPV infections and precancerous cells “are a first sign that vaccination could eventually lead to the elimination of cervical cancer as a public health problem,” the study’s lead author, Mélanie Drolet, an epidemiologist at Laval University in Canada, said in a statement.

The Lancet study expanded upon a 2015 meta-analysis that had looked at the real-world effects of the vaccine. The new analysis was updated to include a total of 65 studies, which spanned eight years and included more than 60 million people living in 14 countries. Each study measured either changes in the number of new HPV infections, genital warts diagnoses or cases of abnormal cells associated with cervical cancer in countries before and after they adopted routine HPV vaccination in girls. (Two countries included in the analysis, the U.S. and Australia, also recommend the vaccine for boys.)

The impact of the HPV vaccination has actually exceeded expectations.

The researchers found that, in these countries, there was a significant decrease in the prevalence of two strains of HPV that cause 70 percent of cervical cancers, HPV 16 and 18. (There are more than 100 strains of HPV, 14 of which are known to cause cancer. The HPV vaccine protects against up to 9 strains.) In addition, there was a decrease in the prevalence of precancerous cells in the cervix, which can develop into cancer.

What’s more, in countries where at least half the population that was targeted for vaccination had actually received the vaccine, researchers saw evidence of herd immunity, meaning there was a decrease in the prevalence of HPV-related diseases even among those who weren’t vaccinated. This is because vaccination leads to fewer HPV hosts.

These countries also saw a decrease in genital warts diagnoses among unvaccinated boys and older women. And among girls within the age groups targeted for vaccination, there were fewer diagnoses of three HPV strains that the vaccine does not specifically protect against, a phenomenon called cross-protection. Countries in which people in multiple age groups received the vaccine also saw a greater decrease in HPV-related disease.

“This paper shows that with a broader age range that’s targeted, you’ll find greater impact in your vaccination program,” Markowitz told NBC News.

Lagging vaccination rates

Despite the widespread benefits of the vaccine, however, HPV vaccination rates in the U.S. are still lagging behind those of other adolescent immunizations. The U.S. was the first country to implement HPV vaccination for both genders, but the CDC has found that many parents and health care providers don’t yet see a need to vaccinate boys. Parents have also expressed concerns about the vaccine and its costs, the CDC found.

According to Debbie Saslow, managing director of HPV and gynecological cancers at the American Cancer Society, the lagging rates are not entirely because parents are against vaccinating their kids; rather, the way some doctors are presenting the vaccine also plays a role.

Two required vaccinations, for tetanus and meningitis, are administered at the same time as HPV, around age 12. Saslow said HPV is usually presented as an optional third vaccine at that time, and one that patients can delay another year.

“Providers often think they’re recommending all three vaccines, but they’re actually making the third, the HPV vaccine, optional,” Saslow told NBC News. “They’re just suggesting it or doctors are setting it apart from the other two in some way.”

The fact that HPV is a sexually transmitted infection could also be a hard concept for parents to come to terms with. Saslow said beliefs about sex may be a factor that deters parents from opting to have their children vaccinated against HPV.

“Despite all that, vaccination rates are continuing to grow,” she said.

Indeed, the number of adolescents in the U.S. who received at least one dose of the HPV vaccine has increased by 5 percent each year since 2013. The CDC recommendseveryone receive the first dose by age 12. Though adults up to age 45 can still be vaccinated, the vaccine may be less effective. And while the WHO does recommend that girls 9 to 13 get vaccinated against HPV, it does not yet recommend that all genders receive the vaccination. That could change in response to study results that continue to show the vaccine has substantial impact on public health.

Cancer prevention

That impact on public health is cancer prevention. Ultimately, that’s the “main goal of the HPV vaccination program,” Markowitz said. “We’re seeing an impact on one of the HPV outcomes that is close to a cancer outcome.” (Because cervical cancer can take decades to develop, it’s not yet possible to study the effects of the vaccine on cervical cancer rates, Drolet noted in the statement.)

