CDC Advisory Panel Recommends Rotavirus Vaccine
CDC's Advisory Committee on Immunization Practices on Tuesday unanimously recommended that all U.S. infants be vaccinated against rotavirus, the Los Angeles Times reports (Gellene, Los Angeles Times, 2/22).
Rotavirus causes diarrhea and inflammation and leads to more than two million hospitalizations and 600,000 deaths worldwide each year, primarily among young children in developing countries. In the U.S., rotavirus causes about 70,000 hospitalizations and 20 to 70 deaths annually.
FDA earlier this month approved Merck's rotavirus vaccine, which will be marketed under the brand name RotaTeq.
The last vaccine developed to treat rotavirus, Wyeth's RotaShield, was taken off the market because in rare cases it caused intussusception, a severe intestinal problem that can be life-threatening.
Merck conducted a test of RotaTeq involving 68,038 infants in 11 countries and found that the vaccine was safe and effective. Researchers found that in the vaccine group, 12 infants developed intussusceptions, compared with 15 in the placebo group.
The results suggest the difference was due to chance. The research also showed that RotaTeq prevented 98% of severe infections and 96% of hospitalizations caused by rotavirus (American Health Line, 2/6).
ACIP voted to recommend that children receive RotaTeq, which is administered orally, at ages two months, four months and six months during regular well-baby visits (McKenna, Atlanta Journal-Constitution, 2/22).
The vaccine should be administered to children between the ages of six weeks and 32 weeks, according to Merck. It is not recommended for children with compromised immune systems and those who are allergic to components of the vaccine (Stobbe, AP/Milwaukee Journal Sentinel, 2/21).
The vaccine is expected to cost $187.50 wholesale for the three-dose series, making it "one of the most expensive vaccines ever marketed," according to the Washington Post. Many doctors are expected to charge more than $300 to administer the vaccines (Gillis, Washington Post, 2/22).
A CDC analysis showed that the cost of immunizing the four million infants born in the U.S. each year against rotavirus would be higher than the cost of treating the disease.
CDC epidemiologist Umesh Parashar said, "Given the launch price by Merck, it is very unlikely to be cost-saving." However, he added that when ACIP considers whether to recommend a childhood vaccine, "economic issues, while important, are secondary" (Los Angeles Times, 2/22).
Mark Feinberg, Merck's vice president of policy, public health and medical affairs, said the expense of the vaccine will be offset by a reduction in the more than $1 billion in annual costs related to rotavirus treatments (Atlanta Journal-Constitution, 2/22).
According to the Times, ACIP's recommendation "all but ensures a large, stable market for the vaccine in the U.S.," and financial analysts expect RotaTeq to generate U.S. sales of $500 million by 2010. In addition, the recommendation likely means that private insurers will cover the vaccine.
The panel is scheduled on Wednesday to vote on whether to add RotaTeq to the federal Vaccines for Children Program, which provides free childhood immunizations to low-income families (Los Angeles Times, 2/22).
If CDC adopts ACIP's recommendation, rotavirus will become the 15th illness against which U.S. children are vaccinated (AP/Milwaukee Journal Sentinel, 2/21). CDC said the recommendation should become official within weeks (Los Angeles Times, 2/22).
GlaxoSmithKline is expected to submit to FDA within one year an application for its own rotavirus vaccine, called Rotarix (Atlanta Journal-Constitution, 2/22).
Jon Abramson, ACIP's chair, said, "This could have a substantial impact," possibly preventing tens of thousands of hospitalizations annually (AP/Milwaukee Journal Sentinel, 2/21).
Vaccine co-developer Paul Offit of Children's Hospital of Philadelphia, said, "There's a great burden of rotavirus in the United States; it is hard to find a kindergartener who hasn't been infected at some point" (Atlanta Journal-Constitution, 2/22).
Parashar said that RotaTeq "generally appears to have a better safety profile than the earlier vaccine. But at the same time it's something we'll continue to look at and hopefully conform absence of risk" (Washington Post, 2/22).
Merck will conduct a second trial of the vaccine with 44,000 children once it reaches the market, according to Feinberg. In addition, CDC will conduct a separate study of about 90,000 children who take RotaTeq (Atlanta Journal-Constitution, 2/22).
CBS' "Evening News" on Tuesday reported on the vaccination recommendation. The segment includes comments from Offit; J. Gary Wheeler, professor of pediatrics at Arkansas Children's Hospital; and the parents of an infant who was hospitalized for rotavirus (Kaledin, "Evening News," CBS, 2/21).
The complete segment is available online in RealPlayer.