Flu Vaccines

August 30, 2013

The flu vaccine that you get at your doctor’s office or pharmacy is the work of highly skilled microbiologists, epidemiologists, physicians and other public health experts too numerous to mention. It also likely required a hen and a rooster monitored by a veterinarian inside a henhouse that met biosecurity requirements.

Sound complicated? It is. The manufacturing of flu vaccines is a highly-orchestrated and complex process.

Vaccine manufacturers each year use millions of fertilized eggs as a culture to grow influenza viruses that, after numerous steps requiring about six months of expert work, become that season’s flu vaccine. And while this tried-and-true method will continue to provide safe and effective vaccines for the foreseeable future, flu vaccines using new, more advanced technologies are arriving on the scene. Some don’t require eggs at all.

The Food and Drug Administration (FDA) and its parent, the U.S. Department of Health and Human Services, have long encouraged the development of new technologies for producing flu vaccines. For example, cell culture technology is used to make vaccines to prevent other infectious diseases, and FDA has been working for a number of years, both on the research and regulatory fronts, to facilitate this for flu vaccines. A major push for cell-based flu vaccines occurred in 2006 as part of a plan to be ready in case of a world-wide epidemic.

In 2010, FDA issued final guidance to assist manufacturers working to develop safe and effective viral vaccines that grow in specially prepared cell lines. In the last two months, FDA has approved two new flu vaccines that, instead of using eggs to grow the influenza virus, use cell lines from either a mammal or insects.

“This is an important advance that will supplement current egg-based vaccines,” said Jerry P. Weir, Ph.D., director of the Division of Viral Products in FDA’s Center for Biologics Evaluation and Research. “The more manufacturing alternatives there are available, the better we can respond to public health emergencies in a timely manner.”

Although egg-based production remains vital, cell technology has some advantages. Unlike eggs, cells can be frozen for later use to grow large volumes of cells. That advantage offers the potential for faster start-up of the vaccine manufacturing process for any unexpected need. This would also be critical if egg supplies were compromised. In addition, some flu virus strains don’t grow that well in eggs at first and may grow better and faster in cells, helping speed vaccine production and availability. Moreover, alternatives to egg-based products provide an option for people with egg allergies.

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Women’s Health FAQ

August 21, 2013

As Assistant Commissioner for Women’s Health at the Food and Drug Administration (FDA), Marsha B. Henderson directs the Office of Women’s Health. She has led women’s health research and educational programs at FDA for over 14 years.

Q: How does FDA work to protect and promote the health of women?

A: We provide women with the information they need to make decisions about the drugs and other medical products they use for themselves and their families. We support scientific and educational projects that promote a better understanding of health conditions that affect women. We also support research that looks for potential differences in how men and women respond to medicines.

Q: Can you provide an example of how men and women differ in response to medicines?

A: Medicines can sometimes cause people to have an irregular heart beat. This affects part of the heart’s electrical cycle called the QT interval, and blood doesn’t pump in and out of the heart at the right pace. This could lead to heart attacks or sudden death. We discovered that certain medicines cause this problem more often in women than in men.

My office provided the initial research grant that allowed scientists at FDA and Georgetown University to study this problem. Additional studies were conducted, and several drugs were removed from the market. FDA now requires that new products be studied to ensure that they do not affect the QT interval—a potentially life-saving requirement.

Q: Your office also works to ensure that women are included in clinical trials. Why is that important?

A: It’s now very clear that medicines and diseases often affect our bodies differently. Women’s body structure can also affect how well devices like hip implants and heart stents work for us. Having women included in clinical trials provides FDA with information that can be used to make better decisions about product safety for both men and women.

Q: Why have there been fewer women than men included in clinical trials?

