I'm USA TODAY editor-in-chief Nicole Carroll, and this is The Backstory, insights into our biggest stories of the week. If you'd like to get The Backstory in your inbox every week, sign up here.
The coronavirus vaccine will start to be distributed 24 hours after it's approved, federal officials announced this week. When will that be? How will it roll out? And who will get it first?
Bottom line: "You've got to be patient," said Jennifer Portman, USA TODAY's health editor.
This week, Pfizer, one of the companies developing a vaccine, said its test looks safe and plans to release data for approval at the end of October. It is expanding its Phase 3 trial from 30,000 to 44,000 people, another sign that things are going well.
USA TODAY patient safety reporter Karen Weintraub explains the phases, which start after a vaccine has been tested in a lab on mice and on monkeys.
Phase 1, she said, "is a very small trial where they're trying to make sure they're not killing anybody. There are hints at effectiveness in Phase 1 but not a lot of data. Phase 2 is a bigger trial phase. Phase 3 is the big trial."
The vaccine will be approved if on average, it is at least 50% effective in Phase 3. "Then there will be a Phase 4," she said, "which is once it's on the market, they're going to continue these trials for some time and make sure there are no side effects six months down the line."
Once the vaccine is approved at the end of Phase 3, there's a regulatory process. The U.S. Food and Drug Administration reviews the data, then the U.S. Centers for Disease Control and Prevention determines how the vaccine will be distributed. Most vaccine candidates will require two doses to be effective.
"It will first go to health workers in hospitals or clinics who are treating COVID patients," said Elizabeth Weise, a USA TODAY health and science reporter. "Maybe front-line providers, police, firefighters, the military will probably have its own section. And then it'll start coming down to people, if they got COVID, probably at highest risk of getting very sick or dying. It depends on which vaccine and who it works best on."
The vaccine can be distributed quickly after approval because companies are already manufacturing it on the assumption theirs will be approved. If they do not get approval, they'll have to destroy all the vials waiting for distribution.
'So, based on your knowledge,' I asked our reporters, 'when do you think there will be a widely distributed vaccine?' This is the question they are asked most often.
The CDC document released this week says the vaccine might be available by early November but "significantly more COVID-19 vaccine may be available for distribution" beginning in January 2021.
But wide distribution?
"I definitely think that's a huge issue on people's minds," Weintraub said. "When can life resume? And I think it's sometime next summer to fall."
A day later, on Wednesday, that's exactly what CDC Director Robert Redfield told the Senate. Any vaccine available in November or December would be very limited and prioritized, he said. “If you’re asking me, ‘When is it going to be available to the American public so we can begin to take advantage of vaccines to get back to our regular life?’ I think we’re probably looking at late second quarter, third quarter 2021.”
We ask this question of our own experts each month as well. USA TODAY created a panel of leaders in medicine, virology, immunology, logistics and supply chain issues to estimate how close we are to a vaccine. We plot their answers on a USA TODAY vaccine clock, on which midnight is the day the pandemic began and noon is the day that a vaccine is freely available to whomever wants it.
Right now, on average, our experts say we're at 7 a.m., up from 4 a.m. in June. Our panel this month was concerned about making sure that data from the vaccine trials is transparent, openly released to the scientific community and thoroughly vetted.
It's a shared concern. On Sept. 3, the Biotechnology Innovation Organization issued a public letter reiterating the strict standards its members follow. “Trusting science – and the scientific process – is the best way out of this pandemic,” said Dr. Michelle McMurry-Heath, BIO's president and CEO.
Fighting COVID-19: How the CDC failed public health officials fighting the coronavirus
USA TODAY medical reporters are focused on tracking this process, holding institutions accountable, making sure the right steps are followed and watching the data.
A USA TODAY/Suffolk Poll released this month showed two-thirds of U.S. voters say they won't try to get a coronavirus vaccine as soon as it becomes available, and one in four say they don't want to ever get it. The poll, taken Aug. 28-31, surveyed registered voters.
"We know what needs to be done. And we'll tell you if it's being done or if it's not being done," Weise said. "And then when we actually get a vaccine, we should have enough information to say there's great data, this vaccine is safe and effective, or there was not great data and there are many questions about this vaccine.
“We are not political. We're science writers who are just going to say, ‘This is what we know. This is the data we have.’”
Portman says the most important thing we can do, as journalists and as citizens, is follow the science, "and it's just going to take a little bit longer than any of us want."
You can reach Nicole Carroll at EIC@usatoday.com or follow her on Twitter here. Thank you for supporting our journalism. You can subscribe to our print edition, ad-free experience or electronic newspaper replica here.
This article originally appeared on USA TODAY: COVID-19 vaccine won't be widely available until summer or fall 2021