US Drug Oversight Agency Issues New Guidelines on COVID-19 Vaccine Approval  

By VOA News |

FILE – A woman holds a small bottle labeled with a ‘Vaccine COVID-19’ sticker and a medical syringe in this illustration. Photo: Reuters

The U.S. Food and Drug Administration has issued a set of strict new guidelines for emergency authorization of a COVID-19 vaccine in defiance of strong objections from the Trump administration.

The guidance released Tuesday by the FDA requires pharmaceutical companies to observe participants in late-stage clinical trials for at least two months after they receive a second and final dose of an experimental vaccine.

The new rules were included in a document prepared for a meeting later this month with the FDA’s vaccine advisory board, which will discuss requirements for either emergency use authorization or the full licensing of a potential vaccine.

The publication of the rules comes a day after several U.S. news outlets reported that the White House had rejected the proposals.  The strict guidelines mean a possible COVID-19 vaccine will not be ready before the November 3 presidential election, undercutting predictions made by President Donald Trump.

The FDA and other federal scientific and regulatory agencies have seen their credibility diminished by constant administration efforts to revise their reports and guidelines to maintain Trump’s more optimistic views about the nature of the pandemic.

“Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate and is critical to building public confidence and ensuring the use of COVID-19 vaccines once available,” Dr. Peter Marks, director of the FDA division responsible for approving vaccines, said in a statement.

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