New Vaccines Help Protect You

Important new vaccines have recently been approved for use and are already making a significant impact in the fight against diseases.

Chances are that you have never come down with a case of diphtheria, smallpox or tetanus. It is more than good fortune or genetic luck of the draw. That's the result of decades of vaccine research and implementation, much of it directed or funded by the National Institutes of Health (NIH). Vaccines take advantage of your body's natural ability to learn how to eliminate almost any disease-causing germ, or microbe, that attacks it. What's more, your body "remembers" how to protect itself from the microbes it has encountered.

Vaccines are a safe, cost-effective and efficient way to prevent sickness and death from infectious diseases. Innovative technologies have made great contributions to recent advances, including the ability to "read" and analyze the genomes of diseasecausing organisms. This new knowledge and technology are instrumental in assisting scientists in creating improved vaccines, designing new strategies and identifying new candidates to prevent diseases for which no vaccines currently exist.

More than 30 vaccines are presently available for protection against infectious diseases. Edward Jenner produced the first vaccine against smallpox in 1798, and, today, children in the United States routinely receive many vaccines in their first few years of life. (See table.)

Recently, new vaccines have been announced for a variety of diseases, including the following:

Shingles

Shingles is an outbreak of rash or blisters caused by the varicella-zoster virus, the same virus that causes chickenpox. Following an attack of chickenpox, the virus lies dormant in the nerve tissue, with the potential of reactivating later in life. When the varicella-zoster virus reactivates, the viruses multiply and the characteristic rash erupts. The first symptom of shingles is often burning or tingling pain in one location or a specific side of the body. Anyone who has had chickenpox is at risk for shingles. This year, more than 500,000 people will develop shingles.

In May 2006, the Food and Drug Administration (FDA) approved use of a vaccine to prevent shingles. The vaccine is recommended for people 60 years of age and older who have had chickenpox but who have not had shingles. Researchers estimate the vaccine could prevent 250,000 cases of shingles that occur in the United States each year and significantly reduce the severity of the disease in another 250,000 cases annually.

The Shingles Prevention Study, one of the largest adult vaccine clinical trials to date, found that a vaccine against shingles prevented about half the cases of shingles and reduced its severity and complications in vaccinated populations that contracted the disease. The trial was conducted over more than 5 years at 22 study sites nationwide and led by the Department of Veterans Affairs in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID).

Stephen E. Straus, M.D., an infectious diseases specialist at NIAID and Director of the NIH National Center for Complementary and Alternative Medicine, who participated in the design, oversight and conduct of the trial, says, "These striking results indicate for the first time that we can use a vaccine to prevent shingles. And among vaccine recipients who did get shingles, the episodes generally were far milder."

Pneumonia

Pneumonia is an inflammatory lung disease caused by a variety of viruses, bacteria and even fungi. Pneumococcal pneumonia is an infection in the lungs caused by bacteria called Streptococcus pneumoniae, also called pneumococcus. These bacteria can infect the upper respiratory tracts of adults and children and can spread to the blood, lungs, middle ear or nervous system.

There are no generally effective treatments for most types of viral pneumonia, which usually heal on their own. The pneumococcal vaccine protects against 23 types of pneumococcal bacteria populations and is effective in approximately 80 percent of healthy adults.

The Centers for Disease Control and Prevention (CDC) estimates pneumococcus causes 40,000 deaths and 500,000 cases of pneumonia annually in the United States. Annually, there are twice as many cases of pneumococcal pneumonia in African Americans than in whites. The disease is responsible for 3,000 cases of meningitis (inflammation of the lining of the spinal cord), 50,000 cases of bacteremia (bacteria in the blood) and 7 million cases of otitis media (inner ear infection) in the United States.

Human papillomavirus (HPV)

On June 8, 2006, the FDA approved the use of the first vaccine, Gardasil, to prevent infection from four types of the human papillomavirus (HPV), which causes cervical cancer.

HPV is one of the most common causes of sexually transmitted infection (STI) in the world. Health experts estimate there are more cases of genital HPV infection than any other STI in the United States. According to the CDC, approximately 6.2 million new cases of sexually transmitted HPV infections are reported every year. At least 20 million people in this country are already infected.

"Cervical cancer is the No. 2 cancer in developing countries, whereas it is a less common cancer in the U.S. and other developed countries," says Douglas Lowy, M.D., deputy director of the National Cancer Institute's (NCI) Center for Cancer Research. "The principal difference is attributable to having high quality Pap screenings in the developed world, whereas this is not available in developing countries."

A second HPV vaccine, Cervarix, will be considered by the FDA soon.

Rotavirus

"Rotavirus is the leading cause of severe gastroenteritis in infants and young children worldwide" says Dr. Anne Schuchat, director of CDC's National Immunization Program. "Nearly every child in the United States is infected with rotavirus by age 5 and most will develop gastroenteritis, leading to a large number of physician visits, emergency room visits and hospitalizations, with a few deaths. Therefore, this vaccine will help reduce one of our most common and potentially severe childhood illnesses."

Each year, rotavirus is responsible for more than 400,000 doctor visits, more than 200,000 emergency room visits, 55,000 to 70,000 hospitalizations, and between 20 and 60 deaths in U.S. children younger than 5 years of age. In developing countries, rotavirus is a major cause of childhood deaths.

Rotavirus vaccine will not prevent gastroenteritis caused by other viruses, but is very effective against rotavirus disease. In clinical trials, the vaccine prevented 59 percent of all causes of gastroenteritis hospitalizations, which highlights the important role of rotavirus in severe childhood gastroenteritis. Complications with previous rotavirus vaccines have been completely resolved.

Flu

FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) met earlier in 2006 to select, in conjunction with the CDC, the influenza virus strains to be included in the influenza vaccine for use in the 2006–07 U.S. influenza season. During this meeting, the advisory panel recommended that vaccines to be used in the 2006–07 season in the United States contain the following: an A/New Caledonia-like virus, an A/Wisconsin-like virus and a B/Malaysia-like virus.

The influenza vaccine composition to be used in the 2006–07 season in the U.S. is identical to that recommended by the World Health Organization.

Fall 2006 Issue: Volume 1 Number 1 Pages 4 - 5