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,
2021
COVID-19 update: CDC panel recommends Pfizer booster shot for some
On September 23, 2021, a panel of experts from the CDC, the Advisory Committee on Immunization Practice (“ACIP”), recommended that three categories of people should receive a COVID-19 booster shot: (1) those aged 65 and older; (2) those in long-term…
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: Biden Administration requires COVID-19 vaccine or proof of negative COVID-19 test for employees at large companies
On September 9, 2021, President Biden announced a new, upcoming mandate that requires all employers with 100 or more employees “to ensure their workforce is fully vaccinated or require any workers who remain unvaccinated to produce a negative test result…
COVID-19 update: United States military requires COVID-19 vaccine
Secretary of Defense Lloyd J. Austin III issued a memorandum on August 25, 2021, mandating immediate and full COVID-19 vaccines for all members of the United States Armed Forces, including the Ready Reserve and National Guard. The memorandum began, “To…
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: White House recommends COVID-19 booster shot for most Americans
On August 18, 2021, the Biden Administration announced with top US health officials a recommendation that Americans receive a COVID-19 booster shot eight months after their second dose was administered. The Administration is not recommending a booster for the one-dose…
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…