In particular, the study found the HPV vaccine led to a reduction in the rates of abnormal pap smear findings. Pap smears are used to detect abnormal cells in the cervix that can sometimes develop into cancer. Five to nine years after a population was vaccinated against HPV, the researchers found a more than 50 percent reduction in cases of these pre-cancerous cells in girls 15 to 19. In vaccinated women 20 to 24, there were one-third fewer cases of these cells.

A separate study, published in April in The BMJ, found a 90 percent reduction in cases of pre-cancerous cells in young women in Scotland within the first decade of introducing the HPV vaccine.

But vaccination is only one piece of cervical cancer prevention; screening is also necessary.

Whether or not a person has received the HPV vaccine, getting cervical cells regularly tested — through Pap tests and HPV screening — is still a crucial to reducing cases of cervical cancer and early detection, said Diane Harper, senior associate director of the Michigan Institute for Clinical and Health Research. Rates of invasive cervical cancer dropped significantly in the U.S. when cancer screening was introduced in the 1940s, and there were less than half the number of cases in 2007 that there were in 1973, largely due to screening.

“Vaccination and screening together make a program,” Harper told NBC News. “Very few HPV cases progress into cancer, but the only way we’re going to find those that do is through the screening program.”

The HPV Vaccine Is Already Dramatically Lowering Rates of Cervical Disease

Source: Gizmodo
Date: 04/03/19
Author: Ed Cara

A new study out Wednesday in the BMJ is the latest to showcase even the short-term benefits of the human papillomavirus (HPV) vaccine. It found that the routine vaccination of preteen girls in Scotland, starting in 2008, led to drastically lower rates of cervical disease by the time the girls turned 20. That included conditions known to raise the risk of cervical cancer later on in life.

There are over 100 different types of HPV that regularly infect humans. Most types cause no symptoms at all, while some can cause annoying but harmless warts on our hands, feet, or genitals, depending on where they like to call home. High-risk HPV types, however, linger in the cells that line the surfaces of our body, triggering changes that can eventually turn them cancerous. These HPV types account for nearly all cases of cervical cancer, as well as a substantial proportion of cancers in the mouth, throat, anus, and penis.

We’ve had a vaccine available for two of the most common high-risk types of HPV since 2006, when it was at first recommended only for teen girls. Over the years, the window of opportunity for getting the vaccine has expanded, as has the number of HPV types it protects against. The newest version protects against seven high-risk types that account for 90 percent of cervical cancers (along with two types that cause genital warts). And young boys and men are now also encouraged to get the vaccine, as are women up to age 45.

Despite this increase in recommended age, getting vaccinated while young provides the most benefit, since it’s incredibly easy to contract HPV once a person becomes sexually active. But rates of childhood HPV vaccination in places like the U.S. are still abysmally low. According to one estimate, only 35 percent of children are fully vaccinated by age 15 (the current guidelines call for kids to begin their vaccination from age 11 to 12, with only two shots needed if they get both by age 15; otherwise three shots are required). That low adherence rate not only hampers the protective effects of the vaccine, it also complicates efforts by researchers to study the real-world impact of the vaccine on a population.

In countries like Scotland, though, routine HPV vaccination was quickly adopted and made commonplace, thanks to a nationally funded vaccination program that targeted 12- to 13-year-old girls starting in 2008, along with a later program that targeted older teens. But there are other factors that make Scotland an ideal country to test the value of widespread HPV vaccination, according to lead author Tim Palmer, a pathologist at the University of Edinburgh.

“Up until June 2016, we started [cervical disease] screening at age 20, so we’re one of the first countries to have immunized women attend for screening,” he told Gizmodo via email. “We are also one of the few countries to be able to link directly the fact that an individual had or had not been vaccinated and her screening outcome many years later.”

Palmer and his team looked at the records of more than 130,000 women in Scotland who received one of these cervical screenings at age 20. They compared women vaccinated for HPV as young girls to slightly older women vaccinated during the catch-up program and to unvaccinated women born in 1988.

