Breaking Vaccine News ! 1 dose of Cervical Cancer vaccine may be as good as the full course

By: BIANCA NOGRADY, Pediatric News Digital Network |

JUNE 9, 2015

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FROM LANCET ONCOLOGY

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VITALS

Key clinical point: One or two doses of the bivalent human papillomavirus vaccine provide a level of protection against cervical HPV infection similar to that of the full three-dose schedule.

Major finding: Vaccine efficacy against HPV16/18 infection was 85.7% for one dose, 76% for two doses, and 77% for three doses.

Data source: Post hoc analysis from two phase III, double-blind, randomized controlled trials of 24,055 women.

Disclosures: The study and included trials were supported by the U.S. National Cancer Institute, National Institutes of Health Office of Research on Women’s Health, and Ministry of Health of Costa Rica (CVT) and GlaxoSmithKline Biologicals SA (PATRICIA). Some authors disclosed ties with GlaxoSmithKline.

One or two doses of the bivalent human papillomavirus vaccine provide a level of protection against cervical HPV infection similar to that of the full three-dose schedule, according to post hoc analysis from two phase III, double-blind, randomized controlled trials with 4 years follow-up.

Data from the Costa Rica Vaccine Trial and PATRICIA trials of the HPV-16/18 vaccine, tested in 24,055 women, showed vaccine efficacy against HPV-16/18 infection for one dose was 85.7%, two doses, 76%, and three doses, 77%, according to a paper published online June 10 in Lancet Oncology.

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The analysis also showed that vaccine efficacy was significantly improved in women who received two doses when the second dose was received 6 months after the first, rather than 1 month (Lancet Oncology 2015, June 10 [doi: dx.doi.org/10.1016/ S1470-2045(15)70199-3]). “If one-dose HPV vaccine administration provides strong protection against HPV-16/18 for the long term, this approach might be what is necessary to overcome the barriers prohibiting vaccine uptake in many world regions,” wrote Aimée R Kreimer, Ph.D., of the National Cancer Institute, Bethesda, Md., and her associates. “These data strongly argue for a direct assessment of one-dose efficacy of the HPV-16/18 vaccine.”

Because these results “were replicated in a cohort of women naive to HPV-16/18 infection at the time of vaccination” these results are “probably relevant to girls in the preferred age range for HPV vaccination (i.e., 11-12 years),” they said..

The study and included trials were supported by the U.S. National Cancer Institute, National Institutes of Health Office of Research on Women’s Health, and Ministry of Health of Costa Rica (CVT) and GlaxoSmithKline Biologicals SA (PATRICIA). Some authors disclosed ties with GlaxoSmithKline.

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One-dose vaccine for developing world?

If human papillomavirus vaccines could be delivered as one dose, while retaining their efficacy against the most oncogenic HPV types 16 and 18, we could substantially decrease the global burden of cervical cancer, particularly in resource-poor settings where an annual vaccination program might be difficult to sustain.

Importantly, strong vaccine protection irrespective of dose also was shown for persistent infection, a recommended outcome measure for assessment of protection in prophylactic HPV vaccine trials.

Dr. Julia M.L. Brotherton is from the National HPV Vaccination Program Register, Melbourne. These comments were excerpted from an editorial (Lancet Oncology 2015, June 10 [http://dx.doi.org/10.1016/S1470-2045(15)70253-6]). She declared research grants from bioCSL/Merck.

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ACIP USA says that Live Flu vaccine is BETTER than Inactivated Flu Vaccine, June 2015

ATLANTA, Georgia — In a rare move, the Advisory Committee on Immunization Practices (ACIP) experts have unanimously endorsed AstraZeneca's FluMist Quadrivalent nasal spray over influenza shots for healthy children aged 2 to 8 years.

Until now, the panel had only issued general recommendations for ratification by the Centers for Disease Control and Prevention, such as annual immunization for everyone older than 6 months. Preferential use of the nasal spray vaccine is already endorsed by Canada, the United Kingdom, Germany, and Israel.

The vote reflected compelling data from 4 randomized controlled trials showing fewer cases of laboratory-confirmed influenza among young children receiving trivalent live attenuated vaccine (LAIV), rather than inactivated influenza vaccine. LAIV was also linked to a decreased risk for otitis media. There was no difference between vaccines with respect to hospitalization, medically attended respiratory illness, or influenza-like illness.

