On Friday, November 26, 2021, the World Health Organization (“WHO”) reported a new variant of COVID-19, the Omicron variant, was detected in South Africa. There is no indication the new variant is more contagious or more lethal, or that it
Yvonne Puig (US)
US Head of Life Sciences and Healthcare Yvonne Puig has a substantial commercial litigation practice in both state and federal courts. She represents hospitals, HMOs, managed care organizations, medical schools and other institutional health care providers and educational services companies. A partner in Norton Rose Fulbright's Austin office, Yvonne's practice involves commercial and health care litigation, antitrust, regulatory and compliance advice, crisis management, staff privileges, exclusive contracting and administrative law.
CMS Issues COVID-19 Vaccine Mandate Interim Final Rule
On November 4, 2021, the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule requiring that Medicare-certified providers implement policies for vaccination of all health care workers against COVID-19. Compliance with the requirement will be a Condition…
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: White House Plan for Vaccinating Children
On Wednesday, October 20, 2021, the White House discussed in a press conference its plan for vaccinating children aged 5 through 11. The White House stated it has worked closely with “governors, pediatricians, pharmacies, community health centers, rural health centers,…
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: 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…
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…