The White House cast aside its objections and endorsed the U.S. Food and Drug Administration’s plans for assessing whether a Covid-19 vaccine should be given to the public, making it likely that a shot won’t be cleared until after the election, people familiar with the matter said. The FDA issued the guidelines soon afterward on Tuesday afternoon, saying it hopes the release “helps the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy for any vaccine that is authorized or approved.”The White House had been simply holding the guidelines for review and then approved them without changes, a senior administration official said. For two weeks, Trump administration officials had expressed opposition to the plan, in large part because it called for a two-month observation period to see whether people who got the vaccine had suffered negative side effects, The Wall Street Journal has reported. That two-month waiting period would make it all but certain that any vaccine couldn’t be approved for use in the U.S. before the election, a target that President Trump had been aiming for.

Source: Wall Street Journal October 06, 2020 19:21 UTC