No comparative information is yet available for quadrivalent LAIV, which became available in 2013 and will be used this season.

In discussions before the vote, manufacturing and physician group representatives spoke out in opposition against the LAIV bias, noting that orders for inactivated influenza vaccine had been placed in February and that some families may be sensitive to the $10 price differential.

"You shouldn't place doctors and families in a situation where, if they don't receive the live vaccine, they feel they're getting an inferior product, because it may not be an inferior product," noted Michael Brody, MD, PhD, a family practitioner from Indianapolis, Indiana.

The ACIP emphasized that LAIV is only preferred "when available," and that vaccination should not be delayed to obtain LAIV.

"Both the live and attenuated vaccine are considered safe and effective.... [N]ot getting [LAIV] is not a major disadvantage," said Jeffery Duchin, MD, from the University of Washington School of Medicine in Seattle and chief of the Communicable Disease Epidemiology and Immunization Section of Seattle and King County Public Health Department.

Other members noted that studies suggest increased efficacy for inactivated influenza vaccine in adults that may extend to older children. LAIV is not indicated for individuals older than 49 years.

ACIP Postpones Vote on Yellow Fever Booster

Another issue discussed during yesterday's meeting was whether the ACIP should follow the World Health Organization's recent decision that a 10-year booster is no longer required for yellow fever vaccine, except in certain types of individuals.

Although available evidence suggests that 1 shot confers lifelong protection, panel members expressed concerns regarding data quality (level 4), particularly with respect to particular groups.

One of the issues raised was whether boosters should still be used among individuals originally vaccinated at younger than 1 year. Panel members cited the cutoff as "arbitrary" and suggested that an age of 5 years may be more appropriate to ensure vaccine response.

"We have incredible data that children younger than 3 years don't respond as well as older individuals," stated Janet Englund, MD, professor of pediatric infectious diseases at the University of Washington and Seattle Children's Hospital, noting that the proposed policy also did not account for older individuals returning to an endemic area after a long period of time. "When they come to be 40 or 50 years old, there is no vaccine we have that lasts that long," she said.

The original ACIP recommendation suggested a continued need for boosters among travelers who last received a vaccine 10 or more years ago and are planning long stays in endemic areas or travel to highly endemic areas such as West Africa; laboratory workers who routinely handle infectious yellow fever; and individuals who might have had a compromised immune response to the initial dose because of young age (younger than 1 year), pregnancy, or HIV infection.

The ACIP convened yesterday and today in Atlanta, Georgia, for 1 of the 3 meetings it holds each year.

Source (needs free registration on medscape)

Comment: In India we do have NASOVAC by Serum Institute of India that is the only available LAIV (Live Flu vaccine). while results between different vaccine brands cannot be directly correlated, it is safe to extrapolate that at the very least it will be equivalent to the available International Inactivated Flu brands in Indian like Influvac, Vaxigrip etc.

'Silent' Celiac Disease Found in Kids at Rheumatology Clinic - Pediatrics Journal , 2015

"Silent" celiac disease (CD), or CD without gastrointestinal symptoms, was present in 2.0% of children presenting for initial pediatric rheumatology evaluation, researchers from the Hospital for Special Surgery, New York City, report in an article published online June 15 in Pediatrics. The authors say celiac testing should be included in the standard initial laboratory workup for pediatric rheumatology patients, as they found that initiation of a gluten-free diet led to resolution of musculoskeletal symptoms in many of the affected patients.

Yekaterina Sherman, BA, and a research team led by Thomas J. A. Lehman, MD, retrospectively reviewed medical charts and data from standardized serologic screening for 2125 patients (age, 2 - 16 years) who presented for care at the Hospital for Special Surgery, Division of Pediatric Rheumatology, between June 2006 and December 2013. The researchers found that 36 patients had previously unsuspected CD. Together with the eight patients known to have CD at study entry, the prevalence of CD during the 6.5-year study period was 2.0%, or about 1 in 48 patients. Prevalence in the general population was 0.7%.

Thirty of the 36 "silent CD" cases were confirmed by endoscopy. Six refused endoscopy but had significant reduction of symptoms with a gluten-free diet.

