The Good, The Bad And The Ugly Of COVID-19 Vaccine Manufacturing Technology Platforms
Not all technology platforms provide the expected benefit of filling in CMC review gaps and speeding coronavirus vaccine approvals.
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US, EU and Canadian authorities recently discussed their approaches to rolling reviews of CMC applications for coronavirus vaccines.
New COVID-19 Vaccines May Be Accelerated By Using Existing Manufacturing Platforms, US FDA's Marks Says
FDA's CBER director says the development of new COVID-19 vaccines can be accelerated by using manufacturing platforms developed for other types of vaccines, thereby reducing the need for product-specific data.
Pfizer is producing vaccine doses at scale now that it has buttoned down the manufacturing process.