COVID-19 Federal Responses: Thursday, September 16, 2021

Moderna officiallyaskedthe Food and Drug Administration (FDA) to authorize a third “booster” dose of its COVID-19 vaccine. Meanwhile,ModernaandPfizerreleased data illustrating that a vaccine booster shot is necessary because the effectiveness of their vaccines decline over time.
Pfizer/BioNTechexpectsto apply for FDA approval for its COVID-19 vaccine for children between the ages of six months and five years old as early as November. The clinical trialresultsfor this age group could be released by the end of October.
National Institutes of Allergy and Infectious Diseases (NIAID) Director Dr. Anthony FaucisaidCOVID-19 case rates are 10 times higher than required to control the pandemic.
The CDC updated its website and guidelines including those on isolation/precautions foradultsandchildrenandquarantinefor children.

Congress

The House Energy and Commerce Committee’s Oversight and Investigations subcommittee will hold ahearingon COVID-19’s health impacts on children on September 22 at 10:30 am ET.

The four military branches set vaccinationdeadlinesfor their personnel.
The Department of Health and Human Services (HHS) ischangingits methodology for distributing monoclonal antibody drugs to states.
National Institutes of Health (NIH)announceda new large-scale study on the long-term effects of COVID-19.
Starting October 1, the U.S. Citizenship and Immigration Services will beginrequiringproof of COVID-19 vaccination as part of certain immigration applications.

Moderna officiallyaskedthe Food and Drug Administration (FDA) to authorize a third “booster” dose of its COVID-19 vaccine.
FDA regulators arepushing backagainst the booster dose recommendations from the Centers for Disease Control and Prevention (CDC) and White House. New and conflicting testimonials concerning a third dose of the COVID-19 vaccine were publicized.
- Meanwhile,ModernaandPfizerreleased data illustrating that a vaccine booster shot is necessary because the effectiveness of their vaccines declines over time.
- The FDA’s Advisory Committee on Vaccines and Related Biological Products willmeetSept. 17 (8:30 am – 3:45 pm ET) to vote on recommendation of a third dose of the Pfizer vaccine.
- CDC还announceda meeting of its Advisory Committee on Immunization Practices (ACIP) to discuss COVID-19 booster shots on September 22-23.
Pfizer/BioNTechexpectsto apply for FDA approval for its COVID-19 vaccine for children between the ages of six months and five years old as early as November. The clinical trialresultsfor this age group could be released by the end of October.
Newresearchshows the COVID-19 vaccine is 90% effective in preventing ICU admission.
National Institutes of Allergy and Infectious Diseases (NIAID) Director Dr. Anthony FaucisaidCOVID-19 case rates are 10 times higher than required to control the pandemic.