Vaccines: The Week in Review 27 July 2013

Vaccines: The Week in Review is a weekly digest — summarizing news, events, announcements, peer-reviewed articles and research in the global vaccine ethics and policy space. Content is aggregated from key governmental, NGO, international organization and industry sources, key peer-reviewed journals, and other media channels. This summary proceeds from the broad base of themes and issues monitored by the Center for Vaccine Ethics & Policy in its work: it is not intended to be exhaustive in its coverage. You are viewing the blog version of our weekly digest, typically comprised of between 30 and 40 posts below all dated “29 June 2013″
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David R. Curry, MS
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Center for Vaccine Ethics and Policy
a program of the
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– Children’s Hospital of Philadelphia Vaccine Education Center
Associate Faculty, Division of Medical Ethics, NYU Medical School

HPV Vaccination Coverage Among Adolescent Girls, 2007–2012; Postlicensure Vaccine Safety Monitoring, 2006–2013 — U.S.

CDC/MMWR Watch [to 27 July 2013]
CDC Telebriefing on human papillomavirus (HPV) vaccination coverage and vaccine safety monitoring
Thursday, July 25, 2013 at Noon ET

Press Briefing Transcript
Excerpt [Editor’s text bolding]
“…Just last month, I had a chance to share with you really good news that HPV vaccination works even better than we anticipated.  The types of HPV, that’s human papillomavirus, that commonly cause cervical cancer in the U.S., had dropped by about half in girls aged 14 to 19 in the seven years since we recommended routinely vaccinating against HPV.  I noted at that time that the results were striking, and would serve – should serve as a wake-up call to increase vaccination rates, because we really can protect the next generation of adolescents against cancers caused by HPV.  Unfortunately, today we have disappointing news.  An article in today’s MMWR shows that HPV vaccination coverage for girls getting the anti-cancer vaccine has not increased at all from one year to the next.  Zero.  We’re dropping the ball.  We’re missing opportunities to give HPV vaccines, and that needs to change to protect girls from cervical cancer.  I’ll provide some more detail and then discuss missed opportunities and information about vaccine safety.

But the article published today has data from what’s called the National Immunization Survey on teen vaccinations.  This is how we measure how we’re doing.  It collects vaccine information for 13 to 17-year-olds using a random digit sample of landlines and, starting in 2011, cellular telephone phones as well.  After a teen’s parental guardian gives permission, we contact the vaccination provider, doctor, nurse practitioner or other provider and mail a questionnaire to get the vaccination history.  The 2012 survey which we’re reporting about today included vaccination records of about 19,000 teens.  And today’s article focuses on HPV vaccination among girls from 2007 to 2012.  Next month we’ll share the data we collected last year on other vaccines recommended specifically for preteens and teens, and that will include vaccination coverage estimates for HPV vaccinations among boys, something that’s only more recently been recommended.

These national data show no progress, zero, with HPV vaccine coverage in 2012.  We’re used to seeing coverage increases of 10 percent per year when a new vaccine hits the market.  Last year we were disappointed at the increase in HPV vaccine was only 4 percentage points.  This year, it’s zero percentage points.  The HPV vaccine coverage hasn’t kept pace with other vaccines recommended for preteens and teens.  One dose does not provide all of the protection that the HPV vaccine series has to offer so we want all girls to get their second and third doses.  By 2011, 34.8 percent of teen girls finished their three-dose series.  2012 data is not different.  It’s 33.4 percent.  Actually, slightly fewer teen girls are given all doses from the previous years.  This is a huge disappointment, but I’m confident that we will turn it around.  And one of the reasons for that is in the next piece of data that we got from this survey.

We assumed that one of the reasons we had such low rates was that adolescents don’t see the doctor regularly so it’s hard to get a three-dose series in.  But actually, we found that – that the data showed that if HPV vaccine were given every single time a young person went to the doctor to get another vaccine, the completion of those series would be at 93 percent.  That’s important, because if we get three-dose series to 80 percent, an estimated 53,000 cases of cervical cancer could be prevented over the lifetimes of girls aged 12 and younger.  Now there are lots of ways we can work together to increase vaccination rates.  A key one is to take advantage of every opportunity to vaccinate against HPV.  The teens are in the doctor’s office, they’re getting another vaccination, but they’re not getting the HPV second and third doses.

