FDA Moves to Apply Vaccine to 6-Month Old Infants – Here’s How to Fight Back

On June 14, 2022, VRBPAC (FDA advisors) will meet to discuss amending the EUA of the Moderna COVID-19 mRNA vaccine to include the administration of the primary series to children and adolescents 6 years through 17 years of age.  On June 15, 2022, they will discuss amending the EUA of the Moderna COVID-19 mRNA vaccine to include the administration of the primary series to infants and children 6 months through 5 years of age, and also to discuss amending the EUA of the Pfizer-BioNTech COVID-19 mRNA vaccine to include the administration of the primary series to infants and children 6 months through 4 years of age.

The FDA is establishing a docket for public comment on this meeting.  The docket number is FDA-2022-N-0904.  Submit either electronic or written comments on this public meeting by June 13, 2022. 

Comments received on or before June 7, 2022, will be provided to the committee.  

Comments received after June 7, 2022, and by June 13, 2022, will be taken into consideration by FDA.

Interested parties can also do a formal oral presentation–several minutes depending on how many public speakers there are. If there are too many people requesting this, there’s a lottery to see who can speak. Deadline to request this is 6 pm ET on June 8.

Here’s the link to search for the docket FDA-2022-N-0904:

https://www.regulations.gov/

1. Go to https://www.regulations.gov/
2. Type in Search: FDA-2022-N-0904-0001
3. Click on Comment button

Here is the link to the meeting page for reference and more details:

https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-june-14-15-2022-meeting-announcement

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