Moderna Inc. Said It will apply to the Food and Drug Administration for authorization of emergency use For its Covid-19 vaccine, as recent study results confirm strong protection against shots.
This comes a week later Pfizer sought FDA approval for his vaccine (Developed with its German partner Bioentech).
“If approved, the vaccine may be available before Christmas in the United States, and it will be up to the governors to decide which parts of the population will be in first order,” Health and Human Services Secretary Alex Azar said Monday morning. Receive them.
Azar said that after Pfizer applied for its emergency use author authorization, the FDA announced an advisory committee meeting for December 10. “If everything is on track, if it proves everything it looks like, we’ll look into approving it in the next few days,” he said. “Moderna is a week behind him. And General Parna [the chief operating officer of Operation Warp Speed] Said we will ship within 24 hours of FDA authorization.
“So, we’re going to have to get both of these vaccines out and into people’s arsenals before Christmas.”
Azar told Tony Dokaupil, co-host of CBS The Morning, that the Centers for Disease Control and Prevention would make recommendations to prioritize vaccine distribution.
“We have something called the CDC’s Advisory Committee on Immunization Practice (ACIP), and they are meeting with us to advise whom – based on the data we have received about these vaccines and the status of the case. We should vaccinate first, “Azar said. “It’s still going on. I hope this week we’ll get more clarity from them in terms of their recommendations and the views of our CDC director. But think of the people in the nursing homes, the most sensitive; Conversations with suspected COVID cases, as the first level of people that we should try to get vaccinated. “
“The federal government will go to the states, and then you said that the governors would have the final say about who gets the vaccine first.” “If you look at some states at the federal level where people are jumping the line because they have money or because they have connections, is there something that’s going to close?”
“Well, again, we are not going to send the vaccine to the states. I want to clarify about that: we are sending it through the general vaccine distribution system,” Azar replied. “Our governors are really like air traffic controllers. They will tell us which hospitals, which pharmacies, where they would like to go. And they will decide which groups to prefer.
“I hope the science and the evidence will be clear enough that our governors will follow the recommendations given to them, and we will definitely call for any inequality or injustice we see in the approach, and we will evaluate all the options we have.”
“I will talk to the vice president today and all the governors of the country,” Azar said. “I have a lot of confidence in our governors to do the right thing here.”
The poll suggests Azar also discussed the government’s strategy for messaging Many Americans are wary of getting vaccinated They believe there is not enough testing.
“We’ve had a very big public affairs campaign in the works. I hope we’ll be on the radio this week and on TV soon after that to help educate people about these vaccines,” Azar said. “One interesting thing: we actually call these campaigns as white-boarding, because the Moderna and Pfizer vaccines are so effective in these clinical trials, we really had to make some changes. Consider that on our campaign materials.”
“And then, the most important thing we’re doing is that we keep politics out of the process, and we’re making sure that you and I have talked a lot through the system and that independent scrutiny.”
Docoupil asked, “Are they specifically targeting populations – black and brown populations, think more vulnerable populations – who are particularly skeptical about something coming through the federal process?”
“Yes, there is a goal, because you know that some aspects of clinical trial research have a very sad and tragic history in relation to what has happened in the past.” “This is the reason why we have focused so much on ensuring significant enrollment of minority communities in these clinical trials, and the updated Moderna data from today’s full clinical trials show that, I think, 30% of those trials were from the underserved communities, in particular. Our African-American and Latinx communities. So, we have a very strong population who have participated in this study, and I want to say, as Secretary, thank you to everyone who has participated in these clinical trials. You really give us hope for the future. Because of these reliable vaccines that are coming now. ”
Dokopil said, “You say you’re working on a messaging campaign; when you’re working on logistics, the timing of the messaging campaign wouldn’t have been earlier. [vaccines]”?
“Really, not Tony,” Azare said. “First of all, we have to be very sensitive. On the other hand, there was a complaint that if we run a campaign to make people aware about the vaccine before the election, there was a lot of concern.
“Also, you want to give it the exact time. You can’t market a month in two months before the vaccine is available. You won’t be affected, so you want to get that time in order with the vaccine. Availability so you have that call. There are two actions that will have the maximum effect.
“Time,” he said, “is right.”
To date, more than 13 million cases of the virus have been reported in the United States. At least one American dies every minute from coronavirus, more than 266,000 people die.
2.4 million cases were diagnosed in November – double that number last month.
U.S. Hospitals in Kovid are still at their highest level ever – about 100,000 – and officials warn that what they call “raising the bar” after Thanksgiving could be even worse.
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