http://www.yourlawyer.com/topics/overview/rotateq Sat, 21 Nov 2009 06:53:33 -0800 pixel-app en http://www.yourlawyer.com/articles/read/12677 Fri, 16 Mar 2007 00:00:00 -0700 http://www.yourlawyer.com/articles/read/12677
The vaccine, sold by Merck and Company under the brand name RotaTeq, was licensed by the Food and Drug Administration (FDA) in February 2006. The Advisory Committee on Immunization Practices (ACIP) recommends RotaTeq for routine vaccination of U.S. infants to protect against rotavirus, which causes severe diarrhea, vomiting, fever and dehydration (gastroenteritis) in children.

Each year in the United States, rotavirus is responsible for more than 400,000 doctor visits; more than 200,000 emergency room visits; and 55,000 to 70,000 hospitalizations. In developing countries, rotavirus is a major cause of childhood deaths, estimated to cause more than half a million deaths each year in children younger than 5 years of age.

Last month, FDA notified healthcare providers and consumers that it had received reports of intussusception following RotaTeq vaccination. Since then, FDA, ACIP and CDC have concluded that the number of intussusception reports after administration of RotaTeq has not exceeded the number expected to occur without vaccination and that the vaccine does not appear to be associated with intussusception.

"Monitoring the safety of a new vaccine is very important," said Anne Schuchat, MD, director of CDC's NationalCenter for Immunization and Respiratory Diseases. "The data we have reviewed are reassuring, and we continue to recommend the RotaTeq vaccine. However, we will continue to carefully monitor reports of possible adverse effects associated with the vaccine and will take appropriate action if there proves to be a problem in the future."

Based on ACIP recommendations, CDC policy calls for routine immunization of all U.S. infants with three doses of RotaTeq administered orally at 2, 4 and 6 months.

RotaTeq is the only vaccine approved in the United States for prevention of rotavirus disease. Studies indicate RotaTeq will prevent about 74 percent of all rotavirus cases and about 98 percent of the most severe cases, including 96 percent of cases requiring hospitalization.

Intussusception is a serious, life-threatening condition that occurs when the intestine or bowel becomes blocked. The condition can occur spontaneously in the absence of vaccination. It is most common among infants in the first year of life, causing about 1,400 infant hospitalizations annually. These cases occurred before use of any rotavirus vaccines in the United States.

The reported intussusception cases were detected through routine monitoring of new vaccines using the Vaccine Adverse Event Reporting System (VAERS). Following licensure and general use of all vaccines in the United States, CDC and FDA closely monitor VAERS reports of potential health problems after vaccination submitted by a variety of sources. Reports to VAERS may be submitted by anyone, including healthcare providers, patients and family members. Physicians and scientists at both agencies review all reports of serious side effects reported to VAERS.

CDC and FDA continue to closely monitor RotaTeq for problems in vaccine recipients. They encourage all healthcare providers and other individuals to report any cases of intussusception or other serious adverse events to VAERS.]]> http://www.yourlawyer.com/articles/read/12543 Thu, 15 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12543
Winkler Sims, head of the state Department of Public Health's immunization division, said the state began distributing the RotaTeq vaccine in July to more than 500 sites that participate in the Children's Vaccine Program. Private providers also have been using the vaccine, with 3.5 million doses distributed nationwide over the past year.

Sims said the state will continue routinely injecting children with RotaTeq because the Food and Drug Administration has not determined that it is unsafe. The vaccine protects children against a rotavirus, which is the leading cause of childhood diarrhea.

"At this point there's no recall on the vaccine," Sims said. "It's just a warning for physicians."

The FDA notified health care providers and consumers that there have been 28 reports of a serious intestinal condition called intussusception in infants since the vaccine was approved last February. The FDA said it was unknown whether the vaccine caused the problem, and said that number of cases was below what authorities would expect to occur naturally each year.

