http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm211101.htm
ROTAVIRUS VACCINE - USA (02): EXTRANEOUS VIRUS
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International Society for Infectious Diseases
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[1]
Date: Fri 7 May 2010
Source: CIDRAP News [edited]
Another rotavirus vaccine found to contain porcine circovirus
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Merck, the company that makes the most commonly given rotavirus vaccine in
the United States, yesterday said it has detected very low levels of DNA
from porcine circovirus (PCV) in its Rotateq vaccine, making it the 2nd
rotavirus vaccine found to contain PCV. The company said in a press release
that it used highly sensitive assays to test its vaccine after an
independent testing laboratory found evidence of the virus in the other
US-licensed rotavirus vaccine, Rotarix, made by GlaxoSmithKline (GSK).
On 22 Mar 2010 the US Food and Drug Administration (FDA) recommended that,
although it doesn't appear that the Rotarix poses any safety risks,
physicians should suspend administering it until government and industry
scientists could review the findings.
The FDA's vaccine advisory panel was scheduled to discuss the Rotarix
findings today [Fri 7 May 2010], and yesterday in advance of the meeting it
posted a notice on Merck's PCV findings for its vaccine. It said
preliminary studies from Merck had identified DNA fragments from PCV
subtype 1 (PCV1), the same subtype found in GSK's vaccine, as well as from
PCV subtype 2 (PCV2).
The FDA said neither has been known to cause illness in humans, though PCV2
can cause illness in pigs. It also said it has no evidence that either of
the vaccines poses a safety risk and that both have strong safety records.
At today's meeting of the FDA Vaccine and Related Biological Products
Advisory Committee (VRBPAC), members were briefed on the latest study
findings from FDA and industry scientists. Most members said the benefits
of the rotavirus vaccines clearly outweigh the risks, though several
expressed concerns about the PCV2 findings in Merck's vaccine, due to the
fact that it can cause disease in pigs.
Yesterday the Centers for Disease Control and Prevention (CDC) reported
that the last 2 rotavirus seasons were shorter than past seasons and that
vaccine coverage has risen to 72 per cent. However, usage is about 13 per
cent lower than 2 other childhood vaccines commonly given to infants. The
CDC findings appear in the latest issue of Morbidity and Mortality Weekly
Report (MMWR)
Some VRBPAC members today voiced a need for transparency when talking to
parents about the rotavirus vaccine PCV findings, but they also worried
that news about contamination with extraneous virus fragments could erode
some of the gains in vaccine coverage.
[byline: Lisa Schnirring]
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communicated by:
ProMED-mail
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[2]
Date: Thu 6 May 2010
Source: FDA (Food and Drug Administration), Vaccine, Blood and Biologics
[edited]
Vaccines and Related Biological Products Advisory Committee meeting
Background material -- porcine circovirus and rotavirus vaccines
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The Vaccines and Related Biological Products Advisory Committee meeting on
7 May 2010 will discuss the findings shared with the public on 22 Mar 2010,
that porcine circovirus type 1 (PCV1) DNA was found in GlaxoSmithKline
Biologicals' Rotarix Vaccine. Additional data pertaining to the Rotarix
vaccine will also be presented to the committee.
The FDA recently received information from Merck and Co, Inc that its
preliminary studies have identified fragments of DNA from PCV1 and from a
related porcine circovirus type 2 (PCV2) in its RotaTeq vaccine. Merck's
findings suggest that the number of PCV DNA fragments in its vaccine may be
smaller than what has been found in Rotarix. These preliminary findings
will be included in discussions with the committee.
The FDA has been working closely with manufacturers of the 2 licensed
rotavirus vaccines, has consulted with experts inside and outside of the
federal government, and has considered issues related to the novel testing
that led to the identification of PCV.
The FDA has no evidence to date that these findings pertaining to Rotarix
and RotaTeq pose a safety risk. Both vaccines have strong safety records,
including clinical trials involving tens of thousands of patients and
clinical experience with millions of patients.
PCV1 and PCV2 are both small, circular viruses composed of a single strand
of DNA. PCV1 and PCV2 are common in pigs. Neither PCV1 nor PCV2 are known
to cause illness in humans, however PCV2 may cause illness in pigs.
Rotarix and RotaTeq are the 2 US licensed vaccines indicated for the
prevention of rotavirus disease in infants. Rotavirus disease causes the
deaths of more than 500 000 infants around the world each year, primarily
in low and middle-income countries. Before the introduction of vaccination,
the disease caused more than 50 000 hospitalizations and several dozen
deaths in the US each year. Rotavirus vaccines are given by mouth to
infants to prevent rotavirus disease, which can cause severe diarrhea and
dehydration.
The FDA will continue to work with both GSK and Merck as additional testing
is conducted by both the manufacturers and FDA to further assess the
findings of PCV DNA in rotavirus vaccines.
After considering the input of the committee's experts and the available
scientific information, the FDA will make further recommendations on the
use of the licensed rotavirus vaccines in the US. The FDA will provide
updates to the public and clinical community through
and other communications.
--
communicated by:
ProMED-mail
[Rotavirus is the leading cause of severe acute gastroenteritis (vomiting
and diarrhea) among children worldwide. Two different rotavirus vaccines
are currently licensed for use in infants in the United States. The
vaccines are RotaTeq (RV5) and Rotarix (RV1). Before being licensed, both
vaccines were tested in clinical trials and shown to be safe and effective.
In these studies, during approximately the 1st year of an infant's life,
rotavirus vaccine was found to prevent almost all (85-98 per cent)
rotavirus illness episodes that were severe and to prevent 74-87 per cent
of all rotavirus illness episodes.
The presence of fragments of the genomic DNA of the 2 circoviruses in both
vaccines suggests that the contamination was present in the original
rotavirus isolate from which the vaccine viruses were derived, and that the
contamination was not introduced during subsequent development and
production of the vaccines, but that remains to be established
conclusively. So far there appear to have been no deleterious consequences
resulting from the presence of these contaminants in the vaccine. - Mod.CP]
[see also:
Rotavirus - Americas: PAHO alert 20100330.1009
Rotavirus vaccine - USA: extraneous virus 20100322.0914]
...................cp/ejp/sh
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