Vaccine Research and Development to Advance Pandemic and Seasonal Influenza Preparedness and Response Lessons from COVID-19 (2022) / Chapter Skim
Currently Skimming:
Summary
Summary
Pages 1-10
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 1... ...
National Influenza Vaccine Modernization Strategy 2020–2030 and the World Health Organization (WHO) Global Influenza Strategy 2019–2030, articulated a need for more effective influenza vaccines, as well as modern manufacturing technologies that are adaptable and can be scaled to meet demand during a pandemic.
|
From page 2... ...
postapproval surveillance for adverse events. The initiative was spearheaded by a committee of domestic and international experts representing a range of sectors (e.g., government, academia, industry, civil society, international public health organizations)
|
From page 3... ...
A priority focus for future basic and clinical research on influenza vaccines should be the investigation into how to overcome issues associated with viral antigenic drift for seasonal vaccines. COVID-19 has resulted in a paradigm shift in vaccine technology, presenting benefits of other vaccine platforms for fast development of pandemic vaccines and the improvement of seasonal vaccine effectiveness.
|
From page 4... ...
supported by governments and funding agencies, the World Health Organization, and the vaccine industry should support, carefully plan, and conduct multi-center international clinical trials and field studies to compare emerging vaccines with stan dard vaccines in, among others, geographically, demographically, and immunologically diverse populations to inform rational and situation based use and manufacture of an extended array of vaccines. Recommendation 2-4: National regulators should engage with the vac cine industry and academic researchers in the development, standard ization, and implementation of innovative assays to evaluate vaccines that induce immunity through mechanisms other than strain-specific neutralizing hemagglutination-inhibiting antibodies in order to reach consensus on the validation of these assays that will allow approval or licensure of influenza vaccines based on a broader range of assays that reflect induction of immunity.
|
From page 5... ...
For this purpose, lessons can be learned from community-engaged work that collaborates and partners with the local community. Recommendations Recommendation 3-1: The World Health Organization, in collabora tion with national public health agencies (e.g., the U.S.
|
From page 6... ...
Recommendation 3-3: The International Coalition of Medicines Regu latory Authorities and the World Health Organization (Global Advisory Committee on Vaccine Safety) should ensure international coordination and collaboration on the timely and transparent review of vaccine safety data during epidemics and pandemics to support real-time deci sion making about the use of vaccines.
|
From page 7... ...
This approach would be most effective if incentivized, and could include • Participating during research and development, data sharing, technology adoption, and training activities with international partners; • Expanding internal capacity to assess the production needs and their risks; • Using scientific evidence to design strategies to reduce risks (e.g., World Health Organization prequalification, licensing, and mar keting) ; and • Formalizing technology transfer (scale-up and scale-out)
|
From page 8... ...
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. Recommendation 5-3: The World Health Organization and the Inter national Coalition of Medicines Regulatory Authorities should encour age and support the coordination between regulatory and public health agencies (e.g., the U.S.
|
From page 9... ...
SUMMARY 9 on the same or similar vaccines, to explain the different underlying circumstances and judgments. Recommendation 5-4: Vaccine manufacturers should adopt a code of conduct for press releases and other communications regarding vac cine trial results and other matters that emphasizes the critical role of regulatory review.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.