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Health, Wellness, Sex and Body Discuss After FDA approves Pfizer vaccine, several steps remain before kids under 12 can be v at the General Discussion; After FDA approves Pfizer vaccine, several steps remain before kids under 12 can be vaccinated Well hoo tha ray, Y'all! ...

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Old 08-23-2021, 10:44 PM
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Default After FDA approves Pfizer vaccine, several steps remain before kids under 12 can be v

After FDA approves Pfizer vaccine, several steps remain before kids under 12 can be vaccinated

Well hoo tha ray, Y'all!


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The Food and Drug Administration’s decision to grant full approval to Pfizer-BioNTech’s two-dose Covid-19 vaccine Monday for people ages 16 and up is a pandemic milestone, but parents may wonder what it means for their young children who still aren’t authorized to get vaccinated.

While Mondays approval doesn’t cover young people ages 12 to 15, they can still get the Pfizer vaccine through emergency use authorization.

No Covid vaccines have been authorized or approved for use in children under 12. Emergency use authorization for younger children is expected in the fall or winter. But several steps need to be taken first, including the completion of clinical trials.

Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, said in a video news conference Monday that trials for vaccines for children continue and that the agency “has to wait for the company to submit the data from those trials so that we have a good safety dataset, because we certainly want to make sure that we get it right in the children ages 5 through 11 and then even in younger children after that.”


Pfizer CEO: FDA approval shows vaccine is 'effective and safe'
The Pfizer vaccine has been shown overall to be safe and highly effective in preventing severe illness among people ages 12 and up, but vaccinating younger children requires extra scrutiny and study. Researchers at Pfizer and Moderna — whose vaccine is approved for people 18 and older — are seeking to answer questions about how safe and effective the vaccines are in children and trying to determine the proper dosage.

Marks said the FDA will “obviously move swiftly once those data are submitted, but first the trials have to be finished up, or at least the parts of the trials that can be submitted to us have to be finished up, and then the data needs to be submitted to us.”

Pfizer CEO Albert Bourla told NBC News’ Lester Holt on Monday that the company is running “very large studies right now” with children under 12. He said it expected that studies on children ages 5 to 11 would be completed in September and that the company could then submit the data to the FDA.

Pfizer expects data on toddlers up to age 4 soon afterward, NBC News has reported. Moderna's timeline for data on children is likely to be in late fall or early winter.

The FDA has asked for four to six months of follow-up safety data from the children’s clinical trials — compared to two months’ follow-up data required for the adult vaccine trials.


'No time to waste': Biden urges people to get vaccinated after FDA approves Pfizer vaccine
The American Academy of Pediatrics, or AAP, said in a statement Monday it “has called on the FDA to work aggressively to authorize a vaccine for ages 11 and younger” as the delta variant spreads throughout the country among unvaccinated people, including children. The organization also discouraged parents from seeking the vaccine “off-label” — a practice in which doctors prescribe approved drugs for unapproved uses — citing a lack of safety and efficacy data.

The AAP said there were 180,000 new cases of Covid-19 among children and adolescents in the week that ended Thursday.
Quote:
“The clinical trials for the Covid-19 vaccine in children ages 11 years old and younger are underway, and we need to see the data from those studies before we give this vaccine to younger children,” AAP President Lee Savio Beers said in the statement. “The dose may be different for younger ages. The AAP recommends against giving the vaccine to children under 12 until authorized by the FDA.”

NBC News reported last month that emergency authorization for Covid-19 vaccines in children under 12 could come in early to midwinter, according to an FDA official. The agency hopes to then move quickly to full approval for that age group.
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Old 08-25-2021, 06:10 PM
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Default Re: After FDA approves Pfizer vaccine, several steps remain before kids under 12 can

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Old 08-25-2021, 06:11 PM
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Default Re: After FDA approves Pfizer vaccine, several steps remain before kids under 12 can

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Old 08-25-2021, 08:13 PM
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Default Re: After FDA approves Pfizer vaccine, several steps remain before kids under 12 can

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Old 08-25-2021, 08:41 PM
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Default Re: After FDA approves Pfizer vaccine, several steps remain before kids under 12 can


9/11: Safety and Health Lessons Learned | EHS Today
https://www.ehstoday.com/emergency-m...essons-learned
"When the EPA made a Sept. 18 announcement that the air was 'safe' to breathe, it did not have sufficient data and analyses to make such a blanket statement," the report noted. Feal believes Whitman misled many workers about the dangers at Ground Zero, causing them to work at the site without masks.

