Featured Research

from universities, journals, and other organizations

FDA Approves New Plasma-derived Product To Treat Complications Of Smallpox Vaccination

Date:
March 3, 2005
Source:
U.S. Food And Drug Administration
Summary:
The U.S. Food and Drug Administration has approved Vaccinia Immune Globulin Intravenous (VIGIV) -- the first intravenous human plasma-derived product available to treat certain rare complications of smallpox vaccination.

The U.S. Food and Drug Administration has approved Vaccinia Immune Globulin Intravenous (VIGIV) -- the first intravenous human plasma-derived product available to treat certain rare complications of smallpox vaccination.

VIGIV, licensed to DynPort Vaccine Company LLC, in Frederick, Md., is made from the pooled plasma of donors who received booster immunizations with the licensed smallpox vaccine -- Dryvax. This plasma contains increased levels of protective antibodies against the vaccinia virus, the live virus used in the currently available smallpox vaccine. The vaccinia virus is similar to the smallpox virus, but does not cause smallpox.

Because the smallpox vaccine is made with this live virus, even though it is a weakened virus, occasionally it can cause infections in susceptible vaccinated people or those in close contact with them. People with weakened immune systems or certain skin conditions are susceptible to vaccine complications. VIGIV helps treat these complications.

The Centers for Disease Control and Prevention (CDC) classifies smallpox as a disease believed to pose the greatest threat to public health from bioterrorism, along with anthrax, botulism, and plague. Historically, up to 30 percent of smallpox cases are fatal. No proven treatment exists. Thus, in people who are considered at high risk for contracting smallpox, such as those who would be called upon to respond to a bioterrorist attack using smallpox as a weapon, the benefits of the highly effective smallpox vaccine outweigh its risks. This approval of VIGIV may help minimize these risks.

The most common side effects from the smallpox vaccine such as a sore arm, fever, and body rashes, are self-limiting and do not require treatment. VIGIV would only be used for rare serious vaccine complications, such as a severe infection of the skin. Those at increased risk for these complications include people with eczema or other skin conditions, and people whose immune systems are suppressed due to diseases or medications, such as steroids or therapies for cancer.

The approval of VIGIV was based on both the safety of the product and prior evidence that the levels of protective antibodies achieved during treatment were adequate for treating complications of vaccination.

In clinical studies of VIGIV in 111 volunteers, the medicine was well tolerated. When adverse effects were noted, they were mild to moderate and included headaches, hives, and other rashes.


Story Source:

The above story is based on materials provided by U.S. Food And Drug Administration. Note: Materials may be edited for content and length.


Cite This Page:

U.S. Food And Drug Administration. "FDA Approves New Plasma-derived Product To Treat Complications Of Smallpox Vaccination." ScienceDaily. ScienceDaily, 3 March 2005. <www.sciencedaily.com/releases/2005/02/050225110501.htm>.
U.S. Food And Drug Administration. (2005, March 3). FDA Approves New Plasma-derived Product To Treat Complications Of Smallpox Vaccination. ScienceDaily. Retrieved October 19, 2014 from www.sciencedaily.com/releases/2005/02/050225110501.htm
U.S. Food And Drug Administration. "FDA Approves New Plasma-derived Product To Treat Complications Of Smallpox Vaccination." ScienceDaily. www.sciencedaily.com/releases/2005/02/050225110501.htm (accessed October 19, 2014).

Share This



More Health & Medicine News

Sunday, October 19, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Microneedle Patch Promises Painless Pricks

Microneedle Patch Promises Painless Pricks

Reuters - Innovations Video Online (Oct. 18, 2014) Researchers at The National University of Singapore have invented a new microneedle patch that could offer a faster and less painful delivery of drugs such as insulin and painkillers. Video provided by Reuters
Powered by NewsLook.com
Raw: Nurse Nina Pham Arrives in Maryland

Raw: Nurse Nina Pham Arrives in Maryland

AP (Oct. 17, 2014) The first nurse to be diagnosed with Ebola at a Dallas hospital walked down the stairs of an executive jet into an ambulance at an airport in Frederick, Maryland, on Thursday. Pham will be treated at the National Institutes of Health. (Oct. 16) Video provided by AP
Powered by NewsLook.com
Raw: Cruise Ship Returns to US Over Ebola Fears

Raw: Cruise Ship Returns to US Over Ebola Fears

AP (Oct. 17, 2014) A Caribbean cruise ship carrying a Dallas health care worker who is being monitored for signs of the Ebola virus is heading back to Texas, US, after being refused permission to dock in Cozumel, Mexico. (Oct. 17) Video provided by AP
Powered by NewsLook.com
Spanish Govt: Four Suspected Ebola Cases in Spain Test Negative

Spanish Govt: Four Suspected Ebola Cases in Spain Test Negative

AFP (Oct. 17, 2014) All four suspected Ebola cases admitted to hospitals in Spain on Thursday have tested negative for the deadly virus in a first round of tests, the government said Friday. Duration: 00:55 Video provided by AFP
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins