Tag: vaccines

Bioethics News

Rural-Urban Gap in Some Vaccination Rates Leaves Health Officials Puzzled

August 25, 2017

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New data on vaccination rates among U.S. teenagers provide some heartening news — but also pose a bit of a mystery.

The report, from the Centers for Disease Control and Prevention, shows parents of teenagers are in the main following the CDC’s advice and keeping their children up to date on vaccines that should be administered in the early teens.

But the 2016 survey revealed big differences in the rates of teenagers who are vaccinated with some but not all recommended vaccines, depending on whether they live in cities or more rural locations. And that fact is puzzling the CDC scientists who analyzed the data, published Thursday in the CDC journal Morbidity and Mortality Weekly Report.

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STAT

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The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Talking back to science?

By Stephen Rainey

In June 2017, the European Court of Justice ruled that it was legal for a French citizen to sue a drug company for damages following a vaccination, and an illness. The ruling caused some consternation as it seemed a legal vindication of anecdote over scientific rigour.

This is a dramatic case, not least owing to the position in which vaccines find themselves, post Andrew Wakefield and the rise of the anti-vaxxer movement. Nevertheless, it forms a part of a wider narrative in which scientific activity is not always very open to questions from outside science. This broader theme is worth some scrutiny.

Vaccine injury

Shortly following a vaccination against Hepatitis B a French citizen, JW, found himself in declining health. Soon after the decline began, a diagnosis of Multiple Sclerosis (MS) was made. Having had no prior personal or family history of such an illness, and having been in good health prior to the inoculation, JW concluded that the injections must have been to blame for his developing MS. His assertion of this was not supported by scientific investigation. Rather, he could think of the vaccination as the only unusual event that preceded closely his sudden, unexpected development of the condition.

The French courts found themselves unable to agree on whether such a basis as this is sufficient to sue a pharmaceutical company. Eventually, the case was sent to the European Court of Justice (ECJ) which ruled,

“…that the temporal proximity between the administering of a vaccine and the occurrence of a disease, the lack of personal and familial history of that disease, together with the existence of a significant number of reported cases of the disease occurring following such vaccines being administered, appears on the face of it to constitute evidence which, taken together, may lead a national court to consider that a victim has discharged his burden of proof.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

Pregnant Women Absent from Zika Vaccine Trials

August 15, 2017

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This uncertainty is a major reason behind researchers’ hesitancy to expose pregnant women to newer vaccines. Women do indeed get vaccinated while pregnant—against the flu or tetanus, diphtheria, and pertussis (Tdap), for example. But “the overall safety for flu and Tdap vaccines was established in very large populations prior to being administered to pregnant women,” says August.

Some vaccines—such as the flu vaccine—included pregnant women in clinical trials. And, notably, pregnant women were included in Phase 3 trials for the new respiratory syncytial virus (RSV) vaccine that prevents a devastating, potentially fatal infection that targets infants.

But recommendations for vaccination during pregnancy are not always backed by clinical trials. “Historically, many of the recommendations have relied on observational data,” writes Johns Hopkins bioethicist Carleigh Krubiner in an email to The Scientist. She, along with August, is part of the working group who wrote the Wellcome Trust-funded guidelines for Zika vaccine administration in expectant moms. In these cases, pregnant women were either intentionally or unintentionally given vaccines, then mother and child were observed.

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See also: PREGNANT WOMEN & THE ZIKA VIRUS VACCINE RESEARCH AGENDA: ETHICS GUIDANCE ON PRIORITIES, INCLUSION, AND EVIDENCE GENERATION

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The Scientist

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The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

Your Zip Code Might Be As Important To Health As Your Genetic Code

When a receptionist hands out a form to fill out at a doctor’s office, the questions are usually about medical issues: What’s the visit for? Are you allergic to anything? Up to date on vaccines? But some health organizations are now asking much more general questions: Do you have trouble paying your bills? Do you feel safe at home? Do you have enough to eat?

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Cholera in Yemen: Why are vaccines not being used?

