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Coronavirus | COVID-19 | Global Pandemic | PLEASE KEEP DISCUSSION TO THIS THREAD

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22 hours ago, Porthos said:

 

 

Is that one or two doses?

 

In the UK, they are only given one dose to under 16s. The risks go up too high for 2.

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6 minutes ago, AndyK said:

Is that one or two doses?

 

In the UK, they are only given one dose to under 16s. The risks go up too high for 2.

 

Two smaller doses (1/3rd the size of an adult dose), it appears:

 

Quote

A key Food and Drug Administration advisory committee on Tuesday recommended a lower dose of Pfizer and BioNTech’s Covid-19 vaccine for children ages 5 to 11, a critical step in getting some 28 million more kids in the U.S. protected against the virus as the delta variant spreads.

 

The endorsement by the agency’s Vaccines and Related Biological Products Advisory Committee will now be considered by the FDA, which could issue a final decision within days. The vote was nearly unanimous, with 17 members backing it and one abstention.

 

The agency doesn’t always follow the advice of its independent committee, but it often does. Next week, a Centers for Disease Control and Prevention vaccine advisory group is expected to make its own recommendation. If it issues an endorsement and CDC Director Dr. Rochelle Walensky signs off, shots for young kids could begin immediately.

 

The Biden administration said it plans to distribute the doses as soon as it’s authorized by the FDA and CDC, which is expected to come early next month. The administration said it’s procured enough vaccine to inoculate all 28 million 5- to 11-year-olds in the U.S., and will distribute it in smaller dosing and with smaller needles to make it easier for pediatricians and pharmacists to administer to kids.

 

Many parents say they are anxiously awaiting the vaccine’s authorization with schools now open across the U.S. and the delta variant driving a surge in children’s cases.

 

Children ages 5 to 11 account for roughly 9% of all reported Covid cases in the U.S., according to data presented to the committee by the FDA on Tuesday. The number of new Covid cases in kids remains exceptionally high, with more than 1.1 million child cases added over the past six weeks, according to the American Academy of Pediatrics.

 

Still, some parents and advocacy groups argue Covid vaccinations for children are unnecessary as studies show kids are less likely to experience symptoms from the disease even though they get infected at similar rates as adults.

 

Some committee members said Tuesday that vaccinating younger groups would help the U.S. move toward Covid’s “endemic” phase, where the virus is still circulating but at lower levels than it is now. Others noted there are unknowns, such as the rate of myocarditis in young kids, but still emphasized that the benefits of the shots outweighed the risks. One member wondered whether they should issue a recommendation only for at-risk children.

 

“We don’t want children to be dying from Covid, even if it is far fewer children than adults, and we don’t want them in the ICU,” member Dr. Amanda Cohn said before the vote.

 

Prior to the vote, Dr. Peter Marks, the FDA’s top vaccine regulator, asked committee members to keep today’s debate “civil,” saying there were strong feelings on both sides.

 

“To be clear, today’s discussion is going to be about the scientific data that are presented, and it’s not about vaccine mandates, which are left to other entities outside of FDA,” Marks said at the top of the meeting. “I ask that we keep our discourse today civil and focus on the science related to this issue so that we can get through a productive discussion.”

 

Pfizer asked the FDA to authorize its vaccine for kids ages 5 to 11 on Oct. 7. The company published data that showed a two-dose regimen of 10 micrograms — a third of the dosage used for teens and adults — is safe and generated a strong immune response in a clinical trial of young children. It said the shots were well tolerated and produced an immune response and side effects comparable with those seen in a study of people ages 16 to 25.

 

Dr. Doran Fink, a deputy director of the FDA’s division of vaccines, said Tuesday a “small army” of FDA staff worked around the clock over the last month to ensure the data on kids they were presenting today was as accurate as possible.

 

The staff of the FDA published an analysis late Friday, saying a smaller dosage of the Pfizer vaccine appears to be safe and highly effective in young kids. They noted the increased risk of myocarditis and pericarditis but said the benefits of the shots, including preventing severe disease, hospitalization and death, would generally outweigh the risk of the rare inflammatory heart conditions.

 

There have been 1,640 cases of myocarditis reported in people under 30 who received Pfizer’s or Moderna’s Covid vaccines as of Oct. 6, Dr. Mathew Oster, a CDC official, told the FDA’s vaccine committee. Just 877 met the CDC’s case definition for myocarditis. He added the agency hasn’t seen increased rates of the condition among children ages 12 to 17.

 

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Oh my lord, it's been a while coming to this thread but after 1 yr and 8 months I finally got exposed to the virus. 

 

The virus knocked me out of work for 19 days and gave me a gambit of the usual symptoms but not loss of taste or smell. I lost at least 14 lbs during this time due to the extreme fatigue which led to dehydration. Obviously, I recovered with the help of family but it did have me quite concerned/depressed during that second week of my experience. At this point, I have a lingering cough that comes and goes but that's it. My doctor did let me try Ivermectin for 3 days but I'm not sure that helped any. Maybe just good old rest, drinking and eating and daily vitamin usage got me through it. Though I did use multiple medications, IV infusion, UBI therapy and Regeneron during that time period. 

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8 hours ago, nghtvsn said:

Oh my lord, it's been a while coming to this thread but after 1 yr and 8 months I finally got exposed to the virus. 

 

The virus knocked me out of work for 19 days and gave me a gambit of the usual symptoms but not loss of taste or smell. I lost at least 14 lbs during this time due to the extreme fatigue which led to dehydration. Obviously, I recovered with the help of family but it did have me quite concerned/depressed during that second week of my experience. At this point, I have a lingering cough that comes and goes but that's it. My doctor did let me try Ivermectin for 3 days but I'm not sure that helped any. Maybe just good old rest, drinking and eating and daily vitamin usage got me through it. Though I did use multiple medications, IV infusion, UBI therapy and Regeneron during that time period. 


Same happend for my vaccinated 17 year old. Took 3 weeks before he was okay.

I have never seen him that sick. 
 

Thank good for the vaccination if things would have been much worse without..

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Got my booster shot. Super easy to get in America. Open to anyone who has a "high risk exposure occupation". Strongly encourage folks to get it. Daughter will get it the second she can.

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Winter will be a factor as we have seen with the Southern Hemisphere in the middle part of this year and with the Northern Hemisphere this time last year. Hopefully with a higher uptake in vaccines in most parts it isn't as bad as far as hospital cases and deaths though. 

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20 hours ago, Ryan Reynolds said:

got my booster , ready for the winter surge

 

Good job. Hmm....this gives me an idea!

 

I am going to reach out to HR to see if I can get the company on board with enticing people to get the booster shot. I get nothing for this since I already got it.

 

Like something simple. Get the booster get a $100 or something. My company is cheap so no way we do much more.

Edited by cdsacken
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1 hour ago, Maggie said:

 

 

My leukemia boards have been following this study...it's assumed the goal is to use the pills for folks who can't get a vaccine reaction who get sick (80+, leukemia, post transplants, etc), b/c the side effects are pretty lousy, but for those types of high risk patients, they don't care much about side effects b/c they live with sucky side effects of health every day.  

 

So, it's great news for the very elderly and sick, but not something reasonably healthy folks should want to do in lieu of vaccinating - aka, if you think vaccine side effects are bad, you haven't tried these pills yet:)...

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