Re: US FDA: Components of Extraneous Virus Detected in Rotarix Vaccine; No Known Safety Risk (Porcine Circovirus 1 (PCV1) DNA fragments)
http://www.promedmail.org/pls/otn/f..._BACK_PAGE,F2400_P1001_PUB_MAIL_ID:1000,81867
Archive Number 20100322.0914
Published Date 22-MAR-2010
Subject PRO/AH/EDR> Rotavirus vaccine - USA: extraneous virus
ROTAVIRUS VACCINE - UNITED STATES OF AMERICA: EXTRANEOUS VIRUS
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A ProMED-mail post
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International Society for Infectious Diseases
<http://www.isid.org>
Date: Mon 22 Mar 2010
Source: U.S. Food and Drug Administration (FDA), News Release [edited]
<http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm205625.htm>
Components of Extraneous Virus Detected in Rotarix Vaccine; No Known
Safety Risk
FDA Recommends Clinicians Temporarily Suspend Use of Vaccine as
Agency Learns More
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The US Food and Drug Administration (FDA) is recommending that health
care practitioners temporarily suspend use of the Rotarix vaccine for
rotavirus immunization in the United States while the agency learns
more about components of an extraneous virus detected in the vaccine.
There is no evidence at this time that this finding poses a safety
risk.
The agency recently became aware that an independent U.S. academic
research team, using a novel technique, has found DNA from porcine
circovirus 1 (PCV1) in Rotarix [vaccine], which is manufactured by
GlaxoSmithKline. PCV1 is not known to cause illness in humans or
other animals. In addition, Rotarix has been studied extensively,
before and after approval, and found to have an excellent safety
record.
Follow-up tests by GlaxoSmithKline and FDA scientists confirmed the
academic team's findings and confirmed that viral components have
been present since the early stages of the vaccine's development,
including during clinical studies. Preliminary testing by both the
academic researchers and FDA scientists of another licensed vaccine
against rotavirus infection, RotaTeq, has not detected components of
PCV1.
"We are making clinicians aware of information recently received by
FDA about the Rotarix vaccine," said Dr. Margaret A. Hamburg,
Commissioner for Food and Drugs. "There is no evidence at this time
that there is a safety concern. The FDA is recommending that
clinicians temporarily suspend use of Rotarix until we can learn more
about the situation. We will keep the public and the clinical
community updated on our findings."
Rotarix and RotaTeq are given by mouth to young infants to prevent
rotavirus disease, which can cause severe diarrhea and dehydration
and is estimated to be responsible for the deaths of more than 500
000 infants around the world each year, primarily in low- and
middle-income countries. Before the introduction of a rotavirus
vaccine, rotavirus resulted in more than 50 000 hospitalizations and
several dozen deaths in the United States each year. The FDA licensed
RotaTeq in 2006 and Rotarix in 2008. Most children vaccinated in the
United States received RotaTeq.
"In many countries, rotavirus causes so much severe illness and death
that the known benefits of continued use of Rotarix far outweigh any
theoretical risk of harm from the vaccine," said Dr. Thomas Frieden,
Director of the Centers for Disease Control and Prevention. "We
anticipate that many countries will decide to continue vaccinating
with Rotarix while more information becomes known."
The FDA will continue to gather more information about the PCV1
components in Rotarix, including whether intact virus, as opposed to
DNA fragments, is present. The agency is assessing current vaccine
testing methods. In 4 to 6 weeks, the FDA will convene an expert
advisory committee and make additional recommendations on the use of
rotavirus vaccines.
The FDA will provide updates to patients, providers, and the general
public as more information becomes available. The agency will also
continue to communicate with the World Health Organization and
counterpart regulatory agencies in other countries.
For more information visit FDA's Update on Rotarix Vaccine1 page
<http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm205585.htm>
--
Communicated by:
ProMED-mail
<promed@promedmail.org>
[Rotarix is one of 2 live-attenuated viral vaccines licensed to
prevent rotavirus disease, which can cause severe diarrhea and
dehydration in young infants. Rotarix vaccine is a live-attenuated
human rotavirus. It causes a slight infection that typically produces
no symptoms, but creates immunity against rotavirus. Rotarix is sold
in the United States as a powder that is to be dissolved in a liquid
that comes with the vaccine in a pre-filled oral applicator. The
vaccination series consists of 2 1-mL doses administered by mouth.
The 1st dose can be given beginning at 6 weeks of age and the 2nd at
least 4 weeks after the 1st dose, but before the child reaches 24
weeks of age.
Rotarix was developed from a live, attenuated form of a rotavirus
that was originally isolated from a child at Cincinnati Children's
Hospital. GlaxoSmithKline took over development of the vaccine and
conducted clinical trials in the United States and overseas. Clinical
trials conducted in 17 countries have shown the vaccine to be more
than 80 percent effective in preventing severe gastrointestinal
disease caused by rotavirus.
The data submitted to the FDA to support the safety of Rotarix
included results from 8 clinical studies that evaluated a total of 71
209 infants who received Rotarix (N = 36 755) or placebo (N =
34,454). The most common adverse reactions reported during clinical
trials for Rotarix were fussiness, irritability, cough, runny nose,
fever, loss of appetite and vomiting. FDA concluded that the
available data supported the safety of the vaccine. In addition to
the FDA, the European Medicines Agency and numerous other foreign
regulatory authorities have licensed Rotarix. The vaccine is now
licensed in 114 countries.
Live attenuated viruses in general are derived and propagated in
cultured cells and must be carefully controlled during development to
prevent contamination by adventitious agents. Furthermore live
attenuated vaccines are not subjected to inactivation prior to
administration. In the present case unspecified components of an an
unrelated viral agent, porcine circovirus type 1 have been detected
in the final rotavirus vaccine. It is not known at present at what
stage in the process of development and production of this vaccine
the adventitious agent was introduced. Porcine circovirus 1, the
contaminant of the Rotarix vaccine, is a small DNA-containing virus
probably restricted to its natural host the pig and propagated by
fecal-oral transmission in pigs. Human rotavirus is a RNA virus with
a genome comprised of 11 double-stranded RNA sub-units. There is no
immunological or genetic relationship between these 2 infectious
agents. - Mod.CP]
