The US Food and Drug Administration (FDA) is expected to issue new, tougher requirements for its approval of a coronavirus vaccine, a move that could obliterate the chances of a shot getting emergency use authorization before Election Day, according to the Washington Post.
Regulators could publish the new approval standards as early as this week, and will do so publicly in an effort to bolster Americans’ eroded trust in the US to ensure the safety a COVID-19 vaccine.
President Trump and his Operation Warp Speed initiative have been pushing for months to have a coronavirus vaccine approved ahead of the November 3.
But according to a new Axios poll, less that less than 40 percent of Americans now say they would get a coronavirus vaccine, with most citing fears over its safety, driven by the Trump administration’s concerted effort to expedite the development process.
Shoring up the standards for emergency use authorization (EUA) that allowed hydroxychloroquine to slip through to the market, the FDA will now require that companies making vaccines continue to follow trial participants for at least two months after they get a second dose of a shot (if one is required), an anonymous source told the Post.
That stipulation alone could easily push the timeline for submitting data for EUA back until after the election for both Pfizer and Moderna, which began enrolling participants in their late-stage trials.
FDA regulators are expected to shore up approval requirements for a COVID-19 vaccine, which could make it impossible to get emergency use authorization before Election Day
Sources close to the matter, but who asked to remain anonymous told the Post that
Source: Daily Mail