Compared to these unvaccinated women, they found, the women vaccinated as young girls were far less likely to have any kind of cervical disease, defined as the growth of abnormal cells in the cervix. Most importantly, the rate of growths classified as a cervical intraepithelial neoplasia (CIN) grade 3 also dropped substantially, by nearly 90 percent. That’s crucial because a CIN3 growth puts women at their greatest risk of someday developing cervical cancer. According to Palmer, the 90 percent reduction they found is the largest drop seen with CIN3 in any population where HPV vaccination is available.

“Thus, we are confident that the reduction in CIN3 will lead to a reduction in cancers,” Palmer said.

The high vaccination rate in Scotland also had indirect effects, they found. The rate of cervical disease in the minority of women who were eligible but did not get vaccinated dropped as well, meaning vaccine coverage was high enough to provide some herd immunity (put simply, the more protected a population is from a disease, the less opportunity the disease has to spread to unprotected people). As expected, women who were older when vaccinated still had a lower rate of cervical disease than unvaccinated women, but not to the same degree as those who got the vaccine when young.

All in all, Palmer said, the study shows that Scotland’s HPV program has been an unmitigated success, one that will continue to pay off for decades. And Scotland’s early success story should provide plenty more motivation for other countries to drive up their own local vaccination rates.

That said, it’ll still take some time before we can really be sure that cervical cancer rates will similarly plummet, since many women develop it in their mid 30s and 40s. But Palmer says his team is already at work studying screening data that might show the vaccine’s effectiveness at preventing earlier cases of cancer.

The growing success of the HPV vaccine might eventually lead to changes in how we screen women for cervical cancer, Palmer said, since there’ll be fewer total cases of cancer to catch—a welcome problem, obviously.

“Ultimately, when routinely immunized women form the majority of the women eligible for screening, the need for cervical screening programs should be reviewed; they may no longer be justified,” he said. “However, this point will not be reached in Scotland for at least 25 or 30 years. Before that stage, the frequency and number of screening tests will need to be reviewed; there are suggestions that just two or three tests in a screening ‘lifetime’ will be adequate.”

Currently, in the U.S., it’s estimated there are 12,000 new cases of cervical cancer annually.

2019-04-04T09:26:20-07:00April, 2019|Oral Cancer News|

Research Update: Vaccine Plus Checkpoint Inhibitor Combos for HPV-related Cancers

Source: MedPage Today
Author: Mark L. Feurst

Two new studies show the profound impact of a combined vaccine and anti-programmed death-1 (PD-1) antibody approach in the treatment of human papilloma virus (HPV)-related cancers.

HPV causes nearly all cervical cancers, as well as most oropharyngeal, anal, penile, vulvar, and vaginal cancers. HPV16 and HPV18 are the leading viral genotypes that increase cancer risk. Given the viral cause of these cancers, immunotherapy has been considered a strong potential approach.

Many patients with the HPV16 and HPV18 subtypes of head and neck squamous cell carcinoma have good outcomes from treatment that includes surgery or chemotherapy and radiation. Although anti-PD-1 therapy is approved for patients who do not respond to treatment or who develop metastatic disease, it benefits only about 15% of patients. The theory, therefore, is that a vaccine could potentially boost the immune systems of patients with HPV-related head and neck cancer, opening the door for better responses to other existing therapies.

Vaccine + Nivolumab in Phase II Study

In the first study, a phase II trial, a tumor-specific vaccine combined with the immune checkpoint inhibitor nivolumab was found to shrink tumors in patients with incurable HPV-related cancers.

“Ours are the first results with this particular approach,” Bonnie Glisson, MD, of the Department of Thoracic Head and Neck Medical Oncology at the University of Texas MD Anderson Cancer Center in Houston, told the Reading Room. “The rates of response and survival are approximately double what have been observed with nivolumab given alone to similar patients. These results will lead to larger, randomized clinical trials of this combination.”

Vaccines specific to HPV antigens found on tumors had previously sparked a strong immune response, but had not by themselves been active against established cancers, she noted.

