When will a vaccine be ready for COVID-19? Speed causes safety concerns – TODAY

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.

Its 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 werent sure, according to a recent poll from The Associated Press-NORC Center for Public Affairs Research.

Among those who said they wouldnt get vaccinated, 7 in 10 worried about safety.

Experts understood why some people might be hesitant right now.

I think its reasonable to be skeptical about a vaccine that doesnt 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 didnt 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 its 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 isnt. 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.

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Obviously, the goal here is to get as many people protected against COVID-19 because you never know if youre 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.

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

If its 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 its 50% effective, more than 90% of people would have to be vaccinated to get to herd immunity.

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. Theyll 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 doesnt have an uncommon side effect problem and show that its, lets 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.

Kuritzkes called it highly unlikely based on everything researchers know about vaccines and how they work. When people experience symptoms, theyre 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, its not 20 million people, Offit said. Thats why the government maintains programs like the Vaccine Safety Datalink and PRISM to monitor the safety of vaccines after their approval.

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 youre fine, he noted. Theres a fragile vaccine confidence in this country, which is why we cant 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.

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 thats proven to be safe and effective will be eventually approved.

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

A. Pawlowski is a TODAY contributing editor focusing on health news and features. Previously, she was a writer, producer and editor at CNN.

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When will a vaccine be ready for COVID-19? Speed causes safety concerns - TODAY