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Highlights From
February 2006 ACIP Meeting
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Highlights From February 2006
ACIP Meeting
by Jennifer Zavolinsky (jennifer@ecbt.org)
The Advisory Committee for Immunization Practices (ACIP)
met in
February to review and make changes to several of the childhood and
adolescent immunization recommendations. The meeting was attended by
Jennifer Zavolinsky, Director of Outreach for Every Child By Two. Below
are the highlights from the meeting in addition to links to related
issues of the Morbidity and Mortality Weekly Report (MMWR) and Centers for Disease Control and Prevention (CDC)
press releases.
Human Papillomavirus Vaccine
(HPV) Vaccine
An overview of the epidemiology of the Human Papillomavirus Virus (HPV)
and details regarding cervical cancer were provided to the ACIP.
There are more than 100 types of HPV. HPV 16 is the most common HPV
type. HPV types 16 and 18 can be attributed to cervical cancer,
high and low grade cervical abnormalities, anal cancer,
vulvar/vaginal/penile cancers and head/neck cancers. HPV
types 6 and 11 are attributable to low grade cervical cancer
abnormalities, genital warts, and recurrent respiratory papillomatosis
(RRP). HPV infection is highly prevalent in both males and
females. HPV acquisition occurs soon after sexual initiation and
most HPV infections clearl quickly.
Two HPV vaccines may be licensed in the near future. GlaxoSmithKline
(GSK) will introduce a bivalent vaccine that protects against HPV 16
and 18. The objective of this vaccine is to prevent cervical
cancer in women. HPV 16 and 18 are responsible for 77% of the
cervical cancers in North America. GSK will be targeting females 10
years old and older with its vaccine. The vaccine is currently in
clinical trials.
Merck’s HPV vaccine (GARDASIL®) is a quadrivalent vaccine that
protects against HPV types 6, 11, 16 and 18. Merck sought Food and Drug
Administration (FDA)
licensure in December 2005 and hopes to attain the license in June
2006. The populations listed in Merck’s current licensure application
are 9-15 year old girls and boys, and 16-26 year old women. It is
anticipated that the HPV vaccine will be given without first screening
for HPV status.
The ACIP discussed their vaccine recommendation considerations for the
HPV vaccine. The Committee believes that Merck’s quadrivalent HPV
vaccine will be licensed only for females 9-26 years of age in mid-2006
and that the vaccine may be licensed for use in males at a later date. They do not know the duration of protection or the need for a booster,
and studies have found high acceptability of the vaccine among
providers and patients.
The proposed recommendation by the ACIP’s HPV Vaccine Workgroup is as
follows, “ACIP recommends routine vaccination of females 11-12 years of
age with 3 doses of quadrivalent vaccine. (Vaccine can start as early
as early as 9 years old if decided by a doctor.)”
Another issue to be decided by the ACIP is whether to recommend
vaccination of females 13-26 years of age who have not been previously
vaccinated.
The HPV Vaccine Workgroup plans to:1. Circulate draft recommendations and options before
the June 2006 ACIP meeting;
2. Continue to work on the recommendation options for
quadrivalent HPV vaccine;
3. Modify the recommendations as needed depending on
FDA licensure; and
4. Develop recommendations for bivalent HPV vaccine
(GSK’s vaccine)
Lance Rodewald of the CDC briefly discussed the fact that paying for the HPV
vaccine will be an issue due to the flat funding of the 317 program. (Note: Congress allocates funds to the CDC via the 317
line item. These funds are used by states to purchase vaccines
for distribution in public health clinics, particularly for those
children in working families that do not have insurance coverage for
vaccines.)
Rotavirus Vaccine
Rotavirus is a viral infection that is the leading cause of
gastroenteritis in infants and young children in the United States and
worldwide. At the meeting, the ACIP members listened to a brief review
of data from Merck’s REST trial and a presentation on the
cost-effectiveness of rotavirus vaccination in the US. In addition,
the results of a national survey of pediatricians’ attitudes regarding
the new rotavirus vaccine were presented. The findings of the survey
suggest that most pediatricians would recommend or strongly recommend
(83%) rotavirus vaccine for their patients, following ACIP’s
recommendation of the vaccine. And, a majority (51%) would begin
using the vaccine within six months of an ACIP/American Academy of Pediatrics (AAP) recommendation.
However, many survey respondents did anticipate numerous potential
barriers to using the new vaccine.
The ACIP voted to recommend pentavalent bovine-human rotavirus vaccine
(PRV) to protect against rotavirus. They recommended that infants
receive three doses of the oral vaccine at two, four, and six months of
age. Children should receive the first dose of the vaccine between 6
and 12 weeks of age and should receive all doses of the vaccine by 32
weeks of age. There is insufficient data on safety and efficacy
outside of these age ranges. This vaccine is being marketed by Merck
under the name RotaTeq. RotaTeq is newly licensed and is
currently the only vaccine approved in the United States for prevention
of rotavirus gastroenteritis. The ACIP also voted to add
rotavirus vaccine to the Vaccines for Children (VFC) Program.
To ensure the safety of the newly licensed vaccine, the CDC plans to
conduct a large study to rapidly detect any possible association
between RotaTeq and intussusception as well as other potential adverse
events through its Vaccine Safety Datalink (VSD) Program. The CDC and
FDA will also regularly monitor reports of intussusception and other
serious adverse events reported to the Vaccine Adverse Event Reporting
System (VAERS). Merck has also committed to conducting a post-licensure
study of approximately 44,000 children. In addition, the manufacturer
will report cases of intussusception to the FDA within 15 days of
receiving them. On February 21st, the CDC issued a press release
reporting that ACIP had recommended the newly licensed RotaTeq
rotavirus vaccine for use in infants.