We also asked parents why they haven’t gotten their daughters vaccinated.  And one of the top reasons is that their doctors didn’t recommend it.  This is critical.  Research consistently showed that a provider’s recommendation to vaccinate is the single most influential factor in determining whether a parent gets their kid vaccinated.  So we need to step up our efforts by talking to parents about the importance of this vaccine.  Doctors need to recommend this vaccine just as they recommend others, and ensure that they’re given every opportunity.  Parents have also told us in other research there are concerns about this – this may be in some way a license or permission to have sex.  But multiple studies have found that preteens and teens who receive this vaccine do not have sex any sooner than their peers who have not received the vaccine.  HPV vaccine does not open the door to sex.  HPV vaccine closes the door to cancer.  The vaccine has to be given before onset of sexual activity.  We can’t let this opportunity go to waste.  And I really would make the analogy to many of our other vaccines.  We make sure that people get vaccinations well before they get exposed.  We’re not saying they’re going to be exposed immediately after.  Just that we want to make sure they get vaccinated well before…”

Human Papillomavirus Vaccination Coverage Among Adolescent Girls, 2007–2012, and Postlicensure Vaccine Safety Monitoring, 2006–2013 — United States
MMWR Weekly
July 26, 2013 / 62(29);591-595
Since mid-2006, the Advisory Committee on Immunization Practices (ACIP) has recommended routine vaccination of adolescent girls at ages 11 or 12 years with 3 doses of human papillomavirus (HPV) vaccine (1). Two HPV vaccines are currently available in the United States. Both the quadrivalent (HPV4) and bivalent (HPV2) vaccines protect against HPV types 16 and 18, which cause 70% of cervical cancers and the majority of other HPV-associated cancers; HPV4 also protects against HPV types 6 and 11, which cause 90% of genital warts.* This report summarizes national HPV vaccination coverage levels among adolescent girls aged 13–17 years from the 2007–2012 National Immunization Survey-Teen (NIS-Teen) and national postlicensure vaccine safety monitoring. Although vaccination coverage with ≥1 dose of any HPV vaccine increased from 25.1% in 2007 to 53.0% in 2011, coverage in 2012 (53.8%) was similar to 2011. If HPV vaccine had been administered during health-care visits when another vaccine was administered, vaccination coverage for ≥1 dose could have reached 92.6%. Safety monitoring data continue to indicate that HPV4 is safe. Despite availability of safe and effective vaccines and ample opportunities for vaccine delivery in the health-care setting, HPV vaccination coverage among adolescent girls failed to increase from 2011 to 2012…

Saudi Arabia MOH Issues Health Regulations for Hajj-1434H

Kingdom of Saudi Arabia: MOH Issues Health Regulations for Those Flocking to Saudi Arabia to Perform Umrah and Hajj-1434H
12 July 2013

[Full text]
Proceeding from the keenness of the government of the Custodian of the Two Holy Mosques to maintain the public health and ensure a safe and healthy atmosphere for the performers of Pilgrimage “Hajj” and Umrah, Allah Willing; in order to enable them to perform the rituals easily, healthily and conveniently, and within the framework of the precautionary measures against Novel Coronavirus (MERS-COV), the Ministry of Health (MOH) has issued health regulations and requirements that must be met by those coming to the Kingdom for performing Umrah  and Hajj for the year 1434 H.

These regulations included the recommendation of postponing the performance of Umrah and Hajj this year in case of the elderly people and patients suffering from chronic diseases such as heart, kidney, and respiratory diseases, not to forget diabetes, as well as patients with congenital and acquired immune deficiency, in addition to patients suffering from tumors, and pregnant women and children.

Within the same vein, the regulations included some tips and health awareness guidelines for citizens, residents and visitors to perform Umrah or Hajj such as: washing hands well and continually with water and soap, or with other hand disinfectants, especially after coughing, sneezing, using a tissue when coughing or sneezing, then getting rid of it in a waste basket, avoiding touching eyes, nose or mouth directly with hands, limiting direct contact with infectious people and avoiding sharing their personal tools, wearing face-masks in overcrowded places, and maintaining hygiene in general. Furthermore, these regulations included obtaining a valid certificate of vaccination against meningitis at least 10 days before travelling to the Kingdom, and up to 3 years, as well as getting a certificate of vaccination against polio-affected countries, according to specific requirements.

It is worth mentioning that the health regulations have shed light on the importance of vaccination against seasonal influenza vaccine, especially for people with chronic diseases such as heart and kidney diseases, diabetes and respiratory and neurological diseases, as well as people with congenital and acquired immune deficiency diseases, metabolic diseases, pregnant women and children under 5 years, aside from people suffering from obesity and overweight.

To view the Health Regulations for Travellers to Saudi Arabia to Perform Umrah & Hajj-1434H.​

Novartis, Biological E Limited in agreement for two vaccines to protect against typhoid and paratyphoid fevers

Novartis announced a development and licensing agreement with Biological E Limited (BioE, India) ) for two vaccines to protect against typhoid and paratyphoid fevers. Under the license, Novartis Vaccines Institute for Global Health (NVGH) will transfer technology to BioE, which will have financial and operational responsibility for manufacturing, further clinical development, approval and distribution in the developing world. The typhoid vaccine (Vi-CRM197) involved has achieved Proof of Concept, had successful Phase 2 results, and will be transferred to BioE. A combined typhoid-paratyphoid vaccine will be transferred once Proof of Concept is completed through early, small-scale studies in humans to determine safety and immunogenicity. The Wellcome Trust continues to support the development of the dual-acting vaccine through a Strategic Award that was awarded in 2009. BioE said it is committed to achieving WHO pre-qualification and fulfill specific obligations to meet Novartis standards. The agreement is worldwide except for developed countries, where Novartis will retain rights.

