NVIC Vaccine E-Newsletter
February 21, 2008
FDA Panel Approves Rotarix Safety 11-1
Consumer Member Vicky Debold Votes "NO" on Proof of Safety by
GSK
by Barbara Loe Fisher
NVIC's Director of Patient Safety, Vicky Debold, Ph.D, RN, who is the
consumer voting member on the FDA Vaccines and Related Biological Products
Advisory Committee, cast the sole dissenting "NO" vote when the Committee
was asked whether GlaxoSmithKline's pre-licensure clinical trials had
proved that rotavirus vaccine (Rotarix) is safe to give to infants. The FDA
Panel voted unanimously that GSK had proven effectiveness but voted 11-1 on
the safety question.
Debold noted that there were more deaths among the healthy infants who
received Rotarix compared to those who received a placebo. She pointed out
that the clinical trials did not inlude premature, sick and otherwise
biologically compromised infants and asked "What is going to happen when
this vaccine is given to children in the real world?" An FDA staff report
analyzing GSK data revealed a statistically significant increase in deaths
related to pneumonia among infants who got Rotarix versus the placebo.
Rotarix vaccine will directly compete with Merck's Rotateq vaccine for
market share. Rotateq, a genetically engineered hybrid live virus vaccine
containing human and bovine strains, has been associated with bowel
blockage (intussusception). Bowel blockage does not appear to be a problem
for live virus Rotarix, which contains genetically engineered human
rotavirus strains, although serious adverse events associated with the new
vaccine have included not only pneumonia and death but also bronchitis and
convulsions.
***********************************************************
"GlaxoSmithKline Plc's infant vaccine to prevent diarrhea caused by the
rotavirus appears safe and effective, based on available data, U.S.
advisers said on Wednesday.........In a briefing prepared for the meeting,
FDA staff had noted a statistically significant increase in deaths related
to pneumonia compared with placebo in Glaxo's largest trial. The panel was
unanimous the vaccine appeared effective and voted 11-1 that it appeared
safe.....Vicky Debold, patient safety director at the National Vaccine
Information Center, was the sole panel member to vote that the data does
not support the vaccine's safety. She noted the infants studied were all
healthy and asked: "What happens when this vaccine is given to children in
the real world?" - Kim Dixon, Reuters, (February 20, 2008)
http://www.guardian.co.uk/feedarticle? id=7324731
"Steven Rosenthal, an FDA medical officer who presented the agency's
review of the vaccine, said there was a higher rate of pneumonia-related
deaths and convulsions among vaccinated infants in one of the main studies.
The overall death rate from any cause, however, was similar between infants
given the vaccine and those in placebo groups. In total there were 118
deaths among all infants in the studies with 19 pneumonia related-deaths
among those receiving the vaccine and 10 among those not receiving it. He
said if Rotarix is approved in the U.S., Glaxo would conduct a
post-marketing study of the vaccine to monitor for potential side effects
such as pneumonia, convulsions and intussusceptions. In briefing documents
prepared for Wednesday's meeting, an FDA staff review said it wasn't clear
what role, if any, the vaccine played in the risk, while Glaxo officials
said there didn't appear to be any link to the vaccine. Clare Kahn, Glaxo's
North American vice president of regulatory affairs, said, "The
risk-benefit ratio is favorable for the intended population." One panel
member voted against the vaccine on safety grounds. Vicky Debold, a nurse
and the panel's consumer representative, said she was concerned about not
just the pneumonia-related deaths but the overall death rate." - Jennifer
Corbbett Dooren, Dow Jones Newswires, (February 20, 2008)
http://news.morningstar.com/newsnet/V iewNews.aspx?
article=/DJ/200802201555DOWJONESDJONLINE000 791_univ.xml
sb
Glaxo rotavirus vaccine appears safe--US FDA panel
Reuters
February 20, 2008
by Kim Dixon
Click here for the URL:
GAITHERSBURG, Md. - GlaxoSmithKline Plc's infant vaccine to prevent
diarrhea caused by the rotavirus appears safe and effective, based on
available data, U.S. advisers said on Wednesday.
The Food and Drug Administration advisory panel voted that the 11 studies
submitted by GlaxoSmithKline support the use of the oral vaccine, which
aims to prevent severe infant diarrhea often caused by infection with the
virus. The FDA typically takes the advice of its expert panels.
The vaccine, called Rotarix and already approved in many countries, could
compete with Merck & Co Inc's RotaTeq vaccine in the United States, if
approved by the FDA. Approval in the United States could intensify the
rivalry between the two drugmakers.
In a briefing prepared for the meeting, FDA staff had noted a statistically
significant increase in deaths related to pneumonia compared with placebo
in Glaxo's largest trial. The panel was unanimous the vaccine appeared
effective and voted 11-1 that it appeared safe. Most members were convinced
by Glaxo's argument the pneumonia deaths were an isolated finding from a
single study likely not due to the vaccine itself. I am not highly
concerned about the pneumonia issue," said Melinda Wharton, a vaccine
expert at the U.S. Centers for Disease Control and Prevention and panel
member.
