Exploring Lessons Learned from a Century of Outbreaks Readiness for 2030: Proceedings of a Workshop (2019) / Chapter Skim
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6 A Spectrum of Considerations for Pandemic Vaccines
6 A Spectrum of Considerations for Pandemic Vaccines
Pages 75-90
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From page 75... ...
In the United States and in Hong Kong, the first vaccines became available at the peak of the major pandemic wave, when it was largely too late for vaccines to provide protection. Closing this timing gap, Katz said, will require improvements in vaccine development, production, and distribution.
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From page 76... ...
Finally, Steven Solomon, principal legal officer at WHO, surveyed some legal considerations related to vaccine response. GLOBAL COORDINATION IN VACCINE DEVELOPMENT: A SNAPSHOT OF THE GLOBAL INFLUENZA SURVEILLANCE AND RESPONSE SYSTEM The past century of infectious disease outbreaks and pandemics has underscored how many population health problems, such as influenza, must include international collaboration and coordination, said Wenqing Zhang, manager of the Global Influenza Programme at WHO.
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From page 77... ...
She explained how this complicated updating process is facilitated by the GISRS system, with updates conducted twice per year for seasonal vaccines and occur on an ad hoc basis for pandemic and prepandemic vaccines. She described the seasonal influenza vaccine cycle as an effective public–private partnership.
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From page 78... ...
Other issues were not necessarily expected, such as initial low yields, difficulty making the vaccine from reassorted vaccine candidates, and difficulty making the antiserum needed for the vaccine's potency test.1 From CBER's perspective, Midthun said, a critical regulatory issue was finding the most expeditious pathway to make the pandemic vaccine available, preferably as a licensed product, though possibly under emergency use authorization.2 CBER determined it could license the monovalent 2009 H1N1 pandemic vaccine as a strain-change supplement to vaccine manufacturers' existing licenses for seasonal influenza vaccines, which speeds up approval by not requiring new clinical data.3 Depending on their regulatory precedents, regulatory agencies in other countries and regions pursued different pathways. For example, the European Medicines Agency approved a core pandemic dossier and mockup for an adjuvanted H5N1 vaccine that switched the H5N1 antigen with the H1N1 antigen, as the most expeditious pathway to licensure (CHMP, 2008)
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From page 79... ...
a universal influenza vaccine that provides broad and durable protection against a swath of influenza strains. FDA has since licensed a cell-based seasonal influenza vaccine, a recombinant hemagglutinin seasonal vaccine, an adjuvanted influenza vaccine for seasonal use, and an adjuvanted H5N1 vaccine.
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From page 80... ...
Sanofi Pasteur, as one of the largest manufacturers of influenza vaccines using both egg-based and recombinant manufacturing technologies, and other vaccine manufacturers view pandemic preparedness not as a business opportunity, but as a public health challenge to which they can contribute, he stated. To prepare for potential pandemics, Sanofi Pasteur is ready to produce as many influenza vaccines as possible and then to collaborate with public and private partners to distribute those vaccines.
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From page 81... ...
He cautioned that because the current system relies on the same manufacturing infrastructure for both seasonal and pandemic influenza vaccines, this system in the event of a pandemic threat forces a difficult decision about when to halt a given year's seasonal vaccine production and switch over to pandemic vaccine production. This choice must be made with minimal knowledge about how the pandemic threat might unfold but with full knowledge that switching production will compromise the next year's seasonal vaccine supply.
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From page 82... ...
The vaccine delays in 2009 highlighted the shortcomings of a deployment system developed "on the fly," said Gellin. WORLD HEALTH ORGANIZATION'S ROLE AND LEGAL CONSIDERATIONS IN VACCINE RESPONSE Steven Solomon, principal legal officer at WHO, explored legal considerations relevant to international vaccine response, including governance, equity, and vaccine donations.
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From page 83... ...
Vaccine Deployment Initiative, Page 20, Copyright (2012)
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From page 84... ...
In 2009, the legal complexities were dealt with relatively quickly with good uptake from potential recipients -- 95 countries were ultimately deemed eligible potential recipients, and 77 countries developed the national deployment plan and received vaccines. However, the major problem was that, in many cases, countries' national deployment plans were unable to accommodate the necessary speed of operation.
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From page 85... ...
The process of developing the candidate vaccine virus in WHO Collaborating Centers also went well, she added, and the H1N1 pandemic vaccine yield was etter than the average yield of the seasonal vaccine. She said that in b terms of surveillance, enough evidence was available to determine which at-risk groups should receive the vaccine in the first round.
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From page 86... ...
Improved Potency Assays Katz asked Midthun to describe the current state of development for improved potency assays, which can help with the timing issues related to pandemic vaccine development. Midthun replied that BARDA has established an influenza vaccine improvement plan in collaboration with CBER, CDC, and NIH.
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From page 87... ...
Gellin remarked that it could be beneficial to involve logistics experts in planning. WHO's Prequalification Process and Eligibility Requirements Katz asked Solomon to elaborate on WHO's prequalification process and its eligibility requirements for potential recipients of donor vaccines.
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From page 88... ...
Gellin replied that BARDA is looking at applying new technologies to compress the development and deployment time frame, but current technology is not sufficiently advanced to beat the first viral wave; he said this highlights the need for a universal influenza vaccine. Solomon remarked that the PIP Framework contributes to progress on the global level because it has precontracted almost 400 million pandemic vaccine doses with preagreements for the terms and conditions.
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From page 89... ...
WHO's Health Emergencies Programme Finally, Gabrielle Fitzgerald, founder and chief executive officer of Panorama, asked how preparedness for pandemic influenza relates to WHO's Health Emergencies Programme, which was established after the Ebola outbreak. Zhang explained that WHO's seasonal influenza program is housed within the Health Emergencies Programme because it is a persistent, annual health threat.
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