“Vaccines are revving up the immune system, but the immunosuppressive tumor microenvironment probably prevents them from working. Our thinking was that inhibition of programmed death-1 (PD-1) would address one mechanism of immunosuppression, empowering the vaccine-activated T lymphocytes to attack the cancer.”

Glisson and colleagues combined the vaccine ISA101, which targets peptides produced by the strongly cancer-promoting HPV16 genotype of the virus, along with nivolumab, a checkpoint inhibitor that blocks activation of PD-1 on T cells.

The single-arm, single-center clinical trial included 24 patients with incurable HPV-16–positive cancer who were followed for 12.2 months. The vaccine was given subcutaneously on days 1, 22, and 50. A nivolumab dose of 3 mg/kg was given intravenously every 2 weeks beginning on day 8 for up to 1 year. Of the 24 patients with recurrent HPV16-related cancers, 22 had oropharyngeal cancer, one had cervical cancer, and one had anal cancer. The overall response rate was 33% (eight patients), and the median duration of response was 10.3 months. Five of eight patients remain in response, the team reported.

The overall median survival was 17.5 months, progression-free survival was 2.7 months, and 70% of patients survived to 12 months.

Grades 3 to 4 toxicity occurred in two patients (asymptomatic grade 3 transaminase level elevation in one patient and grade 4 lipase elevation in one patient), requiring discontinuation of nivolumab therapy. The researchers observed side effects expected from the two treatments separately, but said they were encouraged to see no sign of synergistic side effects caused by the combination.

“The combination was very well tolerated as opposed to other immunotherapy combinations such as combined blockade of PD-1 and CTLA-4,” Glisson said. “The vaccine did stimulate a strong HPV-specific immune response in peripheral blood T cells, although this was not correlated with response or survival. This suggests that other immune-suppressive factors in the tumor environment are contributing to immune evasion.”

Randomized clinical trials of the vaccine and anti-PD1 combinations for cervical and oropharyngeal cancer are ongoing, she added. “These are promising data that will be confirmed in a randomized trial. Positive results could lead to marketing of the first therapeutic HPV vaccine.”

Vaccine Helps T cells Infiltrate HPV-related Head and Neck Cancer

In the second study, another vaccine was shown to boost antibodies and T cells to help them infiltrate tumors and fight off HPV-related head and neck cancer. This approach might complement PD-1 or programmed death-ligand 1 inhibition in HPV-associated head and neck cancers to improve therapeutic outcomes, explained the study’s lead author, Charu Aggarwal, MD, MPH, of the Perelman School of Medicine at the University of Pennsylvania.

“We wanted to know if this vaccine can boost the immune systems of patients with HPV-related head and neck cancer, potentially opening the door for better response rates to other existing therapies. Our findings show that we can.”

Aggarwal and colleagues conducted a Phase Ib/II safety, tolerability, and immunogenicity study of immunotherapy with MEDI0457, a DNA immunotherapy targeting HPV16/18 E6/E7 with interleukin-12 encoding plasmids. The vaccine was delivered via electroporation to 21 patients. One group of patients received one dose before surgery, followed by three doses after surgery. The second group received four doses following chemotherapy and radiation.

Eighteen of the 21 patients (86%) showed elevated T cell activity that lasted at least 3 months after the final vaccine dose, the team reported. Five tumors were biopsied both before and after one dose of the vaccine, and there was evidence of T cells reacting with antigens contained in the vaccine in all five of these samples. One patient who developed metastatic disease and was treated with anti-PD-1 therapy developed a rapid and durable complete response that has lasted more than 2 years.

“We have not seen that kind of infiltration with just one dose of a vaccine before. These findings open the door for utilizing targeted immunotherapy approaches against specific cancer-causing targets like HPV,” said Aggarwal, adding that the vaccine was well tolerated, with no serious side effects reported.

“This response suggests that the vaccine may, in some manner, prime the immune system, potentially boosting the effects of subsequent anti-PD-1 therapy,” she explained, noting that a multi-site clinical trial is now open to patients with metastatic HPV-associated head and neck cancer, who will receive a combination of the vaccine with anti-PD-1 therapy.

