Influenza pandemic planning and performance in Canada, 2009.
Kendal, Alan P. ; MacDonald, Noni E.
This report covers key steps taken in Canada after pandemic H1N1
influenza (pH1N1) 2009 virus emerged, and describes vaccination programs
in some other industrialized nations. We summarize Canadian successes
and challenges, and propose solutions to two priorities.
US experts identified pH1N1 virus in April 2009 from cases in late
March, (1) and retroactively linked it to community outbreaks in Mexico
earlier in March. (2) Most Canadian cases that soon followed were mild,
but clusters of severe cases occurred in several remote Aboriginal
communities. Hospitalizations of younger people rather than the elderly
occurred--unusual for influenza--and characterized this pandemic. (3-6)
Those born prior to 1957 were largely spared because the pH1N1 2009
virus was more related to earlier, rather than recent, H1N1 strains. (7)
The World Health Organization's (WHO) declaration of a
pandemic in mid-2009 (8) stimulated countries to act. Canada's
response was guided by the 2004 Canadian Pandemic Influenza Plan for the
Health Sector. (9) All provinces and territories had jurisdictional
pandemic plans, the completeness of which varied.
International aspects related to the Canadian response
When evaluating "lessons learned" from human cases of
avian influenza in Hong Kong in 1997, influenza experts proposed that
WHO facilitate agreements to expedite international detection of
potential new pandemic strains.10 International Health Regulations of
2005 now require such surveillance and reporting to WHO. (11) But, as
noted above, identification of the first known cases of pH1N1 virus was
delayed, potentially slowing vaccination efforts by a few weeks.
WHO's pandemic declaration legally triggered European
authorization of pandemic influenza vaccines (including some with
adjuvant, like Focetria[TM] and Pandemrix[TM]) in September 2009, before
full approval. (12,13) In October 2009, Canada similarly authorized
Arepanrix[TM], (14) a Canadian-made vaccine like Pandemrix[TM].
Regulatory agencies allowed this in the belief that "the actual
numbers of cases that require hospitalisation and deaths in the pandemic
period is expected to be higher than the numbers seen in recent years
for seasonal influenza". (12)
However, WHO guidelines in 2009 did not stipulate the need for
evidence of severity with regard to a pandemic declaration. (15) Such
inconsistency between criteria to declare a pandemic and criteria to
authorize pandemic vaccine is undesirable. Various people have
questioned the processes for issuing the pandemic declaration and
recommendations for advance stockpiling of antiviral, as well as the
precautionary purchases of large amounts of pandemic vaccines in 2009.
(16) Had WHO maintained the language in its earlier guide that required
"evidence of severe impact in at least one population group"
before declaring a pandemic,17 and had it achieved consensus that pH1N1
severity matched the assumption about impact used by vaccine regulators,
there would be less concern about the scale of vaccine orders. (16)
WHO recommendations for pH1N1 2009 vaccine defined the virus strain
composition. Each country determines its vaccination programs, and these
varied considerably among industrialized countries (refs. 18-22, and
Table 1).
By late January 2010, Canada and Sweden had offered vaccine
universally and had enough doses to meet demand, largely because only a
single dose proved necessary for most people. Canada has not published
national vaccine uptake data. Final rates are about 28% to 55% where
reported. (23-25) Sweden's coverage, as determined from a
combination of vaccination and distribution reports, was about 60% by
January 2010.26 Elsewhere, only specific priority groups were
vaccinated, including at least some children and younger adults
(including pregnant women), and health care workers. Vaccination rates,
based on distribution for their total populations, were therefore lower
at about 7-25% by the end of January 2010 (refs. 27-29, and personal
communication (Dr. Greg Tannock, Burnet Institute, Melbourne, Australia,
January and April 2010)). Coverage rates averaged 35% for target groups
in the US. (29) Data were lacking on safety of adjuvant in pregnancy,
(12) and Canada initiated production of a small supply of adjuvant-free
vaccine. Delayed production necessitated importation of such vaccine,
mainly from Australia. (30)
Global assessment of actual supply and use rates for different
types of pH1N1 2009 vaccines would help future planning.
