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

Moderna officially asked the Food and Drug Administration (FDA) to authorize a third “booster” dose of its COVID-19 vaccine. Meanwhile, Moderna and Pfizer released data illustrating that a vaccine booster shot is necessary because the effectiveness of their vaccines decline over time.
Pfizer/BioNTech expects to 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 trial results for this age group could be released by the end of October.
National Institutes of Allergy and Infectious Diseases (NIAID) Director Dr. Anthony Fauci said COVID-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 for adults and children and quarantine for children.

Congress

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

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

Moderna officially asked the Food and Drug Administration (FDA) to authorize a third “booster” dose of its COVID-19 vaccine.
FDA regulators are pushing back against 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, Moderna and Pfizer released 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 will meet Sept. 17 (8:30 am – 3:45 pm ET) to vote on recommendation of a third dose of the Pfizer vaccine.
- The CDC also announced a meeting of its Advisory Committee on Immunization Practices (ACIP) to discuss COVID-19 booster shots on September 22-23.
Pfizer/BioNTech expects to 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 trial results for this age group could be released by the end of October.
New research shows the COVID-19 vaccine is 90% effective in preventing ICU admission.
National Institutes of Allergy and Infectious Diseases (NIAID) Director Dr. Anthony Fauci said COVID-19 case rates are 10 times higher than required to control the pandemic.