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Thu Oct 7, 2021, 08:18 AM

Pfizer Asks F.D.A. to Authorize Its Covid-19 Vaccine for Children 5 to 11

Source: New York Times

WASHINGTON — Pfizer and BioNTech said on Thursday morning that they had asked federal regulators to authorize emergency use of their coronavirus vaccine for children ages 5 to 11, a move that could help protect more than 28 million people in the United States. The companies have said they were submitting data supporting the change to the Food and Drug Administration. The agency has promised to move quickly on the request and has tentatively scheduled a meeting on Oct. 26 to consider it. A ruling is expected between Halloween and Thanksgiving.

Parents across the United States are anxiously awaiting the regulators’ decision, which could affect family life and the operation of schools. Clearance depends not only on the strength of the clinical trial data, but on whether they can prove to regulators that they are able to properly manufacture a new pediatric formulation. Dr. Janet Woodcock, the acting F.D.A. commissioner, said last week that children might require “a different dosage or formulation from that used in an older pediatric population or adults.” Pfizer has proposed giving children one-third of the adult dosage. That might require adding more diluent to each injection or using a different vial or syringe.

The company was expected to describe the method it intended to use in its submission to the Food and Drug Administration. Regulators will have to examine the purity and stability of mass-manufactured doses of the vaccine and determine that it matches the quality and potency of doses given to children in clinical trials. A pediatric dose will also most likely require new labeling, with special codes that would allow the Centers for Disease Control and Prevention to track specific lots in case of reports of serious side effects.

Children rarely become severely ill from Covid-19, but the Delta variant drove nearly 30,000 of them to hospitals in August. According to the American Academy of Pediatrics, nearly 5.9 million Americans younger than 18 have been infected with the coronavirus. Of the roughly 500 Americans under 18 who have died, about 125 were children ages 5 to 11.

Read more: https://www.nytimes.com/2021/10/07/us/politics/pfizer-fda-authorization-children-5-11.html



This may take a little while before an EUA is approved.

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Response to BumRushDaShow (Original post)

Thu Oct 7, 2021, 08:23 AM

1. "tentatively scheduled a meeting on Oct 6th to CONSIDER it" wow during a PANDEMIC???

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Response to mucifer (Reply #1)

Thu Oct 7, 2021, 08:40 AM

2. They cannot exactly rush into it as children might have a problem with the vaccine and they need to

determine if its safe for them.
After all it kind of would suck to administer it to them and then find out it caused 40% of them to become sterile as adults.

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Response to cstanleytech (Reply #2)

Thu Oct 7, 2021, 08:46 AM

4. I just don't understand why they are considering it now

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Response to mucifer (Reply #4)

Thu Oct 7, 2021, 08:52 AM

5. Who knows *shrug* Maybe they did most of their testing only on adults because

at the time adults were the largest segment of the population that was catching and passing on the virus?

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Response to cstanleytech (Reply #5)

Thu Oct 7, 2021, 08:56 AM

6. My question is why schedule a meeting weeks away when we are in a pandemic. Why not drop

everything and have the meeting now.

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Response to mucifer (Reply #6)

Thu Oct 7, 2021, 09:23 AM

7. They need time to distribute all the voluminous data to the experts on the panel

and then allow some time for those experts to read it all before the meeting where the decision will be made. The same thing happened in late 2020 before the meetings to approve the vaccination for adults. It's still considered emergency approval for children, and it's the established routine. Nobody wants the committee to go into the meeting just flying by the seat of their pants.

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Response to mucifer (Reply #1)

Thu Oct 7, 2021, 08:45 AM

3. The wheels of government...

move at a glacial pace, or so it seems. Especially when it comes to something as important as this.

Parents all over the world will rejoice when the vaccine is approved for the little ones. I know I'll be one ecstatic grandpa when my grandchildren are vaccinated.

If it's approved before Thanksgiving that'll be great. Just a few months ago they were predicting it wouldn't be until early 2022 before it was available, if then.

I think we can handle a Thanksgiving date for approval. We'll all be antsy until they're protected though.

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