Previously, the CheckMate-141 trial tested nivolumab in 361 patients with recurrent or metastatic, chemotherapy-refractory squamous cell head and neck cancer, and the results led to FDA approval in that setting. Sixty three of these patients were HPV16-positive, and the overall response rate among this group was 15.9%, with a median overall survival of 9.1 months.

 

2018-11-08T13:07:57-07:00November, 2018|Oral Cancer News|

HPV vaccine gains support of ADA

Source: Multi Briefs
Date: October 24th, 2018
Author: Tammy Adams

The American Cancer Society estimates there will be more than 50,000 new cases of oral cancer in 2018. And between 70 to 80 percent of these cases will be attributed to the human papillomavirus virus (HPV), a virus that has types associated with oropharyngeal cancer.

These staggering numbers call for action; action the American Dental Society is willing to take. Why? Because the HPV vaccine could prevent the vast majority of these new cases, but compared to other vaccines in the U.S., it is underutilized.

According to a resolution passed recently by the ADA House of Delegates, the ADA urges dentists to support the use and administration of the human papillomavirus virus vaccine, recognizing it as a way to help prevent infection of the types of HPV associated with oropharyngeal cancer.

Resolution 53H-2018 cites recommendations from the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices. It states that the vaccination is a “safe and effective intervention to decrease the burden of oral and oropharyngeal HPV infection.”

The policy is the result of a multifaceted ADA council proposal that includes input from the Council on Scientific Affairs, the Council on Advocacy for Access and Prevention and the Council on Dental Practice. A workgroup committed to the HPV issue and led by ADA volunteer members developed an evidence-based background report to help write the policy.

Dr. Paul Eleazer, past chair of the ADA Council on Scientific Affairs, said that he is encouraged to see the ADA “get behind” this growing crisis, referring to the rising number of HPV-associated cancers being reported. “There is incontrovertible evidence that this virus is responsible for the sharp uptick in oropharyngeal cancers, especially in younger patients and young adults,” said Dr. Eleazer.

In 2017, the ADA Council on Scientific Affairs and Center for Evidence-Based Dentistry published “Evidence-based Clinical Practice Guideline for the Evaluation of Potentially Malignant Disorders in the Oral Cavity” to inform dental professionals about the potential use of adjuncts as triage tools for the evaluation of lesions, including potentially malignant disorders, in the oral cavity. To view this guideline, visit ADA.org/OralCancer.

To read the full resolution related to the HPV vaccine, members can log in to the Member Center on ADA.org and click on “Committee C—Dental Education, Science and Related Matters” under Reports and Resolutions. It is Resolution 53.

2018-10-25T15:38:39-07:00October, 2018|Oral Cancer News|

Australia may become the first country to eliminate one form of cancer

Author: Brad Jones
Date: March 8, 2018
Source: flipboard.com

The International Papillomavirus Society has announced that Australia could become the first country to eliminate cervical cancer entirely.

According to a new study, Australia’s efforts to distribute a human papillomavirus (HPV) vaccine for free in schools have been a resounding success. The sexually transmitted infection causes 99.9 percent of cases of cervical cancer.

In 2007, the Australian federal government began offering the vaccine to girls aged 12-13, and in 2013 it was made available to boys, too. Girls and boys outside of that age bracket but under nineteen are also entitled to two free doses of the vaccine.

Between 2005 and 2015, the percentage of Australian women aged between 18 and 24 who had HPV dropped from 22.7 percent to just 1.1 percent. Immunization rates have increased further since 2015, contributing to what’s being described as a “herd protection” effect.

Coupled with a more advanced screening test that was introduced by the Australian government in December 2017, there are hopes that no new cases of cervical cancer will be reported within ten or twenty years.

