FDA issues COVID-19 vaccine emergency use guidelines

On Tuesday, October 6, the FDA finally published strict standards for COVID-19 vaccine manufacturers wishing to apply for Emergency Use Authorization. The guidelines were being held up at the White House budget office for review.

A senior administration official confirmed to the AP on Monday, October 5, that the White House had blocked FDA’s plans to formally publish the safety guidelines. Politico reported that officials close to Trump told the president that the pharmaceutical industry was opposed to the stricter recommendations.

Former FDA Commissioner Scott Gottlieb, who currently serves on the Pfizer Board of Directors, posted on Twitter Monday night that he was unaware of anyone in the pharmaceutical industry who was opposed to these measures.“These standards have been broadly communicated for months and they were well understood across the industry” Gottlieb said.

Within hours after the  FDA released the guidelines, President Trump said they were “just another political hit job!” in a tweet directed at FDA Commissioner Stephen Hahn.

The FDA submitted these rigorous requirements to the White House in September 2020. According to the New York Times, the submission stalled in the office of Mark Meadows, President Trump’s Chief of Staff.

The New York Times stated that Meadows said the stricter guidelines would “change the rules in the middle of clinical trials.” Meadows also said that FDA Commissioner Stephen Hahn was “overly influenced by his agency’s career scientists.”

The authority was granted to the White House over these kinds of documents through an executive order issued on October 9, 2020, that limits the use of guidance documents by federal administrative agencies.

The administration sticking point is the two-month minimum follow-up period after clinical trial participants receive their final dose of the vaccine or a placebo before an application for emergency authorization can be made. The FDA has also informed vaccine developers that at least five severe cases of Covid-19 among participants receiving the placebo before applying for the emergency authorization.

In the weeks prior to the drafting of the guidance, the  Trump Administration has made statements that raised concerns that the vaccines were being used as a political tool. President Trump has repeatedly suggested that a vaccine would be ready ahead of Nov. 3

In a letter published on Tuesday, October 5, more than 60 leading doctors and public health researchers from universities including Harvard, Yale, and Johns Hopkins, stated that the FDA should provide even more stringent guidelines. They wrote “premature authorization would prolong the pandemic, with disastrous consequences.”

The two-month monitoring period would allow the FDA to be apprised of any severe reactions to the vaccine and should improve public trust in any COVID-19 vaccine that becomes available for distribution.

The public’s trust in government health agencies has demonstrably decreased as administration officials, including the president, have contradicted public statements made by health experts. Manipulation of publicly released documents from the CDC has been confirmed by

numerous news outlets.

A recent Pew Research poll has shown the number of people who would vaccinate has declined from 72 percent to 50 percent.

Learn more about the authorization process and see the guidelines at fda.gov.

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Charles Betzler

Charles Betzler

Long-time Sapulpa resident, Charles Betzler, followed his father, Charlie, into the radio and TV repair business. At age 9, he fixed his first broken radio and his first love is vintage audio equipment. In his 50 + years of technical work, graduation from OSUIT, and years of Continuing Education, Charles, in his capacity as Emergency Management Director of nearby city, designed the Emergency Operations Center, and the radio-activation system for the sirens. In his long career, he has repaired every type of consumer electronics from black-and-white TVs to the latest lap-top.