Vaccine News and Commentary
Religious Objections to Vaccination -- Discussion on Public Radio
On a recent edition of Interfaith Voices
, the public radio program devoted to religious news and discussion, objections to vaccination on religious grounds were among the topics. We appeared as a guest for the segment.
Among the issues discussed were the availability of religious exemptions from U.S. state vaccination requirements, the processes by which such exemptions are granted, and the relationship between these policies and philosophical (or personal-belief) exemptions from school vaccination laws.
The interview can be heard here
Follow us on Twitter: @vaccineethics
As VaccineEthics.org approaches its seventh anniversary next month, our Twitter feed -- @vaccineethics
-- has largely replaced blog.vaccineethics.org as our principal venue for sharing updated information on the latest developments in vaccine ethics and policy.
If you don't already follow us on Twitter, please do so. There you'll find frequent updates regarding research, news, and commentary on vaccination programs and policy in the United States and around the world.
-- VaccineEthics.org staff
Sixth Edition of 'Vaccines' Textbook Published
The newly revised and expanded sixth edition of Vaccines
, the authoritative textbook of vaccine science and policy, has recently been published (Elsevier, 2013). Edited by Stanley Plotkin, Walter Orenstein, and Paul Offit, the nearly 1600-page volume includes up-to-date information about existing vaccines, new vaccines in development, and a range of policy and public health issues related to vaccination activities around the world. Additional information and the complete table of contents can be found here
The volume includes an extensively revised and updated chapter on vaccine ethics
written by Jason L. Schwartz and Arthur Caplan. The chapter discusses ethical issues unique to vaccination, specific ethical considerations throughout the vaccine life cycle (from research and development through implementation), and special topics in vaccine ethics and policy such as HPV vaccination, vaccination of health care workers, eradication campaigns, and vaccination in pandemic preparedness and response.
AMA Ethics Journal Issue on Vaccines
The January issue of Virtual Mentor
, the monthly ethics journal published by the American Medical Association, is titled "Vaccines and Ethics." The 11 papers in the issue
examine a variety of topics related to this area, including HPV vaccination, adult vaccination, parental consent, and vaccine research, among other topics.
Among the papers is "New Media, Old Messages: Themes in the History of Vaccine Hesitancy and Refusal,"
by Jason L. Schwartz of the University of Pennsylvania, Editor of VaccineEthics.org. The paper discusses the long history of public opposition to vaccination and possible lessons from these experiences for contemporary vaccination programs and policy.
Labels: About us, CDC, History, Policy, Recommendations, Risk, Safety
Ethics and Vaccine Refusal
Amid recent news detailing increases in non-medical exemptions
from state vaccination requirements and physician experiences with alternative childhood immunization schedules
, the latest issue of Primary Care: Clinics in Office Practice
is devoted entirely to vaccination. The dozen papers included in the issue explore a variety of topics related to the science and administration of vaccines, with a particular focus on issues relevant to primary care physicians.
Among the papers is "Vaccination Refusal: Ethics, Individual Rights, and the Common Good,"
by Jason L. Schwartz and Arthur L. Caplan of the University of Pennsylvania Center for Bioethics (and VaccineEthics.org). Here is the paper's abstract:
"Among the obstacles to the success of vaccination programs is the apparent recent increase in hesitancy and outright resistance to the recommended vaccination schedule by some parents and patients. This article reviews the spectrum of patient or parental attitudes that may be described as vaccine refusal, explores related ethical considerations in the context of the doctor-patient relationship and public health, and evaluates the possible responses of physicians when encountering resistance to vaccination recommendations. Health care providers should view individuals hesitant about or opposed to vaccines not as frustrations or threats to public health, but as opportunities to educate and inform."
A subscription is required for access to the full paper. Interested readers without such access may contact us
for a personal copy.
Labels: About us, Policy, Recommendations, Risk
Interactive map of vaccine-preventable disease outbreaks
The Council on Foreign Relations
, a Washington, DC-based think tank, announced today
the launch of an interactive map tracking outbreaks of vaccine-preventable diseases.
The map, available here
, presents data about the location and size of outbreaks, the disease(s) involved, and links to news coverage. The resource currently includes information from 2008 to the present and will be updated weekly. Visitors to the site can contribute information about additional outbreaks for review by CFR staff.
