[NVIC] FDA Panel Approves Rotarix: Consumer Member Dissents

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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 GlaxoKline'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.

***********************************************************

" GlaxoKline 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

" 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. " -

Corbbett Dooren, Dow Newswires, (February 20, 2008)

http://news.morningstar.com/newsnet/V iewNews.aspx?

article=/DJ/200802201555DOWJONESDJONLINE000 791_univ.xml

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Glaxo rotavirus vaccine appears safe--US FDA panel

Reuters

February 20, 2008

by Kim Dixon

Click here for the URL:

GAITHERSBURG, Md. - GlaxoKline 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 GlaxoKline 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 Chang/Andre Grenon)

FDA Panel Backs Glaxo's Rotavirus Vaccine

Dow Newswires

February 20, 2008

by Corbett Dooren

Click here for the URL:

WASHINGTON -(Dow )- A Food and Drug Administration panel of vaccine

experts Wednesday backed Rotarix, a GlaxoKline 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, 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 Corbett Dooren, Dow Newswires;

202-862-9294;

jennifer.corbett@...

National Vaccine Information Center

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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.

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consent rights www.nvic.org

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Vaccination Information & Choice Network, Nevada City CA & Wales UK

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