How safe is the fast-track process for the COVID-19 vaccine? Doctors weigh in

Researchers racing to develop a vaccine are “not compromising the safety at all," Dr. Anthony Fauci says, but the rush is making some people hesitant.
Close-up syringe with coronavirus in a drop. Coronavirus pandemic concept. Vaccine
The typical time for vaccine development is 15-20 years, while a COVID-19 vaccine will probably become available within a year-and-a-half of the virus emerging.Anton Petrus / Getty Images stock

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/ Source: TODAY
By A. Pawlowski

Speed is of the essence as governments and companies rush to develop a COVID-19 vaccine that will end the pandemic and help the world return to normal.

It’s also the focus of suspicion as some people wonder whether the rapid pace also means researchers are cutting corners during the process.

Overall, about half of Americans, 49%, said they planned to get vaccinated if a COVID-19 vaccine became available, 20% would refuse and the rest weren’t sure, according to a recent poll from The Associated Press-NORC Center for Public Affairs Research.

Among those who said they wouldn’t get vaccinated, 7 in 10 worried about safety.

Experts understood why some people might be hesitant right now.

“I think it’s reasonable to be skeptical about a vaccine that doesn’t exist yet to prevent a virus that has been elusive and difficult to characterize,” Dr. Paul Offit, an infectious disease physician and director of the Vaccine Education Center at Children's Hospital of Philadelphia, told TODAY. He himself wants to see the data before getting a vaccine.

Offit also didn’t think it was helpful for the government to use “Operation Warp Speed” as the name for its goal to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021.

“I can promise you a scientist did not come up with that phrase. I think it’s terrible,” Offit said.

Even Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, last month admitted he "flinched a little" at the name, fearing that some people may think it implies the fast-track process “is reckless” when it isn’t. Researchers are “not compromising the safety at all, nor is there compromise of scientific integrity," he noted.

What should people know about the vaccine process now? We asked Offit and Dr. Daniel Kuritzkes, chief of the division of infectious diseases at Brigham and Women's Hospital in Boston and professor of medicine at Harvard Medical School.

What’s at stake?

“Obviously, the goal here is to get as many people protected against COVID-19 because you never know if you’re going to be one of those unfortunate people who has a more severe case and because the more people who are protected, the less spread there will be in the community, just like with measles, mumps and all the other viral illnesses that we vaccinate for,” Kuritzkes said.

It’s estimated about two-thirds of the population needs to be immune to COVID-19 to achieve herd immunity. Getting there depends on a vaccine’s effectiveness.

If it’s 80% effective — meaning 8 out of 10 people who were inoculated would not get COVID-19 if exposed to it — then about 80% of the population would need to get the vaccine, Kuritzkes said. If it’s 50% effective, more than 90% of people would have to be vaccinated to get to herd immunity.

How will researchers know a COVID-19 vaccine candidate will be safe and effective?

Phase 3 trials — where the vaccine is given to thousands of people and tested for efficacy and safety — will be critically important, both experts said.

One U.S. company will start this phase of testing on July 27 with 30,000 adults who will either receive the vaccine or a placebo. They’ll be tracked for two years to see whether they get COVID-19 or have any adverse reactions.

“That gives you a very good safety database on which to base a decision on whether or not to approve a candidate vaccine,” Kuritzkes said.

“Assuming that we can reasonably mitigate risk in a phase 3 trial — meaning test it in at least 20,000 people so you can say it doesn’t have an uncommon side effect problem and show that it’s, let’s say, 70% effective for at least four to six months — then I think we can convince the public that this is worth getting,” Offit added.

The government is looking for volunteers to take part in the trials.

Could side effects show up years from now?

Kuritzkes called it “highly unlikely” based on everything researchers know about vaccines and how they work. When people experience symptoms, they’re all short-lived, like local inflammation, a sore arm, and occasionally muscle aches, fatigue and low-grade fever, he noted.

Still, while 20,000 people is a reasonable number of humans to test, it’s not 20 million people, Offit said. That’s why the government maintains programs like the Vaccine Safety Datalink and PRISM to monitor the safety of vaccines after their approval.

Is the speed a concern?

The typical time for vaccine development is 15-20 years, while this vaccine will probably become commercially available within a year-and-a-half of the virus emerging, Offit said.

Are there steps that are being compressed, skipped or overlapping? Yes, “but as long as you do the phase 3 trials, then you’re fine,” he noted. “There’s a fragile vaccine confidence in this country, which is why we can’t release these vaccines before phase 3 trials. That would be a dreadful mistake.”

Much of the speed is due to efforts to reduce the “purely bureaucratic barriers” for getting the clinical trials underway quickly, Kuritzkes added. Similar efforts were made to develop a vaccine for Ebola.

Can people trust the process?

Yes, both experts said. The key part will be the large phase 3 trials.

Both doctors also emphasized it was critically important for the government to get the process right so that only a vaccine that’s proven to be safe and effective will be eventually approved.

“If the first impression of this vaccine is that it’s in any sense unsafe or untested or ineffective, then I think it’s going to be hard to regain the trust of the American public,” Offit noted.