The Council of Foreign Relations' Global Health Program is home to Laurie Garrett
, the well-known author and commentator on global health and infectious disease policy.
ACIP to vote Tuesday on new HPV vaccine recommendation for males
Two years after declining to endorse routine use of Gardasil in males, the CDC's Advisory Committee on Immunization Practices is scheduled to vote tomorrow
on a revised recommendation that would support vaccination of males with the vaccine for protection against genital warts and other HPV-related diseases.
Gardasil has been licensed for the prevention of genital warts in males since October 2009
; an expanded indication in December 2010 added prevention of anal cancer
in both sexes to its approved uses.
In late 2010, we wrote about the status of recommendations regarding Gardasil in males (among other policy and ethical issues related to HPV vaccination) in a paper published in the American Journal of Public Health
-- "HPV Vaccination's Second Act: Promotion, Competition, Compulsion"
. The paper argued that the decision not to endorse routine male vaccination be reconsidered, particularly as additional evidence became available. Here's part of what we wrote:
"Arguments in favor of the broad use of Gardasil among males can be made in terms of direct and indirect benefits. The clearest direct benefit involves genital wart protection, for which the vaccine appears to be highly effective. However, the high cost of the vaccine and the nonfatal nature of genital warts lead to highly unfavorable cost-effectiveness analyses when modeling large-scale vaccination of males for this purpose.
A second class of direct benefits to males involves protection against several anogenital cancers and a respiratory condition caused by the HPV types included in the vaccine. Whereas these benefits are widely believed to exist, the FDA approval of Gardasil for males does not include these indications. Obtaining data sufficient to do so will be difficult, because the conditions are relatively rare and lack the ‘‘precursor lesions’’ of cervical cancer that facilitated approval of the vaccines for females. Including these additional presumed benefits results in cost-effectiveness figures generally accepted as representing a worthwhile investment of health
The indirect benefit of male HPV vaccination is the additional reduction in cervical cancer incidence that would result from targeting a reservoir for the virus. Once again, economic modeling of male vaccination efforts for this additional objective remains unfavorable, suggesting that concentrated attention to vaccinating females is a superior strategy for cervical cancer prevention. However, encouraging both genders to receive the vaccine not only appeals to fairness but also simplifies promotional efforts made by the medical community. It would also symbolize the shared responsibility of men and women in the prevention of cervical cancer
and other sexually transmitted infections.
In October 2009, the ACIP opted against a routine recommendation for male HPV vaccination. As explained in their published guidance, this decision was based on cost-effectiveness data considering only the licensed indication for genital wart prevention. The committee instead adopted a ‘‘permissive use’’ statement that says little beyond acknowledging that the vaccine is available for those who want it. This decision and its consequences for vaccine availability and affordability likely mean that male HPV vaccination will be a rarity for the foreseeable future.
Prominent voices in the public health and vaccination communities have expressed their disappointment with the panel’s recommendation. Public attention to the disparate messages regarding male and female HPV vaccination should cause this important question of ethics and public health to be reopened and discussed far more broadly than it has been thus far.
Amid limited health care resources, concerns over the total costs of broad HPV vaccination programs are well-founded. As our ability to model the financial and medical impact of health policy options grows, so too does the influence of such analyses among policymakers and third-party payers. Among the questions worthy of discussion on this topic is how well even the most sophisticated economic modeling can reflect the values and priorities of communities in improving public health."
You can read the full paper, including references and discussion of additional topics in HPV vaccine ethics and policy, at the AJPH website
Labels: ACIP, CDC, Gardasil, HPV, Policy, Recommendations
VaccineEthics.org at ASBH Meeting in Minneapolis
For those attending the annual meeting of the American Society of Bioethics and Humanities
this week in Minneapolis, VaccineEthics.org will be featured at the Penn Center for Bioethics' table in the exhibit hall.
Information will be available about the website and Penn's other activities and publications related to vaccine ethics and policy. Project staff will also be in attendance to answer questions or discuss ongoing projects.
