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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 injections offer strong protection.
It comes a week later Pfizer has sought FDA clearance for its vaccine (developed with its German partner BioNTech).
On “CBS This Morning” Monday, 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 the governors who would decide which segments of the population would receive them first.
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 what it appears to be, we might consider approval within days.,” He said. “Moderna is roughly a week late. And General Perna [the chief operating officer of Operation Warp Speed] stated that we will ship within 24 hours of FDA clearance.
“So we could see these two vaccines come out and hug people 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 something at CDC called the Advisory Committee on Immunization Practices (ACIP), and they met with us to give us advice on who – based on the data we have on these vaccines and the status of the vaccine. cases, the epidemiology in the country – should we vaccinate first, “Azar said.” It’s still ongoing. Hopefully this week we will get more clarity from them regarding their recommendations and the views of our CDC Director. But think of the people in retirement homes, the most vulnerable; think of healthcare workers who are on the front lines most interacting with suspected cases of COVID, such as the first few groups of people we will try to get vaccinated. “
“The federal government will ship to the states and then you said the governors will have the ultimate authority over who gets the vaccine first,” Dokoupil said. “If you see some states at the federal level where people are skipping the line because they have money or have connections, is there something going to happen to stop that?”
“Well, again, we’re not going to ship vaccines to states. I want to be clear on this: we ship them through the normal vaccine distribution system,” Azar replied. “Our governors are really like air traffic controllers. They will tell us which hospital, which pharmacies, where they would like it to go. And they will determine which groups to prioritize.
I hope the science and the evidence will be clear enough that our governors will follow the recommendations we make to them, and we will certainly speak out against any inequalities or injustices that we see in the approach, and we will assess all of our options as we go. to measure.
“I will speak to all the governors of the country this afternoon with the vice president,” Azar said. “I have a lot of confidence in our governors to do the right thing here.”
Azar also discussed the government’s messaging strategy, as polls suggest many Americans are reluctant to get vaccinated they believe is not sufficiently tested.
“We have a really big public affairs campaign in the works. Hopefully we’ll be on the radio this week and be on TV soon to help educate people about these vaccines,” Azar said. “One interesting thing: We actually had to go back to the whiteboard, as we call it, on these campaigns because Moderna and Pfizer vaccines are so effective in these clinical trials, we actually had to make changes to our. campaign material to reflect this.
“And then the most important thing we do is keep politics out of the process, and we make sure that everything is done through these independent checks in the system that you and I have talked about so often. “
Dokoupil asked, “Are they specifically targeted at populations – thinking black and brown populations, more vulnerable populations – who are particularly skeptical of something going through a federal process?”
“Yes, there is targeting there, because as you know there is a very sad and sorry story relating to some aspect of clinical trial research that has taken place in the past,” a- he replied. “This is why we have been so focused, so very focused to ensure meaningful participation of the minority community in these clinical trials, and the latest Moderna data released today from the full clinical trial demonstrates, I think, that 30% of the trial participants were from communities, especially our African American and Latin American communities. So we have a very robust population that participated in the studies, and I want to say, as secretary, thank you to everyone who participated in these clinical trials. You really give us hope for the future with these credible vaccines that are coming soon. ”
Dokoupil said: “You say you are working on a courier campaign; wouldn’t the time of the courier campaign have been before, while you are working on logistics, while you are developing [vaccines]? “
“Actually, Tony, no,” Azar said. “First of all, we want to be very sensitive. The other side was complaining if we had to organize campaigns to educate people about the vaccine before the election, there was a lot of concern expressed about it. We have delayed these. campaigns.
“But also, you want to time it correctly. You can’t condition a market one month, two months before the vaccine is generally available. You just won’t have the effect, so you want to really time it in sequence with the vaccine. vaccine availability so that you really have that call to action that will have the maximum effect.
“The timing,” he said, “is right.”
To date, the United States has reported more than 13 million cases of the virus. More than 266,000 people have died, and at least one American dies from the coronavirus every minute.
There were 4.2 million cases diagnosed in November – double the number last month.
COVID-related hospitalizations in the United States are also at an all-time high – nearly 100,000 – and officials warn it could soon get worse, with what they call a ‘surge on a wave’ after Thanksgiving.
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