Public health experts on Monday raised alarm over the White House's aggressive push to rush a Covid-19 vaccine into production, an effort which critics say has been apparent since the first weeks of the pandemic.
According to a New York Times report, researchers working on Operation Warp Speed, the public-private partnership established to find a vaccine that could be given to the public within the next few months, are "under constant pressure from a White House anxious for good news."
When the task force was first assembled in April, weeks after the pandemic began and when President Donald Trump was insisting to the public that the coronavirus would likely disappear on its own, the Health and Human Services Department shared a presentation with the White House saying October 2020 should be a firm "deadline" for developing a vaccine and giving "broad access to the public."
"Waiting for a better vaccine to come along may feel like torture, but it is the right move. With so many potential shots on goal, scientists are optimistic that a safe and effective vaccine is out there. We can't afford to jeopardize the public's health and hard-earned trust by approving anything short of that."
—Natalie Dean, biostatistics professor
The Trump administration has since begun promoting late 2020 or early 2021 as the timeframe for a Covid-19 vaccine, but public health officials are concerned that the president's desire to win re-election may interfere with scientists' efforts to ensure a vaccine is safe and effective before it is approved for use by the public.
With Trump campaign officials reportedly calling a potential pre-election vaccine "the holy grail," experts told the Times of their concern that Trump will pressure the Food and Drug Administration (FDA) to approve whichever vaccine is furthest along in the clinical trial process in the weeks before the general election on November 3.
"There are a lot of people on the inside of this process who are very nervous about whether the administration is going to reach their hand into the Warp Speed bucket, pull out one or two or three vaccines, and say, 'We've tested it on a few thousand people, it looks safe, and now we are going to roll it out,'" Dr. Paul A. Offit of the University of Pennsylvania, who serves on the FDA's vaccine advisory committee, told the Times.
Presidential adviser Jared Kushner, who is helping to lead Trump's reelection campaign and influenced the decision to name Dr. Moncef Slaoui as chief scientific adviser to Operation Warp Speed, is reportedly in regular contact with public health officials to speed up the development of a vaccine.
"Researchers are fearful of political intervention in the coming months and are struggling to ensure that the government maintains the right balance between speed and rigorous regulation," the Times reported.
The pressure campaign from the White House has led companies researching vaccines to begin manufacturing millions of doses of the immunization, "essentially on spec so that they can be distributed quickly if they secure approval."
The newspaper's report came a day after Dr. Steven Salzberg, a biomedical engineering professor at Johns Hopkins University, suggested in a Forbes op-ed that vaccines which have entered Phase 3 of their clinical trials, the final step in pharmaceutical testing before approval, should be offered more widely to the public at a faster pace:
We already have two vaccines in phase 3 trials in the U.S. and Europe; each of these trials which will vaccinate many thousands of people, and then wait to see how many get infected... But we don't have to wait. Both of these vaccines (from Moderna and Oxford University/Astra Zeneca) have already been shown, in phase 1 trials, to be safe and probably effective. That's why the companies are moving ahead and giving each vaccine to 30,000 more people: they are fairly confident that the vaccines are safe...So why not start administering millions of doses right now?
Others in the science and public health communities were distraught over Salzberg's suggestion, taking to social media on Sunday to explain why rushing to administer vaccines to millions of people before clinical trials have been completed is, as one science journalist tweeted, "a horrifically bad idea."
"Drug trials exist for a reason. So many things can go wrong," wrote Erin Biba. "If you skip the checks and balances the amount of damage that can be done is astronomical."
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Pulitzer Prize-winning science journalist Laurie Garrett derided Salzberg's piece as an "utterly bonkers, insane, irresponsible article," while University of Florida biostatistics professor Natalie Dean laid out the dangers of offering a vaccine to the public before its efficacy and safety is proven via the painstaking process of completed clinical trials.
Widespread use of an unproven vaccine:
- Gives people a false sense of security if efficacy is really low
- Diverts resources away from other interventions (fixing testing!)
- Makes it harder to evaluate better vaccines
- Jeopardizes safety
- Erodes trust in the process
— Natalie E. Dean, PhD (@nataliexdean) August 2, 2020
In an op-ed at the Times on Monday, Dean questioned the very notion of developing a vaccine for a newly-discovered virus at "warp speed."
Dean noted that in a survey taken by AP-NORC in May, 31% of respondents said they were unsure whether they would get a coronavirus vaccine once one is made available, in a display of the "vaccine hesitancy" which the World Health Organization says could jeopardize the global community's ability to combat the pandemic.
"This hesitancy isn't surprising. Why should we expect Americans to agree to a vaccine before one is even available?" wrote Dean. "I'm a vaccine researcher, and even I would place myself in the 'not sure' bucket... The evidence that would convince me to get a Covid-19 vaccine, or to recommend that my loved ones get vaccinated, does not yet exist."
That data can only be gathered through a complete Phase 3 trial of a vaccine, Dean wrote, showing that a vaccine either provides immunity to Covid-19 or, like the flu vaccine, keeps patients from developing severe symptoms of the illness if they contract it.
Although the public's desperation for a Covid-19 vaccine is understandable, Dean wrote, "a weak vaccine might be worse than no vaccine at all. We do not want people who are only slightly protected to behave as if they are invulnerable, which could exacerbate transmission."
"It is also costly to roll out a vaccine, diverting attention away from other efforts that we know work, like mask-wearing, and from testing better vaccines," she added.
Following the backlash against his article, Salzberg on Monday wrote an update to the Forbes piece, titled "I Was Wrong: We Can't Skip Phase 3 Vaccine Trials."
"If we expand the distribution of vaccines too quickly, and then the vaccine doesn't work, we may seriously undermine the public's trust in any eventual vaccine that really does work," Salzberg wrote. "That in turn will reduce the number of people willing to be vaccinated, which could cause serious harm to public health."
The Trump administration, the researchers who are under pressure from the White House, and the public must "resist the desire" to push for a rushed vaccine by the election, early 2021, or any specific date, Dean suggested.
"Creating vaccines is hard, and we should be prepared for the reality that some promising ones will not meet the F.D.A.'s criteria," she continued. "Researchers and the government should also commit to transparency so that people can see the results for themselves to understand the regulatory decisions. Waiting for a better vaccine to come along may feel like torture, but it is the right move. With so many potential shots on goal, scientists are optimistic that a safe and effective vaccine is out there. We can't afford to jeopardize the public's health and hard-earned trust by approving anything short of that."