Labels: About us
"Ethics of Vaccination Programs" Paper Published
The journal Current Opinion in Virology
recently published a paper titled "Ethics of Vaccination Programs" by Jason L. Schwartz and Arthur Caplan of the Penn Center for Bioethics. This review article examines recent developments in vaccine ethics and policy, with particular attention given to the 2009-10 H1N1 influenza pandemic, disease eradication efforts, and vaccine risk controversies.
The paper will appear in a forthcoming print edition of the journal. A pre-publication copy
is now available online (subscription required). The paper's abstract:
Ethical issues are present at each stage in the vaccine product life cycle, the period extending from the earliest stages of research through the eventual design and implementation of global vaccination programs. Recent developments highlight fundamental principles of vaccine ethics and raise unique issues for ongoing vaccination activities worldwide. These include the 2009–10 H1N1 pandemic influenza vaccination campaign, renewed attention to the potential global eradication of polio, and the ongoing evaluation of vaccine risk controversies, most notably the alleged link between childhood vaccines and autism. These cases present ethical challenges for public health policy-makers, scientists, physicians, and other stakeholders in their efforts to improve the health of individuals, communities, and nations through vaccination.
Labels: About us, Eradication, Pandemic flu, Polio, Risk, Safety
Conference on Research in Vaccines for Emergencies
On September 12, a one-day conference titled "Quest for Research Excellence: Research Integrity Challenges in Vaccine Development and Distribution for Public Health Emergencies" will be held in Philadelphia at the College of Physicians of Philadelphia.
includes speakers from state and federal public health agencies, academia, and the pharmaceutical industry. Sessions will explore vaccine development, distribution strategies during public health emergencies, and the role of public trust in the success of vaccination programs.
Additional information and registration is available here
Labels: About us, HHS, Pandemic flu, Research
CDC advisors reconsidering HPV vaccine for boys
At last week's meeting of the CDC Advisory Committee on Immunization Practices, the committee revisited the issue of whether the HPV vaccine Gardasil should be recommended for routine use in adolescent boys and young adult men. The vaccine was licensed by the FDA in October 2009 for the prevention of genital warts among males, but the ACIP declined at that time to give the vaccine a full recommendation for males.
The New York Times
both wrote about the meeting and the competing arguments on this topic raised by committee members and others in attendance. The key considerations are the medical and economic consequences of genital warts and the overall cost-effectiveness of HPV vaccination programs aimed at both sexes compared to females alone. Any change in the current recommendation would not be made until 2011.
Earlier this fall, we wrote about the debate regarding recommendations for HPV vaccination in males and other current issues in HPV vaccine policy in a paper published in the American Journal of Public Health, "HPV Vaccination's Second Act: Promotion, Competition, and Compulsion
Labels: ACIP, CDC, Gardasil, HPV, Policy, Recommendations
"History of Vaccines" website launched
The College of Physicians of Philadelphia recently launched "The History of Vaccines,"
an interactive website exploring the history of vaccination from Edward Jenner's smallpox vaccine to the present.
The site provides a remarkable amount of information on historical and contemporary debates in vaccination policy. It also highlights many of the scientists and research achievements that have contributed to the development of vaccines in the 20th and 21st centuries.
In addition to original articles, the site includes historical images, multimedia features, and interactive graphics that explore topics in vaccination science and policy.
Conference on Vaccine Mandates -- Philadelphia, Sept. 21
The Penn Center for Bioethics is organizing a one-day conference on September 21 titled "The Science, Ethics, and Politics of Vaccine Mandates."
The conference is free and open to the public. It is co-sponsored by The Children's Hospital of Philadelphia and the University of Pennsylvania Health System.
The agenda includes presentations and panel discussions on school vaccination requirements for children, mandatory flu vaccination for health care workers, the history of vaccine mandates, and other topics. The speakers include representatives from federal, state, and local public health agencies; the pharmaceutical industry; clinical medicine; and academia.
More information and instructions for registration are available at the conference website
Labels: About us, Mandates, Policy
Government requires private insurance plans to fully cover recommended vaccines
As part of the Obama administration’s health-care reform efforts, private insurers will soon be required to fully cover a number of preventive health services
, with no patient co-pays or deductibles permitted. Included in this list are all vaccines recommended by the Advisory Committee on Immunization Practices (ACIP). Here is coverage of the announcement from ABC News
, the New York Times
, and Reuters
.According to new regulations released by the Department of Health and Human Services (HHS)
, as of September 23 all new or revised insurance plans must include all preventive services recommended by the United States Preventive Services Task Force and the ACIP. In addition to vaccines, other covered preventive services include colonoscopies, mammograms, well-child visits, and screening for chronic conditions.
