By Jeff Overley

Law360 (October 6, 2020, 10:53 PM EDT) -- The U.S. Food and Drug Administration incurred President Donald Trump's wrath Tuesday by unveiling guidance that could push back authorization of a COVID-19 vaccine, and a government vaccine expert resigned with a denunciation of the commander-in-chief's pandemic response.

Tuesday's events occurred as the U.S. approached 7.5 million confirmed coronavirus infections and 211,000 related deaths, according to Johns Hopkins University.

Here are four developments to know.

Pre-Election Vaccine Approval Looks Less Likely

Guidance released Tuesday afternoon described data that the FDA wants to see before granting a so-called Emergency Use Authorization for a vaccine to prevent infections by the novel coronavirus.

A provision of the guidance that attracted widespread attention said that EUA applications should contain at least two months of follow-up data collected after patients have been fully vaccinated, including data about adverse events and coronavirus infections.

The most-advanced vaccine trials only started over the summer, and requiring two months of post-vaccination tracking — to say nothing of the time needed to organize data, submit it and allow the FDA to review it — would leave little time for the agency to authorize a vaccine before the presidential election on Nov. 3.

Trump has repeatedly predicted that an immunization for COVID-19 will win authorization before voters go to the polls. "The vaccines are coming momentarily," he said in a video posted to Twitter on Monday night. The president had just left the Walter Reed National Military Medical Center in Bethesda, Maryland, where he was treated over the weekend after testing positive last week for COVID-19.

But on Tuesday night, Trump was no longer optimistic, firing off a tweet that tagged FDA Commissioner Stephen Hahn and dubbed the FDA's vaccine guidance a "political hit job." 

New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job! @SteveFDA

— Donald J. Trump (@realDonaldTrump) October 7, 2020

There are statutory standards that must be satisfied for an EUA, including a determination by the FDA that a product's "known and potential benefits … outweigh its known and potential risks." Tuesday's guidance essentially tells vaccine makers how they can meet those standards.

The FDA on Tuesday also posted a briefing document for a highly anticipated advisory committee meeting on Oct. 22 that will feature a general discussion of standards for emergency authorization and formal licensure of COVID-19 vaccines, but not discussion of any specific vaccine candidates.

Tuesday's briefing document said that the FDA "expects to convene" a separate advisory committee session to discuss any specific EUA requests for a coronavirus vaccine. It's not clear how soon such a session could occur.

Asked whether Tuesday's guidance would likely preclude the agency from granting an EUA prior to Nov. 3, an FDA spokesperson told Law360 that "manufacturers decide whether and when to submit a request" for emergency authorization or full approval.

White House officials had no immediate comment on the FDA's guidance. The FDA spokesperson said that the White House cleared the guidance, but the spokesperson didn't specify whether that clearance happened before or after the guidance was posted online.

FDA Brass Scramble to Shore Up Public Trust

In conjunction with Tuesday's guidance, two of the FDA's highest-ranking officials delivered speeches focused heavily on alarming signs of bipartisan mistrust among Americans in the scientific independence of the vaccine review process.

Commissioner Hahn, in a keynote speech at the virtual annual conference of the Food and Drug Law Institute, said that "science will guide our decisions" and that the "FDA will not permit any pressure from anybody to change that."

FDA Chief Counsel Stacy Cline Amin, in a speech immediately after Hahn's, noted that the agency has faced rebukes for authorizing the emergency use of malaria drug hydroxychloroquine and antibody-rich blood plasma in the treatment of COVID-19; critics accused the agency of caving to pressure from Trump, and the FDA later withdrew its hydroxychloroquine EUA. While Amin defended those authorizations, she also said that a vaccine would be held to higher standards.

"FDA believes the risk-benefit calculus under an EUA is much different when evaluating a prophylactic that would potentially be given to millions of healthy people than it is when evaluating a therapy that would only be given to people who are already sick and fighting for their lives," she said.

Amin alluded to concerns that premature approval of a vaccine could backfire if the immunization is later found to be unsafe, given that many patients could be harmed and huge numbers of Americans could refuse to be vaccinated for long periods of time going forward, possibly prolonging the pandemic.

"The FDA realizes that authorizing or licensing a vaccine for COVID is perhaps the most consequential action the agency will ever take," the chief counsel said.