But eight years ago, a high number of intussusception cases led to withdrawal of the first rotavirus vaccine. There were no deaths reported in the 28 new cases of intussusception, but 16 infants did require intestinal surgery, the FDA reported.

The FDA wants vaccine providers to report all cases of intussusception to the Vaccine Adverse Events Reporting System.

To gain FDA approval, RotaTeq, which is manufactured by Merck & Co. Inc., passed safely through a trial of 70,000 infants. To further confirm the vaccine's safety, Merck is conducting another study of 44,000 infants, and the CDC Vaccine Safety Data Link is conducting a study 90,000 infants, according to the FDA.

RotaTeq requires three doses. Some of the cases of intussusception occurred after the first dose, some after the second and some after the third. About half the cases occurred one to 21 days after one of the vaccinations; no cases were reported later than 73 days after a vaccination.
]]> http://www.yourlawyer.com/articles/read/12534 Wed, 14 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12534
The condition, called intussusception, is the same that led to the withdrawal of the first rotavirus vaccine eight years ago.

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

"It looks like this is the natural background rate that we are seeing," said Michelle G. Goveia, medical director for pediatric medical affairs at Merck, which makes the vaccine.

In yesterday's public health notification, the FDA said it wanted to encourage reporting of any additional cases of intestinal twisting or blockage to help it assess risks associated with the three-shot vaccine series.

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

The vaccine received FDA approval in February 2006. About 3.5 million doses of RotaTeq have been distributed in the United States, but not all have been used, the agency said.]]> http://www.yourlawyer.com/articles/read/12535 Wed, 14 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12535
The announcement, coming eight years after Wyeth was forced to withdraw its own rotavirus vaccine in response to similar reports of intestinal blockage, raises questions about a high-profile vaccine that was developed by Merck based on research done at Children's Hospital of Philadelphia and the nearby Wistar Institute.

"Of the 28 cases of intussusception, the number that many have been caused by the vaccine or occurred by coincidence is unknown," the FDA stated on its Web site. It said it issued the public health notification to encourage reporting of additional cases.

Paul A. Offit, chief of infectious disease at Children's Hospital and co-inventor of the vaccine, said the FDA's notice was contradictory and would unnecessarily scare doctors and parents.

"The fact that only 28 cases of intussusception have been reported after 3.5 million doses of the vaccine have been distributed is encouraging because it strongly suggests that no connection exists," Offit said.

Offit and Merck said the number of problems reported by the FDA was actually lower than what would be expected to occur in unvaccinated children.

In its public notice, the FDA also said the report "does not exceed the number expected" naturally. Noting that adverse events typically are underreported, the agency said its experience with the Wyeth rotavirus vaccine had led to data about problems "being evaluated continually."

It urged pediatricians and parents to report cases of intussusception online or by calling 1-800-822-7967.

Merck had conducted extensive clinical trials on the vaccine, including one involving 70,000 people that looked specifically for intussusception.

"We feel that physicians should continue to administer RotaTeq to appropriate infants," said Michelle Goveia, a Merck medical director. "There is no causal relationship with these cases."

Merck's stock rose 10 cents a share to $43.95 yesterday.

Both Wistar and Children's Hospital earn royalties from the sale of the vaccine that could be worth millions of dollars. In 2005 Wistar sold a portion of its anticipated royalties for $45 million days after an FDA advisory panel voted unanimously that RotaTeq was effective and did not appear to cause intestinal complications.

RotaTeq, given in three doses, was approved for sale in the U.S. early last February, and quickly recommended for inclusion among routine vaccinations.

Rotavirus infects millions of children worldwide, causing an estimated 500,000 deaths a year, mostly in developing countries. In the U.S., it is responsible for more than 400,000 doctor visits, 70,000 hospitalizations and as many as 60 deaths.]]> http://www.yourlawyer.com/articles/read/12537 Wed, 14 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12537
There haven't been any deaths associated with Merck's RotaTeq vaccine, which guards against the highly contagious rotavirus, the FDA said Tuesday after the markets had closed.