THE WORLD ISN’T CATCHING UP

In the US, the HPV vaccine is not free. It can cost as much as $450 for the full regimen, according to the Association of Reproductive Health Professionals, although financial assistance is often available. In 2016, 78.6% of 15-year-old Australian girls, and 72.9% of 15-year-old Australian boys were vaccinated – but only 50% of American girls between 13 and 17, and 38% of American boys between 13 and 17 had received the vaccination, as per data published by the Henry J. Kaiser Family Foundation.

The situation is much worse in the developing world, where papillomavirus incidence rate remains high. “Two-thirds of the world’s population of women don’t get access to what Australian women do,” said Joe Tooma, the chief executive of the Australian Cervical Cancer Foundation. “Unless we do something, it will still be one of the major cancer killers in developing countries.”

Administering the HPV vaccine in schools has also proven to be effective in a trial that took place in Bhutan. Offering this kind of free access to the vaccine in other developing countries may seem like an expensive measure, but as the Australian example shows, it could ease the burden of cervical cancer down the line.

 

ASCO Urges Aggressive Efforts to Increase HPV Vaccination

Source: www.medscape.com
Author: Zosia Chustecka
 

Human papillomavirus (HPV) vaccines have now been available for 10 years, but despite many medical professional bodies strongly recommending the vaccine, uptake in the United States remains low.

Data from a national survey show that about 36% of girls and 14% of boys have received the full schedule of HPV vaccines needed to provide protection (Vaccine. 2013;31:1673-1679).

Now the American Society of Clinical Oncology (ASCO) has become involved, and in a position statement issued today the organization calls for aggressive efforts to increase uptake of the HPV vaccines to “protect young people from life-threatening cancers.”

“With safe and effective vaccines readily available, no young person today should have to face the devastating diagnosis of a preventable cancer like cervical cancer. But unless we rapidly increase vaccination rates for boys and girls, many of them will,” ASCO President Julie M. Vose, MD, said in a statement.

“As oncologists, we see the terrible effects of these cancers first hand, and we have to contribute to improving today’s alarmingly low vaccination rates,” she added.

The new policy statement is published online April 11 in the Journal of Clinical Oncology.

The statement notes that HPV vaccination has been previously recommended by many US medical societies, including the American Cancer Society, the American College of Obstetrics and Gynecology Committee, the American Dental Association, the American Head and Neck Society, the American Nurses Association, the American Pharmacists Association, the Association of Immunization Managers, the Society for Adolescent Medicine, and the Society of Gynecologic Oncology.

In addition, a joint letter was sent out to all physicians urging them to give a strong recommendation from the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the American College of Physicians, the Centers for Disease Control and Prevention, and the Immunization Action Coalition.

Now oncologists are specifically being asked by their professional body, ASCO, to join in with the push toward greater uptake of the HPV vaccines.

“ASCO believes oncologists can play a vital role in increasing the uptake of HPV vaccines,” the new policy statement says. “Although most oncologists will not be direct providers of these preventive measures, this does not abrogate us from contributing to this process. Our unassailable role in the mission to lessen the burden of cancer…places us in a position of influence. We should use interactions with our patients, primary care colleagues, and health care systems to raise awareness of HPV-related cancers and the role of vaccination in preventing them.”

Oncology providers have a responsibility to serve as community educators.

“Oncology providers have a responsibility to serve as community educators, disseminating evidence-based information to combat misconceptions concerning the safety and effectiveness of the HPV vaccine,” it continues.

“ASCO encourages oncologists to advocate for and actively promote policy change to increase vaccination uptake,” the statement concludes.

Issues With the Statement

However, there are a few issues with the statement, says a prominent researcher in the field of HPV and cervical cancer, Diane Harper MD, professor and chair of the department of Family and Geriatric Medicine, University of Louisville, Kentucky. Dr Harper, who was approached for comment, was involved in early clinical trials with both HPV vaccines (Gardasil, Merck & Co, and Cervarix, GlaxoSmithKline), and has emphasized the need for ongoing screening with Pap tests to prevent cervical cancer.

