National Infant Immunization Week, April 21-28

Posted under Blog, CDC, center for disease control and prevention, Companies, Diagnostics, Funding, Health, Health Care, healthcare, immunization, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, vaccine, Videos by biotechnow@bio.org (Biotechnology Industry Organization)

Routine immunization of one birth cohort (i.e. people born in a particular year) during childhood prevents about 20 million cases of disease and 42,000 deaths in the U.S. These statistics are staggering, especially when we consider how far vaccinology and preventive medicine have come in such a short time period. Today, vaccines help protect children against 14 diseases before the age of two. Many diseases that parents once feared have been long forgotten. In the 1950s, nearly every child in the U.S. contracted measles. In 2011, 222 measles cases were reported in the U.S according to a report published last week by the Centers for Disease Control and Prevention (CDC), and this was the highest number of reported measles cases in the U.S. in 15 years.

New vaccines continue to be developed by private companies, both large and small, and by non-profit product development organizations. In 2006, vaccines against rotavirus, a leading cause of severe diarrhea in infants and young children in the U.S., were introduced. A study published by the CDC in the New England Journal of Medicine last September estimated that rotavirus vaccination prevented approximately 65,000 hospitalizations of children under age 5 from 2007 to 2009 and resulted in $278 million in healthcare cost savings. Innovative vaccines against diseases such as tuberculosis, meningococcal B disease, and respiratory syncytial virus (RSV) are currently in development and could significantly improve the health of children if added to the CDC’s childhood immunization schedule.

With these statistics, it may seem hard to deny the benefits of immunization. Yet, vaccines are sometimes the victims of their own success. They are so effective that parents are unable to remember the illness and associated disability and death that a vaccine prevents. To remind the American public about the positive impact of vaccination on the lives of infants and children, National Infant Immunization Week was launched in 1994. To learn more about this annual initiative led by the CDC, Dan McGirt, Director of Communications at BIO, spoke with Dr. Yabo Beysolow, a Medical Officer at CDC as well as a pediatrician and mother of three children. The podcast is available here.

In recognition of National Infant Immunization Week, Dr. Yabo Beysolow, Medical Officer at the CDC, talks about the benefits of immunization for children under the age of two and the achievements of immunization programs in promoting healthy communities throughout the U.S.

As Vaccine Exemptions Rise, Risk of Outbreaks Intensifies

Posted under Blog, CDC, center for disease control and prevention, Companies, Diagnostics, Funding, Health, Health Care, herd immunity, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, vaccination, vaccine, Videos by biotechnow@bio.org (Biotechnology Industry Organization)

Generally, we think of vaccines as protecting the vaccinated. We often forget that vaccines, when administered to enough people, protect those in the community who cannot be vaccinated due to certain health conditions, who are too young to be vaccinated, or who experience vaccine failure. This “herd immunity,” as it’s called, is analogous to the concept of ‘safety in numbers’ and is critical to outbreak prevention. However, as reported by Valerie Bauerlein and Betsy McKay in yesterday’s article “Where Could the Next Outbreak of Measles Be?” in The Wall Street Journal increasing numbers of vaccine exemptions in states such as California, Oregon, Washington, and Montana are threatening herd immunity. “Overall vaccination rates in some of these communities are under 80 percent, far below the threshold that is needed to prevent an outbreak for certain diseases.”

Approximately 95 percent of a community must be immunized against measles to ensure herd immunity, as the disease is highly contagious. According to the Centers for Disease Control and Prevention (CDC) , “measles is so contagious that if one person has it, 90 percent of the people close to that person who are not immune will also become infected with the measles virus.” The virus is spread through droplets and can remain in the air for up to 2 hours after an infected person has left the room. Complications from measles range from ear infections and pneumonia to miscarriage and death.

Due to the contagious nature of the disease and the increasing number of exemptions in which parents opt out of vaccination requirements for children, measles outbreaks have been a growing concern for public health officials. As has been recently reported by various news outlets, including USA Today, the 2012 Olympic Games in London this summer present a perfect opportunity for a large scale outbreak. In fact, most cases of measles in the U.S. are imported by unvaccinated American travelers returning home from abroad. A 2008 measles outbreak in San Diego was caused by an unvaccinated 7-year-old boy who contracted the disease in Switzerland and then passed it to children at his school and in his doctor’s office. To prevent such outbreaks, people in the community who are recommended to be vaccinated against measles and other diseases should receive these life-saving vaccines, if not to protect themselves to protect those who cannot get vaccinated.

Is the Polio Vaccine an Anti-Patent Success Story?

