Executive Summary
White House and HHS are increasing pressure on FDA Commissioner Hahn to clear Pfizer and Moderna’s COVID-19 vaccines as soon as possible – potentially skirting the advisory committee process. The move is leaving a last-minute political stain on a regulatory process the FDA fought hard to keep science-based and could foster a new wave of vaccine hesitancy amongst the American public.
Renewed pressure by US President Donald Trump and his advisors on Food and Drug Administration Commissioner Stephen Hahn to swiftly authorize a COVID-19 vaccine is raising red flags for vaccine experts who fear the politicians’ actions will leave Americans distrustful of any resulting emergency use authorization, regardless of the actual credibility of FDA’s decision.
Hahn was called to the White House twice this week and questioned on the speed of clearance, including why the agency couldn’t authorize Pfizer Inc./BioNTech SE’s vaccine before the planned 10 December advisory committee. (Also see “US FDA’s COVID Whirlwind: Pfizer Vaccine Adcom Set; Monoclonal EUAs Cleared; Trump Aggrieved” – Pink Sheet, 22 Nov, 2020.)
The White House also confirmed to the Pink Sheet that it will hold a White House summit on COVID-19 vaccines on 8 December, two days ahead of the FDA advisory committee meeting, another event that is seen as ramping up the pressure for FDA to move fast and politicizing the situation.
Perception May Trump Reality
Jason Schwartz, an expert on vaccination policy at Yale, said he worries these recent actions will be “counterproductive” and taint the “really good job” FDA has done in standing up an independent and science-based COVID-19 vaccine review process that has been reassuring to the scientific community after more controversial COVID-19 era decision-making like the now-pulled EUA for hydroxychloroquine. (Also see “Renewed Political Pressure on Hydroxychloroquine for COVID Highlights Need For Independent US FDA” – Pink Sheet, 7 Jul, 2020.)
“To see these meetings with the FDA commissioner now two days in a row, to see this summit organized next week, I worry that those signals can create anxiety about the role of politics in this review process where everything else to date suggests there’s nothing to worry about in that concern,” Schwartz said.
“And it’s the perception that matters, as much as the reality in terms of the public confidence. It’s just not helpful to saying loud and clear how these are science base decisions, informed by career nonpartisan officials, following time tested processes. All that gets muddy when you start hearing about White House meetings and big sort of ceremonial conferences, before an FDA decision was made,” he told the Pink Sheet.
Peter Lurie, president of the Center for Science in the Public Interest and former FDA associate commissioner, said he doesn’t think FDA “has any intention of caving,” to these latest White House actions, but like Schwartz he worries that the attempts on their own could undermined vaccine confidence.
“It adds to the narrative that the process for the vaccine is somehow subject to politics, even if Trump tries and fails to manipulate it,” Lurie said.
White House Press Secretary Kayleigh McEnany said on 2 December that the White House meeting between Hahn and Trump’s chief of staff is “par for the course,” when “trying to save American lives with a vaccine in record time” referring to the vaccine as “the Trump vaccine.”
But her comments indicate a focus on finding any possible way to move even faster.
The current speed “is remarkable progress,” compared to the normal development timeline for vaccines, McEnany said, “but we still want to make sure that it comes as fast, as expeditiously, but as safely as possible, because we know that each day that passes there are more American lives at stake. So we want to make sure it comes as quickly as the data allows it to.”
The late 1 December emergency authorization of the Pfizer/BioNTech vaccine by the UK’s Medicines and Healthcare products Regulatory Agency also appeared to put a fire under the US political leadership. (Also see “UK First To Authorize Pfizer/BioNTech COVID-19 Vaccine” – Pink Sheet, 2 Dec, 2020.)
“While the FDA completes its review, the approval of another independent regulatory body should give Americans additional confidence in the quality of such a vaccine,” Health and Human Services Secretary Alex Azar said during a press call on 2 December.
Public Confidence Already Shaky
The current situation is especially fraught because it comes after months of public skepticism that FDA might issue a vaccine EUA that wasn’t “driven by an appropriate degree of scrutiny or transparency,” due to the fraught hydroxychloroquine and convalescent plasma EUAs and concern Trump wanted clearance in time for the early November presidential elections. (Also see “Plasma Authorization Raises Fears Of Politically-Influenced COVID-19 Vaccine Decisions, Compromised FDA” – Pink Sheet, 24 Aug, 2020.)
These circumstances had already raised levels of vaccine hesitancy explained John Moore, a professor of microbiology and immunology at Weill Cornell Medical College. (Also see “Speed Of Coronavirus Vaccine Development May Hurt Public Confidence” – Pink Sheet, 14 Jun, 2020.)
Moore said he gets inquiries every day from friends and colleagues, including “sophisticated faculty-level scientists” asking about the safety of COVID-19 vaccines and whether the public can trust them.
The only way to overcome this public mindset Moore said is “to persuade everybody that the FDA is doing what the FDA always does, considering all the evidence in a rational and thorough way, including consulting outside independent experts. … So when we get into a scenario where a politician is short-circuiting the process for selfish reasons then you have a problem.”
Moore said experts like himself rely on the transparency of the typical FDA process so they can confidently tell friends and colleagues that they can get behind the vaccines.
“FDA needs to stay the course and follow the protocol they already laid out,” said Amy Pisani, the executive director of Vaccinate Your Family. “Any variation from the course will make it very difficult to explain.”
Hahn Stands His Ground
The White House has repeatedly put FDA in tight spots, explained Gregg Gonsalves of the Yale School of Public Health, because the administration’s pandemic response policies have “ignored” many other public health practices that are not biomedical interventions, making biomedical solutions even more critical as the virus spreads uncontrolled throughout the country.
The president “has grasped” at every potential silver bullet that has come down the pike like hydroxychloroquine or convalescent plasma and “the vaccine is the last one on his watch,” Gonsalves said. “FDA is in the hot spot because they weren’t able to say no to convalescent plasma or hydroxychloroquine … and FDA has been put in an untenable position, but to Hahn’s credit he stood up in October and said the vaccine approval was going to be by the book.”
Indeed, Hahn appears to be sticking to his prior commitments despite the new White House pressure.
In an interview with CBS on 2 December, Hahn said his meeting with the White House the day before was about “understanding the process” of FDA’s review.
“I feel like we have come to a very good spot with respect to the time that our scientists need to evaluate these data. … I am confident that the process we have in place is the right one. … We’re going to follow that process,” Hahn said.
Later in the interview he also reiterated that the vaccines will be looked at by the FDA’s vaccines advisory committee before an EUA is issued.
Meanwhile, other groups have started rallying to support Hahn.
“We must all continue to support the FDA and ensure the agency remains steadfast in carrying out a trusted and transparent process. It must not be susceptible to political pressure – not from the current administration nor any government – and allow the scientific process to unfold,” Friends of Cancer Research Chair and Founder Ellen Sigal said in a 2 December statement.
Comfort With Fast EUA After Advisory Committee
Despite the concerns about the latest string of political interference, most experts the Pink Sheet spoke with were comfortable with FDA fairly quickly granting an EUA for Pfizer or Moderna, Inc.’s vaccines after their respective advisory committees, assuming the committee is clearly positive and there are no major concerns.
Pisani, who said she is working with a coalition to draft a statement denouncing the latest White House interference in the vaccine process, said FDA officials have indicated an EUA could come just a few days after a positive advisory committee meeting.
https://pink.pharmaintelligence.informa.com/PS143391/Trumps-Last-Minute…