For vaccines, these regulations further add to the importance and influence of the ACIP. Already, the committee’s recommendations are routinely adopted in full by CDC. Also, it has direct authority to add newly recommended vaccines to the Vaccines for Children (VFC) program, the federal entitlement program that provides vaccines to uninsured or underinsured children. The new consequences of ACIP recommendations for private insurance plans will further emphasize the committee’s broadened mandate in recent years to evaluate the cost-effectiveness and overall health policy implications of its actions, in addition to scientific and medical assessments of the impact of proposed vaccine recommendations. Accordingly, the insurance industry is likely to be far more interested in the work of the ACIP, as it will now directly determine the vaccines that must be included in their plans.
For patients, physicians, advocates of immunization, and vaccine manufacturers, these regulations will certainly be viewed as good news. While coverage of recommended pediatric vaccines by private insurers is generally quite good, co-pays and administrative costs can present obstacles for some patients. For adult immunization, the impact of the regulations are likely to be even more significant, as coverage for recommended adult vaccines is highly variable, often only partially covering ACIP-recommended vaccines or requiring significant co-pays. Not surprisingly, adult vaccination rates have lagged far behind those of children. While financing considerations are among many obstacles impeding adult vaccination efforts, these new regulations for third-party insurance plans will certainly be seen as beneficial.
on the government website detailing the new regulations highlights a specific consequence of the ACIP’s recent decisions regarding HPV vaccines. The ACIP has recommended routine HPV vaccination for females aged 9-26 since 2006 but declined last fall to recommend vaccination of males with Gardasil because of concerns regarding cost-effectiveness. Instead, the committee adopted a ‘permissive use’ statement regarding vaccination of males, neither a recommendation for or against it.
While the language regarding the regulations’ impact on HPV vaccine coverage is rather obtuse, it states that after a short grace period on account of the relatively new recommendation for Cervarix, insurers will be required to fully cover both HPV vaccines in all recommended populations (currently girls and women 9-26). It appears however, that there is no such requirement for insurance coverage of male HPV vaccination, since it lacks an ACIP recommendation.
-- Guest post by Laura Backup, Intern at Penn Center for Bioethics
Labels: ACIP, Business of Vaccines, Cervarix, Economics, Gardasil, HPV, Policy, Recommendations, Vaccination rates
CDC declines to endorse mandatory flu vaccination for health care workers
In draft guidance on preventing influenza in health care facilities, the CDC declined to include mandatory vaccination policies for health care workers among recommended strategies to improve vaccination rates. The document, "Updated Guidance: Prevention Strategies for Seasonal Influenza in Healthcare Settings,"
was published in today's Federal Register.
Vaccination of patients and health care providers (HCP) is described in the report as the "most important measure to prevent seasonal influenza transmission." Vaccination rates for health care workers have long been viewed by health officials as discouragingly low. A variety of approaches have been tried to increase vaccination coverage in this group, all with very limited success.
On this topic, the report notes:
"Strategies to improve HCP vaccination rates include providing incentives, providing vaccine at no cost to HCP, improving access (e.g., offering vaccination at work and during work hours), and requiring personnel to sign declination forms to acknowledge that they have been educated about the benefits and risks of vaccination. While some have mandated influenza vaccination for all HCP who do not have a contraindication, it should be noted that mandatory vaccination of HCP remains a controversial issue."As we've noted previously
, mandatory vaccination of health care workers against influenza has received increasing attention in recent years. This was particularly true last fall, with a short-lived requirement for state health care workers in New York and many other institutions introducing mandatory vaccination policies
The choice to acknowledge mandatory health care worker vaccination without specifically endorsing the approach mirrors CDC's typical public comments on school vaccination requirements for children. In that context, CDC regularly defers to state health officials, noting that such policies are not within the purview of the federal government.
