Does Public-Private Collaboration Work
in Pandemic Preparedness?
Theresa Tam, Director, Division of Immunization and Respiratory
Diseases, Public Health Agency of Canada
Theresa Tam provided an overview of Canada’s pandemic vaccine strategy. The
country’s pandemic preparedness planning began in earnest after the Hong
Kong influenza outbreak in 1997. Canada’s Public Health Agency obtained a
commitment from federal, provincial, and territorial government officials to
form a Pandemic Influenza Committee and develop a pandemic vaccine plan.
By March 2001, the agency had reached a working agreement that included
contracts for egg and vaccine supplies.
The Pandemic Influenza Committee includes representation from all of
Canada’s provinces and territories as well as an ethicist. The committee
provides a forum for working out technical aspects of the plan and makes
recommendations to governmental decision makers. A separate Vaccine Supply
Working Group oversees details of the vaccine and egg-supply contracts.
A Private-Public Sector Collaboration
Canada’s direct experience with SARS, as well as an outbreak of H7 influenza
in British Columbia, presented an opportunity to test the country’s pandemic
vaccine strategy. Tam noted that the plan was published in February 2004
“because it was very useful during SARS.”
The goal of the plan is to vaccinate all Canadians at an arbitrarily designated
rate of eight million doses (a third of Canada’s population) per month, with
the assumption that two doses of vaccine will be needed. Priority for allocating
the vaccine will be based on the country’s guidelines for vaccine use during
shortages, and includes strategies for delivery, storage, and securing the supply.
The plan includes clinical trial protocols and a mechanism for surveillance of
adverse events. Tam noted that the Public Health Agency offers “one-stopshopping,”
including purchasing, promotion, delivery, and surveillance, for its
vaccine programs. “From our manufacturers’ point of view, private-public
sector collaboration is of paramount importance in pandemic preparedness and
for a … free market where there is really no incentive for the manufacturer to
generate … vaccines.”
The agency issued an RFP for a 10-year vaccine contract that is linked to
annual supply. “The manufacturer that won the contract has 50 percent of the
annual requirement pretty much guaranteed,” said Tam. The agency has
offered a multi-year contract to handle the other 50 percent of the annual
supply. Only two suppliers have contracted with the agency to provide three
SESSION 2—PLANNING AND RESPONSE TO PANDEMICS 43
products, which is less than optimal, admits Tam, “…but that is the reality of
the situation now.”
Canada currently provides influenza vaccine to about one-third of its
population annually. The federal government pays a pandemic readiness fee
that is linked to sales of the annual influenza vaccine. The more vaccine the
manufacturer sells, the less the government pays in pandemic readiness fees.
The manufacturer is responsible for building production capacity, although
the government has built the filling lines for existing technology. However,
indemnity and compensation are still under discussion, with the manufacturers’
expectation that these issues will be handled by the government.
Canada’s pandemic vaccine strategy is viewed as a work in progress. The
Influenza Vaccine Committee is working on mock pandemic vaccine
production to address the numerous technical issues mentioned earlier in the
colloquium. In a similar vein, the committee hopes to conduct mock clinical
trials. The committee is working with G7 + Mexico governments to select
more efficient protocols. Finally, the committee hopes to offer its experience
and advice to WHO and GHSAG countries that are planning international
pandemic preparedness plans.
“From our manufacturers’ point of view,
private-public sector collaboration
is of paramount importance
in pandemic preparedness and for a …
free market where there is really no incentive
for the manufacturer to generate … vaccines.”
—THERESA TAM, PUBLIC HEALTH AGENCY OF CANADA
44 PANDEMIC INFLUENZA: CAN WE DEVELOP A GLOBAL VACCINE POLICY?
Session 2 Discussion of Planning
and Response to Pandemics
Feasibility
Barry initiated the discussion following Session 2: “The problem in getting
money is a political awareness problem. If this is sold not as public health but
as national security…that’s a way to get attention…in the United States. And
if you sell it as national security…then a natural outgrowth of that funding
would be surveillance.” He also suggested that the number of vaccine
manufacturers could be increased if the government chooses to split contracts,
a strategy that was used successfully in the defense industry.
