For every week we didn’t have a COVID-19 vaccine, more people died, more children were kept out of school, and more damage was done to society.
Yet it’s become increasingly clear that the FDA put the brakes on the vaccine at the 11th hour, delaying its authorization because Democrats — worried it would help Donald Trump’s 2020 re-election prospects — undermined public confidence in the vaccine development efforts.
We may never know how much damage was done in the name of politics. But one victim is clear: Americans’ trust in their government and public health experts.
Democrats are trying to deflect blame for this scandal by claiming the inverse: That the Trump administration undermined public trust by irresponsibly trying to “rush” the vaccine for political gain.
Last month, in a Congressional report provocatively titled “A ‘Knife Fight’ with the FDA: The Trump White House’s Relentless Attacks on FDA’s Coronavirus Response,” the House Select Subcommittee on the Coronavirus Crisis alleged that Trump administration officials “blocked FDA from issuing guidance on coronavirus vaccine authorizations for weeks in an attempt to ensure that the first vaccine could be authorized before the 2020 presidential election.”
It claims that the administration’s actions “resulted in damaging consequences for the coronavirus response” by undermining public confidence in the vaccine.
But the report, and the testimony of former FDA commissioner Dr. Stephen Hahn to the commission on which it is based, reveal these assertions are misleading, politically motivated distortions.
In reality, it was Trump opponents who undermined public confidence resulting in new FDA guidelines that delayed vaccine availability and likely cost lives.
Here are the facts:
We know from interviews that vaccine trials were proceeding faster than anticipated and that an announcement about vaccine efficacy was possible by the end of October 2020 with authorization soon to follow.
On Sept. 9, 2020, Pfizer CEO Albert Bourla announced on the “Today Show” that Pfizer had joined a pledge with other pharmaceutical companies to follow FDA guidance and to only request a vaccine emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study. Pfizer’s trials were moving faster than expected and he predicted the company would likely have results by the end of October.
Five days later, on “Face the Nation,” Bourla said that there was more than a 60% chance Pfizer would know results by the end of October.
That didn’t happen. Instead, on November 9, six days after the presidential election, Pfizer announced that its COVID-19 vaccine candidate was 90% effective. Eleven days later it filed a vaccine emergency use authorization request — the first in the U.S. — that was granted on December 11.
The delay followed a curious FDA decision to toughen its standards for COVID vaccine safety review (effectiveness guidelines were unchanged). The agency would now require a median follow-up of 60 days after the vaccine shots to check for adverse side effects.
The House report fails to mention that these new guidelines—submitted to the White House and HSS on September 21 — revised earlier June 2020 guidelines that stated the “safety evaluation of COVID-19 vaccines . . . should be no different than for other preventive vaccines for infectious diseases.”
In his book “Warp Speed,” Paul Mango, former HHS Deputy Chief of Staff for Policy who was intimately involved with the vaccine effort, reports that vaccine developers understood the earlier guidance to mean trials would only be required to monitor for adverse events for, at most, 42 days after the second dose.
So why did the FDA add 18 days to the side effects check?
Officials at the White House had the same question. FDA commissioner Hahn reported push-back from administration officials with “questions about whether the 60-day meeting [sic] follow-up in particular was appropriate given the urgency of the situation.” He repeatedly said the interactions were “cordial” and not “contentious.”
The report insinuates that administration officials who questioned the need for an additional 18 days of follow-up were solely interested in the political goal of getting a vaccine out before the election. Yet the report admits that, “When asked if President Trump ever expressed a specific desire to have a vaccine approved before the election, Dr. Hahn replied in the negative.”
In fact, when the majority (Democratic) counsel repeatedly asked if President Trump or others “express[ed] a desire to have the vaccines available before Election Day?” Hahn responded, “President Trump expressed his desire for these to be approved as quickly as possible to save lives” and that “There was no one at the White House who contacted me and expressed a desire for a specific timeframe for emergency use authorization.”
Paul Mango echoes this in “Warp Speed.” He attended every briefing of the Warp Speed team in the Oval Office and never heard “President Trump ask the team to have a vaccine prior to Election Day.”
Dr. Hahn acknowledged that administration officials “across the board” were interested in speeding up the development and approval of vaccines. Yet he viewed that as normal: “I mean, we were in a public health emergency and it was totally appropriate to ask the question, what can you do to speed this up to get lifesaving treatments, vaccines, et cetera, into the hands of people?”
Hahn also made it clear that administration officials continued to press him on speeding up vaccine authorization well after the election which undermines the contention that all the administration cared about was pre-election approval.
After the new guidelines, Bourla wrote in an open letter on the Pfizer website, that, “we may know whether or not our vaccine is effective by the end of October,” but that because the FDA was now requiring 60 days of safety data, they did not expect to be able to file for an emergency use authorization until the third week of November.
It is clear that delayed EUA submission resulting from the new FDA safety guidelines was consequential.
