A subject receives a shot in the first-stage safety trial of a potential vaccine by Moderna for COVID-19 at the Kaiser Permanente Washington Health Research Institute in Seattle on March 16.
Q: Will COVID-19 vaccines issued under an EUA continue in the licensing process and eventually be fully licensed using a Biologics License Application?
site-https://www.thewyco.com/news/staying-ahead-with-innovation-19-12-2020
A: Yes. Our expectation is that the sponsors (the vaccine companies) will submit an application, and it’s their call if it’s an EUA or a BLA. Then they would submit, subsequently or in real time, a BLA. We will, of course, prioritize the application for an Emergency Use Authorization, but we will then go through the normal reviews.
How the FDA will encourage people to take the vaccine
Q: What more could be done to encourage people to take an authorized vaccine? Is there anything you can do as head of the FDA to encourage people to get vaccinated?
A: I was a doctor before I became FDA commissioner. If you explain something to a patient — if you share that in a transparent way and then you do what you say you’re going to do — that builds trust. We will follow our process, look at the criteria — we’ll be transparent about those.
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Q: Will you get the vaccine yourself? Either in April or May when it may become available to the general public, or do you fit in one of the categories that are likely to have access sooner, such as front-line medical workers?
A: I’ve been clear, I would not allow the agency to authorize or approve a vaccine that I wouldn’t want my own family to get. No one at FDA would want that to occur.
When it’s appropriate for me to get the vaccine, from the guidelines’ point of view, I will get that vaccine. I would strongly urge my family to get it. I have 100% confidence in the staff at FDA. If it would enhance confidence in the vaccine, I would get the vaccine as soon as it is authorized.
site-https://jsfiddle.net/Latj9dm4/
Maria Harvey and her sister Ashley Makridakis protest mandatory flu vaccinations outside the Massachusetts Statehouse on Aug. 30 in Boston. Public health authorities say flu shots are very important this year to avoid overburdening the health system amid the coronavirus pandemic.
Q: An employer or school cannot require someone to get a vaccine issued under an EUA, right?
site-https://paiza.io/projects/Tq0uGe6TU5aa-xLssaokcw?
A: Institutions may require individuals to take an FDA-approved vaccine or apply for an exception. However, EUA products are still considered investigational.
site-https://ideone.com/5KPgPC
It’s possible that some employers or schools will have questions or concerns about an investigational product issued an Emergency Use Authorization, which is why we will be as transparent as possible about the data and information we use to make our decision. This should help those organizations determine what is most appropriate for them.
site-https://ytwegdsvnbdvtmpboxnet.hatenablog.com/entry/2020/12/19/130906
How long it will take for a vaccine to be authorized
There are several steps to the vaccine authorization process. First, a company must apply to the FDA. Then, the FDA must go through the application and send it to an outside review board called the Vaccines and Related Biological Products Advisory Committee (VRBPAC). That committee meets on Dec. 10 and will send the FDA its comments and recommendations. Only then can the FDA make a final decision on a vaccine.
Q: How long should we expect FDA to deliberate after it hears from that committee?
A: We expect it to be days, but it’s very dependent on the complexity of the data and the comments we get back from VRBPAC.
Q: So it could be longer?
site-https://pastelink.net/2ebq8
A: We cannot prejudge our process; our scientists have to make the decision. We will take the time that’s needed to make the right call on this.
We want to move quickly because this is a national emergency, but we will make sure that our scientists take the time they need to make an appropriate decision. It is our job to get this right and make the correct decision regarding vaccine safety and efficacy.
site-https://pasteio.com/xvUlhNXqrnsJ
Staff members monitor patients at Stormont Vail Health on Nov. 18 in Topeka, Kan. The hospital has devoted an entire floor to COVID-19 patients.
Q: How much paperwork does an EUA involve? In the old days, there was so much paperwork, it came in on wooden pallets. Can you give us a metric?
site-https://blog.goo.ne.jp/ytwegdsvnbdv/e/535d80ed6b40705483eac3334555daff
A: These applications are very complicated. This is thousands of pages of information that our scientists have to go through. … FDA is one of the few, if not the only, regulatory agencies in the world that looks at the raw data in a clinical trial. We refer to it as the line data. We analyze the data, we have expertise in that, we’ve done that for years. This is why it takes us time because it’s very complicated.
site-http://www.onfeetnation.com/profiles/blogs/film-streaming-hd-4
That’s another issue that I believe should provide great comfort to the American people: These scientists will do the number crunching. We have biostatisticians, we have scientists. We don’t just accept the conclusion of our sponsors — we will come to our own conclusion.
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site-https://www.mydigoo.com/forums-topicdetail-209310.html
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site-https://dcm.shivtr.com/forum_threads/3282480
Wooten had decided to enroll her daughter in the remote learning plan at Mississippi’s DeSoto County School District last summer, when infection rates were surging and hospitals ran out of ICU beds. …
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site-https://medium.com/@liviw50751/trump-on-sunday-briefly-appeared-to-acknowledge-that-4bacb201d465
The cable news host, broadcasting from her home office and explaining her makeup-free appearance with humorous self-effacement, revealed that the “close contact” she had been exposed to, as her quarantine had been explained during her absence, was Mikula, her partner of more than 21 years.
site-https://steemit.com/news/@allocinemafr/trump-on-sunday-briefly-appeared-to-acknowledge-that
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Diary game
Hello everyone, As now the diary game season 3 is never ending season. Everyday so many people post diary entries from all over the world, most of us uses Google plus code and What's3words to put location of the image that we have used in our post.
Get valuable post in your diary by following these guidelines -
site:https://www.thewyco.com/general/jack-dorsey-and-mark-zuckerberg-will-face-congress-again-19-12-2020
I have also seen some newcomers also some old users don't use any of the way to put location for their images and this prevent them from receiving higher rewards.
When you are posting a image it's necessary to indicate the location and caption because it really matters "Where the picture was taken" and "What it indicates".
My Town in Ten pics
Along with diary game, You can still post for New Challenge - My Town In Ten Pics challenge @steemcurator01 team is still giving votes to the posts for this challenge.
site:
Use What3words
@steemcurator01 team is keen to see people using What3words in their posts and sharing their entries on Twitter (if they have some followers) and tag @what3words in your tweets in case we can attract their attention on Steem.