Osterholm commented that a pandemic vaccine plan would not work if the
seed strain selected for use in the vaccine is not effective. Stöhr offered some
assurance, noting that a network of eligible rating centers perform antigenic and
genetic proximity or distance analysis of the circulating virus to the potential
pandemic prototype strains. This kind of analysis will reveal whether a new
prototype strain needs to be developed. He noted that “…it is extremely likely—
and this is what most of the immunologists and influenza vaccine experts would
say—that the relative proximity of this strain to the emerging pandemic strain
would allow the United States to expect a very significant reduction in the
morbidity as well as…mortality.” Osterhaus reiterated his previous comment
that we are continuously adding viruses to the repository of circulating virus
strains. Using reverse genetics, he argued, viruses in this repository could be
converted into a seed virus, saving two to three months in production time.
Fostering Industry Involvement
Stöhr reminded the participants to focus the discussion on ways to involve
industry in pandemic preparedness planning. “Perhaps we should turn it
around,” he said. “How does the industry want to be involved? What are the
obstacles? What are the concerns?”
Jadhav suggested recruiting the vaccine manufacturers in India, China,
Indonesia, and Brazil that are currently producing oral polio vaccine (OPV) for
WHO’s polio eradication campaign. WHO plans to recommend discontinuing
OPV use when the last polio case has been found, potentially freeing the
vaccine manufacturers for other uses, including pandemic influenza vaccine
production. Two participants objected to this idea, noting that the facilities
must still be maintained during non-pandemic years, and that inactivated polio
vaccine production will continue. Jadhav argued that developing country
manufacturers will refrain from producing inactivated polio vaccine because of
intellectual property rights (IPR) and royalty issues.
SESSION 2—PLANNING AND RESPONSE TO PANDEMICS 45
Gaining International Commitments
Heymann commented on the importance of including the G7 + Mexico in
pandemic preparedness planning. He noted that the group played a significant
role in gaining a commitment from Canada. In addition, Heymann suggested
that someone should present the issues raised in this meeting to developing
country vaccine manufacturers.
Schwartz admitted that HHS has not been as active in seeking international
collaborations as GHSAG countries have done. However, HHS has begun an
investigation of the IPR issue as a barrier to influenza vaccine production. In
addition, HHS initially expressed interest in coordinating international clinical
trials of pandemic-like vaccines, but the lack of regulatory harmonization has
impeded progress in this area. Schwartz recommended dividing the studies of
antigen-sparing strategies among GHSAG countries.
Tam commented that Canada’s collaboration with GHSAG has been more
productive concerning the antiviral portion of pandemic preparedness
planning. However, more modeling of different vaccine strategies (i.e.,
outbreak control or pandemic response) is needed before the group can decide
how it will share pandemic vaccine among all participants. In the meantime, a
grid that contains all of the clinical trials, ongoing or planned, is being
developed. This will help Canada select a project that is not currently addressed
in other clinical trials.
Stöhr added that the most developed countries are going to drive the
international discussion on global pandemic preparedness. Further, most of the
influenza vaccine manufacturers are located in industrialized nations. This offers
the possibility of engaging these countries in pandemic vaccine production for
the greater public good. The United States and Japan have decided to support
this effort, but the EC has not yet agreed to commit funding.
Lewis Miller asked Kang whether the Korean government is encouraging
vaccine development and production. Kang replied that Korea’s vaccine
manufacturers have formed a consortium, which will fund half of the vaccine
production. (The other half will be funded by the government.) The
consortium is planning to build an egg-based production facility, using
technology from foreign manufacturers.
