CNN reported vaccine experts “want assurances from the US Food and Drug Administration that it won’t authorize a vaccine” against COVID-19 “unless it has first been studied on at least 30,000 people in clinical studies.” NIH Director Francis Collins “has already said there needs to be 30,000 participants in the Phase 3 clinical trials.” FDA Center for Biologics Evaluation and Research Director Dr. Peter Marks said at a BIO Digital event on Tuesday that his agency understands “that if you’re going to be thinking about treating hundreds of millions of people with a vaccine, you’re going to want to have safety data sets to start that are reasonably sized.”
Ability of coronavirus vaccines to advance depends on willingness of people to be trial subjects. The New York Times reports the ability of novel coronavirus vaccines currently under development to move forward is going to be contingent “not only on science and funding, but also on the willingness of tens of thousands of healthy people to have an unproven solution injected into their bodies.” The Times adds that while “vaccine research has never moved this quickly – potentially meaning enhanced risks for volunteers – it has never been easier to recruit subjects, according to Dr. John E. Ervin, who is” supervising a vaccine trial at the Center for Pharmaceutical Research in Kansas City, Mo. For the vaccine’s Phase 1 trial, “90 people applied for the 20 slots in Kansas City.”
Former health officials say secrecy about how government decided to back coronavirus vaccine makers could undermine public confidence in process
NPR reports former federal health officials say the secrecy behind how the White House’s Operation Warp Speed has selected the five coronavirus vaccine makers that it has granted lucrative government contracts could undermine public confidence in any eventual vaccines. Most of the vaccine makers to receive the contracts “are pillars of the pharmaceutical industry: AstraZeneca, Johnson & Johnson, Merck and Sanofi,” and only Moderna, which is “working with the National Institute of Allergy and Infectious Diseases, isn’t a well-known name.” Former FDA Associate Commissioner of Public Health Strategy and Analysis Dr. Peter Lurie says that increased transparency can lead to “full public trust in the process.”
From the news release of the American Association for Justice.
