NVIC Vaccine E-Newsletter
February 20, 2008
FDA Committee Votes Today on New Rotavirus Vaccine
by Barbara Loe Fisher
Today, the FDA Vaccines and Related Biological Products Advisory Committee
(VRBPAC) will vote on whether or not GlaxoSmithKline has proved that its
new rotavirus vaccine (Rotarix) is safe and effective. An FDA staff
analysis of the clinical trial data submitted by GSK, which was released on
Feb. 15, revealed that Rotarix was associated with an increase in
pneumonia-related deaths and convulsions. In addition, there were 27 cases
of Kawasaki disease, which involves fever and blood vessel inflammation, a
serious disease that has also been associated with Merck's rotavirus
vaccine (RotaTeq).
Vicky Debold, PhD, RN, who is Director of Patient Safety for the National
Vaccine Information Center (NVIC), has been appointed as the consumer
voting member on VRBPAC and will be participating in the FDA Committee's
discussion of the quality and quantity of the science presented by GSK in
its efforts to secure a license for Rotarix. VRBPAC briefing documents on
Rotarix may be viewed at:
http://www.fda.gov/ohrms/dockets/ac/08/br
iefing/2008-4348b1-00-index.html
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GlaxoSmithKline Plc's rotavirus vaccine is effective but also associated
with an increase in pneumonia-related deaths and other reactions, U.S.
regulatory staff said in documents posted on Friday. The review comes ahead
of a U.S. Food and Drug Administration advisory meeting on Wednesday to
consider approval of the oral vaccine, which aims to prevent rotavirus
infection, a cause of severe infant diarrhea that requires hospitalization.
The virus is a major killer of children in developing countries, but deaths
in the United States are rare........In a conclusion section, the FDA
documents said the drug was effective at preventing rotavirus-related
gastroenteritis, but also noted the pneumonia-related deaths and
convulsions........The biggest study, which enrolled about 63,000 children,
also found an increase in convulsions in children given the drug, named
Rotarix. Another study found an increased rate of bronchitis, compared with
placebos.......Last year, the label for Merck's [rotavirus] vaccine was
changed to include reports of Kawasaki disease, a serious but uncommon
illness that causes fever and blood- vessel inflammation. The FDA staff
summary said there were 27 cases of Kawasaki disease reported with Glaxo's
vaccine, with 3 cases occurring within 30 days of vaccination.," - Kim
Dixon, Reuters, (February 15, 2008)
http://health.yahoo.com/news/reuters/glaxo_rotavirus_dc.html
gsk
Pneumonia deaths seen with Glaxo vaccine: FDA
Reuters
February 15, 2008
by Kim Dixon
Click here for the URL:
GlaxoSmithKline Plc's rotavirus vaccine is effective but also associated
with an increase in pneumonia- related deaths and other reactions, U.S.
regulatory staff said in documents posted on Friday.
The review comes ahead of a U.S. Food and Drug Administration advisory
meeting on Wednesday to consider approval of the oral vaccine, which aims
to prevent rotavirus infection, a cause of severe infant diarrhea that
requires hospitalization. The virus is a major killer of children in
developing countries, but deaths in the United States are rare.
FDA staff said its analysis of 11 studies revealed that in the largest
trial, there was a statistically significant increase in deaths related to
pneumonia compared with placebos, documents posted on the FDA's Web site said.
Bernstein Research analyst Tim Anderson said safety issues could mar his
forecasts for the drug reaching sales of $1.3 billion by 2012. The drug
could compete with Merck & Co's RotaTeq vaccine, and a negative safety
label for Glaxo could give Merck an advantage, he said. The two "are
battling it out in the area of pediatric rotavirus vaccines," Anderson
said. Deutsche Bank analyst Brian Bourdot downplayed the FDA report, noting
the European Medicines Agency has already considered some of the same
safety issues with Rotarix, which is already approved outside the United
States.
Merck's vaccine is sold in both the United States and abroad. Anderson said
Glaxo's two-dose regime, compared with Merck's three-dose course, could
give it an advantage depending on how the safety data are interpreted.
The issues with Rotarix come on the heels of problems with Glaxo's
blockbuster Cervarix vaccine, a rival to Merck's cervical cancer prevention
shot Gardasil. Approval of Cervarix was delayed by the FDA in December and
Glaxo says it aims to respond to the agency's concerns during the second
quarter of this year.
In a conclusion section, the FDA documents said the drug was effective at
preventing rotavirus-related gastroenteritis, but also noted the
pneumonia-related deaths and convulsions. It did not appear to make a
recommendation to the advisory panel.
That expert panel will weigh the staff review, but makes its own
recommendation, which is typically followed by the FDA.
The rate of pneumonia-related death was 0.051 percent with the Glaxo
vaccine, versus 0.019 percent with a placebo, a difference that
statistically was not likely due to chance.
The biggest study, which enrolled about 63,000 children, also found an
increase in convulsions in children given the drug, named Rotarix. Another
study found an increased rate of bronchitis, compared with placebos.
Rotarix was found not to be linked with a bowel condition called
intussusception that caused an earlier rotavirus drug sold by Wyeth to be
pulled off the market, FDA staff said.
Glaxo, in documents prepared for the FDA meeting, noted that respiratory
infections like pneumonia account for "dramatically greater numbers and
proportions of infant deaths in Latin America, compared to the U.S."
The study took place primarily in Latin America. Last year, the label for
Merck's vaccine was changed to include reports of Kawasaki disease, a
serious but uncommon illness that causes fever and blood- vessel inflammation.
The FDA staff summary said there were 27 cases of Kawasaki disease reported
with Glaxo's vaccine, with 3 cases occurring within 30 days of vaccination.
(Reporting by Kim Dixon; Editing by Brian Moss and Steve Orlofsky, Richard
Chang)
National Vaccine Information Center
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NVIC is funded through the financial support of its members and does not
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founder.
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