Planning and implementing Canada's response
Committees
Canada's Public Health response was led by the Public Health
Agency of Canada (PHAC) through a Special Advisory Committee (SAC) for
pH1N1 virus; SAC was comprised of Chief Medical Officers of Health from
all provinces and territories. This committee reviewed and approved
policies, including ones missing from the Pandemic Plan. Separate PHAC
expert groups or consultants supported deliberations over pandemic
issues such as vaccines, antiviral use, surveillance, infection control
and communications. PHAC posted public documents approved by SAC, and
other information from PHAC, on a website. (31)
The experts faced many challenges, including determining the amount
of time patients should wait before returning to normal activities in
the community. Lacking hard data on infectious periods, their interim
precautionary recommendations in May and June 2009 were that patients
should stay at home for 7 days after illness onset (documents archived).
This could be problematic, especially for children feeling well after a
few days. Updated advice in August 2009 was more practical;
specifically, for most low-risk settings, patients should stay home
until they are symptom-free and able to fully participate in daily
activities. (32) Guidance for hospitals with regard to patient
visitations appeared only in February 2010, (33) when pH1N1 activity had
all but disappeared in Canada.
Work done by the committees to fill gaps existing before the pH1N1
pandemic will improve Canada's Influenza Pandemic Plan. Involving
those Canadians most affected by the pH1N1 official guidance documents
in evaluating the strengths and weaknesses of the recommendations
therein should be of assistance to those revising the Plan.
Using ad hoc pandemic advisory groups in a future pandemic may not
be the best use of Canada's limited number of experts. They could
be overwhelmed by adding ever-increasing tasks to existing heavy
professional responsibilities, and by fragmenting tasks that need
integration. We noted the problem especially in how vaccination policies
were developed in 2009. Although a Pandemic Task Group was responsible
for drafting pandemic vaccine recommendations, the National Advisory
Committee on Immunization (NACI) retained responsibility to make
seasonal influenza vaccine recommendations.
The benefit of a separate process for pandemic vaccine
recommendations is unclear and it complicated coordination with use of
seasonal vaccine. (34) NACI is experienced in assessing influenza
vaccine safety and performance, and in making recommendations even when
scientific uncertainties exist. Canadian physicians and nurses normally
receive and implement NACI's recommendations, which they appear to
trust. Why not continue to use NACI to make integrated influenza vaccine
recommendations in a pandemic, building on this committee's role?
Other existing committees of professional societies and official
advisory groups might be more efficient at preparing updated policy
drafts in other complex areas, such as infection control practices.
Whatever committee system evolves, Canada currently does not
involve active clinicians and administrators with primary responsibility
for clinical health care delivery within the core national pandemic
policy committee. Such experts would help ensure that clinical needs are
fully considered, which was not the case in 2009 (see below).
Determining Disease Impact
PHAC determined impact by collating timely surveillance reports,
and collecting standardized data about early cases, from all provinces
and territories. They also collected an important subset of data about
severe cases for analysis. However, the provinces and territories have
not yet agreed collectively how to rapidly establish coordinated
multi-jurisdictional field studies in an emergency, with quick
data-sharing between different jurisdictions and unified analysis.
Consequently, the attack rate with pH1N1 virus across Canada is not
known, and we are only left with speculation about the causes for
severity in remote Aboriginal populations. (35,36)
Clinical Care
Because vaccine was not initially available, clinical care was the
main way to reduce the severity of cases in 2009. Intensive Care Units
(ICUs) were the safety net for the most serious illness. Unfortunately,
the National Pandemic Plan lacked many operational specifics about
clinical care, and did not address the additional resources for
increased use of clinical services and supplies, other than governmental
stockpiling of antivirals.
