An increasing number of healthcare experts say they’re concerned that the FDA may give an emergency use authorization to a COVID-19 vaccine before all the vital data regarding its safety and effectiveness is available. Getty Images
  • In the United States, the push to create and release a vaccine under the title Operation Warp Speed has made headlines.
  • President Donald Trump said he hoped to have a vaccine in October, which would mean it being approved just before the November election. 
  • Experts say the Food and Drug Administration (FDA) needs to have completed a phase 3 trial before approving the vaccine.

For the first time in modern history, the global scientific community is focused on one singular goal: find an effective COVID-19 vaccine as soon as possible.

There are currently more than 160 potential vaccine candidates being researched or studied across the globe. If one is approved in the next few months, it will be the fastest ever development and approval for a vaccine for a new disease.

Technically two vaccine candidates have been approved for limited and emergency use in China and Russia, but those countries haven’t yet released data of critical phase 3 trials to show those vaccines actually work and are safe. 

In the United States, the push to create and release a vaccine under the title Operation Warp Speed has made headlines, especially after President Donald Trump said he hoped to have a vaccine in October, which would mean it being approved just before the November election. 

But potential political influence and a name like “Warp Speed” has also made the American public wary of a newly approved vaccine.

An August study from NPR, PBS NewsHour, and Marist found that 35 percent of American adults said they wouldn’t take a COVID-19 vaccine. 

It’s not just the American public who are worried about the vaccine. Increasingly, healthcare experts say they’re concerned that the Food and Drug Administration (FDA) may give an emergency use authorization (EUA) to a COVID-19 vaccine before all the vital data regarding its safety and effectiveness is available. 

We talked to experts to explain what an EUA is, and what they’re watching for as the FDA reviews COVID-19 vaccines.

How vaccine testing works

While there are more than 160 vaccine candidates being researched, there are only nine that have reached the critical phase 3 trials. 

In these trials, thousands or tens of thousands of people are given either the experimental vaccine or a placebo. The researchers then see if those who received the vaccine end up being less likely to develop the disease, in this case COVID-19. 

Researchers also look for signs that the vaccine itself is harming the trial participant. Side effects can be as minor as a sore arm or as major as a serious immune reaction, or, extremely rarely, temporary paralysis.

Without this data, researchers can’t know for sure if their experimental vaccine is working, and whether it can lead to certain side effects. 

The FDA has some of the most stringent standards for approving vaccines in the world. A July study published in the Annals of Internal Medicine found that over a 20-year period, the FDA-approved vaccines were remarkably safe and effective. 

The FDA also monitors associated side effects or issues with vaccines after they’re released to the public.

A side effect that has a 1 in 1 million chance of occurring may only be detected after a vaccine is released to the public rather than in a phase 3 trial that involved tens of thousands of participants.

By monitoring vaccines after they’re released, the FDA can decide whether steps should be taken to adjust or pull a vaccine from the market. 

What is an EUA? 

Normally, it takes years or decades for an experimental vaccine to go through enough testing that FDA officials feel confident it’s safe for widespread use. 

Before the COVID-19 vaccine, one of the fastest vaccines ever brought to market is the mumps vaccine, created and released in about 4 years. 

To get people access to a COVID-19 vaccine earlier, the FDA can approve a medication or vaccine through the emergency use authorization, or EUA.

The commissioner of the FDA can issue an EUA for a medical treatment, test, or other medical device in an emergency situation when there are no other adequate or approved options. 

This doesn’t mean the FDA will approve any treatment in an emergency. There usually has to be some evidence that treatment will be helpful, or at least not further harm the patient. 

“Under the EUA authority, the FDA evaluates requests for authorization very quickly using the evidence that is available, carefully balancing the risks and benefits of the product as we know them, in addition to evaluating other criteria,” according to the FDA website

Once approved, the FDA can monitor new data and either revise or revoke the approval.

The agency revoked approval for the malaria medication hydroxychloroquine after it was initially given emergency approval to treat people with COVID-19. 

Experts alarmed at potential authorization before phase 3 trial is finished

In recent weeks, news about political pressure on the FDA has made headlines that worry public health experts.

According to The New York Times, Treasury Secretary Steven Mnuchin and the White House chief of staff Mark Meadows reportedly suggested in a meeting with Democratic lawmakers that the administration may give emergency approval for a COVID-19 vaccine before all data is released from a phase 3 study. The White House disputed this account. 

Dr. William Schaffner, an infectious disease expert at Vanderbilt University School of Medicine, says the previous approval of hydroxychloroquine and convalescent plasma has made him concerned that the FDA is bowing to political pressure. 

Both in the hydroxychloroquine episode and now this most recent episode with the emergency use authorization for convalescent plasma, many of us have been concerned that those decisions were hasty and perhaps inappropriate,” he told Healthline. “They both appeared to have been made under political pressure.” 

Schaffner says the FDA is expected to consult with a board of external experts who routinely advise on immunization practices before giving approval.

“We are very worried that there might be a premature EUA for a vaccine before it has been vetted through the usual regulatory processes, which includes an external body of experts outside the FDA,” Schaffner said. “The FDA Commissioner Hahn said that procedure would be adhered to, but I’m sorry — I remain very concerned that there would be substantial political pressure to short-circuit the usual process.” 

