FDA authorizes Pfizer-BioNTech vaccine for children 5 to 11
Source: Washington Post
Regulators on Friday authorized the Pfizer-BioNTech coronavirus vaccine for children 5 to 11 years old, a watershed moment celebrated by parents yearning for a return to normal life but viewed with ambivalence and outright skepticism by others worried about the potential risk of unknown side effects. The Food and Drug Administration’s emergency clearance is for a two-shot regimen administered three weeks apart.
The dose, 10 micrograms, is one-third that used for adolescents and adults. In a clinical trial of 5- to 11-year-olds, the vaccine was almost 91 percent effective at preventing covid-19, the illness caused by the virus, and did not cause any serious complications. The issue of safety, nevertheless, was a main focus of regulators and their advisers, partly because the vaccine has been linked to rare cases of cardiac side effects in another group — male adolescents and young men. The symptoms have tended to be mild and treatable, doctors say.
The FDA authorization is the latest step by the Biden administration to extend the reach of vaccines in hopes of taming a dangerous and vexing virus. The inoculation of adults, which began last December, recently entered a new phase, with booster shots for all three vaccines used in the United States available for many. About 28 million children are in the newly eligible group of 5- to 11-year-olds.But the process of getting vaccines cleared for younger school-age children has been fraught, with members of the FDA’s outside advisory committee expressing some angst and disagreements during a vociferous public debate this week.
In the end, the panel voted 17 to 0, with one abstention, to recommend the vaccine, agreeing with the FDA that the benefits outweighed the risks under most scenarios. The discussion about the shot is expected to resume Tuesday when the Advisory Committee on Immunization Practices, which advises the Centers for Disease Control and Prevention, is scheduled to meet to recommend how to use the vaccine. After CDC Director Rochelle Walensky signs off, probably on the same day, providers will be able to begin administering the vaccine.
Read more: https://www.washingtonpost.com/health/2021/10/29/fda-approves-vaccine-for-kids/
What will be left now will be CDC's ACIP to discuss and vote on approval (they are scheduled November 2nd/3rd) and then the CDC Director sign-off, assuming the ACIP approves, and done.
= new reply since forum marked as read
So glad the kids are being protected! 
Sounds like pos putin has been busy there, too. 
Last edited Sat Oct 30, 2021, 01:09 AM - Edit history (1)
https://upload.democraticunderground.com/110861595
I wondered the same thing. Maybe a different vax last week? 
Maybe dosage vote or something?
FIRST the vaccine committee (in this case, FDA's vaccine committee - "VRBPAC" ) discusses and votes to recommend approval or not - which is what they did last week. But then the FDA Commissioner (in this case, Acting Commissioner Janet Woodcock) can agree or disagree with the Committee's recommendation. She agreed - this is what this OP is about.
So now it goes to the CDC next week for a similar process - CDC's vaccine committee - "ACIP", which will do the same - discuss and vote to recommend (or not recommend), followed by the CDC Director agreeing or disagreeing and doing the final sign off if it is agreed upon.
Hope that makes sense!
Just looked at their draft agenda (they are meeting Tues. Nov. 2nd & Wed. Nov. 3rd) and they will be doing the COVID-19 vaccine discussion and I assume vote, during that Tuesday session.
So considering how quickly CDC Director Rochelle Walensky acted the last time (for the Moderna/Janssen (J&J) boosters), I wouldn't be surprised if she approved the pediatric vaccines by the next day - Wednesday (or even that Tuesday night). 
I got some grand-nieces/nephews as well as one of my youngest nephews, who are in that age group.
although earlier, one of the slides they put up last week showed Pfizer as a booster for 12 and up (however CDC eventually modified that guidance at some point) -
However on CDC's website (the latest as of Oct. 27, 2021) they have this - https://www.cdc.gov/coronavirus/2019-ncov/vaccines/booster-shot.html
Updated Oct. 27, 2021
Some COVID-19 Vaccine Recipients Can Get Booster Shots
People 65 years and older, 50–64 years with underlying medical conditions, or 18 years and older who live in long-term care settings should receive a booster shot. People 18 years and older should receive a booster shot at least 2 months after receiving their Johnson & Johnson/Janssen COVID-19 vaccine.
IF YOU RECEIVED
Pfizer-BioNTech or Moderna
You are eligible for a booster if you are:65 years or older Age 18+ who live in long-term care settings Age 18+ who have underlying medical conditions Age 18+ who work or live in high-risk settings
When to get a booster:
At least 6 months after your second shot
Which booster should you get?
Any of the COVID-19 vaccines authorized in the United States
IF YOU RECEIVED
Johnson & Johnson’s Janssen
You are eligible for a booster if you are:18 years or older
When to get a booster:
At least 2 months after your shot
Which booster should you get?
Any of the COVID-19 vaccines authorized in the United States
Choosing Your COVID-19 Booster Shot
You may choose which COVID-19 vaccine you receive as a booster shot. Some people may have a preference for the vaccine type that they originally received, and others may prefer to get a different booster. CDC’s recommendations now allow for this type of mix and match dosing for booster shots.
I think since they only recently started collecting data on the under 18 crowd, the jury is still out (I suppose barring a physician requesting it for a severely immuno-compromised adolescent for off-label use under strict medical care), and that is because they have a higher incidence of potentially experiencing a rare myocarditis reaction (which supposedly resolves for most who end up with that as an adverse event).
I figure by the time they have enough data to eventually get around to submitting for the 6 months - 4 years old set, enough time may have passed to determine if a booster is actually going to be needed with the 5 and up group and if it is even tolerated.
It's possible that since Pfizer has been using a smaller dosage of 10ug for the younger kids, they might end up considering using that amount as a booster for the adolescents 12-15, who are currently receiving a full 30ug dose for their initial 2-shots. I recall some discussion during one of the meetings about whether the smaller doses might be what is needed to mitigate issues with myocarditis in the younger individuals.
when/if they need booster. Guess we have to wait, but hopefully CDC is on top of it. At least now we have adults in charge mostly...
Thanks again