Judge Says Government Misled Public on 9/11 Air Quality ...
https://www.cnsnews.com/news/article...11-air-quality
Judge Says Government Misled Public on 9/11 Air Quality. (CNSNews.com) - A federal judge has lashed out at former Environmental Protection Agency leader Christine Todd Whitman for telling people the air was safe to breathe in lower Manhattan immediately after the 9/11 terrorist attacks. Judge Deborah Batts' comments came in a ruling allowing a ...


Just trust the gov't. agency, it says it's OK.
Even before enough study is done.
they wouldn't say that if they weren't confident.
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Old 08-26-2021, 07:04 AM
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Default Re: After FDA approves Pfizer vaccine, several steps remain before kids under 12 can

So now Pfizer will take full liability for any claims arising from their vaccine.

Right?
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Old 08-26-2021, 12:22 PM
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Default Re: After FDA approves Pfizer vaccine, several steps remain before kids under 12 can

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Originally Posted by GottaGo View Post
So now Pfizer will take full liability for any claims arising from their vaccine.

Right?
I believe that they are now liable. However, my guess is that somewhere, someone in the administration and written in some language somewhere that will shield these companies from any such litigation. As closely as they are aligned with many movers and shakers in our government, I would suspect this to be more accurate than not.
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Old 08-26-2021, 05:30 PM
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Default Re: After FDA approves Pfizer vaccine, several steps remain before kids under 12 can

Quote:
Originally Posted by mr wonder View Post
Incorrect

Quote:
Regulation of tobacco by the U.S. Food and Drug Administration began in 2009 with the passage of the Family Smoking Prevention and Tobacco Control Act by the United States Congress. With this statute, the Food and Drug Administration (FDA) was given the ability to regulate tobacco products.
They were only given the ability to regulate tobacco products, there is no approve or disapprove prosess given to the FDA
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Old 08-26-2021, 06:26 PM
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Default Re: After FDA approves Pfizer vaccine, several steps remain before kids under 12 can

One-Third Of New Drugs Had Safety Problems After FDA Approval
May 9, 2017 12:29 PM ET
https://www.npr.org/sections/health-...r-fda-approval
The Food and Drug Administration is under pressure from the Trump administration to approve drugs faster, but researchers at the Yale School of Medicine found that nearly a third of those approved from 2001 through 2010 had major safety issues years after the medications were made widely available to patients.
Seventy-one of the 222 drugs approved in the first decade of the millennium were withdrawn, required a "black box" warning on side effects or warranted a safety announcement about new risks, Dr. Joseph Ross, an associate professor of medicine at Yale School of Medicine, and colleagues reported in JAMA on Tuesday. The study included safety actions through Feb. 28.
"While the administration pushes for less regulation and faster approvals, those decisions have consequences," Ross says. The Yale researchers' previous studies concluded that the FDA approves drugs faster than its counterpart agency in Europe does and that the majority of pivotal trials in drug approvals involved fewer than 1,000 patients and lasted six months or less.

It took a median of 4.2 years after the drugs were approved for these safety concerns to come to light, the study found, and issues were more common among psychiatric drugs, biologic drugs, drugs that were granted "accelerated approval" and drugs that were approved near the regulatory deadline for approval.
Drugs ushered through the FDA's accelerated approval process were among those that had higher rates of safety interventions. These approvals typically rely on surrogate endpoints, meaning that researchers measured something other than survival, such as tumor size, to determine whether the drugs worked.
"This [finding on surrogate endpoints] has the greatest relationship to policy today," Ross says. "In the 21st Century Cures Act, there's a push to have the FDA move to further support the use of surrogate markers ... [but] they're more likely to have concerns in the post-market setting."

President Barack Obama signed the 21st Century Cures Act into law on Dec. 13. It offers ways to speed drug approval by pushing the FDA to consider evidence beyond the three phases of traditional clinical trials. The new process has made some researchers worry that it will open the door for approvals of drugs that haven't been adequately tested.
"I'm actually sympathetic to the idea that there are ways in which the FDA can be more streamlined and do a quicker job," says Dr. Vinay Prasad, a hematologist-oncologist and professor at Oregon Health and Sciences University who did not work on the study. "The one place you don't want to cut a corner is safety and efficacy prior to coming to market."
The FDA's system for reporting drug- and device-related health problems is voluntary. The reports are not verified, and critics say this system is underutilized and filled with incomplete and late information. The FDA also monitors other available studies and reports to determine whether it needs to take action on a particular drug.
...
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