Thus, while the national plan recognized that many patients with
lung dysfunction might need treatment, improving the national ventilator
supply was not addressed early on. Similarly, the Plan states:
"primary assessment should also include monitoring of oxygen
saturation (e.g., pulse oximetry, arterial blood gases) whenever
possible both at presentation, and routinely during subsequent
care" (Annex G, 3.2.1, ref. 9). But no funds were allocated to
support purchase of extra pulse oximetry equipment. Many patients with
uncomplicated illness went to Emergency Rooms instead of consulting
their family physician, seeking antiviral or other treatment. (37)
Unlike in the United Kingdom, (38) no national policies existed
expediting access to antivirals.
In areas with high virus activity, ICUs came close to capacity,
partially because of late diagnosis or antiviral treatment of patients
to prevent severe disease. (35) Some health authorities opened triage
sites and decreased the burden on emergency departments and
physicians' offices (as suggested in the Canadian Pandemic Plan).
Each jurisdiction had to develop their own approaches. Federal plans did
not include costs of surges in consultations with physicians, pharmacy
dispensing fees for the "free" antiviral supply, and extra
hospital or triage clinics.
[FIGURE 1 OMITTED]
Several key antiviral issues were not anticipated. Therefore,
special authorization was needed for dispensing oseltamivir for <1 yr
olds, a known high-risk age group. (39) Furthermore, the stockpile
largely comprised adult doses, not paediatric capsules or liquid
preparations. Health authorities gave out details of a cumbersome
procedure to prepare paediatric suspensions at the approved dosages for
infants <12 months, for older children when paediatric capsules were
lacking, or for children refusing capsules. (40) Policies for access to
antiviral in remote locations were also lacking. After reports of severe
impact in remote Aboriginal communities, the latter became high-priority
locations for use of early antiviral treatment. However, physicians to
authorize antiviral use are usually scarce in isolated areas. Before the
main pandemic wave occurred, BC developed a regulation and decision tool
authorizing trained registered nurses to dispense oseltamivir in remote
areas. (41)
Pandemic impact varies over time and geographic area. Had the
elderly been susceptible to the pH1N1 virus, its impact would have been
much greater. Thus, scalable models for increasing care in a pandemic
are needed. Figure 1 provides a hypothetical model scheme, something
lacking in the National Plan.
Vaccination
Officials in many countries--including Australia, Sweden, the UK
and the US (Table 1)--anticipated limited vaccine supply by the time of
the main pandemic wave and prioritized vaccine use. The United
Kingdom's Chief Health Officer advised on July 1, 2009 that,
"as not all vaccine will be available immediately, there will
inevitably be a need to prioritize the vaccination activity", (42)
and listed priorities shortly after.
Canada waited until mid-September 2009 before listing groups who
might benefit most from vaccination, but still deferred recommending
prioritization. (43) When Canada's first vaccine supplies became
available in late October 2009, the second H1N1 wave was in progress.
(22,25) The supply reached about 2 million doses per week (corresponding
to about 6% of the total population), inadequate to noticeably dampen an
epidemic in progress. Nevertheless, consistent with national policy,
vaccine was initially offered universally in many jurisdictions, e.g.,
Ontario. (44) Some other jurisdictions prioritized use of the limited
supply, e.g., NL,(45)--something which most provinces subsequently had
to do for several weeks.
Other countries' plans for phased vaccine use (Table 1)
appeared well suited to the low impact of pH1N1 2009 virus in older
adults, the need for first vaccine use where it would do most good
(assuming pandemic waves would occur early in winter), and the limited
rate of vaccine supply.
By the end of the vaccination campaign, which was stimulated by
media coverage of deaths in otherwise healthy children and adults, (25)
several locations achieved their highest-ever influenza vaccine coverage
of about 40-60%. (23,24) This was not a universal finding, and
Toronto's coverage of 28% was no better than usual. (25) Lack of a
system to record the numbers and ages of people vaccinated in most
locations prevents accurate national assessment of vaccine coverage.