Both daily cases and daily deaths started to rise in mid-October 2020 and peaked in mid-January 2021. The 7-day moving average of COVID deaths reached the highest level during the entire pandemic on January 13, 2021. Had vaccines been authorized weeks earlier — during a period when COVID deaths averaged thousands per day — tens of thousands fewer would have died.
Why did the FDA change its vaccine authorization guideline?
Hahn indicated that FDA began to formulate new guidelines during the summer to counteract public concerns that the agency “might be cutting corners and that it might not be safe or effective.”
In “Warp Speed,” Paul Mango confirms that Dr. Peter Marks, Director of the FDA Center for Biologics Evaluation and Research, which approves vaccines, told him the FDA was concerned about vaccine hesitancy resulting from comments questioning the speed of vaccine development. Marks told him new guidance was “essential to shoring up vaccine confidence.”
The House report claims that President Trump’s public comments that “[i]t wouldn’t hurt” to have a vaccine available before election day was responsible for the decrease in public confidence. But Hahn downplayed the impact of Trump’s tweets. “It was . . . the entire set of circumstances.” he said, including “A presidential election, bitter divisions in the country and in Congress” and according to Hahn, but unmentioned by the report, “The people who said they wouldn’t take the vaccine if it was authorized under President Trump’s watch.”
Those people were candidates Biden and Harris, who, along with their political, scientific and media allies, repeatedly criticized the vaccine development under President Trump and impugned the FDA’s independence and integrity.
Hahn believed statements by candidate Biden such as “If and when the vaccine comes, it’s not likely to go through all the tests that need to be done” and by candidate Harris that she wouldn’t take a vaccine promoted by Trump, unfairly cast doubt on the FDA. The Biden/Harris campaign website explicitly maligned Hahn and the FDA.
Senate Democratic leader Chuck Schumer also questioned the safety of the vaccines then in development and the FDA’s integrity, claiming the agency was succumbing to Trump administration pressure. He was joined by then New York Governor and media darling, Andrew Cuomo, who said he would not trust a vaccine approved by the FDA and federal government.
Biden medical allies such as Dr. Ashish Jha, then dean of the Brown University School of Public Health and now Biden’s COVID-19 Response Coordinator, said he was “deeply worried” about the speed of vaccine development. Dr. Ezekiel Emanuel, a noted bioethicist, former Obama advisor, and then advisor to the Biden campaign, organized a letter, with multiple signatories, urging Pfizer to defer seeking vaccine authorization until “at least late November.”
A September 10, 2020 editorial in the Journal of the American Medical Association fueled doubts by claiming that “some” unnamed and uncited persons were concerned that political appointees would, “insist on an EUA for a vaccine over the recommendation of FDA career scientists.” It claimed that Dr. Hahn, had “indicated that the FDA is willing to use an Emergency Use Authorization (EUA) for vaccines before phase 3 trials are complete.”
Yet the editorial cited an August 7 JAMA article authored by FDA officials including Drs Hahn and Marks — “Unwavering Regulatory Safeguards for COVID-19 Vaccines” — in which they committed to only issuing an EUA once a phase 3 trial or interim analysis of such a trial that met pre-specified success and safety criteria was complete. In addition, the editorial writers surely knew that any authorization would only occur following a public discussion at the FDA’s Vaccines and Related Biological Products Advisory Committee.
Mainstream media “fact checkers” amplified public doubts. The Washington Post, for example, stated that Trump was “misrepresenting how fast a vaccine will be available.” NBC news asserted vaccines by year end would be a “miracle.”
The House report has the story backwards. Trump administration officials urged speed in vaccine development to save lives, not for political gain. President Trump would have, no doubt, been thrilled to have an announcement of effectiveness or vaccine authorization prior to the election — what politician in his position would not have?
But there is no evidence that he unduly pressured the FDA or undermined its scientific processes. Nor is there evidence that he forced Pfizer to publicly predict when it would have effectiveness data and be able to apply for authorization.
It was pressure from candidates Biden and Harris and their allies that forced the FDA to revise its guidelines and delay vaccine authorization. That same pressure likely influenced a Pfizer decision to alter its research protocol on when to first assess vaccine efficacy that changed their announcement of vaccine efficacy from pre- to post-election.
Moreover, contrary to the report’s implication that there was a tremendous delay between the submission of the proposed revised guidelines to the White House and their public release, the total process took only two weeks. And while the report claims the FDA had to defy the administration to release the new guidelines, Hahn’s testimony was that the White House approved the guidelines, unchanged, before they were released on October 6.
If the American people want to know who injected politics into science, delaying vaccines and causing thousands of unnecessary deaths, they need look no further than the current White House and its media and academic enablers.
Joel Zinberg, MD, is a senior fellow at the Competitive Enterprise Institute and director of public health and wellness at the Paragon Health Institute.