Vicky Debold, patient safety director at the National Vaccine Information
Center, was the sole panel member to vote that the data does not support
the vaccine's safety. She noted the infants studied were all healthy and
asked: "What happens when this vaccine is given to children in the real
world?"
Rotavirus results in the hospitalization of about 55,000 children each year
in the United States and the death of over 600,000 worldwide, according to
the U.S. Centers for Disease Control and Prevention. Glaxo said it plans
several observational studies to monitor worrisome safety signals,
including the pneumonia deaths, if the drug is approved in the United
States. "We have a high level of confidence in the safety of the vaccine,"
Glaxo's vice president for regulatory affairs Clare Kahn told the panel.
(Reporting by Kim Dixon, editing by Richard Chang/Andre Grenon)
FDA Panel Backs Glaxo's Rotavirus Vaccine
Dow Jones Newswires
February 20, 2008
by Jennifer Corbett Dooren
Click here for the URL:
WASHINGTON -(Dow Jones)- A Food and Drug Administration panel of vaccine
experts Wednesday backed Rotarix, a GlaxoSmithKline PLC (GSK) infant
vaccine designed to help protect infants from a gastrointestinal illness
caused by rotavirus.
The panel unanimously said it believed the vaccine was effective and voted
11 to 1 in favor on the question of whether the vaccine was safe. The votes
amount to a recommendation that the agency approve the vaccine.
The agency isn't required to follow the advice of its outside panels of
medical experts, but usually does. The FDA is expected to decide whether to
approve Rotarix by April 3.
Rotavirus infection hits most children before age five. Although rotavirus
deaths in the U.S. are rare, the infection still causes about 50,000 to
70,000 hospitalizations each year. Rotarix, like a similar vaccine by Merck
& Co. (MRK) called RotaTeq, is designed to protect infants against
rotavirus during their first two years of life, when the infection's
symptoms are most likely to be severe.
Merck's vaccine has been on the U.S. market since 2006 and federal health
officials have been monitoring it for links to a rare bowel problem called
intussusception. A Wyeth (WYE) vaccine was pulled off the market in 1999
after it was linked to the ailment, which is marked by a twisting or
obstruction of the intestine that can be fatal.
About a year ago, the FDA issued a public-health advisory discussing 28
reports of intussusception seen among infants who were given Merck's
vaccine. The Centers for Disease Control later cleared the vaccine, saying
intussusception rates among vaccinated infants were lower than what would
be found in the general population. Still, federal health officials
continue to monitor RotaTeq and would do the same for Rotarix, assuming it
is approved.
So far, 11 clinical studies of Glaxo's vaccine, involving more than 75,000
children, don't show an increased risk of intussusception, with six cases
reported among children receiving the vaccine in clinical studies compared
with seven cases seen among patients receiving a placebo, or fake vaccine.
However, Steven Rosenthal, an FDA medical officer who presented the
agency's review of the vaccine, said there was a higher rate of pneumonia-
related deaths and convulsions among vaccinated infants in one of the main
studies. The overall death rate from any cause, however, was similar
between infants given the vaccine and those in placebo groups. In total
there were 118 deaths among all infants in the studies with 19 pneumonia
related-deaths among those receiving the vaccine and 10 among those not
receiving it.
He said if Rotarix is approved in the U.S., Glaxo would conduct a post-
marketing study of the vaccine to monitor for potential side effects such
as pneumonia, convulsions and intussusception.
In briefing documents prepared for Wednesday's meeting, an FDA staff review
said it wasn't clear what role, if any, the vaccine played in the risk,
while Glaxo officials said there didn't appear to be any link to the vaccine.
Clare Kahn, Glaxo's North American vice president of regulatory affairs,
said, "The risk-benefit ratio is favorable for the intended population."
One panel member voted against the vaccine on safety grounds. Vicky Debold,
a nurse and the panel's consumer representative, said she was concerned
about not just the pneumonia-related deaths but the overall death rate.
Panel member Melinda Wharton, the deputy director of the Centers for
Disease Control and Prevention's National Center for Immunization and
Respiratory Diseases, said she wondered if lowering the risk for
gastrointestinal illnesses made infants more susceptible to respiratory
illnesses such as pneumonia. She explained that it is relatively uncommon
to be ill with more than one virus at a time.
Rotarix, which is on the market in about 100 countries, is an oral vaccine
designed to be given in two doses. In the U.S. it would likely be given to
two- and four-month old children. Merck's vaccine, also given orally, is
typically given in a three-dose series at two, four and six months.
By Jennifer Corbett Dooren, Dow Jones Newswires;
202-862-9294;
jennifer.corbett@dowjones.com
National Vaccine Information Center
NVIC E-News is a free service of the National Vaccine Information Center
and is supported through donations.
NVIC is funded through the financial support of its members and does not
receive any government subsidies. Barbara Loe Fisher, President and Co-
founder.
Learn more about vaccines, diseases and how to protect your informed
consent rights www.nvic.org