Posted under Blog, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, patent, Patently BIOtech, Penicillin, Pharmaceuticals, polio, Public Policy, Salk, Startups, Universities, vaccine, Videos by biotechnow@bio.org (Biotechnology Industry Organization)

By Hans Sauer, Deputy General Counsel for Intellectual Property, Biotechnology Industry Organization

Question from a Reader:

Heather: Whether Jonas Salk believed in patenting research or not isn’t important, at least not to me. What I do find important, and hadn’t realized until reading this article, is that the polio vaccine was extremely successful despite the fact that it wasn’t patented. That sounds like an interesting story because it goes against the current dogma of ‘we won’t invest in it if it’s not patent protected’. I’m curious to know if there have been other vaccines/drugs that have bucked the patent system but remain successful.

Response:

Heather, thank you for your interest in this important issue.

Unfortunately, it’s not so much a question of bucking the patent system as it is a question of who steps up to the plate if there are no incentives to invest. Usually, nobody does. There are literally hundreds (if not thousands) of examples of promising drug molecules which are not being developed because they are owned by no one. The polio vaccine is actually a good, and unusual, example of a tremendously important product that, for various reasons, lacked commercial incentives for it to be developed by private companies – maybe the absence of patent protection had something to do with that. Ultimately, developing the polio vaccine required such a big societal effort, requiring field trials on millions of children, that it would have been impossible for a single company to handle (and so expensive that it would have amounted to corporate suicide). Instead, the development of the vaccine required an unusual, coordinated effort by charitable foundations, the U.S. government, and many other entities.

Penicillin is another example. It was discovered in the 1920s and languished for many years in the public domain. The molecule wasn’t owned by anyone, and there was no commercial incentive to invest in its development. It was only during World War II that penicillin became strategically important to the U.S. and British governments. It was developed through a process of compulsory government contracting, as part of the wartime effort. Notably, while penicillin itself was not patentable because it had already been known for a long time, the government contract lab did obtain a patent on the method for mass-producing it.

These two success stories are neither typical nor a realistic model for the development of new medicines. It is true that sometimes a government and charitable foundations must step up and support the development of exceptionally important drugs for which there is no other commercial incentive. The drug molecule may be long-known and unpatented. Or it may be useful only for a medical condition that is so rare that a drug company could not recoup its investment. When the government or charitable foundations fund the development of such drugs, they often do so in partnership with drug companies – think of it as the public sector “splitting the risk” with private companies. But it is rare indeed for a drug to be developed by a government alone, absent a commercial incentive for private investment. For one, governments are not particularly good at developing drugs. We know this from experience with former socialist countries, which produced Nobel Prize-winning chemists and physiologists but no drugs. Even our own government-funded researchers prefer to do what they do best: studying the molecular basis of diseases and understanding the biological mechanisms and interactions that keep us healthy or make us sick. Biotech companies, on the other hand, are good at the tedious and lengthy task of developing medicines. Think of it as two sides of an equation, where public research often provides the “science” and the private sector contributes the “engineering.” So the typical situation today in the U.S. is that generous public funding is used to support basic biological research at government laboratories and research universities, and that private companies shoulder the task, at staggering cost, of translating these basic discoveries into real-world solutions for disease.

According to the Tufts Center for the Study of Drug Development, the total capitalized cost of developing the average biopharmaceutical requires nearly a decade of work and an investment of $ 1.2 billion. Patents can provide some assurance to the investors who are considering whether to invest in a biotech company to help it fund the lengthy and expensive drug development process necessary to produce a new life-enhancing, and in some cases life-saving, medical therapy. Without a patent, there is limited opportunity for a return on that significant investment.

It is important to remember that patents are granted for a fixed period of time.  During that time, the patent owner has exclusive rights to the patented invention (that he or she has the option to license to others). After the patent expires, the invention is in the public domain and everyone can access it. In the biopharmaceutical world, this is often when generic drugs become available.

Approval for AIDS Vaccine at Canadian University

Posted under Blog, Companies, Diagnostics, Discovery, Funding, Health, Health Care, HIV/AIDS, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, vaccine, Videos by biotechnow@bio.org (Biotechnology Industry Organization)

The Food and Drug Administration has given Canadian researchers approval to test a vaccine for HIV/AIDS on humans. Researchers from the University of Western Ontario are hopeful that with further tests, a vaccine could be on the market in about five years. Similar to the approaches used to develop vaccines for polio, influenza, rabies and hepatitis A, the vaccine is the first based on a genetically modified, killed whole virus and is the only HIV vaccine currently under development in Canada, and one of the only few in the world.

Beginning next month, a clinical trial on 40 HIV-positive volunteers will begin.  Following the trials, tests will begin on 6,600 HIV-negative but high-risk category volunteers. These tests will focus on immune responses and effectiveness of the vaccine in two more phases.

To read more about the University of Western Ontario’s AIDS vaccine, please follow this link.