This can also reduce statistical confidence of some reported rates of
severe adverse events. (46)
In Table 2, we suggest some lessons that may improve future
distribution and use of pandemic vaccine. Lower-than-expected stability
of Arepandrix[TM] vaccine (47) supports the idea that a second vaccine
source is desirable, as the possibility of manufacturing problems can
never be excluded. The ideal that at least some pandemic vaccine should
be accessible in a timely manner to all countries also needs
consideration.
Lessons learned and priorities for the future
Many notable successes occurred during the pH1N1 2009 pandemic
(Table 3A). These include the apparent effectiveness of PHAC's
campaign to improve personal hygienic practice of hand-washing,
evidenced by the proliferation and use of hand sanitizers in the
country; and a joint Federal-Provincial-First Nations effort to improve
pH1N1 virus prevention and treatment in BC, which improved health care
access for Aboriginal people. (48) Key challenges mentioned in this
commentary are summarized in Table 3B. We have added reassessing risks
and responses as knowledge of the pandemic grows, an especially
important issue for multinational organizations. (16)
We suggest two key priorities for Canada to resolve, as they had
such a dramatic impact on national response:
Priority 1: Better preparedness for surges in clinical services.
Cause of challenge in 2009: Limited stakeholder role for clinical
health care representatives in core policy-setting groups.
Solution: Designate a "National Pandemic Health Care
Committee" to plan emergency responses, including surging demand
for both clinical and public health care services, and to ensure funding
for increased staff and supply needs of both sectors.
Priority 2: Match vaccination policy with rate of supply.
Cause of challenge in 2009: Processes in the National Pandemic Plan
did not result in properly estimated weekly vaccine supply, did not
clearly state attainable disease prevention objectives for vaccination,
or efficiently integrate seasonal and pandemic vaccinations.
Solution: Utilize National Advisory Committee on Immunization, with
extra resources as needed, to assess risk and make recommendations about
pandemic vaccination policies. Phase vaccine recommendations to maximize
benefit of available vaccine, including consideration of school
vaccination programs to reduce community spread.
CONCLUSIONS
Canada achieved many successes in 2009, but must not be
complacent.49 Lessons learned from any pandemic threat include the need
to update risk-assessment and risk-management processes, (10) currently
an important topic in terms of international guidance. (16) The specific
questions to address in Canada when updating influenza pandemic
preparedness plans include:
* What international steps will ensure urgent, modern diagnosis of
disease outbreaks?
* Did Canadians find health policies in 2009 to be timely and
effective for societal needs?
* How can Canada meet large surges in demand for primary and
emergency clinical care?
* How can medical supplies, vaccines and antiviral be available
quickly with low waste?
* Can jurisdictions agree on how to rapidly run joint field studies
with centralized analysis?
Responses at the local level (e.g., Toronto (25)), as well as in
places with generally similar approaches to health care delivery to
those of Canada, should be reviewed, as we have done on a small scale
concerning vaccinations. The UK government has already received a full,
independent review of the response in 2009. (38) This is very relevant
to Canada, especially as the UK now has 4 National Health Authorities
with devolved responsibilities, like Canadian provinces in many ways.
(38) The sooner Canada has its own independent reviews, the sooner it
can use the information to enhance Canadian preparedness.
Acknowledgements: We thank the following for help in locating or
reviewing international data on vaccination programs: Johan Druelle,
Sanofi Pasteur, Lyon, France; Thomas Hallgren, Central Hospital,
Karlstad, Sweden; C.R. Madeley, Newcastle-on-Tyne, UK; Greg Tannock,
Burnet Institute, Melbourne, Australia. We also appreciate critical
comments provided by Walt Dowdle, Task Force for Global Health, Decatur,
GA, USA. Translation of the abstract was kindly done by Dr. Danielle
Grenier, Medical Affairs Director of the Canadian Paediatric Society.
