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White House approves FDA guidelines on Covid-19 vaccine review



The White House rejected its objections and endorsed the US Food and Drug Administration’s plans to consider whether a Covid-19 vaccine should be given on a large scale, making it likely that a shot would not be cleared until after the election will when those familiar with the matter said.

The FDA issued the guidelines shortly thereafter on Tuesday afternoon, hoping the publication “will help the public understand our science-based decision-making process that ensures the quality, safety and effectiveness of the vaccine for any vaccine approved or approved.”

The White House merely kept the guidelines for review and then approved them unchanged, a senior administration official said.

A White House Office of Management and Budget spokeswoman said, “OMB officials have never opposed the FDA guidelines, and those guidelines have not been stopped.”

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Trump administration officials had spoken out against the plan for two weeks, in large part because it required a two-month observation period to determine whether people who received the vaccine had experienced negative side effects, the Wall Street Journal reported.

That two-month wait would make anything but certain that a vaccine could not be approved for use in the U.S. before the elections, a goal that President Trump had sought.

After the objections were raised, White House officials, including Chief of Staff Mark Meadows, and the OMB refused to sign the guidelines during talks with FDA officials, according to a person familiar with the matter.

A senior administration official said Mr. Meadows and other officials questioned the need for the FDA to change vaccine standards, which they believe have been effective for decades. Mr Meadows wanted to make sure that additional guidelines are based on science and not political pressure, the official said.

However, the FDA was ready to follow its guidelines, even though the White House had not signed and the agency had given vaccine manufacturers the details.

Governments around the world are debating the timetable for offering Covid-19 vaccines to the public as drug makers accelerate development. WSJ’s Daniela Hernandez explains the potential health risks associated with rapid vaccines. Photo: Siphiwe Sibeko / AP

The administration’s support suggests it would postpone whether and when a vaccine should be approved for use for the health authority.

The back and forth with the FDA over the guidelines had raised partisan concerns that President Trump might try to intervene on political grounds and make a decision by election.

The guidelines set the standards that any Covid-19 vaccine must meet in order for the FDA to quickly approve its use during the pandemic. Typically, the FDA can take weeks or months to review an experimental vaccine. Given the urgent needs of the pandemic, the agency wanted to conduct its review much faster while also making sure the vaccine was working safely.

After such a review, the FDA could approve a vaccine for use during the pandemic. The so-called emergency permit would be valid until the end of the pandemic. Thereafter, vaccines would require standard agency approval to continue to be used.

The guidelines put together by the agency contained the same stringent requirements that a lengthy review would have involved. For example, they needed a vaccine to reduce the rate of Covid-19 disease in subjects by 50% or better compared to people in the study who were given a placebo.

According to the guidelines, subjects had to be observed for two months after receiving a shot, although FDA officials told the White House that serious side effects would occur within six weeks of the injection, people familiar with the matter said.

Aside from questioning the wait time, White House officials also complained that the FDA was late in coming up with its plans to adjust, as key studies for leading vaccine candidates may have important results for the population by the end of this month could deliver said.

However, the FDA had already passed the guidelines to companies, telling them that they should expect their vaccines to meet standards in order to gain approval.

The drug companies have stated that they support efforts to ensure that vaccines are approved on the basis of scientific evidence rather than political action. Pfizer last week Inc.

Board chairman Albert Bourla sent a notice to staff expressing his support for “rigorous independent scientific assessment and a solid independent approval process”.

Health officials have raised concerns that many Americans will not take the vaccine if they fear it has been rushed for political reasons. A majority of people in the US must take a vaccine to prevent the virus from spreading, and schools, businesses, and other institutions have to reopen without strict precautions.

Peter Marks, the chief FDA official overseeing vaccine approval, said the agency is open and clear about how a vaccine is “critical to building public confidence and ensuring the use of Covid-19 vaccines, as soon as they are available “is rated.

The FDA sought, in large part, White House approval in this case to reassure skeptical Americans that vaccines would meet high standards before they were made available to the public, according to one person familiar with the problem.

President Trump has announced that he would like to have a vaccine available before the November 3rd presidential election.

Mr Trump has also said a vaccine will be widely available this fall, although his administration’s health officials, including Robert Redfield, director of the U.S. Centers for Disease Control and Prevention, have said more realistically next summer.

Write to Thomas M. Burton at tom.burton@wsj.com and Rebecca Ballhaus at Rebecca.Ballhaus@wsj.com

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