The Great Vaccination Debate Rages On: Is There Any Solution?

By Allison M. Whelan (Guest Blogger)

For many years now, there has been ongoing debate about childhood vaccinations and the recent measles outbreak in Disneyland and its subsequent spread to other states has brought vaccinations and questions about communicable diseases back to the headlines.  Politicians, including potential presidential candidates such as Hilary Clinton, Rand Paul, and Chris Christie, are also wading back into the debate.

Most recently, five babies who attend a suburban Chicago daycare center were diagnosed with the measles. As a result, anyone in contact with these infants who has not received the MMR (measles, mumps, rubella) vaccine must remain home, essentially quarantined, for the next twenty-one days—the incubation period for measles. All five of these infants were under the age of one and therefore did not yet have the chance to receive the vaccination, which is not administered until one year of age.

The Chicago outbreak is a prime example of why public health officials emphasize the reliance on herd immunity to protect those who are not yet, or cannot be, vaccinated for legitimate reasons. Unfortunately, the United States has reached a period where it can no longer place much reliance on herd immunity, particularly as more parents decide not to vaccinate their children against very contagious, yet highly preventable diseases. Illness and death are two of life’s certainties, but why should they be given that they are preventable in this situation?  What are the strongest, most rational arguments in this debate? What policy solutions should states consider?  Several options have been proposed over the years, some more feasible and likely than others. Read More

European Responses to the Ebola Crisis: Initiatives at the European Medicines Agency (EMA)

By Timo Minssen

The current Ebola outbreak already attracted much attention on “Bill of Health” resulting in some excellent blogs on a horrible topic.

While it is evident that the current health crisis requires both immediate responses and more sustainable changes in health care policy, research and regulation, medicines regulators are collaborating internationally to find innovative solutions enhancing evaluation of and access to potential new medicines to fight Ebola outbreaks. In a statement announced by the International Coalition of Medicines Regulatory Authorities (ICMRA) in September 2014, regulators around the world led by the FDA and the EMA have vowed to collaborate in supporting accelerated evaluation of experimental new drugs to treat Ebola virus infections and say they will encourage submission of regulatory dossiers. This clearly backs up the World Health Organization’s (WHO) decision to test experimental Ebola treatments in infected patients in the current outbreak region in West Africa and to speed up the development of vaccines.

In the following I would like to summarize and discuss some of the recent European responses to the current crisis starting with an overview on recent initiatives at the EMA.

Like its US counterpart, the EMA leads a close and consistent dialogue with public and private developers of Ebola products and spends much effort in reviewing available information on the various experimental Ebola treatments currently under development. These experimental drugs range from experimental antivirals or vaccines based on the adenovirus or stomatitis vaccine to experimental therapies based on mono- and polyclonal antibody technologies. One of these unapproved antibody combination drugs – MAPP Biologicals’  ZMapp – has already been used in some care workers affected by Ebola. Other experimental drugs that are currently reviewed by the EMA include Biocryst’s BCX 4430, Fab’entech’s Hyperimmune horse sera, Sarepta’s AVI-7537, Toyama Chemicals and MediVector’s Favipiravir and Tekmira’s TKM-Ebola.

Other companies such as Bavarian Nordic  and the Russian Mikrogen are close to follow.

In addition to monitoring experimental drugs and enhancing global collaboration, the European Medicines Agency has like the FDA initiated several activities in order to support and speed up the development of these drugs towards market approval.  Read More

NY Court Upholds Social Distancing Policy Requiring Unvaccinated To Stay Out of School

By: Ross D. Silverman, JD, MPH (Twitter: @phlu)

Fairbanks School of Public Health and McKinney School of Law, Indiana University, Indianapolis.

This has been a big year for outbreaks of Vaccine-Preventable Illnesses (VPIs) in the United States. While we are only halfway through 2014, there have been more measles cases this year than we have seen since before 2000, when the Federal government officially declared the United States “measles free” (in other words: there are no more domestically-generated measles cases; all of our outbreaks are imported). We’ve also seen large mumps and whooping cough outbreaks. You can follow all the disease outbreak action, both here and worldwide, via the Council on Foreign Relations’ very cool interactive map.

States use their police power authority under the Constitution to try to minimize our risk of exposure to VPIs. First, every state requires that children demonstrate proof of immunization against many VPIs as a condition of entry into schools, preschools and day cares. States also permit exemptions to these laws – every state allows a child who may be medically susceptible to injury from vaccines to receive an exemption (with proper documentation of vulnerability), and most states allow parents to apply for an exemption based on either religious or broader philosophical grounds. A combination of factors, including: a nearly two decade trend of increasing numbers of families obtaining exemptions and clustering in particular communities (or avoiding vaccine requirements by taking advantage of law loopholes, such as if a state’s vaccine law does not cover private schools); waning effectiveness of vaccination protections over time (as has been seen with whooping cough); increased international travel facilitating ready reimportation of VPIs from abroad; and many more immunocompromised individuals living in our communities; have slightly weakened our overall protection against VPI outbreaks. Read More