r/ZeroCovidCommunity • u/Jazzlike-Cup-5336 • 20d ago

The Guardian: Pfizer Covid vaccine for young children may not be renewed by FDA

The FDA recently informed Pfizer that it may not renew the Emergency Use Authorization for its pediatric COVID vaccine for the 2025 respiratory season.

Pfizer currently has 3 different presentations and indications:

  • 3µg of antigen for ages 6mo-4yrs (this is the one that may get cancelled)

  • 10µg of antigen for ages 5-11yrs (this one will still be available)

  • 30µg of antigen for ages 12+

This would make Moderna’s Spikevax the only authorized option for ages 6mo to 4 yrs. They would essentially switch places, since Spikevax only just received a broadened indication to include ages 6mo to 11yrs this past July. Spikevax contains 25µg of antigen for the 6mo-11yrs population, and 50µg for the 12+ population.

Moderna’s newly approved mNEXSPIKE vaccine only has 10µg of antigen, but is only approved for 12+. Same for Novavax, only 12+. In theory though, since both of those have BLA approval, they could be prescribed to children off-label.

Link to the article: https://www.theguardian.com/us-news/2025/aug/09/pfizer-covid-vaccine-fda-children-dfa

72 Upvotes

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14

u/Ok_Complaint_3359 20d ago

Oh man 😭😭

11

u/smallfuzzybat5 20d ago

Not good for my 4 year old who is due in the fall

4

u/Jeninsearchofzen 19d ago

Same…i hate this timeline. I just want my child to be as protected as he can.

-6

u/[deleted] 20d ago

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2

u/ZeroCovidCommunity-ModTeam 20d ago

Content removed for trolling.