A: In the 1960s, there were public health tragedies in other countries where babies were born with birth defects because their mothers took a medicine called thalidomide during pregnancy. Thanks to Dr. Frances Kelsey, a FDA scientist, we did not approve the drug for sale in the U.S. at that time. So, the problem did not affect as many women in this country. Nonetheless, the horror of thalidomide influenced FDA to set rules in 1977 that basically excluded women from participating in clinical trials. The ban was lifted in 1993. The Office of Women’s Health led this effort and worked with FDA’s review centers to change the regulations. The inclusion of women is much better today. Because some challenges remain, we continue to support projects on women in clinical research.

Q: What else are you working on?

A: The Office of Women’s Health has an outreach program called “Take Time to Care” that connects women with easy-to-read materials and videos on everything from diabetes to hair dyes.

Q: How do you get the information to women?

A: Women can watch the videos and get free copies of our materials online at http://www.fda.gov/womens. We also work with a national network of partners who help disseminate our information. Our partners have ranged from health clinics and colleges to chain drug stores and the syndicated advice column “Dear Abby.”

Q: Dear Abby?

A: Yes. For several years, the “Dear Abby” column has announced our information kits during National Women’s Health Week in May to its 110 million readers. Partners like “Dear Abby” and Parade magazine have helped us reach out to women who wouldn’t necessarily think to look to FDA for free health information.

Q. Earlier you also mentioned research and training.

A: We fund grants for scientists at FDA and our sister agencies, such as the National Institutes of Health (NIH), to conduct research in areas like breast cancer imaging, device safety and hormones. These projects have produced more than 200 published articles that help health professionals better understand and treat women’s health problems. We also sponsor workshops for health professionals and we’ve partnered with NIH to develop free online courses which train researchers to look for sex differences.

Q: What is the greatest hope for improving women’s health?

A: Most of the chronic conditions like heart disease can be avoided, or certainly delayed, by healthy behavior—eating right, getting screenings and using medicines wisely. My hope is that women can use FDA resources to help them make healthy life choices.

Q: You seem happy in your work. Why?

A: I work with dedicated, enthusiastic scientists and advocates for women’s health. I enjoy mentoring the graduate students who come through our office. And I love the challenge of entrepreneurial government—building public-private partnerships.

Migraine Medications

August 12, 2013

If you’re one of the more than 30 million Americans who suffer from migraines, you know that calling them “just another headache” is like calling a hurricane “just another storm.”

Fortunately, says neurologist Eric Bastings, M.D., deputy director of the Division of Neurology at the Food and Drug Administration (FDA), there are practical measures you can take to prevent painful migraines and FDA-approved medications to either stave off their onset or relieve their pain. There are two basic kinds of medications for migraine: abortive medications (also called acute medications) that treat migraines after they begin, and preventive medications that help keep migraines from developing in the first place.

In January 2013, FDA approved an acute medication that uses a widely-prescribed drug for treating migraines (sumatriptan, name brand Imitrex), but delivers the drug through a new mechanism — a transdermal system in the form of a patch that can be wrapped around a patient’s upper arm or thigh. (Transdermal drug delivery is absorption through the skin.)

“Although consumers are familiar with using a patch for, say, smoking cessation, this is the first patch FDA has approved to treat migraines,” says Bastings.

What Causes a Migraine?

According to the National Institutes of Health (NIH), about 12 percent of the U.S. population experience migraines. Migraines affect both children and adults, but affect adult women three times more often than men.

Bastings explains that migraines are neurovascular headaches. They are characterized by throbbing and pulsating pain caused by the a temporary widening of blood vessels in the brain, triggered by abnormal activation of nerve pathways involved in the transmission of pain signals.

Characteristics of a migraine frequently include:

  • Pain typically on one side of the head
  • Pain that has a pulsating or throbbing quality
  • Moderate to intense pain that affects daily activities
  • Nausea or vomiting
  • Sensitivity to light or sound
  • Aura, visual disturbances that signal the beginning, such as dots, flashing lights or blind spots

Bastings also says that a number of studies show that migraines are underdiagnosed by patient and physician, alike. “Many people don’t recognize the symptoms as belonging to migraine,” he says. Or they don’t think of sharing information about the occasional headache with their physician, even if it is severe.