Navigation Links
FDA OKs New Rotavirus Vaccine
Date:4/4/2008

It's designed to ward off gastroenteritis, which causes vomiting and diarrhea in children

FRIDAY, April 4 (HealthDay News) -- The U.S. Food and Drug Administration has approved a second oral vaccine for the prevention of rotavirus, an infection that causes vomiting and diarrhea in infants and children.

The Rotarix vaccine is a liquid and given in a two-dose series to infants from 6 to 24 weeks of age.

Rotavirus causes an estimated 2.7 million cases of gastroenteritis in U.S. children each year -- and about 55,000 to 70,000 of those children require hospitalization. Between 20 and 60 deaths are attributed to the infection. Without vaccination, nearly every child in the United States would likely be infected at least once with rotavirus by age 5, the FDA said in its late-Thursday announcement.

There are many strains of rotavirus; the new vaccine protects against rotavirus gastroenteritis caused by the G1, G3, G4, and G9 strains, the agency said.

"This vaccine provides another option to combat and reduce a potentially severe illness that affects so many children," Dr. Jesse L. Goodman, director of FDA's Center for Biologics Evaluation and Research, said in a prepared statement released Thursday night.

In studies involving more than 24,000 infants, Rotarix was effective in preventing both severe and mild cases of gastroenteritis caused by rotavirus during the first two years of life. The most common adverse reactions reported during clinical trials were fussiness, irritability, cough, runny nose, fever, loss of appetite and vomiting, the FDA said.

Rotarix is manufactured by GlaxoSmithKline Biologicals, of Rixensart, Belgium.

In 1999, a different rotavirus vaccine from another manufacturer was voluntarily withdrawn from the U.S. market because of an association with an increased risk of intussusception, or intestinal folding, which can lead to potentially life-threatening intestinal blockage. Intussusception can occur in children who haven't been vaccinated, but to help ensure that Rotarix doesn't increase the risk of intussusception, GlaxoSmithKline Biologicals conducted a study of more than 63,000 infants.

That study found no increased risk of intussusception in children who received Rotarix (31,673 infants) compared to those who received a placebo (31,552 infants). Increased rates of convulsion and pneumonia-related deaths were observed in the Rotarix recipients in the intussusception study, but these events were not observed in other studies conducted by the manufacturer, the FDA said.

Although the FDA said it has concluded that the available data do not establish that these adverse events are related to the vaccine, the agency has asked GlaxoSmithKline Biologicals to conduct post-marketing safety studies involving more than 40,000 infants to provide additional safety information.

The new FDA approval coincided with the release of results from a clinical trial of a different oral rotavirus vaccine in Latin American infants.

That study found that two doses proved effective against severe rotavirus gastroenteritis for up to two years when given during the first two weeks of life.

The double-blind, placebo-controlled phase III study included 15,183 healthy infants from 10 countries. They were randomly assigned to receive two oral doses of either the RIX4414 vaccine or a placebo.

The children were monitored until they were 2 years old. During that time, 32 of the 7,205 (0.4 percent) of children in the vaccine group had severe rotavirus gastroenteritis, compared with 161 of 7,081 (2.3 percent) of those in the placebo group.

Vaccine effectiveness was 80.5 percent to 82.1 percent against the wild-type G1 rotavirus strain, 77.5 percent against pooled non-G1 strains, and 80.5 percent against pooled non-G1 P(8) strains. Vaccine efficacy for hospital admissions for rotavirus gastroenteritis was 83 percent and admission for diarrhea of any cause was 39.3 percent.

The findings were published in the April 5 issue of The Lancet.

"Inclusion of this vaccine in routine pediatric immunization schedules can be expected to greatly reduce the burden of rotavirus disease worldwide," concluded Prof. Miguel O'Ryan, of the Institute of Biomedical Sciences at the University of Chile, and colleagues.

An accompanying commentary was written by Prof. Keith Grimwood of the Queensland Paediatric Infectious Disease Laboratory at Royal Children's Hospital and University of Queensland in Brisbane, Australia.

The World Health Organization, he wrote, "is awaiting efficacy data (on the vaccine) from low-income countries of Africa and Asia, where much greater strain diversity exists and where 413,000 rotavirus deaths occur every year compared with 15,000 in Latin America and 200 in Europe."

More information

The U.S. Centers for Disease Control and Prevention has more about rotavirus.



-- Robert Preidt



SOURCE: U.S. Food and Drug Administration, news release, April 3, 2008; The Lancet, news release, April 4, 2008


'/>"/>
Copyright©2008 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. FDA APPROVES ROTARIX(R) [Rotavirus Vaccine, live, oral], THE FIRST VACCINE LICENSED TO COMPLETE THE ROTAVIRUS IMMUNIZATION SERIES BY FOUR MONTHS OF AGE
2. FDA Advisory Committee Recommends US Approval of Rotavirus Vaccine
3. Vaccine Induced Inflammation Linked to Epidemic of Type 2 Diabetes and Metabolic Syndrome
4. Clinical trial will test new HIV/AIDS vaccine
5. Researchers Successfully Test Ebola Vaccines
6. MITOCHONDRIAL DYSFUNCTION, VACCINES AND AUTISM: 1 in 50 Children Could Be at Risk
7. HIV Vaccine Funding: Enough is Enough, Says AHF in Baltimore Sun
8. NIAID to convene HIV Vaccine Summit
9. Study Finds Single Dose of Iomai Patch With Pandemic Flu Vaccine Achieves Protective Levels
10. UNC, Harvard develop inhaled TB vaccine
11. U.S. Health Officials Back Off Preference for New MMRV Vaccine
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... ... 2016 , ... Austin residents seeking Mohs surgery services, can now turn to ... Dr. Russell Peckham for medical and surgical dermatology. , Dr. Dorsey brings specialization to ... fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was under the direction of ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin Johnson has ... he has implemented orthobiologic procedures as a method for treating his patients. The ... first doctors to perform the treatment. Orthobiologics are substances that orthopaedic surgeons use ...
(Date:6/24/2016)... ... ... June 19, 2016 is World Sickle Cell Observance Day. In an effort to ... treatments, Serenity Recovery Center of Marne, Michigan, has issued a pain management ... (SCD) is a disorder of the red blood cells, which can cause episodes of ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Comfort Keepers® of ... Cancer Society and the Road To Recovery® program to drive cancer patients to and ... other adults to ensure the highest quality of life and ongoing independence. Getting ...
(Date:6/24/2016)... ... June 24, 2016 , ... Puradigm® & Innovative ... has initiated cultivation and processing operations at its production facility, and opened its ... Puradigm is the manufacturer of a complete system of proactive air and surface ...
Breaking Medicine News(10 mins):
(Date:6/26/2016)... 2016 Jazz Pharmaceuticals plc (Nasdaq: ... Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended ("HSR"), ... Inc. ("Celator"; Nasdaq: CPXX ) expired effective ... As previously announced on May 31, 2016, ... agreement under which Jazz Pharmaceuticals has commenced a tender ...
(Date:6/26/2016)... 2016 Story Highlights: ... within the health care industry is causing providers to ... , Deloitte offers a suite of solutions for health ... efficient cost optimization: labor resource analysis, revenue cycle optimization ... better outcomes and better economics ...
(Date:6/24/2016)... , June 24, 2016  Collagen Matrix, Inc., ... development and manufacturing of collagen and mineral based ... today that Bill Messer has joined ... to further leverage the growing portfolio of oral ... Bill joins the Collagen Matrix executive ...
Breaking Medicine Technology: