Trump might Block Stricter FDA Guidelines for COVID-19

On Wednesday, the U.S. President Donald Trump said he may or may not approve any new, stricter FDA standards for an emergency authorization of a COVID-19 vaccine, stating such a proposal would seem to be political.

Politically-Driven Proposal?

Trump has said many times that a vaccine for COVID-19, the disease spreading rapidly because of the coronavirus, could be ready for distribution before the November 3 presidential election.

On Tuesday, the Washington Post reported the U.S. Food and Drug Administration would roll out the guidance to amplify transparency and public trust as health experts have become substantially concerned regarding the interference by the Trump administration in the approval process to rush out a vaccine.

However, Trump questioned why a vaccine would be required to be delayed and said such a proposal by the FDA would seem to be politically-driven.

“We’re looking at that and that has to be approved by the White House. We may or may not approve it,” Trump said at a White House news conference when asked about the Post report.

“That sounds like a political move. Because when you have Pfizer, Johnson & Johnson, Moderna, these great companies, coming up with the vaccines, and they’ve done testing and everything else, I’m saying why would they have to be adding great length to the process.”

Trump further added he had “tremendous trust” in those companies.

700 Million Doses by late March/April 2021

Some of the vaccine developers were expected to have definitive trial results prior to the presidential election. Pfizer Inc. had been the exception, although its timetable could slip with the latest guidance.

Moderna Inc. has stated that it is unlikely to have data in October. AstraZeneca Plc’s trial in the United States is stopped while investigators try to figure out whether a serious neurological problem occurred in one participant in the company’s U.K. trial was because of the vaccine.

U.S. Food and Drug Administration head Stephen Hahn did not directly talk about the Washington Post report when testifying before the Senate earlier on Wednesday.

However, he did say regulators would likely offer additional information on the emergency use of the authorization process.

At the same hearing, U.S. Centers for Disease Control and Prevention head Robert Redfield stated that he expects there to be about 700 million doses of vaccines rolled out by late March or April, which is enough for 350 million people.

“I think that’s going to take us April, May, June, you know, possibly July, to get the entire American public completely vaccinated,” Redfield told the U.S. Senate Health, Education, Labor and Pensions Committee.