Nevertheless, advocates of required health care worker vaccination believe that the other strategies listed in the report have already been tried and have failed to boost vaccination rates sufficiently. The lukewarm statement on mandatory vaccination in today's report will likely be viewed by this group as a missed opportunity to continue building momentum for the policy nationwide.
Today is not the first time that the CDC has passed on an opportunity to endorse mandatory flu vaccination policies for health care workers. In a September 2009 story in the New York Times
on this issue, CDC director Thomas Frieden said, “This is just not the right flu season to take this on,” alluding then to the challenges presented by the mass vaccination program against H1N1 influenza underway at that time.
Today's report is draft guidance for which public comment is invited. A final version is expected to be published this fall prior to the upcoming flu season.
Labels: CDC, health care workers, Mandates, Policy, Seasonal flu
FDA delays decision on Gardasil for women 27-45
On Wednesday, the FDA announced it was extending its review of Merck’s application to broaden the indicated age range for Gardasil to include women ages 27-45. The initial FDA approval in 2006 was for 9-26 year-old girls and young women. In 2009, an expanded indication also approved the vaccine for males ages 9-26. Merck’s pending application argues that the benefits of HPV vaccination extend to older women, preventing cervical lesions from viral types responsible for a significant percentage of cervical cancer cases.The Wall Street Journal reports
that a decision by the FDA had been expected as early as this week. With the recent postponement, Merck may be waiting for a decision until the end of 2010.
From a business perspective, Reuters Health suggests
that this regulatory delay may be particularly ill-timed for Merck as it battles GSK’s Cervarix:
“Gardasil was once thought to be a potential monster selling product for Merck, but sales have stalled amid competition from a rival GlaxoSmithKline product and because many younger women have already been immunized with Gardasil, limiting the market size.”
-- Guest post by Justin Silpe, Intern at Penn Center for Bioethics
Labels: Business of Vaccines, Cervarix, FDA, Gardasil, GSK, HPV
HHS gives thumbs up to 2009 school-based pandemic vaccination programs
A recently released Department of Health and Human Services (HHS) report
indicates that School-Located Vaccination Programs established during the H1N1 pandemic were an efficient method of distributing the vaccine to children. CIDRAP News described the findings
Children and young adults age 6 months-24 years were among the priority groups for vaccination, based on CDC recommendations. According to the report, in November and December 2009, federal officials conducted reviews of 38 school-based clinics throughout six states. HHS researchers assessed the extent of coverage, implementation techniques, and adherence to CDC recommendations.
On average, these school-based programs vaccinated 28% of enrolled students during one-day clinics. This rate compares favorably to state and national data reflecting other methods of vaccine administration, according to the authors of the report.
There were some concerns reported with school-based vaccination. Many of the participating schools described difficulties in processing paperwork, communicating with parents, securing adequate staff, and establishing efficient billing systems. Widespread non-compliance with certain CDC recommendations was also observed, such as monitoring vaccine storage temperature.
Looking forward, the report notes the need to simplify the consent process and refine the distribution of educational materials to parents. Officials concluded that school-based vaccination programs are a practical strategy for vaccine distribution, but that such programs should receive additional official guidance and assistance in planning.
-- Guest post by Laura Backup, Intern at Penn Center for Bioethics
Labels: Adolescents, Allocation, HHS, Pandemic flu, Recommendations, Swine flu
H1N1: vaccine coverage data released; 70+ million surplus doses to be discarded?
included interim data on H1N1 vaccination coverage, both among health care personnel
as well as the general public
For health care workers, an estimated 37.1% received the H1N1 influenza vaccine this year according to the CDC survey. An impressive 61.9% received the seasonal influenza vaccine, a significant increase over the previous high (49%) for annual flu vaccination in this population. The accompanying editorial note suggests that increased vaccine promotional efforts and health care worker mandates can be credited for this increase. Coverage for both flu vaccines are higher among those working in hospitals and lowest among employees of long-term care facilities.
