Transcript H1N1 Vaccine - California Maternal Quality Care Collaborative

H1N1 Influenza
Management Issues for
Pregnant Women and
Newborns
Elliott Main, MD
Chair, Dept OB/GYN
California Pacific Medical Center
San Francisco
(Revised October 29, 2009)
H1N1: Pregnancy Issues
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Epidemiology-Current CDC numbers
Pregnancy-specific Concerns with H1N1
Recommendations for Triage and Treatment of
Possibly Infected or Exposed Mothers
– Prior to Labor
– During Labor
– Recommendations for Prophylaxis
– Safety of Medications
H1N1 Flu Vaccine
– Safety of other Influenza Vaccines
– How to Order and Use Free Vaccine from the State
1. Late June: Widespread activity on both coasts.
1. 2 months later, shows less geographic influenza activity.
2. California is no longer in the “widespread” group.
1. By September, the South East is particularly hard hit.
1. By mid-October, the entire nation has widespread flu outbreak.
1. Adult deaths from influenza are not increased this year or this summer.
www.cdc.gov/flu/weekly Oct. 17, 2009
1. Pediatric deaths due to flu are highly unusual at this time of year and are
equal to the level seen in the height of winter.
2. The absolute numbers are small.
www.cdc.gov/flu/weekly Oct. 17, 2009
Summer
Fall
Winter
1. Basically ALL influenza this summer and fall is H1N1 (Type A, not H3).
2. Rate declined as the summer progressed. But….
www.cdc.gov/flu/weekly Oct. 17, 2009
Epidemiology Summary:
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Large US and California peak in May/June
2009, faded and then came back in fall
Currently nationwide, worst in the East
Children and pregnant women are at
greater risk than with usual influenza
strains and therefore are highest priority
groups for the vaccine
Most illness is mild but these high risk
groups are at risk for serious M/M
What Will Happen When School
Opens?
Pregnant Women are a
High-Risk Population for H1N1
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6x more likely to get infected with H1N1
4x more likely to be hospitalized
(Jamieson et al, Lancet July 29, 2009)
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6x more likely to die than other adults
Deaths related to pneumonia with
subsequent ARDS requiring mechanical
ventilation
At least 6 maternal deaths in Northern CA
General Recommendations
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If sick with an influenza-like illness (ILI):
Fever (>100F, 37.8C) plus at least cough or
sore throat and possibly other symptoms like
runny nose, body aches, headaches, chills,
fatigue, vomiting and diarrhea
Should stay home and keep away from others
as much as possible, for at least 24 hours after
fever is gone (without the use of fever-reducing
medicine).
www.cdc.gov/flu/weekly/
Sept. 1, 2009
Telephone Triage
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Do NOT want patients with ILI to
come to an OB/GYN’s office
Phone triage:
– If fever plus symptoms then consider
treatment (see recommendations)
– BUT, If respiratory concerns (dyspnea,
chest pain, tachypnea) NEEDS TO BE
EVALUATED with O2 sat and exam
(? Primary care/Urgent care/ER)
ACOG /
CDC
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Released
Oct 15, 2009
Usable for
office, clinic
or OB Triage
ACOG
websitehttp://www.
acog.org/departments/resour
ceCenter/2009H1N1TriageT
reatment.pdf
Key Points for ILI Triage
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Screen for significant respiratory problems
– History/symptoms
– O2 sat, CXR, ABGs as clinically indicated
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Patients who improve and then worsen are at high
risk
Assess for OB, social and medical co-morbidities
– PTL
– Asthma, HIV
– Inability to care for self
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Follow-up within 24-48hrs!
Influenza A Testing
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Treatment decisions should NOT be based
on test results
High rates of false negatives for rapid
assays—depending on specific test,
sensitivity ranges from 10-70% for H1N1
Specific tests for H1N1 are send outs,
many Health Departments are no longer
offering them except for severe cases,but
some hospital labs will be getting rapid
and specific tests in the next 6 weeks
Treatment for Pregnant Women
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Early treatment recommended for suspected
cases without waiting for laboratory confirmation
Tamiflu® (oseltamivir) is now the drug of choice
for its systemic activity: 75mg bid for 5 days
– Class C: based on limited human safety studies but to
date no human fetal injury has been reported
– All experts conclude that treatment is supported by
overwhelming evidence of benefit compared to serious
risk of harm from the virus
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Even if symptoms started more than 48hrs prior to
presentation to care, treatment is still indicated
Updated Interim Recommendations for the Use of Antiviral Medications in the
Treatment and Prevention of Influenza for the 2009-2010 Season. CDC
October 16, 2009 http://www.cdc.gov/h1n1flu/recommendations.htm
Prophylaxis for Pregnant Women
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Infected persons may shed virus beginning ONE DAY
before they develop symptoms and up to 7 days after they
become ill.
