Moderna Inc. said it will apply to the Food and Drug Administration for emergency use authorization for its COVID-19 vaccine, as the latest study results confirm the shots offer strong protection.
This comes a week after Pfizer asked for FDA authorization for its vaccine (developed with its German partner BioNTech).
On Monday’s “CBS This Morning,” Health and Human Services Secretary Alex Azar said, if approved, vaccines could be available in the United States before Christmas, and that it would be governors who decide which segments of the population would be first in line to receive them.
Azar said that, after Pfizer applied for its Emergency Use Authorization, the FDA announced an advisory committee meeting for December 10. “If everything is on track, everything proves out what it appears to be, we could be looking at approval within days after that,” he said. “Moderna is basically one week behind that. And General Perna [the chief operating officer of Operation Warp Speed] said that we’ll ship within 24 hours of FDA authorization.
“So, we could be seeing both of these vaccines out and getting into people’s arms before Christmas.”
Azar told “CBS This Morning” co-host Tony Dokoupil that the Centers for Disease Control and Prevention will create recommendations to prioritize vaccine distribution.
“We have at the CDC something called the Advisory Committee on Immunization Practices (ACIP), and they have been meeting with us to give us advice on whom — based on the data that we’ve got on these vaccines and the state of the case, the epidemiology around the country — should we vaccinate first,” Azar said. “That’s ongoing still. I hope this week we’ll get greater clarity from them in terms of their recommendations and our CDC director’s views. But be thinking people in nursing homes, the most vulnerable; be thinking healthcare workers who are on the frontlines of most interacting with suspected COVID cases, as the first tranches of people that we’ll try to get vaccinated.”
“The federal government will ship to the states, and then you said governors will have ultimate authority about who gets the vaccine first,” Dokoupil said. “If you see at the federal level certain states where people are jumping the line either because they have money or they have connections, is there something that is going to happen to stop that?”
“Well, again, we’re not going to be shipping vaccines to the states. I do want to be clear about that: We’re shipping it through the normal vaccine distribution system,” Azar replied. “Our governors are really like air traffic controllers. They’re going to tell us which hospital, which pharmacies, where they would like it to go. And they will be determining which groups to be prioritized.
“I would hope that the science and the evidence will be clear enough that our governors will follow the recommendations that we will make to them, and we’ll certainly call out any inequities or injustices that we see in approach, and we’ll assess all of our options as we go.
“I’ll be talking to all the nation’s governors this afternoon with the vice president,” Azar said. “I have a lot of confidence in our governors to do the right thing here.”
Vaccine czar on distribution timeline
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Azar also discussed the government’s strategy for messaging, given that polls suggest many Americans are wary of taking a vaccine they believe isn’t sufficiently tested.
“We have got a very large public affairs campaign in the works. I hope we’ll be on radio this week and getting on TV soon thereafter to help educate people about these vaccines,” Azar said. “One interesting thing: we actually had to go back to the, as we call it, white-boarding on these campaigns, because the Moderna and Pfizer vaccines are so highly effective in these clinical trials, we’ve actually had to make some edits to our campaign materials to take account of that.
“And then, the most important thing we’re doing is we’re keeping politics out of the process, and we’re making sure that everything is done through those independent checks in the system that you and I have talked about so often.”
Dokoupil asked, “Are they targeted in particular to populations – thinking Black and Brown populations, more vulnerable populations — who are particularly skeptical about something coming through a federal process?”
“Yeah, there is a targeting there, because as you know there is a very sad and sorry history in connection with some aspects of clinical trial research that have happened in the past,” he replied. “That’s why we have been so focused, so very focused to ensure significant minority community enrollment in these clinical trials, and the latest Moderna data out today from the full clinical trial demonstrates, I think, 30% of those in the trials were from underserved communities, especially our African-American and Latinx communities. So, we have a very robust population that participated in the studies, and I want to say, as secretary, thank you to everybody who participated in these clinical trials. You really give us hope for the future because of these credible vaccines that now are going to be coming.”
Dokoupil said, “You say you’re working on a messaging campaign; wouldn’t the time for the messaging campaign have been prior, while you’re working on logistics, while you’re developing [vaccines]?”
“Actually, Tony, not,” Azar said. “First off, we want to be very sensitive. The other side was complaining if we were to put campaigns out to educate people about the vaccine before the election, there was a lot of concern expressed about that. We held those campaigns back.
“But also, you want to time it just right. You can’t condition a market a month, two months before general vaccine availability. You just won’t have the effect, so you want to time it really right in sequence with vaccine availability so that you really have that call to action that will have the maximum effect.
“The timing,” he said, “is right on.”
As of Monday, the U.S. has had more than 13 million reported cases of the virus. More than 266,000 people have died, with at least one American dying of coronavirus every minute.
There have been 4.2 million cases diagnosed in November — double the number last month.
COVID-related hospitalizations in the U.S. are also at their highest point ever — nearly 100,000 — and officials warn it could soon get even worse, with what they’re calling a “surge upon a surge” after Thanksgiving.
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