OCTOBER VACCINE SURPRISE WATCH: Ten Questions to Ask if an Emergency Use Authorization is Announced

Washington, DC – Today, in advance of tomorrow’s key FDA Advisory Committee meeting, Accountable Pharma along with advisor Dr. Aaron Kesselheim, Professor of Medicine at Brigham and Women’s Hospital/Harvard Medical School and renowned expert on pharmaceutical policy, clinical trials, and the FDA, released the following ten questions that members of the media should be ready to quickly ask the Trump Administration if an Emergency Use Authorization (EUA) is announced for a COVID-19 vaccine or other treatment in the coming weeks. 

“We have seen this Administration issue problematic Emergency Use Authorizations for hydroxychloroquine and convalescent plasma and apply political pressure to career scientists and public health officials throughout the last 6 months, and it would be devastating for public confidence in their government’s vaccine process if that were to happen again,” said Dr. Aaron Kesselheim. “If the Administration announces a vaccine or antibody EUA in the coming weeks the media should ask these questions to help the public understand whether the announcement was driven by scientists or politics.”

Ten questions to ask when you hear about an EUA from the Trump Administration

1. Where did this authorization emerge from? 
   • Was this supported by the career scientists and public health officials at the FDA, or was it pushed by Sec. Azar and accepted by the FDA? 
   • Was this EUA requested by the drug company or was it initiated by the government?
      
2. Will the review memos from internal reviewers like the FDA’s Office of Vaccine Research and Review be released? 
   • This would allow independent review of the scientific basis for the authorization.
      
3. Will a “commissioner’s finding” be released, as FDA Center for Biologics Evaluation and Research Director Peter Marks mentioned could happen? 
   • Given the stakes and timing as well as this Administration’s history of allowing political pressure to drive EUAs, that should happen in this case.
      
4. Will detailed review of safety and efficacy data be released at the time of the EUA announcement or will there be a delay?
   • It has been the case that this release is delayed by a few weeks after an EUA is announced, but It is critical that the data be available immediately so that there can be independent review and concerns about politicization can be addressed. 
      
5. What were the outcomes of the trial?  For example, what kind of reduction in severity was observed?
   • The FDA has released guidance on the type of efficacy data they are expecting from a vaccine and it will be important that data are released that show that a vaccine authorized for emergency use actually met them. 
      
6.  Was the emergency use authorized on actual clinical measures or surrogate measures, such as presence of antibodies?
   • The FDA has committed to not using surrogate measures on their own for a vaccine EUA, so it will be important to confirm that this was the case.
      
7. Is there any discrepancy between the population of the trial and for whom the vaccine is authorized for emergency use?
   • Especially given the disparate impact of COVID-19 across different populations, it is critical that any EUA align initially with the populations tested in the trial.
      
8. How does the EUA impact continued generation of knowledge about the vaccine or therapeutic?
   • Is there any plan in place for ongoing real-world safety monitoring? 
   • Is there a plan for re-examination of the EUA, and what would be expected to sustain an official approval?
   • How will the EUA impact trials for this or other vaccine/therapeutic candidates?
      
9. Was the FDA’s Vaccines and Related Biological Products Advisory Committee asked to meet to review this specific authorization request?
   • If so, why was it not public? If not, why not?
      
10. What’s the pricing and distribution plan for the vaccine?
    • For a vaccine, will there be a need for booster shots or yearly vaccinations, and if so, how is that being accounted for in the pricing to reflect the substantial taxpayer investment inCovid19 vaccine development?

The Trump Administration has a history of inappropriately pressuring the FDA on Emergency Use Authorizations. This was especially notable in the case of hydroxychloroquine, when Food and Drug Administration (FDA) Commissioner Stephen Hahn caved to President Trump’s pressure by issuing an emergency use authorization for the unproven treatment after President Trump called it a “game changer” and explicitly called for it to be approved, which then had to be revoked in the face of continued evidence of the drug’s dangers. And we saw it happen when President Trump and Commissioner Hahn held a press conference to hype blood plasma treatments, which was roundly criticized as a “major breach,” “bullying…at the Highest Level,” an “alarming development,” and based on “nonsensical, inflated claims.” Hahn subsequently apologized.

President Trump has also personally attacked and bullied government scientists, calling them members of the “deep state” and explicitly saying that they may delay a vaccine until November 4th in order to hurt him politically. 

A timeline of political pressure on health officials

• October 13: President Trump took another swipe at his government’s top infectious diseases specialist Dr. Anthony Fauci, saying “Tony’s pitching arm is far more accurate than his prognostications.”
   
• October 7: President Trump released a video that, among other claims, hypes experimental drugs that he personally used and that he claims he will pressure the Food and Drug Administration (FDA) to approve. Trump once again contradicted members of his own Administration and claimed that the fact that a vaccine isn’t available “before Election Day” is “political.”
   
• October 6:  “White House Agrees to FDA’s Guidelines for Vetting Covid-19 Vaccines”…Trump calls it “political hit job.”
   
• October 5: Reports emerge that the White House, in consultation with the drug industry, has overruled the FDA and plans to block the new guidance.
   
• September 28: White House objections may prevent FDA from releasing stricter guidelines drawn up for the emergency authorization of coronavirus vaccines.
   
• September 21: President Trump once again claimed that a vaccine will be approved “within a matter of weeks” and that it will be available to the public “long before the end of the year, maybe…maybe by the end of October,” contradicting  his top public health officials.
   
• September 16: President Trump publicly scolded the Centers for Disease Control and Prevention Director Robert Redfield following his testimony to Congress that mask use was critical in preventing the spread of COVID-19 and that a vaccine would likely not be available to the American public until “late second quarter, third quarter 2021.”
   
• August 30: WaPo: “Inside Trump’s pressure campaign on federal scientists over a covid-19 treatment”
   
• August 25: NPR: “FDA’s Hahn Apologizes For Overselling Plasma’s Benefits As A COVID-19 Treatment”
   
• August 24: “Trump’s FDA Intimidation Campaign Pays Off With Politically-Convenient Announcement; Further Undermines Trust in Vaccine, Treatment Approval Process”
   
• August 22: Trump dials up the pressure with another tweet “The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!”
   
• August 19: Trump insinuates that FDA is trying to hurt him politically through delay: “It could be a political decision because you have a lot of people over there who don’t want to rush things because they want to do it after November 3”
   
• August 18: “Trump Dials Up Pressure for Pre-Election Vaccine, Wonders if “Deep State” Will Delay Vaccine Announcement Until November 4th”
   
• August 17: “Trump Pushes Another COVID-19 “Miracle Cure” Hawked By His MyPillow Buddy, Housing Secretary; Watchdog Urges FDA to Stand Up to Pressure”
   
• August 6: “Watchdog Group to FDA: Patients Need More Than Words On Vaccine Safety Assurance; Supports Health Expert Calls for Additional Transparency”
   
• July 15: “NEW REPORT – Operation Warp Speed at Two Months: $4 Billion for Drug Companies, Zero Assurances for Patients and Taxpayers”
   
• June 25: “New Vaccine Report Highlights Trump Administration’s Drug Company Connections, Need for Vaccine Program Transparency”
   
• June 24: “As Dr. Fauci Expresses Hope for Vaccine By End of Year, Patients Need Assurances That Trump Pressure Won’t Corrupt Development Process”
   
• June 8: “Watchdog Calls for Independent Patient Advocate to Audit ‘Operation Warp Speed’”
   
• May 26: “Lack of Transparency, Conflicts of Interest Surround Trump’s “Operation Warp Speed” Vaccine Development Program”

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