Technical Concerns
Osterhaus asked Tam to explain how Canada plans to deal with technical
issues, such as the use of adjuvants in a pandemic influenza vaccine. In Europe,
the vaccine manufacturers have chosen 10 different possible adjuvants, and
plan to conduct preclinical studies next year. Perhaps there would be an
opportunity to coordinate studies of technical issues such as this. Tam replied
that Canada has not yet begun its own clinical trials precisely because it needs
46 PANDEMIC INFLUENZA: CAN WE DEVELOP A GLOBAL VACCINE POLICY?
international input. Canada’s vaccine manufacturers have followed European
manufacturers’ decision to add alum (the gold-standard adjuvant) to the
vaccine at the end of the production process. Canada has no other adjuvants
available to them because of IPR barriers.
Schwartz asked industry participants to consider what incentives companies
would require to share their “master files” on technical areas such as
adjuvanted vaccine with pandemic vaccine developers. Lewin interpreted the
question as, “…[H]ow applicable is the clinical data from one vaccine to
another…[and]…what is required for licensure.”
Vaccine Policy and Planning in the Americas
Raw gave a brief overview of PAHO’s pandemic preparedness activities,
including its vaccine policy development and access to vaccines. Last year,
PAHO entered an agreement with Aventis that allowed Brazil to purchase
influenza (epidemic) vaccine for 50 percent of the cost allotted by PAHO’s
Revolving Fund for Vaccine Procurement. Thus, everyone in Brazil over age 60
received the influenza vaccine, and the number of hospitalizations due to
pneumonia and influenza was reduced by two-thirds.
Currently, Brazil is building a facility that will be capable of producing 30
million doses influenza vaccine using egg-based technology. Eggs are easy to
obtain in Brazil, which is one of the largest exporters of chicken in the world.
The facility is expected to become operational next year. PAHO hopes to keep
this production facility operational once local needs have been served through
an agreement with Aventis to produce vaccine for the northern hemisphere.
This will allow the facility to remain in use year-round.
Raw also said that Brazilian public health professionals already know how to
administer intradermal vaccines because of their experience with intradermal
hepatitis B vaccine. PAHO is also looking for adjuvants to be combined with
influenza vaccine. If intradermal injection and adjuvants increase their
production substantially, PAHO may decide to sell any excess vaccine on the
open market in Latin America.
Oliva provided further comments on PAHO’s pandemic vaccine situation,
noting that Brazil is the only country in Central and South America that will
be capable of producing enough pandemic influenza vaccine to supply its own
country and generate some excess vaccine for sale in the region. Additional
sources of pandemic vaccine will be needed throughout the region.
Pandemic “Hot Spots”
Mason asked whether it would be possible to obtain agreements from all
influenza vaccine manufacturers worldwide to dedicate a certain percentage of
their output to pandemic “hot spots.”
SESSION 2—PLANNING AND RESPONSE TO PANDEMICS 47
Lewin pointed out that decisions regarding vaccine distribution may not be in
the hands of the vaccine companies. “It’s a question of…each country…say[ing],
‘If the plant is in my country, it’s supplying the U.S. first,’” he said.
Schwartz agreed with Osterholm and Lewin on this point. But he
suggested that seeking an agreement with a branch of the government other
than HHS or Homeland Security, such as the State Department, might invite
a less nationalistic approach.
Hedging Against Vaccine Shortages
Tam reported that Canada has hedged against possible shortages by investing
in production facilities in the country. This is especially important as Canada
does not have multiple suppliers. Salisbury reported that the United Kingdom
has five suppliers plus a contingency stock of 450,000 doses. Hall noted that
UNICEF pays a “vaccine security premium” to ensure that it has at least four
suppliers for each vaccine. “It means that we may not buy only the cheapest
vaccine, because we think the cost of [having] no vaccine may be greater than
a premium we pay to have multiple sources.”
Gordon pointed out that during a severe influenza epidemic in the mid-
1980s, the government prohibited vaccine shipments outside the United
States, where the production facility was located, even though the
manufacturer (Connaught Laboratories) was Canadian. In addition, BioShield
legislation requires the secretaries of HHS and Homeland Security to sign off
on any vaccine shipments designated for outside the United States.