White House agrees to FDA guidelines for coating-19 vaccine

The White House brushed aside its objections and supported the US Food and Drug Administration’s plans to assess whether a Kovid-19 vaccine should be widely given, making it likely that a post-election The shot will not be approved, people are familiar with the matter stated.

The FDA released the guidelines Tuesday afternoon, stating that it expects the release to “help the public understand our science-based decision-making process that is the quality of the vaccine for any vaccine authorized or approved , Assures safety and efficacy. “

A senior administration official said the White House held the guidelines for review and then approved them without any changes.

A spokesperson for the White House’s Office of Management and Budget said, “OMB officials had never opposed FDA guidance, and this guidance was not held.”

For two weeks, Trump administration officials had opposed the plan, in large part because it asked for a two-month period of observation about whether people receiving the vaccine had suffered negative side effects, The Wall Street The Journal has reported.

This two-month waiting period will make it certain that no vaccine can be approved for use in the US before the election, a goal that President Trump was targeted for.

Following the objection, White House officials, including Chief of Staff Mark Meadows, and OMB officials refused to sign the guidelines during negotiations with FDA officials, according to a person familiar with the matter.

A senior administration official said Mr. Meadows and other officials questioned the FDA’s need to change the vaccine’s standards, which he found effective for decades. The official said that Mr. Meadows wanted to ensure that any additional guidelines were based on science and not on political pressure.

However, the White House had not signed on, and the agency had informed the vaccine manufacturers about the details, although the FDA was prepared to follow its own guidelines.

Governments around the world are debating the timeline for offering the Kovid-19 vaccine to the public, as drug manufacturers speed up development. Daniela Hernández of the WSJ reports the potential health risks associated with fast-tracking vaccines. Photo: Siphiwe Sibeko / AP

The administration’s support suggests that it would defer to the health agency whether and when a vaccine should be cleared for use.

Partial concerns with the FDA back and forth over the guidelines had raised that President Trump could try to interfere in the election and decide for political reasons.

Such standards are mentioned in the guidelines that any Kovid-19 vaccine would need to meet the FDA to allow its use during an epidemic. Generally, an FDA review of an experimental vaccine can take weeks or months. Given the urgent need created by the epidemic, the agency wanted to conduct its review rapidly, while still ensuring that the vaccine works safely.

After such a review, the FDA can cleanse a vaccine for use during an epidemic. The so-called Emergency Use Authority will last until the epidemic is over, after which the standard approval of the agency will be required for vaccines to remain in use.

The guidelines the agency put together included the same strict requirements that would have to be entered into a lengthy review. For example, they needed a vaccine to reduce the rate of Kovid-19 disease by 50% in test subjects or better than those in the trial who received a placebo.

Guidelines needed to see study subjects up to two months after the shot was fired, even though FDA officials told the White House that serious side effects appeared within six weeks of the injection, people familiar with the case said.

In addition to taking up the waiting period issue, White House officials also complained that the FDA was presenting its plans too late to accommodate the companies, as key studies for leading vaccine candidates by the end of this month Can provide significant results, people said.

But the FDA had already given guidelines to the companies and asked them to expect them to meet the standards to secure their vaccine authorization.

Drugmakers have said they support efforts to ensure that vaccines are cleared based on scientific evidence, not politics. Last week, Pfizer Inc.

Chief Executive Albert Borla sent a note to employees expressing support for “a rigorous independent scientific evaluation and a strong independent approval process”.

Health officials have expressed concern that many Americans will not take the vaccine if they are worried that it was taken for political reasons. Most people in the US will need to take a vaccine to prevent the spread of the virus and to reopen without taking strict precautions for schools, businesses and other establishments.

The agency’s views are open and clear, said Peter Marks, a senior FDA official who oversees the vaccine’s authority: how it will evaluate the vaccine “as critical to building public confidence and ensuring the use of Kovid-19 vaccines once available to do.”

The FDA sought massive White House approval to reassure white Americans in the case that they would meet higher standards before being made available to the public, according to a person familiar with any vaccine issue.

President Trump has said he wants a vaccine available before the presidential election on November 3.

Mr. Trump has also said a vaccine will be widely available this fall, even though his administration’s own health officials, including the US Center for Disease Control and Prevention Director Robert Redfield, said that next summer Is more realistic.

Write Thomas M. at [email protected] Rebecca [email protected] in Burton and Rebecca

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