However, the agency has received reports of 28 cases of a complication in which an infant's intestine gets blocked or twisted, causing an obstruction. This condition, called intussusception, can occur by itself, and the FDA doesn't know how many of the 28 cases were linked to the vaccine. Sixteen infants required surgery.

"Because vaccine adverse events are not always reported to FDA, there may be additional cases of intussusception following vaccination of which we are unaware at this time," the agency says. The agency has ordered a label revision to reflect the new information and is encouraging consumers to tell it about suspected cases.

Intussusception was the reason why Wyeth (WYE) removed a similar vaccine in 1999 after only one year on the market.

Merck is overseeing a post-marketing survey of 44,000 infants to determine the rate of intussusception, and the federal Centers for Disease Control and Prevention is conducting its own study of 90,000 infants. The FDA said the number of cases at this time is within the range of expected side effects based on the CDC's calculations for unvaccinated children between the ages of 6 weeks to 35 weeks.

Merck's clinical trials found no significant difference in the intestinal obstruction between some 35,000 infants getting the vaccine and another 35,000 getting a placebo. Six vaccine patients and five placebo recipients developed intussusception.

The FDA approved the vaccine 12 months ago. Approximately 3.5 million doses had been distributed through Feb. 1, although some doses haven't been administered, the agency says. Infants receive three doses. A doctor squeezes the liquid vaccine from a tube into an infant's mouth.

The vaccine, which is sold in 34 countries, produced $163 million in sales last year. Applications for its approval have been filed in more than 100 countries.]]> http://www.yourlawyer.com/articles/read/12541 Wed, 14 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12541
The FDA noted “28 post-marketing reports of intussusception following administration of Rotavirus, Live, Oral, Pentavalent vaccine (trade name RotaTeq), manufactured by Merck and Co. One portion of the intestine telescopes into a nearby portion, causing the intestinal obstruction. The most common site is where the small intestine joins the large intestine.”

At this point, it is unclear whether or not the vaccine is causing the intestinal problems, but the high incidence of this condition has led the FDA to issue an alert even though the number of cases hasn’t exceeded the “expected” rate.

“Approximately 3.5 million doses of RotaTeq have been distributed in the United States through February 1, 2007,” the FDA said. “Not all of these doses have been administered. Since its licensure on February 3, 2006 until January 31, 2007, 28 cases of intussusception have been reported in the U.S. in infants who received RotaTeq. The reported 28 cases occurred after dose 1, dose 2, and dose 3. Approximately half of the cases occurred 1 to 21 days after vaccination, with a range of 0 to 73 days. Sixteen of the 28 infants with intussusception required hospitalization and surgery on their intestine. The remaining 12 infants had reduction of the intussusception by contrast or air enema. No deaths due to intussusception were reported.”

In 1999, Wyeth was forced to pull its rotavirus vaccine from the market due to similar concerns about intussusception. Although rotavirus may cause fever, diarrhea, and vomiting, it is not usually fatal. However, the Centers for Disease Control and Prevention (CDC) still recommends that infants be vaccinated against it. Merck is currently in the midst of a large study of 44,000 children related to their vaccine, but they won’t have complete findings from the study until the end of next year.

RotaTeq had international sales of approximately $163 million in 2006, but that figure is expected to triple in the next three years.
]]> http://www.yourlawyer.com/articles/read/12533 Tue, 13 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12533
Intussusception can occur spontaneously in the absence of vaccination. Of the reported 28 cases of intussusception, the number that may have been caused by the vaccine, or occurred by coincidence, is unknown.

FDA is issuing this notification both to encourage the reporting of any additional cases of intussusception that may have occurred or occur in the future after administration of RotaTeq, and to remind people that intussusception is a potential complication of RotaTeq,.

