When will a coronavirus vaccine be ready? One just got fast-tracked by the FDA
As the novel coronavirus continues to infect people worldwide, multiple vaccines are in various stages of development.
On Tuesday, the U.S. Food and Drug Administration (FDA) fast-tracked a vaccine being developed by biotech firm Moderna. On May 6, the FDA approved the vaccine to proceed to Phase 2 and is expected to begin Phase 3 in “early summer of 2020.”
Vaccines go through Phase 1, which involves small groups of people getting a trial vaccine, according to the CDC. Phase 2 is when the vaccine goes to a larger group of people “who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended,” the CDC said. Phase 3 is when the vaccine is expanded to thousands and tested for “efficacy and safety.”
Being fast-tracked means the FDA can review data on the vaccine “on a rolling basis” so the agency doesn’t have to wait until everything is completed and analyzed, according to Time.
“It’s validation that the FDA believes this is a very credible exercise,” Dr. Stephen Hoge, president of Moderna, told Time.
President Donald Trump said he expects there to be a vaccine “by the end of 2020,” according to NPR.
Dr. Anthony Fauci, the country’s leading infectious disease expert on the White House Coronavirus Task Force, said during a March 30 briefing that he thinks the vaccine will be ready for the public in 12 to 18 months.
“If we start seeing an efficacy signal, we may be able to even use a vaccine at the next season,” he said. “So things are going to be very, very different.”
Some experts say it could take longer than that timeline.
Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security, told Vox that Fauci’s timeline is “very ambitious.” Kendall Hoyt, a vaccine and biosecurity expert at Dartmouth, told Vox it was “challenging” but possible: “It’s conceivable we could have something in that timeline — if everything goes right.”
Others agree that the 12-to-18-month timeline is “optimistic” and that vaccines usually take 8 to 10 years to develop.
“Tony Fauci is saying a year to 18 months — I think that’s optimistic,” Dr. Peter Hotez, a leading expert on infectious disease and vaccine development at Baylor College of Medicine told CNN. “Maybe if all the stars align, but probably longer.”
“I don’t think it’s ever been done at an industrial scale in 18 months,” Dr. Amesh Adalja, a senior scholar on emerging infectious disease at the Center for Health Security at Johns Hopkins University, told CNN. “Vaccine development is usually measured in years, not months.”
Even if a vaccine is developed more quickly than usual, experts say it’s possible that it won’t be available to everyone.
“There will be a capacity problem because a large percentage of the world population will need a vaccine,” Hoyt told Vox. “You’re just not going to get enough. Vaccine companies are not built to produce enough vaccines for the whole world in a short timeframe.”
And there is risk in trying to get a vaccine out to the public too quickly.
Fauci said during his testimony to Congress on Tuesday that there could be repercussions to rushing vaccine trials, McClatchy News reported.
“I must warn that there’s also the possibility of negative consequences where certain vaccines can actually enhance the negative effect of the infection,” he said. “The big unknown is efficacy. Will it be present or absent, and how durable will it be.”
The U.S. has rushed a vaccine in the past. In 1976, in response to a swine flu outbreak that the CDC originally thought could be close to the 1918 “Spanish flu” strain, the U.S. promised a vaccine, The Smithsonian Magazine reported. After people were vaccinated with an “improperly tested vaccine,” around 450 people got a neurological disorder called Guillain-Barré syndrome.
This story was originally published May 15, 2020 at 11:40 AM with the headline "When will a coronavirus vaccine be ready? One just got fast-tracked by the FDA."