Prophylaxis is indicated for pregnant women with close
contact with confirmed, probable or suspected H1N1
influenza during the period above
The drug of choice for prophylaxis during pregnancy is not
clear. Either/or:
– Tamiflu® (oseltamivir): 75mg once daily for 10 days
– Relenza® (zanamivir): two 5mg inhalations once daily for 10 days
Updated Interim Recommendations for the Use of Antiviral Medications in the
Treatment and Prevention of Influenza for the 2009-2010 Season. CDC
October 16, 2009 http://www.cdc.gov/h1n1flu/recommendations.htm
Medication Summary
Antiviral medication dosing recommendations for treatment or
chemoprophylaxis of novel influenza A (H1N1) infection
Treatment
Chemoprophylaxis
Oseltamivir
(Tamiflu®)
75-mg capsule twice
per day for 5 days*
75-mg capsule once
per day for 10 days*
Zanamivir
(Relenza®)
Two 5-mg inhalations
(10 mg total) twice per
day for 5 days
Two 5-mg inhalations
(10 mg total) once per
day for 10 days*
*Currently recommended first choice medications.
CDC: Updated Interim Recommendations for the Use of Antiviral Medications in the
Treatment and Prevention of Influenza for the 2009-2010 Season. 10/16/2009
Given this Morbidity…The Key is
Vaccination!
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6x more likely to get infected with H1N1
4x more likely to be hospitalized
(Jamieson et al, Lancet July 29, 2009)
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6x more likely to die than other adults
Deaths related to pneumonia with
subsequent ARDS requiring mechanical
ventilation
At least 6 maternal deaths in Northern CA
H1N1 Vaccine
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Strongly recommended for
– Pregnant women
– Parents of children under 6mos (i.e. partners!)
– Health care providers with direct patient contact
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Safety
– Use “Flu Shot” (fragments of killed/inactivated virus) not
“nasal spray” (live-attenuated virus),
– Thimerosol free vials
– No adjuvents are used
– Field tested in July/August in >4,000 people, tests in
pregnant women underway in September, no ill effects
– Produced with same techniques as prior flu vaccinessafe in pregnancy
2009 H1N1 Influenza Vaccine and Pregnant Women. CDC September 3,
2009 http://www.cdc.gov/h1n1flu/vaccination/pregnant_qa.htm
H1N1 Vaccine (as of 10/28/09)
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Will be distributed free by the State:
– www.CalPanFlu.org
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National delay in vaccine production so
local distribution also dealyed
– Kaiser and County Clinics this week
– Hospitals and offices in midNovember…
Single dose will generate immunity in 8-10
days rather than 2-3 weeks
2009 H1N1 Influenza Vaccine and Pregnant Women. CDC September 3,
2009 http://www.cdc.gov/h1n1flu/vaccination/pregnant_qa.htm
H1N1 Vaccine
1. Live Attenuated Influenza Vaccine (LAIV)
(aka Flu-Mist)—NOT TO BE GIVEN TO
PREGNANT WOMEN
-- OK for Postpartum women, healthcare workers
(even those on L&D)
2. H1N1 Flu Shot (killed) Vaccine, two types:
-- Multi-dose vial with the preservative Thimerosal
(contains ethyl-mercury)
-- Single-dose vial without Thimerosal
California Law requires that pregnant women
and children under 3 receive the Thimerosal–
free vaccine
Thimerosal
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There is a national shortage of Thimerosal-free
vaccine (even less than regular vaccine)
CDC, ACOG, IOM have all said strongly that
Thimerosal is NOT a problem in pregnancy
Autism-worriers in California had succeeded in
getting the State Legislators (2006) to write a law
that pregnant women should not get Thimerasol
Given the shortages, on October 15, 2009
Director of California DPH issued an order
suspending the ban on Thimerosal…
(temporarily: Oct 12 to Nov 30)
What about the risks from the last
Swine Flu vaccine?
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In 1976 there was a national effort to
immunize everyone to prevent an earlier
(very different) swine flu.
(BTW, only a single person died in that entire outbreak)
– Guillon-Barre Syndrome (GBS) occurred in
1/100,000 persons with multiple deaths
– Ever since, influenza vaccines have been made
quite differently and the annual seasonal flu
vaccines have NOT been associated with GBS
(<1/1,000,000). H1N1 is made the same way.
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Each vaccine is subjected to safety trials
including pregnant women
H1N1: Isolation Issues
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Mother
Newborn
Staff Protection
Family Members
Visitors
Caring for Mother/Infants
CDC--July 6, 2009 Written Guidelines
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Infants of Moms who are confirmed or probable
H1N1
– Consider separating mom and infant until
• Mother has been on antiviral medication for 48 hours
• Fever has fully resolved
• Cough and secretions are controlled
– Breast milk can be expressed
When conditions are met mom can be united with
infant but should wear facemask
 Infant should be cared for by a well family
member
Most mothers have rejected this approach!