The second paper provides the first state-by-state estimates
of H1N1 vaccine uptake, based on telephone surveys. According to the report:
"Among persons aged ≥6 months, 2009 H1N1 vaccination rates by end of January ranged from 12.9% in Mississippi to 38.8% in Rhode Island (U.S. median: 23.9%). Coverage among children aged 6 months through 17 years ranged from 21.3% in Georgia to 84.7% in Rhode Island (U.S. median: 36.8%), and was higher than the rate among adults for all states (U.S. median: 20.1%)"
A related story was featured prominently in today's Washington Post. According to the piece
by Rob Stein, as many as 91 million doses of H1N1 vaccine were delivered in the U.S., leaving 138 million doses unused. Even after tens of millions of doses are donated or preserved for potential future use (reference to a possible 'third wave' is made by experts quoted in the story), over 70 million doses might be discarded as the current H1N1 vaccination program seemingly nears conclusion and expiration dates approach. The story also includes early retrospective assessments of the successes and lessons of the response by U.S. and WHO health officials.
Labels: Business of Vaccines, CDC, health care workers, MMWR, Pandemic flu, Policy, Stockpiles, Swine flu, Vaccine supply
H1N1 Roundup -- WHO guidance, 2010 vaccine plans, CDC stockpile reduction
Several headlines regarding H1N1 influenza this week:
- A story in today's Washington Post reports on a WHO statement yesterday noting that "it was too early to declare that the H1N1 pandemic had peaked and [urging] nations around the world to remain vigilant." The statement appears not to be directly related to the current H1N1 situation in the U.S. and Europe, where this second peak of the pandemic has passed. More concerns are present for the Southern Hemisphere, where winter is approaching and the virus' spread may be increasing in some regions, according to WHO. Yesterday's statement advises countries to 'maintain' their surveillance programs, replacing previous recommendations to 'intensify' them. More details are available in this WHO statement.
- Earlier this week, an FDA vaccine advisory committee voted to include a 2009 H1N1 pandemic influenza strain in the 2010-2011 'regular' flu vaccine (i.e., next winter). This recommendation comes a few days after an identical statement from a WHO committee. It does not come as a surprise, given how common the pandemic H1N1 virus has been this flu season compared to other flu viruses. Experts have long said that if H1N1 had emerged a few months earlier in 2009 than it did, it likely would have been included in the standard seasonal flu vaccine, eliminating the need for (and challenges created by) two influenza vaccines this season. Here's coverage from the Wall Street Journal and CIDRAP News, and a statement posted on Flu.gov.
- As supply of the current H1N1 vaccine continues to far exceed demand and vaccine doses approach expiration dates, CDC announced earlier this week plans to reduce by 50% the inventory of vaccine doses held at their central distribution facilities. This is another indication that the current H1N1 vaccination program is winding down.
Labels: CDC, Pandemic flu, Policy, Recommendations, Seasonal flu, Stockpiles, Swine flu, WHO
Mumps outbreak continues in NY/NJ
Friday's issue of MMWR
included a report on the ongoing mumps outbreak
in the New York metropolitan area. Nearly 1,500 cases have been identified thus far in Brooklyn and nearby counties; 97% of those infected are members of Orthodox Jewish communities.
Unlike many reports of disease outbreaks among religious groups, vaccine refusal is not a significant contributor to the outbreak. According to the MMWR report, 88% of those infected had received at least one dose of the combined MMR vaccine and 75% had received two doses, with higher percentages found among the younger age groups in which most cases have occurred. This illustrates the long-known fact that the mumps vaccine (like any vaccine) is less than 100% effective at preventing disease. High vaccination rates among communities provide additional protection through "herd immunity," but outbreaks such as this invariably will occur, public health officials explain.
As for what may be contributing to the spread of cases in this particular outbreak, an editorial note explains:
"...prolonged, close contact among persons might be facilitating transmission. Within the affected religious community, cases have occurred predominantly among school-aged boys, who attend separate schools from girls. The higher rate among boys might be a result of the additional hours that boys in this community spend in school compared with girls, including long periods in large study halls, often face-to-face with a study partner."
The report adds that larger family sizes among the affected community and fairly limited interaction with those outside it (even those in nearby neighborhoods and counties) might further explain the scope and limits of the outbreak.
Here is additional coverage from the Associated Press
, and the New York City Department of Health
, which is organizing free MMR vaccination clinics for those in the affected communities with incomplete vaccination histories.
Labels: CDC, MMR, MMWR, Mumps, New York, Outbreaks