Yesterday, March 29, 2022, the CDC launched a new calculator designed to help individuals exposed to COVID-19 discern how many days of quarantine and/or isolation are necessary. This tool was created in order to aid in the prevention of spreading
FDA
COVID-19 Update: New Variants and Vaccine Research
During a recent Q&A, a representative with the World Health Organization warned that the Omicron variant is not the last of its kind. Dr. Maria Van Kerkhove explained that the next variant is likely to be more transmissible and could…
COVID-19 Update: Panel of FDA Vaccine Advisers Vote in Favor of Vaccination for Children
On Tuesday, October 26, 2021, the FDA’s Vaccines and Related Biological Products Advisory Committee members voted to approve vaccinations for children aged 5 through 11. Specifically, the panel addressed the following question: “Based on the totality of scientific evidence available,…
COVID-19 update: Efficacy of mask use and vaccinations for children
On October 1, 2021, the CDC issued its weekly “Morbidity and Mortality” report and noted according to a July 1 – September 4, 2021 study that “[s]chool mask requirements, in combination with other prevention strategies, including COVID-19 vaccination,…
COVID-19 update: Availability of the Pfizer vaccine
On September 17, 2021, the US Food and Drug Administration’s (“FDA”) Vaccines and Related Biological Products Advisory Committee rejected Pfizer’s application for the booster shot of its COVID-19 vaccine for all individuals. The advisory committee was tasked with discussing Pfizer’s…
CMS issues proposed rule repealing Medicare pending new “reasonable and necessary” definition and HHS issues proposed rule implementing provisions of the No Surprises Act
On Wednesday, September 15, 2021, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule that would, among other things, repeal the pending new definition for items and services that are considered “reasonable and necessary” under Medicare Parts…
COVID-19 update: FDA warns against COVID-19 vaccine for children younger than twelve
On September 10, 2021, the Acting Commissioner of Food and Drugs, Janet Woodcock, M.D., and Director of the Center for Biologics Evaluation and Research, Peter Marks, M.D., PhD., issued a statement on behalf of the FDA regarding the…
COVID-19 Update: Pfizer vaccine fully approved by FDA
On August 23, 2021, the US Food and Drug Administration (“FDA”) granted full approval for the Pfizer-BioNTech COVID-19 (“Pfizer”) vaccine for individuals sixteen-years-old and older. This change shifts the vaccine from emergency-use only and is the first COVID-19 vaccine granted…
COVID-19 Update: FDA announces availability of COVID-19 booster shot for immunocompromised
On August 12, 2021, the United States Food and Drug Administration (“FDA”) authorized a COVID-19 vaccine booster for immunocompromised individuals. Because booster vaccines were not previously authorized under the FDA’s emergency use authorization, the FDA’s announcement today was a necessary…
COVID-19 Update: Pfizer-BioNTech Vaccine Approved for Teens
On May 10, 2021 the U.S. Food and Drug Administration (“FDA”) announced that the Pfizer-BioNTech Emergency Use Authorization (“EUA”) would be expanded to include children ages 12-15. Previously, the vaccine had been approved for individuals 16 and older. The press…