Vaccine Research and Development to Advance Pandemic and Seasonal Influenza Preparedness and Response Lessons from COVID-19 (2022) / Chapter Skim
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5 Regulatory Science
5 Regulatory Science
Pages 107-118
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From page 107... ...
The chapter then considers how lessons learned from the development of COVID-19 vaccines (shown in Box 5-1) can be applied to both seasonal and pandemic influenza vaccines in the dimension of regulatory science.
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From page 108... ...
There are already multiple licensed influenza vaccines, established correlates of immunity, and the opportunity to test new seasonal influenza vaccine platforms through phase III trials every year. At the same time, current vaccines and vaccine platforms are insufficient to meet the global need for pandemic influenza, which therefore is the focus of this chapter.
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From page 109... ...
The Medicines and Healthcare Products Regulatory Agency in the United Kingdom did not require clinical trials to be as large as those for FDA review; however, the small number of older adults in initial trials for AstraZeneca vaccines later led to confusion about whether the vaccine worked in older adults and affected initial country decisions on adoption (Davis, 2021)
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From page 110... ...
In September 2020, for example, nine leading vaccine companies pledged to support high safety standards and to not file for regulatory authorization or approval until established clinical benchmarks had been met (Loftus and Hopkins, 2020)
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From page 111... ...
Under public pressure, several manufacturers released the protocols for their phase III clinical trials, which boosted confidence in their rigorous approach (COVID vaccine confidence requires radical transparency, 2020)
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From page 112... ...
REGULATORY SCIENCE: APPLYING LESSONS FROM THE DEVELOPMENT OF COVID-19 VACCINES TO VACCINES FOR INFLUENZA The rapid development of COVID-19 vaccines on novel platforms has important implications for the development of new vaccines against pandemic influenza. For example, the tremendous success of mRNA vaccines has created hope that similar success and scale can be achieved for influenza (Anand and Stahel, 2021)
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From page 113... ...
Turning to the rapid adaptation of seasonal influenza vaccines for pandemic influenza, regulators will want to consider what data can be acquired in the interpandemic period, such as phase I and phase II data for vaccines targeting common pandemic subtypes (Krammer and Palese, 2014)
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From page 114... ...
Public Communications and Transparency Applying the lessons from COVID-19 vaccine development, regulatory agencies, and WHO can commit to transparency as a key principle in oversight of influenza vaccines. Regulators can provide updates on the status of clinical trials (including basic information about clinical holds)
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From page 115... ...
Such broad promulgation of basic standards for production can reduce the chance that vaccines will not receive authorization or will experience serious manufacturing quality problems. Conclusion 5-4: There is a strong need to develop a robust and coor dinated review process for influenza vaccines with consistent standards globally to minimize vaccine development delays and mitigate the cred ibility issues arising from variable decisions across countries.
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From page 116... ...
should commit to transparency in the oversight of clinical trials, review of data, authorization, and approval of pandemic influenza vaccines, in cluding the release of facility inspection findings, clinical trial protocols, and clinical data that are the basis of decision making. Regulators should convene independent advisory committees to systematically review data, make recommendations, and build public understanding and confidence prior to the authorization or approval of novel vaccines.
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From page 117... ...
. COVID vaccine confidence requires radical transparency.
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From page 118... ...
2021. COVID-19: A catalyst to accelerate global regulatory transformation.
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