"The majority of the newly diagnosed CD cases, 22 out of 36 (61.1%), presented with musculoskeletal complaints alone and none of the classic symptoms of CD, such as abdominal pain, short stature, weight loss, and failure to thrive,” the authors write. “In fact, only 12 patients reported a history of [gastrointestinal]-related complaints." They note that these data provide further evidence that symptom-based case finding will miss the majority of CD cases in children.

Pediatric CD Guidelines Need a Rewrite

The researchers suggest that current clinical guidelines for CD screening published by the American College of Gastroenterology and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition be revised to include children with musculoskeletal complaints.

Current guidelines do not consider such patients to be a high-risk group and do not specifically recommend screening of this population. The guidelines recommend CD screening for children with failure to thrive, persistent diarrhea, recurrent abdominal pain, constipation and vomiting, dermatitis herpetiformis, dental enamel hypoplasia, osteoporosis, short stature, delayed puberty, iron-deficient anemia, asymptomatic diabetes mellitus, autoimmune thyroiditis, Down syndrome, Turner syndrome, Williams syndrome, selective immunoglobulin A deficiency, and a history of a first-degree relative with CD.

Clinicians using the current guidelines rather than screening all children with musculoskeletal complaints would have missed all but six of the asymptomatic CD cases in the study population. The authors note that prompt detection of CD would not only enable the patient to achieve the benefits of early initiation of a gluten-free diet but also avoid the dangers of unnecessary immunosuppressive therapy.

If CD Is Present, Is This Really Idiopathic Arthritis?

The association between CD and musculoskeletal complaints raised a further interesting question: Is this really "idiopathic arthritis" if it resolves with treatment of CD?

"Our data suggest that there may be a subset of patients with 'silent' CD who present with isolated musculoskeletal symptoms and that perhaps [juvenile idiopathic arthritis] is not an appropriate diagnosis in these cases. Clinicians must be vigilant in cases such as these to evaluate appropriately for CD," the authors note.

The authors have disclosed no relevant financial relationships.

Pediatrics. Published online June 15, 2015. 

Source (requires free registration at Medscape)

Comment: For rheumatology clinics, this is an important observation. However it is also something that practising pediatricians need to remember and add to the list of large number of non specific symptoms that requiring screening for celiac disease.

Should you get HPV vaccination above the age of 26 years ?

HPV vaccine after age 26: Should you get one?

JENNIFER GUNTER, MD | CONDITIONS | JUNE 14, 2015

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Currently the HPV (human papilloma virus) vaccines are approved in the United States up to the age of 26. This has nothing to do with safety but due to the fact that the studies submitted to the Food and Drug Administration (FDA) involved this age range. The HPV vaccines were primarily studied in women aged 26 years and younger because age is a significant factor in acquiring HPV. If you want to show that your vaccine can help people you need to study as many of your target population as possible. You also need to make translating your work to the general population practical — doing antibody levels to see who is immune is an expensive barrier, so age became the proxy.

The peak risk of acquiring cancer causing HPV is under the age of 25 so the younger the women, the more likely the vaccine will be given before exposure to HPV occurs. That’s why targeting 11 and 12-year-old is important. In addition, the immune response to the vaccine may be more robust around age 11 or 12. However, what if you are 27 and for whatever reason never got vaccinated against HPV or are 38 and the vaccine didn’t exist when you were in the target age range? Could the HPV vaccine be helpful for women over the age of 26?

New data looking at antibodies in the blood against HPV tells us that the risk of having either HPV 16, 18 (the most cancer causing types) or both over the age of 30 is 24 percent  for women with a history of normal pap smears. For those with a history ofhigh-grade dysplasia the risk of having one or both of the viruses jumps to 44 percent. The highest risk age group for HPV 16/18 is ages 30 to 39 years — 33 percent of women in this age range will be positive, and if they have a history of high-grade dysplasia it rises to 55 percent.

The risk of HPV declines after 39, no one know if the natural antibody levels simply drop or if this is due to different cumulative sexual practices in older women (one study shows that antibody levels to HPV 16 don’t decrease with age).

In the study I linked to above the biggest modifiable risk factor for HPV 16 or 18 was the number of sexual partners — three or more lifetime partners increased the risk six fold. A history of having Chlamydia (a sexually transmitted infection) almost doubled the risk.

It’s easy to see why governments looking for the best impact for each public health dollar have focused on ages 11 and 12. If you get everyone before they are sexually active, then everyone can benefit. But what about you as an individual?