This is also one of the issues she raises about the ASCO statement, which does not mention screening. “All messages about HPV vaccination must be couched in terms of continued lifetime screening for cervical cancer,” Dr Harper told Medscape Medical News.

The ASCO statement highlights the potential that HPV vaccination has for preventing cancer. (Both vaccines protect against HPV types 16 and 18, and Gardasil offers additional protection against several other types). The statement notes that HPV is the cause of nearly all cervical cancer cases and that HPV genotypes 16 and 18 are responsible for 70% of cervical cancers. In the United States, HPV is responsible for 60% of oropharyngeal cancers, 90% of which are caused by HPV 16. HPV is also the cause of 91% of anal cancers, 75% of vaginal cancers, 69% of vulvar cancers, and 63% of penile cancers, again with HPV 16 as the predominant oncogenic genotype.

However, the statement also notes that “because of the long latency and the prolonged preinvasive phase after infection with HPV, many years of follow-up are needed for the ongoing trials to demonstrate a significant reduction in HPV-related cancers.”

Therefore, intermediate outcomes are being used as surrogate endpoints, it continues. HPV vaccines have been shown to prevent new cancer-causing HPV genotype-specific infections and resultant diseases, such as grades 2 and 3 cervical intraepithelial neoplasias (CIN), vaginal, vulvar, and anal intraepithelial neoplasias (as precursor lesions to cancer).

There is “almost certainty that cancers caused by oncogenic HPV genotypes will be dramatically reduced,” according to the statement.

Dr Harper told Medscape Medical News that the studies conducted to date have shown that “Cervarix has a 93% efficacy against CIN 3 regardless of HPV type; Gardasil has a 47% efficacy against CIN 3 regardless of HPV type, and Gardasil 9 is equivalent to Gardasil in the prevention of CIN 3 disease regardless of HPV type. None of these vaccines can prevent all CIN 3 or potentially all cancers.”

“Hence, the most important take home point is that screening is absolutely necessary as a prevention tool for preventing cancer by early detection of disease that when found, is curable,” Dr Harper emphasized.

Also, Dr Harper noted that the studies ended at prevention of CIN 2/3 disease as a clinical outcome. CIN 3 on average progresses to cancer in 20% of women within 5 years, and to 40% of women in 30 years. But, she points out, “there are no long-term follow-up studies that show that cancers will be averted.”

“The modeling exercises indicate that we have to wait at least 40 years before we will have a detectable decrease in cervical cancers from vaccination, assuming that at least 70% of the population being surveyed is vaccinated,” she added.

In its statement, ASCO cites the success of widespread vaccination against hepatitis B virus in reducing the incidence of liver cirrhosis and liver cancer as “an exemplary health model that supports more widespread HPV vaccination.”

But Dr Harper argues that “the prevention of liver cancer was an unexpected highlight of HBV vaccination. The primary purpose was to relieve the symptoms of chronic HBV sufferers. The continual re-infection with HBV seems to allow a natural infection to act as a booster in this population, which may not be the same for HPV.”

There also remains a question of how long the protection offered by HPV vaccination will last.

The ASCO statement says, “Both vaccines have a known duration of protection of at least 5 years, with ongoing study of the full duration of their effect,” and it notes that “additional research is needed to evaluate duration of protection to determine if booster doses are required.”

Dr Harper said, “Estimates of long-term effectiveness are based on antibody titers, yet there is no surrogate of protection defined by antibody titers.”

She added: “I agree that observational studies will inform the public health authorities about when a booster will be needed and whether it is needed sooner if only 2 doses are received vs later if 3 doses​ are received.”

Last, but not least, there is the issue of safety.

The ASCO statement notes that both Gardasil and Cervarix “reported excellent short- and long-term safety results in clinical trials. The most common adverse effects were mild and included injection site pain (approximately nine in 10 people) and swelling (approximately one in three), fever (approximately one in eight), headache, and fatigue (approximately one in two). These symptoms were transient and resolved spontaneously. The incidence of serious adverse effects was low and was similar to those who received placebo (aluminum-containing placebo or hepatitis A vaccine).”