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Considerations Regarding Novel H1N1 Flu Virus in Obstetric Settings. CDC
July 6, 2009. http://www.cdc.gov/h1n1flu/guidance/obstetric.htm
Excellent YouTube Video for
Pregnancy Questions at Flu.gov
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August 27, 2009
CDC, ACOG, ACNM, NIAD, HHS Leaders
Wide range of practical maternity related
questions (60min long) (check out minute 35
for intrapartum discussion)
Can be recommended for ALL pregnant
women and ALL providers
www.flu.gov/news/knowwhattodo.html
Know What to Do About the Flu Webcast Archive: Pregnant Women and New
Moms. CDC August 27, 2009 http://www.flu.gov/news/knowwhattodo.html
Caring for Infants-II
CDC Webinar—August 27, 2009
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Stresses a “Case-by-case, Common Sense”
approach to isolation issues of H1N1 infected
mothers with newborns
If mother “really sick”, then separation is best
If mother on treatment and doing “ok”, then they
can be together based on clinical judgment.
Use recommendations for seasonal flu:
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Surgical mask and hand washing for mother
Breast feeding recommended
Isolette for infant when not at breast vs nursery (?)
The difficulty is that the CDC has never put this in writing…
Know What to Do About the Flu Webcast Archive: Pregnant Women and New Moms.
CDC August 27, 2009 http://www.flu.gov/news/knowwhattodo.html (min 34 of 60)
Staff Protection-Mask Contoversy
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Surgical v. N95
– Many experts v. Cal OSHA
– Not much data with H1N1,
lots of opinions
– Surgical masks appears to be effective for seasonal flu
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On Sept 3, 2009: IOM report to US OSHA and
CDC made a strong recommendation
for fit-tested N95…
Liverman et al. Respiratory Protection for Healthcare Workers in the Workplace
Against Novel H1N1 Influenza A: A Letter Report. Institute of Medicine
Full PDF available at: http://www.nap.edu/catalog.php?record_id=12748#toc
Recent RCT of N95 v. Surgical
Masks for H1N1
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1,936 ED/Resp Ward RN and MDs in Beijing
Cluster randomized: surgical masks v. N95
Consistent use for 4 consecutive weeks
Controls-”usual practice” at 9 hospitals
Consistent surgical mask use was no better than
controls for prevention of clinical respiratory
illness (6.7% versus 9.2%, P=0.159) or of
influenza-like illness (0.6% versus 1.3%,
P=0.336).
MacIntyre C, et al "The first randomised, controlled clinical trial of surgical masks compared
to fit-tested and non-fit tested N95 masks in the prevention of respiratory virus infection in
hospital health care workers in Beijing, China" ICAAC 2009; Oral session K-1918b.
(September 16, 2009)
Recent RCT of N95 v. Surgical
Masks for H1N1--con’t
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Compared with controls, N95 respirators reduced
the rate of clinical respiratory illness 60% (3.9%
versus 9.2%, P<0.001) and the rate of influenzalike illness by 75% (0.36% versus 1.3%,
P=0.035).
The advantage of N95 respirators was substantial
compared with surgical masks (RR 0.58 for
clinical respiratory illness, P=0.019).
MacIntyre C, et al "The first randomised, controlled clinical trial of surgical masks compared
to fit-tested and non-fit tested N95 masks in the prevention of respiratory virus infection in
hospital health care workers in Beijing, China" ICAAC 2009; Oral session K-1918b.
(September 16, 2009)
Recent RCT of N95 v. Surgical
Masks for H1N1--con’t
Does it work as well in hospitals with higher levels
of hand hygiene?
 Adjustment for differences between hospitals in
the level of handwashing, vaccination, and other
factors that would impact infection risk only
increased the apparent effectiveness of the N95
mask in staving off influenza to 96% (OR 0.04,
95% CI 0.01 to 0.15).
So Mask AND Hand Hygiene give best results!
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MacIntyre C, et al "The first randomised, controlled clinical trial of surgical masks compared
to fit-tested and non-fit tested N95 masks in the prevention of respiratory virus infection in
hospital health care workers in Beijing, China" ICAAC 2009; Oral session K-1918b.
(September 16, 2009)
National Shortage of N95 Masks
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California is releasing N95 masks
from their “strategic Stockpile”
Given the shortage, a number of
hospitals are reverting to surgical
masks, as recommended for
seasonal influenza
Visitors—This will Change as the
Season Goes On!
Individualized by hospital based on local Flu incidence,
likely in step-wise manner. Difficult balance between
Family-Friendly and Infection Control. Some
examples given below, in stages:
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All visitors must be well. No visitor children except
well siblings to PP(?) No children at all in NICU(?)
No visitor children under 16 in ALL units in hospital
No visitors of all ages except
partners/parents/guardians
How are visitors being screened at entrance, in
lobby, at nursing station?
Stay Tuned…!
Changes Every Week
“The only thing that’s certain
is uncertainty.”
Dr Thomas Frieden
Director CDC
On the difficulties of
preparing for swine flu...
Additional Resources
Visit www.CMQCC.org for
more information, many documents
and links to state, national and ACOG
resources
This website pulls together
pregnancy H1N1 information
from many sites