The tireless efforts of the many government employees, academics,
clinicians, allied health professionals, pharmaceutical company
employees, volunteers and others in all corners of Canada and other
countries who worked to meet extra demands during much of 2009 in
response to the emergence of pH1N1 2009 influenza virus also should be
fully recognized and acknowledged by all.
Received: April 10, 2010 Accepted: August 20, 2010
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Alan P. Kendal, PhD, [1] Noni E. MacDonald, MD [2]
Author Affiliations
[1.] Adjunct Professor of Epidemiology, Rollins School of Public
Health, Emory University, Atlanta, GA
[2.] Professor of Paediatrics, IWK Health Centre, Dalhousie
University, Halifax, NS
Correspondence: Dr. Alan P. Kendal, 710-188 Douglas Street,
Victoria, BC V8V 2P1, Tel/Fax: 250-383-2944, E-mail:
[email protected]
Disclaimer: Alan Kendal was the Special Advisor for Influenza to
the Principal Health Officer, BC, Canada, during 2009. Opinions
expressed here are not to be considered those of the Government of
British Columbia.
Conflict of Interest: None to declare.
Table 1. Variation in pH1N1 Influenza Vaccination Programs
in Selected Industrialized Countries
Vaccine Use Australia Canada
Types and targets
Adjuvant--egg grown NO All groups
Adjuvant-free--egg grown All groups Option in
pregnancy
Adjuvant-free, cell-culture NO NO
Live attenuated option NO NO
Phases planned YES NO, but used
(see comment 2)
Phase 1
Front-line health staff & social workers YES
Pregnant women YES YES
Children Health risk, All 6 mo to 4 yrs
>9 yrs
Adults Health risk Health risk
Seniors Health risk NO
Aboriginal YES YES
Phase 2 Add 6 mo to 9 yrs Add any who ask
Later additions Add any who ask
Main vaccination sites
GPs and specialists Most vaccine Not in first phase
Public health clinics or Most vaccine
new community sites
Retail pharmacy &
food stores
Schools
Notification of eligibility Media Media
Appointments Some sites Mainly not
Vaccine use, January 2010
Approx. overall coverage 30% * 40%, see
(* = doses supplied as comment 3
% population)
High priority coverage Denominator Not known
unknown
Comments 1: See ref. 18 1: See text and
refs. 23-25, 30,
43-45
2: 2010 seasonal 2: Vaccine for
vaccine with all planned; but
pH1N1 will be priorities needed
free to extended at first
high-risk groups
3: Doses
administered not
reported
nationally; range
from 28% to about
55% reported in 3
locations
referenced above
Vaccine Use England France
Types and targets
Adjuvant--egg grown All except egg >9 yrs, if no
allergy special
vaccine risk
Adjuvant-free--egg grown NO Pregnancy,
<10 yrs,
transplants
Adjuvant-free, cell-culture Egg allergy Egg allergy
Live attenuated option NO NO
Phases planned YES YES
Phase 1
Front-line health staff & social workers & social workers
Pregnant women YES, see comment 2 YES; <3 mo only
if other risk
Children Health risk, >6 mo Caregivers of
<3 yr. old
Adults Health risk NO
Seniors Health risk NO
Aboriginal NO NO
Phase 2 Add healthy >6 mo Add all >6 mo
to 5 yrs to 18 yrs
Later additions Add all >18 yrs
Main vaccination sites
GPs and specialists Most vaccine From Jan 2010
Public health clinics or Most vaccine
new community sites
Retail pharmacy &
food stores
Schools
Notification of eligibility From GP Mailed voucher
from government
Appointments Yes, at GPs For target group,
time window
Vaccine use, January 2010
Approx. overall coverage 20%*, see 10% *, see
(* = doses supplied as comment 3 comment 2
% population)
High priority coverage 45%; see Denominator
comment 3 unknown
Comments 1: See refs. 19,28 1: See ref. 27
2: Cell-grown 2: About 7
vaccine optional million,
on request in priority
pregnancy vaccinated
by March
3: About 13
million doses
distributed and
4 million in
priority groups
vaccinated by
mid-January;
estimate assumes
all these were
in Phase 1
priority group
of 9 million
Vaccine Use Sweden US
Types and targets