The advisory committee briefing document contained an appendix with advice that has already been shared with vaccine developers. That underscored how publication of the guidelines was less about informing the pharmaceutical industry and more about conveying transparency that could soothe a suspicious populace.

"Being open and clear about the circumstances under which the issuance of an Emergency Use Authorization for a COVID-19 vaccine would be appropriate is critical to building public confidence and ensuring the use of COVID-19 vaccines once available," Peter Marks, the FDA's director for biologic medicines, said in a statement Tuesday.

Marks and Hahn made similar pronouncements about transparency and public confidence in June, when the FDA released separate guidance on COVID-19 vaccine approvals. But since then, some polls have found Americans becoming less eager to get vaccinated, even as the pandemic continues severely disrupting virtually every aspect of social life.

In a survey last month, the Pew Research Center found that 49% of adults would probably or definitely decline to get a COVID-19 vaccine if available, up from 27% in May. The same survey found that 78% of adults — including 69% of Republican-leaning respondents and 86% of Democratic-leaning respondents — were more concerned about vaccine approval occurring before safety and effectiveness were established than approval occurring too slowly.

A CNN poll released Monday found mixed reactions. The percentage of respondents who said they would not try to get vaccinated had risen to 45% from 40% in an August poll. But about 60% of respondents were very or somewhat confident in the approval process, while less than 40% lacked confidence, numbers that were essentially unchanged from August.

Big Pharma Hails Transparency

Drug industry reaction to the FDA's actions was largely favorable on Tuesday, continuing a noteworthy recent trend in which pharmaceutical companies — typically eager to get products approved — have been conspicuously calling for caution on COVID-19 vaccines.

Stephen J. Ubl, chief executive of trade group Pharmaceutical Research and Manufacturers of America, said in a statement that drugmakers "welcome the agency's efforts to instill confidence in the rigorous safety of these potential vaccines."

In another statement, Michelle McMurry-Heath, chief executive of the Biotechnology Innovation Organization, called the FDA's guidance "an important step forward in providing greater regulatory clarity for vaccine makers and in earning the American people's trust in any future vaccines."

Rep. Frank Pallone, D-N.J., chairman of the House Energy and Commerce Committee, said in a statement on Tuesday night that "President Trump attempted to block FDA" from issuing the guidance based on purported objections from vaccine manufacturers.

Pallone said that his staff connected Tuesday with representatives of several vaccine developers — including Johnson & Johnson, Moderna Inc., Novavax Inc., Pfizer Inc. and Merck & Co. Inc. — and that "each of the companies indicated that they did not lobby the White House against FDA's guidance and that they are supportive of public release of the agency's guidance."

Vaccine Expert Resigns, Fires Parting Shots at HHS

Tuesday night also saw a new development in the saga of Dr. Rick Bright, a pandemic and vaccine expert who led the Biomedical Advanced Research and Development Authority at the U.S. Department of Health and Human Services until April, when he claimed to have been demoted for opposing Trump's promotion of hydroxychloroquine.

Bright's lawyers at Katz Marshall & Banks LLP announced that Bright resigned Tuesday from a position at the National Institutes of Health and filed a new charge at the U.S. Office of Special Counsel that alleged "constructive discharge based on the failure of NIH leadership to assign him any meaningful work."

"In this administration, the work of scientists is ignored or denigrated to meet political goals and to advance President Trump's reelection aspirations," Bright said in an addendum to a complaint alleging retaliation by political appointees, including HHS Secretary Alex Azar.

Among many allegations, the addendum asserted that NIH Director Francis Collins praised but ultimately rejected Bright's recommendations last month for a national coronavirus testing strategy. Collins did so "based on purely political considerations," specifically his expectations that the Trump administration would balk, according to the addendum.

The refusal is dangerous because "as winter approaches, it will become increasingly important to combine testing" for the novel coronavirus and influenza, Bright wrote, echoing a point that the administration's political appointees at HHS have themselves made repeatedly in recent months.

The seven-day average number of new COVID-19 cases peaked in late July at roughly 66,000 daily infections. Cases then gradually declined to an average of roughly 34,000 daily cases in mid-September before starting to rise again, and the average on Tuesday exceeded 43,000 new daily infections, according to the COVID Tracking Project.

HHS representatives did not immediately respond to a request for comment Tuesday evening on Bright's resignation.

--Editing by Emily Kokoll.

Update: This article has been updated with comments from an FDA spokesperson.

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