Navigation Links
FDA: Rotavirus Vaccine May Harm Infants

The government warned on Tuesday of potentially life-threatening twisting of the intestines in infants vaccinated// against a virus that is the leading cause of early childhood diarrhea.

The condition, called intussusception, is the same that led to the withdrawal of the first rotavirus vaccine eight years ago.

The Food and Drug Administration said it was unknown whether the recently approved vaccine, called RotaTeq, caused the 28 new cases. The condition also can occur spontaneously. Indeed, the reports don't exceed the numbers expected to occur naturally each year _ the so-called background rate, the FDA said.

"It looks like this is the natural background rate that we are seeing," said Dr. Michelle Goveia, medical director for pediatric medical affairs at the vaccine's manufacturer, Merck & Co. Inc. Goveia suggested heightened concerns about the previous vaccine, made by Wyeth, prompted the FDA to act.

In Tuesday's public health notification, the agency said it wanted in part to encourage reporting of any additional cases of intestinal twisting or blockage to help it assess any risks associated with the three-shot vaccine series. It also said the vaccine's label would mention the cases of intussusception.

"It's a known serious, life-threatening adverse event that is being seen at an expected level postmarketing. But because it is so serious, we asked the company to change the label," FDA spokeswoman Karen Riley said.

Dr. Paul Offit, the vaccine's co-inventor, said the 28 reports were well below the hundreds of cases one would expect naturally. He suggested the FDA wanted to "shake the tree" for more reports about the vaccine.

"I am actually encouraged by those data: 28 cases, when you would have expected at least 500 cases, that is really reassuring," said Offit, of the Children's Hospital of Philadelphia. "I don't see how those numbers suggest something's awry. If anything, they s uggest nothing's awry."

The 28 cases included 16 infants who required intestinal surgery. There have been no reports of deaths.

RotaTeq received FDA approval in February 2006. At the time, the FDA and Merck said trials of the vaccine involving nearly 70,000 infants indicated it did not increase the risk of intussusception. But Merck and the Centers for Disease Control and Prevention are conducting follow-up studies of tens of thousands more infants to track any long-term effects of the vaccine. The FDA also is monitoring reports.

About 3.5 million doses of the Merck vaccine have been distributed in the U.S., though not all have been used, the FDA said.

The earlier rotavirus vaccine, Wyeth's RotaShield, was pulled from the U.S. market in 1999 after it was linked to a small increase in intussusception. It had been on the market a year.

In the United States, rotavirus sickens about 2.7 million children younger than 5, sends up to 70,000 to the hospital and causes 20 to 70 deaths each year.

Source-Bio-Bio Technology

Related medicine news :

1. Diarrhea Vaccine Trials Promises Prevention of Rotavirus Infection
2. New Vaccines To Combat Rotavirus
3. Child Diarrhoea Due To Rotavirus:Quick Relief By Short Course Drug
4. Rotavirus Vaccine – NT Shows the Wa
5. Experts Call for Rotavirus Vaccine for All
6. Experts Warn of Rising Incidence of Rotavirus in Pakistan
7. WHO Passes Rotavirus Vaccine
8. Call for Rotavirus Vaccine Funding
9. Vaccine Funding A Welcome Weapon Against Deadly Rotavirus
10. Rotavirus can Spread Beyond the Intestine
11. Vaccine to quit smoking?
Post Your Comments:

(Date:10/13/2017)... ... 13, 2017 , ... Apple Rehab Shelton Lakes , which specializes in ... the facility as part of a disaster drill on October 3rd. , Apple Rehab ... City Emergency Manager, as well as the Connecticut Long Term Care Mutual Aid ...
(Date:10/13/2017)... RIDGE, N.J. (PRWEB) , ... October 13, 2017 , ... ... annual Holly Day Market. Featuring a collection of specialty vendors and unique items from ... of personalized and quality-focused health and wellness services offered by the VNA. The ...
(Date:10/13/2017)... ... ... Global Healthcare Management’s 4th Annual Kids Fun Run brought out many kids this ... by Global Healthcare Management’s CEO, Jon Letko, is aimed at getting kids excited about ... ages; it is a non-competitive, non-timed event, which is all about having fun and ...
(Date:10/13/2017)... ... October 13, 2017 , ... ... viewers the lowdown on sciatica in a new episode of "Success Files," which ... current events and innovation and investigates each subject in-depth with passion and integrity. ...
(Date:10/13/2017)... ... 2017 , ... “The Journey: From the Mountains to the Mission Field”: the ... in the Philippines. “The Journey: From the Mountains to the Mission Field” is the ... She has taught all ages and currently teaches a class of ladies at her ...
Breaking Medicine News(10 mins):
(Date:9/25/2017)... , Sept. 25, 2017   Montrium , ... File solutions, today—from the IQPC Trial Master Files ... , NL)—announced that EastHORN Clinical Services has selected ... programs and TMF management. EastHORN, a leading European ... platform to increase transparency to enable greater collaboration ...
(Date:9/19/2017)... HistoSonics, Inc., a venture-backed medical device company developing a non-invasive, robotically assisted, platform ... leadership team developments today:   ... ... Tom Tefft ... Veteran medical device executive Josh Stopek , PhD, who has led ...
(Date:9/12/2017)... PARIS and NEW YORK , Sept. 12, ... ethical performance ratings for global supply chains, has published the first annual ... the CSR performance of more than 20,400 companies evaluated by EcoVadis, based ... years 2015 and 2016. ... EcoVadis Global CSR Risk & Performance Index ...
Breaking Medicine Technology: