Dr. Arnold Monto thinks he and his colleagues will be back at their offices at the University of Michigan School of Public Health and otherwise resuming relatively normal lives by the spring, maybe early summer at the latest.
“We're going to have a lot of people immune [by then],” said Monto, a renowned epidemiologist and the acting chair of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). The committee is scheduled to have a marathon nine-hour session on December 10 to discuss Emergency Use Authorization for Pfizer’s COVID-19 vaccine.
“And then the next one is probably going to be [the vaccine created by] AstraZeneca,” Monto said in an online presentation Wednesday, entitled Is the End in Sight? An Inside Look at the COVID-19 Vaccine Development and Approval Process. “But there have been some issues [with that vaccine] that have been in the media. It's hard to judge that."
If approved, initial shipments of the Pfizer vaccine could begin rolling out almost immediately, with Moderna’s vaccine coming right on its heels: VRBPAC will reconvene on December 17 to discuss EUA of Moderna’s vaccine.
“My best guess is that it's going to be into the late winter, early spring, before we're going to have enough doses available [for everyone]. Because this is going to be driven by the number of doses available.”
Monto, whose career spans seven decades, offered assurances about the safety of any vaccine that does get FDA approval for emergency use.
“What I want to convince you of today, is that we are doing exactly what we ordinarily do with vaccine development, but on a shorter timeline,” he said.
“...There's no reason to think that, with this kind of efficacy that we're seeing [in clinical trials] we're going to have any safety problems.”
But, he added, the caveat with COVID-19 is that there’s still so much we don’t understand about the virus. And as vaccines are distributed far more widely, some people may experience mild side effects: some muscle aches or fever, similar to the flu or shingles vaccine, Monto says.
We also haven’t seen the long-term effects of these vaccines, Monto says. Drug companies have only had about two months to watch what happens after trial participants get the second dose of these vaccines. For Pfizer and Moderna’s vaccine, a second dose is needed a few weeks after the first is administered in order for it to offer full protection.
Even though that’s a shorter window for observation, Monto says the VRBPAC members decided it was sufficient, given the urgency of the need for a vaccine.
“And what we're going to have to do is watch what happens going forward,” he says. “There is no indication that we're going to have any surprises, but obviously you don't know what's going to happen as you go forward. And safety monitoring is going to continue.”
The first vaccines given emergency use authorization will be the “first generation” of COVID vaccines, Monto says, and longer-term observational studies will help experts develop improvements down the line.
“You're going to have to study them in comparative trials,” he says. “And observationally, are we actually going to be able to say which vaccine gives you longer protection? That's going to be, again, observational data.”
But the vaccines we have now, should be able to do the most urgent job.
“First things first, we can stop the pandemic through use of the current vaccines,” Monto says. “And through, unfortunately, the herd immunity that's building up because of bad behavior. Bad behavior may be having good results, in terms of getting natural infections, producing antibody in the population, which didn't happen last spring. And that, combined with a vaccine, is going to result, I would predict, in a decrease in transmission in our populations.”
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