PLOS Medicine Specialty Consulting Editor Lorenz von Seidlein urges the WHO to act in response current cholera outbreak in Yemen According to Oxfam/BBC the current cholera outbreak in Yemen has caused more cases and deaths

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

Zika Rewrites Maternal Immunization Ethics

July 20, 2017

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Ever since the shocking realization in 1961 that the morning sickness pill thalidomide caused shortened limbs in babies, doctors have been extremely wary of giving any medicine to a pregnant woman—and testing experimental drugs has raised even more concerns. But the recent discovery that exposure to Zika virus in utero can cause severe brain damage and other problems in children triggered an international effort to develop a vaccine for pregnant women. A new report written by an ad hoc group of prominent researchers, bioethicists, clinicians, and drugmakers concludes that pregnant women should be included in trials of Zika vaccines, once safety in animals and nonpregnant adults is demonstrated. The risk/benefit issues spelled out in the report also apply to experiments with maternal immunization for other diseases, which are winning increasing support.

Researchers have been too reticent to include pregnant women in clinical trials of vaccines, contends the working group behind the report. “Even for the vaccines we now recommend in pregnancy, pertussis and flu, the original trials did not include pregnant women,” says Carleigh Krubiner, a bioethicist at the Johns Hopkins Berman Institute of Bioethics in Baltimore, Maryland, who is part of the group, which was sponsored by the London-based Wellcome Trust. “This project is trying to be more proactive.”

The half-dozen Zika vaccine trials now taking place only enroll women of childbearing age who are on contraception or have a sterile male partner. That is appropriate, according to the risk/benefit analyses spelled out in the report, as these early studies assess only safety and basic immune responses.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

Vaccines Promoted As Key To Stamping Out Drug-Resistant Microbes

July 19, 2017

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The battle against drug-resistant superbugs has neglected a key weapon, scientists say: using vaccines to quell the spread of resistance.

As drug-resistant infections sweep across the globe, public-health organizations have focused mainly on developing new antimicrobial treatments and cutting the overuse of existing ones, to prevent resistant strains emerging.

But not enough attention has been paid to vaccines as a defence strategy, say microbiologists and vaccine-developers from academic institutes and drug companies around the world. They attended a meeting at the Wavre, Belgium-based campus of drug firm GSK on 6–7 July, to discuss the issue with representatives from funding agencies and regulatory authorities.

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Image: By User:Graham Beards – Own work, CC BY-SA 3.0, https://commons.wikimedia.org/w/index.php?curid=10936866

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Nature News

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The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

The Zika Vaccine Research Agenda & Pregnant Women

The Ethics Working Group on ZIKV Research & Pregnancy provides recommendations to ensure that pregnant women are responsibly and equitably included in the Zika virus vaccine research and development agenda.

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Zika virus vaccine development is proceeding rapidly, with a number of vaccine candidates already moving into Phase II clinical trials. These are trials that are designed to look for evidence of efficacy.

As the public health community races to develop Zika virus vaccines, now is a critical time to ensure that research and development efforts adequately address the needs of pregnant women and their offspring. To this end, the Ethics Working Group on ZIKV Research & Pregnancy, an interdisciplinary group of international experts in vaccinology, maternal and child health, public health and ethics, has developed Ethics Guidance for including the needs and interests of pregnant women and their offspring in the Zika virus vaccine research and development agenda: Pregnant Women & the Zika Virus Vaccine Research Agenda: Ethics Guidance on Priorities, Inclusion, and Evidence Generation.

A vial of the NIAID Zika Virus Investigational DNA Vaccine, taken at the NIAID Vaccine Research Center’s Pilot Plant in Frederick, Maryland. Credit: NIAID

This Ethics Guidance argues that global concern about the devastating effects of Zika virus infection in pregnancy for normal fetal development, pregnant women and their offspring is not enough. Pregnant women and their babies should also be front and center in Zika virus vaccine development.

Unless specific actions recommended by the Working Group are taken soon, pregnant women and their offspring will not be able to share fairly in the benefits of whichever vaccines prove efficacious.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

Zika Vaccines Protect Mouse Fetuses

With comments from our Ruth Faden: The first-of-its-kind study follows on the heels of ethicists’ urging vaccine developers to conduct clinical trials in pregnant women.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.