The CDC issued a press release about the ACIP’s new rotavirus vaccine
recommendations. To read the press release, visit: http://www.cdc.gov/od/oc/media/pressrel/r060221.htm
General Recommendations on
Immunization
The ACIP members reviewed the General Recommendations on Immunization
document and the ACIP voted to approve the revised document including
the changes that were discussed during the meeting. To view the 2002
version of the General Recommendations, go to
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5012a1.htm.
Varicella Zoster Immune Globulin
The ACIP was informed about the current status of Varicella Zoster
Immune Globulin (VZIG) in the United States and was given an update on
a new product which is now available as an investigational new drug
(IND). In October 2004, the ACIP was informed that the only US-licensed manufacturer of VZIG had stopped production. In July
2005, the FDA encouraged new investigational drug applications for VZIG. In October 2005, the ACIP approved recommendations for IGIV use
as an alternative to VZIG although VZIG was still preferred. And
finally, in February 2006, an application for VariZIG (IND), a new
VZIG, was submitted to the FDA.
Investigational VariZIG is being distributed by FFF Enterprises.
For more information about VariZIG and how to obtain it for patients,
please view the March 3, 2006 article, “A New Product (VariZIG™) for
Postexposure Prophylaxis of Varicella Available Under an
Investigational New Drug Application Expanded Access Protocol,” in the
MMWR at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5508a5.htm.
Tdap (tetanus, diphtheria, and
acellular pertussis) Vaccine
The use of tetanus,
diphtheria, and acellular pertussis (Tdap) vaccine for health
care workers, including a cost-analysis, was discussed during the
meeting. The ACIP voted to recommend Tdap vaccine for health care
workers to protect workers from pertussis and to reduce the
transmission to their patients. It will most likely replace TD as a
vaccine for this population. There was also discussion at the meeting
on whether the ACIP should recommend the Tdap vaccine for adults 65 and
older, although a recommendation would be considered “off label”, since
the FDA did not approve the Tdap vaccine for older adults. The ACIP
voted against recommending the vaccine for ages 65 and older until further
scientific evidence for use among this population is established.
On March 24th, the CDC published "Preventing Tetanus, Diphtheria, and
Pertussis Among Adolescents: Use of Tetanus Toxoid, Reduced Diphtheria
Toxoid and Acellular Pertussis Vaccines" in MMWR Recommendations and
Reports.
To access the PDF version of the recommendations, which includes all
the appendices, go to: http://www.cdc.gov/mmwr/PDF/rr/rr5503.pdf
To access the HTML version of the recommendations, go to: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5503a1.htm
Influenza Vaccination
During the influenza vaccine discussion, there was debate among the
ACIP members on whether to encourage annual influenza immunization for
all as a strategy to move towards universal vaccination. The ACIP
(which was evenly divided on this issue) decided to issue a statement
that will include a message regarding the ACIP’s continued evaluation
of a universal vaccination strategy.
The ACIP unanimously voted to recommend routine influenza vaccination of
children 24-59 months of age, and their household contacts and out of home
caregivers. This extends the previous recommendation to now include all
children 6 months to 59 months of age. (The previous recommendation had
been for children 6 months to 23 months old, household contacts and
caregivers.) The ACIP voted to include the influenza vaccine for 24-59 month olds in
the VFC Program.
The ACIP also voted to change the tiering language to reflect no
prioritization unless vaccine supply is delayed or decreased and
suggests that contingency plans be formulated in advance to deal with
possible shortages.
The new ACIP recommendations will include language regarding the two
new vaccine strains and the resistance found to adamantanes. The
recommendations will also reiterate the importance of providing two
doses of vaccine to previously unvaccinated children six months to nine
years of age, and will emphasize routinely offering influenza vaccine
in December.
On February 23rd, the CDC issued a press release reporting that ACIP
had recommended that children ages six months to up to five years receive
yearly influenza vaccination.
To read the complete press release, go to:
http://www.cdc.gov/od/oc/media/pressrel/r060223.htm
Presentations from the February ACIP meeting are online at http://www.cdc.gov/nip/ACIP/mtg-slides-feb06.htm.
The next ACIP meeting will be held June 29-30 in Atlanta. Individuals
wishing to attend the meeting must pre-register online at http://www.cdc.gov/nip/ACIP/dates.htm
Herpes Zoster Vaccine
The ACIP listened to presentations on the herpes zoster vaccine and its
storage and handling requirements (i.e., this vaccine must be stored in
the freezer.) ZOSTAVAX, Merck’s herpes zoster vaccine, will
be the first intervention available to prevent herpes zoster (HZ) and
its complications, including PHN
(Postherpetic neuralgia). PHN is pain in the area of the rash
that is present after HZ resolution. Up to 20 percent of HZ patients develop PHN.
There are an estimated one million cases of HZ per year in the United
States. Approximately 90 percent of these cases occur in immunocompetent
individuals. Clinical studies of ZOSTAVAX in adults are in progress and
the Shingles Prevention Study was written up in the June 2005 issue of
the New England Journal of Medicine
- http://content.nejm.org/cgi/content/extract/352/22/2266. |