There is nothing wrong with getting the HPV vaccine over the age of 26, although in most countries that will mean you have to pay for it yourself. It just means the older you are, the less likely you will get the full protection as the risk increases with age that you have already been exposed. Women over the age of 26 who are most likely to benefit would never have had an abnormal Pap smear, have no history of Chlamydia, and have less than three lifetime sex partners. However, 45 percent of women between the ages of 30 and 39 with a history of high-grade dysplasia will still be negative for HPV 16 and 18 and so almost half will get protection from the HPV vaccine. Australia, a real leader in the fight against HPV, recommends the vaccine for women up to the age of 45. If you want to eradicate the virus getting as many people covered as possible is the way to go.

Given the new vaccine covers nine types of HPV there is a greater chance that more women over the age of 26 regardless of sexual history will get some protection, but whether it’s will be worth the $390 is an individual decision. Since two doses seems to be as effective as three a strategy for women over the age of 26 who are paying out-of-pocket might be to consider 2 doses (which currently costs $260).

However, until we can improve vaccination rates among adolescents in the United States there will be a steady stream of women who have to try to figure out if they want to spend their money on the vaccine or take their chances.

Jennifer Gunter is an obstetrician-gynecologist and author of The Preemie Primer. She blogs at her self-titled site, Dr. Jen Gunter.

Image credit: Shutterstock.com

Comment: In India, HPV vaccines are licensed till the age of 45 years. I as a pediatrician do recommend it to mothers since none of them have taken it as a child, due to its recent development. If the message is reinforced by the gynecologist it can definitely increase the accpetance in the older women as well. (unfortunately most of the time they believe that I am intruding their turf and do not recommend it!) 

Bengaluru mom, doctor set up free vaccination reminder service for Indian kids

Jun 03 2015 : The Times of India (Bangalore)

Sunitha Rao

Bengaluru:





When Janan Bharath became a mother she struggled to balance car ing for her baby, doing all the household chores and her regular schedule at work. Be fore she realized it, she had missed two routine vaccina tions for her baby.Though she quickly made up for it, it struck her tha many parents, caught up in the whorl of parenthood probably forget too.
She began working with paediatrician and fellow Ben galurean Dr Ranjan Kumar Pejaver and seven years later they came up with a free tex messaging reminder service to ensure that mothers take their children for their shots on time. The IAP-Immuni zeIndia service was rolled ou as a pilot programme in 2013 and launched nationwide in March 2014.
Today, the service alerts 4.6 lakh parents get about vac cination schedules has been adopted by the Indian Acade my of Paediatrics. The World Health Organization has evinced interest in replicat ing the method in Latin America.
Once a parent enrolls for the free service by texting the child's name and date of birth, the reminders pop up for the next 12 years till all vaccinations are completed.Three reminders are sent: Two before the due date and one after. It is free of cost across all mobile phone net works in the country.
“My mother was shocked when I first told her that I had missed vaccination for my son. She asked me what was more important. I felt so guilty and wished there had been someone to remind me,“ says Bharath.
“That's when the thought of a reminder service using technology struck me. I knocked on the doors of many hospitals and finally founded Immunization India Charities,“ she says.
Dr Pejaver, professor of pediatrics and neonatology, Indian Academy of Paediatrics, explains that more than 1.5 million children under the age of 5 die every year in the country and 1 million or more are disabled because they are not vaccinated.
“A major reason is that parents often forget to vaccinate the child on time as most of them do not maintain a vaccination calendar for their child,“ says Dr Pejaver.
“This is seen in both urban and rural areas. For the first three months, the new mother is very careful as the family chips in and helps her.Once she returns to work, immunization is postponed or forgotten. But immunization if missed has repercussions,“ he says. “That's what we want to prevent.“
TIMES VIEW
The vaccine reminder app is another example of how technology can be used well. It's also an indication of how dependent we've become on our cellphones. Earlier, mothers would use a hardcopy calendar to mark the days when the next vaccination was due and diligently follow it. In these days of too many distractions and advanced facilities, this reminder app should do the trick and get busy mothers and their babies to doctors.Vaccination is crucial for a child's being, notwithstanding its rejection by some misguided persons in the West, and if it takes an app to ensure it's done, so be it.

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