Agency has said it could authorize a vaccine for younger children in a matter of weeks after receipt of trial data
FDA Approves Pfizer Booster Shots for Seniors, High-Risk Americans
Exactly who qualifies as high risk because of health or work reasons is not yet clear
FDA Panel Says Yes to Pfizer Booster Shots for People 65+
Same independent panel of experts said no to booster shots for Americans younger than 65 years
FDA Advisory Panel to Hold Meeting Today on COVID-19 Booster Shots
Advisory panel will review a variety of evidence, including new data from Israel
FDA Advisory Panel Set to Meet on COVID-19 Booster Shots
Public session could add clarity or controversy to what some feel has been a confusing decision-making process
Two Top Officials in FDA Vaccine Review Office to Retire
Retirements come as agency mulls decisions about COVID-19 vaccine approvals, authorizations for younger children, and booster shots.
Moderna Readies for Full Vaccine Approval, as Pfizer Submits Data on Booster Shot
Right now, Moderna vaccine only authorized for emergency use in Americans 18+ years; Pfizer boosters available to immunocompromised
Pfizer-BioNTech COVID-19 Vaccine Receives Full FDA Approval
Prescribing information includes warning about risks for myocarditis and pericarditis, particularly in men younger than 40 years
REGEN-COV Authorized for Postexposure Prophylaxis in High-Risk Individuals
Emergency use authorization indicated for those who have been exposed to SARS-CoV-2 and have an immunocompromising condition
FDA to Prioritize Full Approval for Pfizer COVID-19 Vaccine
Full approval could help boost vaccination efforts in the United States