Dr. Paul Offit, director of the Vaccine Education Center and an attending physician in the division of infectious diseases at Children’s Hospital of Philadelphia, joined a presentation hosted by the National Press Foundation earlier this month. During his talk, he voiced his concerns about a possible approval before the election.

“I don’t see how that’s possible, unless what happens is that the administration dips their hand into Warp Speed, pulls out a couple of vaccines, and says, ‘Look, we’ve tested these thousands of people, it looks to be safe. The immune responses are great…’ I think that would be a mistake,” he said.

Dr. Art Caplan, a bioethicist at NYU Langone Medical Center, said he was “deeply concerned” that the FDA will be influenced by the president, citing the emergency approval of convalescent plasma and hydroxychloroquine despite a lack of evidence that they were effective treatments. 

“They just really show that they’re not going to stand up to concerted pressure from the president and his advisers,” said Caplan.

“So I am really, deeply worried, because I think it may give him a little boost in the election, but it’ll really damage trust in vaccines,” he said. 

When an EUA could be used 

Schaffner says an EUA should only be used for a COVID-19 vaccine after a full phase 3 trial is completed. He says about 30,000 people are expected to be a part of phase 3 trials taking place.

In these trials, about 15,000 people would get the vaccine, and the other 15,000 would get a placebo.

“If the trial is permitted to be completed, we will have information on the vaccination of about 15,000 people. It’s large but not huge… it’s comparable to what we often get with other new vaccines,” he said. 

“The concern that we all have is that there might be an issuance of an EUA before the trial is completed, in which case, say the trial is half completed,” he said. Then “the so-called safety database will be much smaller, and that is a large concern.” 

Schaffner says whether this vaccine is approved properly or not will likely have far-reaching consequences for public health.

“If something bad happens down the road after we start giving this vaccine to hundreds of thousands of people if not millions, that could cast a profound shadow, not only over other COVID-19 vaccines that are being tested, but over vaccines generally, and it would fuel the vaccine-hesitant and anti-vaccine movement,” he said. 

In an interview with Reuters, Dr. Anthony Fauci, the director of the National Institutes for Allergies and Infectious Disease, said if the vaccine is approved early, it would make getting complete phase 3 data nearly impossible. 

“The one thing that you would not want to see with a vaccine is getting an EUA (emergency use authorization) before you have a signal of efficacy,” Fauci told Reuters in a phone interview.

“One of the potential dangers if you prematurely let a vaccine out is that it would make it difficult, if not impossible, for the other vaccines to enroll people in their trial,” he said. 

The reason is that if a person gets vaccinated, they likely wouldn’t be eligible to be a part of a new vaccine trial. 

FDA under the microscope

With a significant number of Americans expressing concern about the safety of a potential COVID-19 vaccine, senior FDA officials have been trying to reassure the public.

FDA Commissioner Dr. Stephen Hahn posted a lengthy Twitter thread this week insisting any vaccine approval will be based on scientific evidence and not political pressure.

Additionally, officials, including Hahn, released an essay earlier this month aimed at reassuring the public.

Hahn, with Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), and Dr. Anand Shah, deputy commissioner for medical and scientific affairs at the FDA, published their viewpoint in the Journal of the American Medical Association to assure the public that all steps will be taken to ensure a safe and effective vaccine, and to set out what benchmarks a vaccine will need to meet to get approval. 

“First and foremost, FDA is committed to ensuring that any vaccine is manufactured in accordance with all of FDA’s quality standards and that its safety and effectiveness are verified before being authorized or licensed,” the authors wrote. 

“Second, to achieve population-wide immunity, a COVID-19 vaccine would need to be widely deployed. It is therefore critical that the data derived from nonclinical and clinical studies clearly demonstrate that the vaccine is safe and effective for widespread use,” they wrote.

The essay also said that any vaccine would have to be approved by the FDA vaccine advisory committee, which is expected to meet in October. 

Marks gave a presentation at the National Press Foundation event this month, and said he’s concerned about the lack of public confidence in vaccines.

“That confidence is so important, because the way we have had the incredible public health successes over the past century — elimination of smallpox, essentially elimination from polio from our country, and the near elimination of measles with the exception of imported cases — is because of high levels of vaccination,” Marks said. 

He said approval would be given for a COVID-19 vaccine only if there was enough data that the vaccine was safe and effective. 

“We don’t though have any intention of using emergency use authorization to take a vaccine of suboptimal effect or an unproven vaccine, to bring it forward. That would be doing such a disservice here,” he said. 

Marks said an EUA could be appropriate to cut through red tape that may delay access to the vaccine.

“It is possible that we could issue an emergency use authorization, once studies have demonstrated the safety and effectiveness of the vaccine, but before, a manufacturer has submitted or the FDA has completed its formal review of a biologics license application,” he explained. 

Marks said the goal for his team at the FDA is to reassure the public that if a COVID-19 vaccine is approved, it’s because there’s enough data to show that it’s effective and safe. 

“We need to make sure that we do our best, to take anyone who might be on the fence about taking a vaccine and helping them over that fence,” he said.

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