WHO: World Hepatitis Day 2013

WHO: World Hepatitis Day 2013
News Release
24 July 2013

On World Hepatitis Day (28 July), WHO is urging governments to act against the five hepatitis viruses that can cause severe liver infections and lead to 1.4 million deaths every year. Some of these hepatitis viruses, most notably types B and C, can also lead to chronic and debilitating illnesses such as liver cancer and cirrhosis, and in addition to, loss of income and high medical expenses for hundreds of millions of people worldwide…

…“The fact that many hepatitis B and C infections are silent, causing no symptoms until there is severe damage to the liver, points to the urgent need for universal access to immunization, screening, diagnosis and antiviral therapy,” says Dr Keiji Fukuda, WHO Assistant Director-General for Health Security and the Environment.

“Many of the measures needed to prevent the spread of viral hepatitis disease can be put in place right now, and doing so will offset the heavy economic costs of treating and hospitalizing patients in future.”

This year, in the run up to World Hepatitis Day, the Organization is releasing its first-ever country hepatitis survey, covering 126 countries. The WHO “Global policy report on the prevention and control of viral hepatitis in WHO Member States” identifies successes as well as gaps at country level in the implementation of four priority areas. The priority areas are raising awareness, evidence-based data for action, prevention of transmission, and screening, care and treatment.

The findings show that 37% of the countries have national strategies for viral hepatitis, and more work is needed in treating hepatitis. It also highlights that while most of the countries (82%) have established hepatitis surveillance programmes, only half of them include the monitoring of chronic hepatitis B and C, which are responsible for most severe illnesses and deaths…

World Hepatitis Day Statement by HHS Secretary Kathleen Sebelius and HHS Assistant Secretary for Health Dr. Howard Koh

IVI launches new matrix-based organization

IVI said it launched a new matrix-based organization “as part of its efforts to increase efficiency and accountability in management and implementation of its research projects.” The key elements of the new organization, which has been put in place in line with IVI’s new Strategic Plan, are the introduction of formal portfolio and project management, and a greater focus on vaccine pipeline and delivery. IVI now comprises of the following units:
:: Portfolio Management
:: Development and Delivery
:: Laboratory Sciences
:: Finance & Administration
:: Communications & Advocacy
:: Human Resources

The Portfolio Management Unit has three main programs as of now: Cholera, Typhoid and Dengue, and also includes the functions of Portfolio Manager, Grant Manager, and Business Development Manager. The Development and Delivery Unit has four departments: Clinical Development and Regulatory, Epidemiology, Biostatistics and Data Management, and Access. As well, an internal Portfolio Management Committee has been created to overlook IVI’s research and development projects.

IVI noted that these changes have been made “to ensure that IVI will be well-positioned to achieve maximal impact and deliver on its mission – the discovery, development, and delivery of safe, effective and affordable vaccines for developing nations.”

UN to establish WHO-led Interagency Task Force on the Prevention and Control of Noncommunicable Diseases

United Nations to establish WHO-led Interagency Task Force on the Prevention and Control of Noncommunicable Diseases
Note for media

22 July 2013 | Geneva – The Economic and Social Council (ECOSOC) adopted a resolution requesting the UN Secretary-General to establish a United Nations Interagency Task Force on the Prevention and Control of Noncommunicable Diseases. The Task Force will be convened and led by the WHO and will be created by expanding the mandate of the existing United Nations Ad Hoc Interagency Task Force on Tobacco Control and the work to support the implementation of the WHO Framework Convention on Tobacco Control (WHO FCTC). The resolution was adopted in ECOSOC’s 2013 Substantive Session being held in Geneva, Switzerland.

The Task Force will coordinate the activities of all UN organizations to implement the WHO Global Action Plan for the Prevention and Control of NCDs 2013-2020, adopted by the World Health Assembly in May 2013. This is important because new WHO estimates show that 3 of the 4 leading causes of death worldwide are linked to noncommunicable diseases, specifically cardiovascular diseases and chronic obstructive pulmonary disease.

The Action Plan aims to achieve 9 voluntary global targets, including a 25% reduction in premature mortality from cardiovascular diseases, cancer, diabetes, and chronic respiratory diseases by 2025. The plan provides a road map and a menu of policy options for Member States, WHO, other UN organizations, NGOs and private sector entities to implement collectively.

Heads of State and Government in 2011 recognized the role and responsibility of governments in reducing noncommunicable diseases through the United Nations Political Declaration on the Prevention and Control of NCDs. With this resolution, ECOSOC is following up on those commitments.

WHO will convene a formal meeting with Member States on 13 November 2013 to complete the work on a draft terms of reference for the UN Task Force on NCDs.