However, worldwide there continue to be reports of adolescents who report chronic side effects and pain syndromes after being vaccinated against HPV. Some of these have been documented in the medical literature, with physicians reporting instances of previously healthy athletic girls becoming incapacitated with pain, fatigue, and autonomic dysfunction, and some remaining permanently disabled.

The US Food and Drug Administration and the Centers for Disease Control and Prevention have repeatedly said that HPV vaccines have an excellent safety record and that no causal associations have been found with atypical or unusual pain syndromes or autonomic dysfunction. The European authorities have investigated two chronic syndromes reported with HPV vaccination, and have said that there is no evidence to show causation.

However, Danish researchers who were among the first to report these syndromes criticized the investigation and are conducting their own study. There have also been lawsuits filed in several countries, and a class action lawsuit is now planned in Japan against the government and the vaccine manufacturers.

In an interview with Medscape Medical News, lead author on the ASCO statement, Howard H. Bailey, MD, from the University of Wisconsin Carbone Cancer Center, Madison, said that the concerns over safety should not be dismissed and should be studied further.

These issues need to be studied further, even if the authorities say that the vaccines are safe, he emphasized. These reports of girls becoming very ill, having pain syndrome and weakness, should not be diminished, he said, adding: “We can’t just ignore these reports…if there is risk involved, then that needs to be sorted out better.”

However, there is always a possibility that the syndromes and side effects that have been reported “have nothing to do with the vaccine,” Dr Bailey commented, citing the case of now-discredited theory linking autism to the pediatric vaccine for measles, mumps, and rubella.

There may be other explanations for the symptoms that are reported, or it could be that the symptoms/syndrome would have developed in the individual, anyway, but the vaccination precipitated it sooner, he suggested.

Dr Bailey noted that across the United States physicians are very sensitive to the fact that rates of pediatric vaccination have gone down because of the link that had been made to autism, subsequently shown to be false. Even though science eventually showed no link between the vaccine and autism, public confidence in the vaccine was damaged.

“When a person’s life has been devastated by an illness, that is very important, but if it turns out that the illness is not related to the vaccine, and in the meantime, the concerns over safety have stopped thousands of young people from being vaccinated….”well, eventually this will mean that there are more people who die from cancer, he said.

“I would be very reluctant right now to shut down the goals of vaccination over what has been reported, because the bottom line is that we have a tremendous problem with the rising incidence of HPV related cancers including in men as well as women when it comes to oropharyngeal cancers here in the States,” he added.

“The data, at least in my opinion, are so strong that HPV vaccination if it’s done in a [systematic] way will reduce the incidence of these cancers…I don’t want to stop whatever progress we are making when there is at best disagreement over whether these things are associated,” he said, although he also added that “maybe if it was my daughter, I would feel differently.”

Dr Bailey also addressed some of the other issues that had been raised about the ASCO statement, and said he agreed about the importance of screening.

“Even if vaccination does all the things we expect it to do, there is no doubt that cervical cancer screening needs to continue, and that’s a pretty standard recommendation across all of the groups,” he said. “We do not mean to diminish the importance of continued screening,” he said, but he added that screening lies in the domain of other physicians, such as primary care and gynecology, whereas this statement was targeted specifically at oncologists. “To take a step back, we are taking the view of cancer physicians, who take care of women, who are unfortunately too often dying of cervical cancer, and…we wanted to remind people that HPV vaccination can prevent this…as well as other associated cancers,” he said.

“The audience in North America has not been paying attention to this vaccination issue very much,” he continued, and “we wanted to remind oncologists and the public that at the heart of the issue is cancer prevention.

“We have this relatively easy way of preventing cancers over and above the ways that we already use,” he added.

“We wanted to remind people, especially in the oncology community, that there is this intervention out there that we think is highly, highly likely — if applied and used in a population format — will significantly reduce the number of women dying of cervical cancer, the number of men and women dying from oropharyngeal cancer, which is increasing in the US…and that was the main focus of the article,” Dr Bailey commented.

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

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