Current Status

Approximately 3.5 million doses of RotaTeq have been distributed in the United States through February 1, 2007. Not all of these doses have been administered. Since its licensure on February 3, 2006 until January 31, 2007, 28 cases of intussusception have been reported in the U.S. in infants who received RotaTeq. These cases have been reported to the Vaccine Adverse Event Reporting System (VAERS). The reported 28 cases occurred after dose 1, dose 2 and dose 3. Approximately half of the cases occurred 1 to 21 days after vaccination, with a range of 0 to 73 days. Sixteen of the 28 infants with intussusception required hospitalization and surgery on their intestine. The remaining 12 infants had reduction of the intussusception by contrast or air enema. No deaths due to intussusception were reported.

The number of intussusception cases reported to date after RotaTeq administration does not exceed the number expected based on background rates of 18-43 per 100,000 per year for an unvaccinated population of children ages 6 to 35 weeks (CDC, unpublished data).

History

RotaTeq is indicated for the prevention of rotavirus gastroenteritis and was studied pre-licensure in a clinical trial population of approximately 70,000 infants (35,000 infants received RotaTeq and 35,000 received placebo), and no significant increased risk of intussusception was found (e.g., six cases were seen in RotaTeq recipients vs. five in placebo recipients). However, a different rotavirus vaccine, which is no longer marketed, may have increased the incidence of intussusception following its use. Therefore, to further evaluate whether, in the general population, RotaTeq could be associated with increased rates of intussusception or other serious adverse events, not only is VAERS data being evaluated continually, but Merck is conducting a post-marketing study of approximately 44,000 infants, and the CDC Vaccine Safety Data Link is conducting a post-marketing study of approximately 90,000 infants.

Recommendations

Because vaccine adverse events are not always reported to FDA, there may be additional cases of intussusception following vaccination of which we are unaware of at this time. This information is important in helping FDA and CDC assess whether RotaTeq may be associated with an increased risk of intussusception and, if so, to what degree. Therefore, we are encouraging all health care professionals, and any other individuals, to report any cases of intussusception or other serious events that may be associated with the use of RotaTeq to VAERS, which is maintained by FDA and CDC. For a copy of the vaccine reporting form, call 1-800-822-7967 or report on line to www.vaers.hhs.gov

Parents should contact their child’s doctor immediately if the child has stomach pain, vomiting, diarrhea, blood in their stool or change in their bowel movements, as these may be signs of intussusception. It is important to contact the child’s doctor if there are any questions or if the child has any of these symptoms at any time after vaccination, even if it has been several weeks since the last vaccine dose.

FDA and the CDC will continue close monitoring of intussusception and other adverse events associated with RotaTeq. The RotaTeq label and Patient Product Information have been updated to include post-marketing reports of intussusception. The dosage and administration schedule remains unchanged in the label.]]> http://www.yourlawyer.com/topics/overview/rotateq Tue, 13 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/topics/overview/rotateq Infant Vaccine RotaTeq Linked to Intestinal Problems RotaTeq gained FDA approval in February 2006 and is manufactured by Merck. At the time, the FDA and Merck said trials of the vaccine involving approximately 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 is monitoring reports additionally. About 3.5 million doses of the Merck vaccine have been dispersed in the U.S., though not all have been used, the FDA said.

On February 13, 2007 the U.S. government issued a warning for a potentially life-threatening condition called Intussusception that causes the twisting of the intestines in infants vaccinated against a virus that is the leading cause of early childhood diarrhea. Intussusception originally led to the withdrawal of the first rotavirus vaccine eight years ago. The FDA said it was not know yet whether the newly approved vaccine, called RotaTeq, caused the 28 new cases.

The reports don't surpass the numbers expected to occur naturally each year, the so-called background rate, the FDA said. With this 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 post marketing. But because it is so serious, we asked the company to change the label," FDA spokeswoman Karen Riley said. The 28 cases included 16 infants who needed intestinal surgery. To date there have been no reports of deaths.

"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. 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.

If your child was given the vaccine Rotateq and suffered Intussusception, please fill out the form at the right for a free case evaluation by a qualified defective drugs attorney.]]>