Adjuvant--egg grown All groups NO
Adjuvant-free--egg grown NO All, but some age
restricted
Adjuvant-free, cell-culture NO NO
Live attenuated option NO 2-49 yrs, x
pregnant or
high risk
Phases planned YES YES
Phase 1
Front-line health staff YES YES
Pregnant women YES YES
Children Health risk, Health risk, &
>9 yrs 6 mo to 4 yrs
Adults Health risk NO
Seniors Health risk NO
Aboriginal NO NO
Phase 2 Add all >6 mo Add all 5 yrs
to 18 yrs to <19 yrs
Add Health risk
19-64 yrs
Later additions Add all >18 yrs
Main vaccination sites
GPs and specialists Most vaccine Not in first phase
Public health clinics or Most vaccine in
new community sites 1st phase
Retail pharmacy & Shopping centres YES, when supply
food stores in phase 3 increased
Schools YES YES, especially
with live vaccine
Notification of eligibility Media Media
Appointments Mainly not Mainly not
Vaccine use, January 2010
Approx. overall coverage >60%, see 25%
(* = doses supplied as comment 2
% population)
High priority coverage Not known 35%
Comments 1: See ref. 26 1: See refs. 21,29
2: Data reported 2: Coverage varied
early January 3X by jurisdiction
Note: Data on programs and vaccine use were from refs. listed in
comment 1, and personal communication from persons listed in the
text and in acknowledgements. Local variations occurred and most
programs included household caregivers/contacts of some
high-priority groups.
Table 2. Principles for Success in Pandemic Influenza
Vaccination Program
Vaccine supply security: Consider more than one vaccine in case of
manufacturing problems
Vaccine logistics: Seek vaccines with standard handling needs, e.g.,
good shelf life after opening
Goals: Set timelines to reach priority targets that match realistic
rate of vaccine supply
Reaching families: Use trusted parts of health care system by
involving family doctors
Reaching adults: Make vaccine available at after-working-hours sites
(pharmacies, food store sites)
Reaching workers: Enable workers to access vaccine without using
sick leave
Build trust: Present risk/benefit balance ethically, including
unknowns, in consistent messages
Resources: Fund extra immunization/safety monitoring staff, and
logistical costs (not just vaccine)
Table 3A. Successes in Canada's Planning for pH1N1 2009 Influenza Virus
Planning: Core aspects of Canada's National Plan set policy and helped
procure vaccine
Virus detection: Modern diagnostic testing and enhanced surveillance
were rapidly put in place
Remote communities: Lessons from early remote outbreaks improved
interventions elsewhere
Behavioural changes: Handwashing and coughing "etiquette" appeared
widely accepted
Clinical response: Skilled intensive care staff directly saved lives
Antiviral use: Oseltamivir available from the stockpile, and use in
<1 yr olds quickly authorized
Vaccine supply: Advance work enabled authorization of adjuvant
vaccine before epidemic peak
Vaccine utilization: Record immunization coverage in a short
timeframe in many locations
Vaccine safety: Expanded rapid checks of vaccine adverse events,
including in adults
Research: Important data quickly obtained from ICUs, and other
research projects implemented
Table 3B. Challenges in Canada's Responses to pH1N1 2009
Influenza Virus
Policy development: Not reliably timely or practical enough for
national health care emergency
Resources: Minimal federal support to meet surge in demand for
clinical health care
Aboriginal communities: Lack of advance preparations for multiple
severe disease outbreaks
Data on impact: No process for rapid national study in multiple
jurisdictions
Antiviral use: Unprepared for large need for children, or ensuring
early access in remote areas
Vaccination: Ambitious objectives did not conform to realities of
supply and demand
Vaccine safety: Limited vaccine uptake data, needed to strengthen
community adverse event analysis
Risk management: No independent analysis of Canada's plans as
global data evolved
